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Pharma Spectrum Organisation of Pharmaceutical Producers of India

Volume 4

Issue 8

August 2011

INDEXINTERNATIONAL1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. IPR Regulatory New Products R&D / Clinical Trials Mergers & Acquisitions / Collaborations Pricing Trade & Others Animal Health Biotechnology Medical Diagnostics / Devices New Appointments 1 3 6 7 11 14 14 18 18 19 20

DOMESTIC1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. IPR Regulatory New Products R&D / Clinical Trials Mergers & Acquisitions / Collaborations Pricing Trade & Others Animal Health Biotechnology Medical Diagnostics / Devices New Appointments OPPI Related News 20 20 24 25 28 28 29 32 32 33 33 34

Organisation of Pharmaceutical Producers of India


Pharma Spectrum

InternationalIPRPressure Mounts For A New Form Of Medical Innovation To Improve Access To MedicinesJuly 19, 2011, Pharma Letterhttp://www.thepharmaletter.com/file/105904/pressure -mounts-for-a-new-form-of-medical-innovation-toimprove-access-tomedicines.html?utm_source=2009_11_06Pharma+Clean&utm_campaign=30d1ce47ceRSS_EMAIL_CAMPAIGN&utm_medium=email A second meeting has been hosted in the European Parliament by Carl Schlyter (Greens-EFA, Sweden) on the subject of improving access to medicines though Medical Innovation Prizes and civil society is uniting to put pressure on the European institutions to support a model of medical innovation which meets public health need.

annual market size for the drug in the US stands close to $100 million. Only about three weeks back, Astellas had filed a patent suit against Sagent Strides, a joint venture between the two companies Strides Arcolab and Sagent Pharma in the district court of New Jersey in the US. Sagent Pharma is a specialty injectible firm based out of US.

DRL Sued For Patent InfringementJuly 14, 2011, Zeebiz Newshttp://zeenews.india.com/business/news/news_content .aspx?newscatid=3&newsid=27067 Roche Palo ALTO LLC and Helsinn Healthcare SA filed a patent infringement litigation against Dr Reddy's Laboratories for anti-nausea drug Aloxi. A patent infringement case has been filed in federal court in the New Jersey district on July 8, alleging that the generic drug makers will violate two patents of the drug that expire in 2024. Aloxi injection is used in adults to help prevent the nausea and vomiting due to chemotherapy. Apart from Dr Reddy's, Roche has also filed suits against Sandoz Inc and Teva Pharmaceuticals over the same issue.

Ranbaxy Refusing To Pay Legal Costs, Cover Losses, Says US Drugstore ChainJuly 18, 2011, Economic Timeshttp://economictimes.indiatimes.com/news/news-byindustry/healthcare/biotech/pharmaceuticals/ranbaxyrefusing-legal-costs-us-drugstore-chain-riteaid/articleshow/9265312.cms A retailer of Ranbaxy drugs in the US has filed a complaint alleging that the Indian drugmaker has refused to cover the legal costs and losses the retailer has suffered in defending the company for selling a generic drug that has shown undesirable side effects. Pennsylvania-based Rite Aid, the third-largest drugstore chain in the US, is currently fighting numerous cases in the US, with consumers seeking damages for not warning them about the side effects of heartburn and nausea drug 'metoclopramide', whose original and generic version it sold at its stores.

Brazil Patent Office Scores Victory Over Multaq CaseJuly 13, 2011, Pharma Letterhttp://www.thepharmaletter.com/file/105750/brazilpatent-office-scores-victory-over-multaqcase.html?utm_source=2009_11_06Pharma+Clean&utm_campaign=038fa63df4RSS_EMAIL_CAMPAIGN&utm_medium=email The Brazilian Instituto Nacional da Propriedade Industrial (INPI) won another victory in the courts related to pharmaceutical patents. The Specialized Section of the Federal Court of Appeal of the 2nd Region unanimously upheld the decision which keeps a pharmaceutical product in the public domain. The drug in question was dronedarone, the active ingredient of French drug major Sanofis (Euronext: SAN) atrial fibrillation drug Multaq.

Strides To Settle Patent Dispute With AstellaJuly 16, 2011, Financial Expresshttp://www.financialexpress.com/news/strides-tosettle-patent-dispute-with-astella/818015/ Bangalore-based sterile injectible firm, Strides Arcolab, is close to settling its ongoing patent dispute with Tokyobased innovator firm Astella Pharma over drug Adenosine injection (brand name Adenoscan) in the US market. The

Pfizer Bids For Extension In EU



July 11, 2011, Fierce Pharmahttp://www.fiercepharma.com/story/pfizer-bids-770mlipitor-extension-eu/2011-0711?utm_medium=nl&utm_source=internal Pfizer is poised for a Lipitor reprieve in Europe. The company has asked for 6 months' of additional exclusivity in most EU countries under regulations designed to

Organisation of Pharmaceutical Producers of India


Pharma Spectrumpromote pediatric drug trials. The extension could be worth almost $800 million as it staves off generic competition until May 2012, the Financial Times reports. Pfizer is in line for the 6-month extension because of studies in children with a genetic disorder that causes high cholesterol. The company plans to launch a chewable, grape-flavored version of Lipitor in November as a result of those trials. "Pfizer certainly pulled off a bit of a coup," Heart UK's Dermot Neely told the FT.

Glenmark Daiichi




July 5, 2011, Hindu Business Linehttp://www.thehindubusinessline.com/companies/articl e2158240.ece Glenmark has settled its litigation with Daiichi Sankyo Inc and Genzyme Corporation over the sale of Glenmark's generic version of Colesevelam Hydrochloride in the US. This is the sixth settlement in less than two years for the company. Daiichi Sankyo markets Colesevelam Hydrochloride as a powder for oral suspension and as a tablet under the Welchol brand name, to treat cholesterol and type-2 diabetes mellitus.

Pressing For Strong IPR Regime In FTA With India: EU Tells WTOJuly 11, 2011, The Economic Timeshttp://economictimes.indiatimes.com/news/economy/i ndicators/pressing-for-strong-ipr-regime-in-fta-withindia-eu-tells-wto/articleshow/9171874.cms The European Union has informed the WTO that it is pressing for inclusion of strong IPR regime in the free trade agreement under negotiations with India even as the Commerce Ministry has maintained that New Delhi will not yield to the EU on this issue. The 27-nation bloc gave this input to the World Trade Organisation (WTO) which has recently completed a Trade Policy Review of the EU. According to the policy document, the EU has concluded FTAs with Central America, Colombia and Peru, which include detailed provisions on effective protection and enforcement of Intellectual Property Rights (IPR).

Teva Sold Generic Lipitor In UK, Despite Ongoing Patent Proection, FT ReportsJuly 4, 2011, Pharma Letterhttp://www.thepharmaletter.com/file/105510/tevasold-generic-lipitor-in-uk-despite-ongoing-patentproection-ft-reports.html Despite the fact that US drugs behemoth Pfizer (NYSE: PFE) has patent protection for its blockbuster cholesterol lowerer Lipitor (atorvastatin) well into next year, Israelheadquartered Teva Pharmaceutical Industries (Nasdaq: TEVA) last month started selling a generic version Lipitor in the UK, reports the Financial Times.

UK Judge Denies AstraZeneca/ Medimmune Patent RightsJuly 7, 2011, Pharma Letterhttp://www.thepharmaletter.com/file/105617/ukjudge-denies-astrazenecamedimmune-patent-rights.html The High Court this week ruled that Anglo-Swedish drug major AstraZeneca (LSE: AZN) subsidiary MedImmunes two patents on screening techniques used in drugs including Swiss pharma companies Roche (ROG: SIX) and Novartis (NOVN: VX) wet age-related macular degeneration Lucentis (ranibizumab) treatment were invalid, clearing the way for both companies to produce the drug without paying royalties to MedImmune, the Financial Times reported. A spokeswoman for AstraZeneca told The Pharma Letter that, in January 2009, MedImmune informed Novartis that the importation, manufacture, marketing and distribution of Lucentis in Europe infringed the firms patents.

Cipla Gets US Court Order Over Patent Infringement, To AppealJuly 1, 2011, Minthttp://www.livemint.com/2011/06/30162434/Ciplagets-US-court-order-over.html Drug major Cipla today said it has received an order from a US district court that the sale of its animal healthcare product, PetArmor Plus, has infringed on the patent held by Merial Ltd. The company has received an order dated 21 June, 2011, from a US District Court, Middle District of Georgia, against a petition filed by Merial Limited ruling that the sales of PetArmor Plus allegedly infringed a patent held by Merial Ltd, Cipla said in a filing to the Bombay Stock Exchange. Future sales of PetArmor Plus have been suspended in the United States, it added. The district court has stayed the above order for 60 days in order to enable the company to appeal, Cipla said, adding that it is in the process of filing an appeal against the order.

Organisation of Pharmaceutical Producers of India


Pharma Spectrum Calls For Wider Data Exclusivity Reforms Should Not Be Supported In Australia, Says GMiAJune 28, 2011, Pharma Letterhttp://www.thepharmaletter.com/file/105386/calls-forwider-data-exclusivity-reforms-should-not-be-supportedin-australia-says-gmia.html?utm_source=2009_11_06Pharma+Clean&utm_campaign=d7643aea7fRSS_EMAIL_CAMPAIGN&utm_medium=email Most of the worlds population live with no more than six years or no data exclusivity at all, with regard to pharmaceutical patents. Many countries have no data exclusivity including major markets such as India and Brazil. Many countries such as Australia, New Zealand, China, Singapore, South Korea, Israel, Chile, Taiwan, Turkey, Jordan and Saudi Arabia have five or six years data exclusivity. Only Japan, the USA and Europe (bound under the single European Union law) currently have data exclusivity periods that are for 10 or more years...... There was much awaited good news for Anglo-Swedish drug major AstraZeneca (LSE: AZN) last night, when the US Food and Drug Administration approved the companys blood-thinning drug Brilinta (ticagrelor) to reduce cardiovascular death and heart attack in patients with acute coronary syndromes (ACS). AstraZenecas shares rose as high as 2.7% to $50.77 in after-market trading in the USA last night.

Merck & Co Gets EU Approval For Victrelis; Pfizer Withdraws Macugen Indication ExtensionJuly 20, 2011, Pharma Letterhttp://www.thepharmaletter.com/file/105928/merckco-gets-eu-approval-for-victrelis-pfizer-withdrawsmacugen-indicationextension.html?utm_source=2009_11_06Pharma+Clean&utm_campaign=30d1ce47ceRSS_EMAIL_CAMPAIGN&utm_medium=email US drug giant Merck & Co says that the European Commission has approved Victrelis (boceprevir) for the treatment of chronic hepatitis C (CHC) genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy. Chronic hepatitis C virus (HCV) is a potentially serious viral infection of the liver that affects an estimated four million people in Europe. The drug was cleared for this indication by the US Food and Drug Administration in the spring (The Pharma Letter May 16).

US House Passage Of Patent Reform Legislation Gets Mixed ReceptionJune 27, 2011, Pharma Letterhttp://www.thepharmaletter.com/file/105346/ushouse-passage-of-patent-reform-legislation-gets-mixedreception.html?utm_source=2009_11_06Pharma+Clean&utm_campaign=43691b2a4eRSS_EMAIL_CAMPAIGN&utm_medium=email The US House of Representatives last week passed HR 1249, the Leahy-Smith America Invents Act, with broad bipartisan support. The Senate passed its version of the bill (S 23) on March 8 by a vote of 95 to 5. The two chambers will now work out differences between the bills and then a final vote on a compromise bill will have to take place (likely in the Senate). The legislation also takes steps to help the underfunded US Patents Office deal with a backlog of 1.2 million pending applications, which forces inventors to wait three years for a decision.

WHO Calls For Ban On Unreliable TB Blood TestsJuly 20, 2011, Medical Expresshttp://medicalxpress.com/news/2011-07-unreliable-tbblood.html "Based on the evidence, (these) tests lead to misdiagnosis and mistreatment of patients. They are a waste of time and resources," Mario Raviglione, director of the WHO Stop TB Department, told reporters. "We are calling on governments to ban the use of these tests." An estimated two million such diagnostics, which look for antibodies or antigens in the blood, are used every year, and up to half of them could give false results, Karin Weyer, who works for the same department, said. She warned that companies which continued to sell these diagnostic tools would be knowingly selling a faulty product.

RegulatoryUS FDA At Last Approves AstraZeneca Blood-Thinning Drug BrilintaJuly 21, 2011, Pharma Letterhttp://www.thepharmaletter.com/file/105971/us-fdaat-last-approves-astrazeneca-blood-thinning-drugbrilinta.html

Organisation of Pharmaceutical Producers of India


Pharma Spectrum AstraZeneca Wins FDA Approval For Blockbuster Hopeful BrilintaJuly 20, 2011, Fierce Biotechhttp://www.fiercebiotech.com/story/breaking-newsastrazeneca-wins-fda-approval-blockbuster-hopefulbrilinta/2011-07-20 The FDA has approved AstraZeneca's blood thinner Brilinta (ticagrelor) for acute coronary syndromes, breaking the Big Pharma company's long losing streak at the agency and pushing the regulator's approval record on new drugs so far this year to 21--a match for all of last year. But the approval did come with a catch: AstraZeneca will have to conduct a risk evaluation and mitigation strategy program, including outreach to make sure doctors tell patients the risk of bleeding rises when they take aspirin at doses above 100 milligrams a day. Millennium Development Goals and other public health challenges. The five BRICS countries are bringing a new voice, a new perspective and new solutions to todays global challenges, said UNAIDS Executive Director Michel Sidibe who participated in the First BRICS Health Ministers Meeting, together with World Health Organization Director General Margaret Chan.

FDA Approves Dr Reddys Generic Version Of GlaxoSmithKlines ArixtraJuly 13, 2011, First Worldhttp://www.firstwordplus.com/Fws.do?articleid=4B07DC B8753C47A2BF8AA44F7CADCD49 The FDA on Wednesday approved a generic version of GlaxoSmithKlines Arixtra (fondaparinux) manufactured by Dr. Reddys for use in treating deep vein thrombosis (DVT). Dr. Reddys version is the only generic of Arixtra approved to date and CEO G.V. Prasad noted that "given that this is a complex generic molecule, which is difficult to manufacture at scale, competition is likely to be limited for the foreseeable future." The executive said that the generic will be introduced into the US market in a phased launch. Dr. Reddys initially filed for FDA approval of its version of the product in March 2009, but a decision was delayed due to concerns about the drugs manufacturing process, which involves more than 50 stages, as well as largescale synthesis. The Indian drugmaker will manufacture the product in four doses in pre-filled, single- dose syringes using a patented process developed by Alchemia.

French Regs




July 14, 2011, Fierce Pharmahttp://www.fiercepharma.com/story/french-ministeroverhauls-pharma-regs/2011-0714?utm_medium=nl&utm_source=internal The scandal surrounding Servier's Mediator drug in France has spawned a new approach to regulating pharma. Under pressure from an increasingly distrustful public, Health Minister Xavier Bertrand has proposed sweeping changes to France's regulatory framework, InPharm reports. French regulators have been feeling the political heat from recent disclosures linking as many as 2,000 deaths with the now-withdrawn diabetes drug Mediator. The Servier drug was allowed to stay on the market in France after it had been withdrawn for safety reasons in other European markets.

Pfizer, J&J's Alzheimer's Drug Might Get Boost From FDA Trial RulesJuly 12, 2011, Fierce Biotechhttp://www.fiercebiotech.com/story/pfizer-jjsalzheimers-drug-might-get-boost-fda-trial-rules/2011-0712 There are no good drugs yet for treating Alzheimer's disease, which is notoriously complex and poses many challenges to developers. Yet with the nudging of industry and academics, the FDA has loosened some safety restrictions on trials for amyloid-lowering drugs against the disease, making it that much easier for companies like Pfizer, J&J and Eli Lilly to advance their experimental treatments, Reuters reports today. Since a dozen Alzheimer's patients had a brain-swelling condition in a 2008 study of Pfizer and J&J's drug bapineuzumab, the FDA has made developers perform additional testing on patients who are in trials for such treatments and has restricted patients from participating

First Meeting Of BRICS Health Ministers Brings New Leadership To Global HealthJuly 13, 2011, Pharma Letterhttp://www.thepharmaletter.com/file/105764/firstmeeting-of-brics-health-ministers-brings-new-leadershipto-global-health.html Universal access to medicines was a key topic of discussion at a meeting this week of health ministers from Brazil, Russia, India, China and South Africa (BRICS) in Beijing, China. The meeting, hosted by the government of China, aimed to identify opportunities for BRICS countries to promote wider access to affordable, quality-assured medicines, with a view to reaching the

Organisation of Pharmaceutical Producers of India


Pharma Spectrumif they have had more than two occurrences of certain small blood leaks in the brain, Reuters reports. Is it too soon for the FDA to call 2011 a good year for drug approvals? Maybe not. CDER director Janet Woodcock claims that new chemical and molecular entity approvals have reached a 20-year high, and that two-thirds of drug applications are reviewed in a timely matter. So far this year 20 drugs have been approved, compared to just 21 in all of 2011. Her remarks were delivered in testimony before a U.S. House of Representatives subcommittee on health. The drug industry and FDA are indeed having a banner year.

WHO Lauds India's Effort To Combat HIV In Africa, S AmericaJuly 12, 2011, Indian Expresshttp://ibnlive.in.com/generalnewsfeed/news/wholauds-indias-effort-to-combat-hiv-in-africa-samerica/754177.html International health organisations today lauded India for providing effective and affordable medicines to combat Meningitis and HIV/AIDS in Africa and South America.Appreciating India's role, the Director General of World Health Organisation, (WHO), Dr Margaret Chan made a particular mention of the supply of medicines at an affordable cost by Indian pharmaceutical companies to help dealing with the outbreak of Meningitis in Africa at the first BRICS Health Ministers conference here.Union Health Minister, Ghulam Nabi Azad along with Ministers from member countries attended the conference. While all the multi national companies declined to supply the vaccine at cheaper rates Serum Institute of India did so for as cheap as 50 cents for a unit, which saved millions of lives in Africa, Chan said.The conference was held here today to discuss steps to deepen cooperation and coordination among the member countries on health related issues.

USFDA Bans Import Of Drugs From Dr Reddy's Mexico PlantJuly 7, 2011, Economic Timeshttp://economictimes.indiatimes.com/news/news-byindustry/healthcare/biotech/pharmaceuticals/usfdabans-import-of-drugs-from-dr-reddys-mexicoplant/articleshow/9126942.cms The US health regulator has imposed an import ban on products made at Dr Reddy's Laboratories' Mexican plant for violation of current good manufacturing practices (CGMP). According to a notice on the US Food and Drug Administration (USFDA), the American drug regulator has imposed an import ban on products made at Dr Reddy's Mexican arm -- Industrias Quimicas Falcon de Mexico SA for violation of good manufacturing practice rules. The company's Mexican arm, which produces intermediates and active pharmaceutical ingredients had received a warning a letter from the USFDA last month. The import ban follows a warning letter issued by the USFDA on June 3. The regulator cited "lack of corrective actions" by the firm after it had sought certain explanations following an inspection of the company's Mexico facility in November 2010.

EU Plans Revision Of GMP Regulation To Target Indian Pharma ManufacturersJuly 11, 2011, Pharmabiz, Joseph Alexanderhttp://www.pharmabiz.com/NewsDetails.aspx?aid=6387 0&sid=1 The Swedish authorities are pushing for tighter environment laws by the European Union targeting the pharmaceutical production by the third world countries in general and India in particular. The current proposal by the Swedish Medical Products Agency (MPA), if gets through, may put Indian manufacturing units under added pressure. The health ministers of the EU have already informally discussed the proposal to revise the EU legislation on Good Manufacturing Practices (GMP) and report by the MPA that was submitted to the Swedish government.

Cadila Gets USFDA Warning For Violating Manufacturing Norms At Gujarat PlantJuly 7, 2011, Business Standardhttp://www.business-standard.com/india/news/cadilagets-usfda-warning-for-violating-manufacturing-normsat-gujarat-plant/441854/ The US Food and Drug Administration (USFDA) has issued a warning to Cadila Healthcare for violation of current goods manufacturing practice (CGMP) regulations for finished pharmaceuticals at its facility in Gujarat. The regulator has given the company 15 days to take corrective measures and report back to it. In a letter to the chairman of the company, Pankaj Patel, dated June 21, the US regulator said it had identified significant violations of CGMP regulations for finished

Woodcock: New Drug Approvals Reach 20-Year HighJuly 8, 2011, Fierce Biotechhttp://www.fiercebiotech.com/story/woodcock-newdrug-approvals-reach-20-year-high/2011-07-08

Organisation of Pharmaceutical Producers of India


Pharma Spectrumpharmaceuticals during its inspection of the company's plant at Sanand, in Gujarat earlier this year. Attorney General Lisa Madigan alleged that GSK and SB Pharmco engaged in unfair and deceptive practices when they manufactured and distributed certain lots of the drugs Kytril, Bactroban, Paxil CR and Avandamet. Madigan and other attorneys general involved in the case alleged that from 2001 to 2004, drug batches were manufactured improperly at a facility in Cidra, Puerto Rico. The investigation involved instances in which certain batches were not sterilized or medication contained different dosages than indicated on the bottle, among other alleged violations.

EMA Publishes Format For Submission Of Information On Medicines; Welcomes Falsified Medicines DirectiveJuly 5, 2011, Pharma Letterhttp://www.thepharmaletter.com/file/105546/emapublishes-format-for-submission-of-information-onmedicines-welcomes-falsified-medicinesdirective.html?utm_source=2009_11_06Pharma+Clean&utm_campaign=815c7171c6RSS_EMAIL_CAMPAIGN&utm_medium=email The European Medicines Agency says it has reached the first milestone in the implementation of the new pharmacovigilance legislation, by publishing the format in which pharmaceutical companies need to submit information on all of the medicines authorized or registered in the European Union. The format shows the types of information that companies will need to submit to the EMA by the legal deadline of 2 July 2012.

New ProductsEisai Announces Japan Launch Anticancer Agent HalavenJuly 20, 2011, BioSpectrum Asiahttp://www.biospectrumasia.com/content/200711JPN16 685.asp Eisai announced the launch of its novel anticancer agent Halaven in Japan for the treatment of inoperable or recurrent breast cancer. Halaven is the first novel anticancer agent to be discovered and developed by the Eisai. Having simultaneously submitted marketing authorization applications to the regulatory authorities in Japan, the United States and the European Union (EU) in March 2010, the company first launched Halaven in the US in November of the same year, and began marketing the agent in the UK, Germany and other European countries in April 2011.


Canadians Waiting Over Two-And-AHalf Years For Governments To Approve New DrugsJuly 1, 2011, Pharma Letterhttp://www.thepharmaletter.com/file/105432/canadian s-waiting-over-two-and-a-half-years-for-governments-toapprove-new-drugs.html?utm_source=2009_11_06Pharma+Clean&utm_campaign=46f947aa61RSS_EMAIL_CAMPAIGN&utm_medium=email Canadas federal and provincial government bureaucracies are taking more than two-and-a-half years on average to approve new prescription drugs, thereby depriving many Canadians of the latest in new medicines, finds a new report from the Fraser Institute, Canadas leading public policy think-tank. On average, it takes Health Canada nearly 16 months to approve new drugs as safe and effective.

Optimer Launches Fidaxomicin Tabs To Treat CDAD In Patients 18 Years Of Age And OlderJuly 20, 2011, Pharmabiz, San Diegohttp://www.pharmabiz.com/NewsDetails.aspx?aid=6404 5&sid=2 Optimer Pharmaceuticals, Inc. announced the commercial launch of DIFICID (fidaxomicin) tablets for the treatment of Clostridium Difficile-Associated Diarrhoea (CDAD) in patients 18 years of age and older. In two large phase III clinical studies, DIFICID had clinical response rates at the end of the 10-day treatment period that were non-inferior to oral vancomycin. In addition, DIFICID was superior to vancomycin in sustained clinical response, defined as clinical response at the end of treatment and survival without proven or suspected CDAD recurrence through 25 days beyond the end of treatment. With the commercial availability of

GSK To Pay $40.75M To Settle Case Involving P.R. PlantJune 23, 2011, Fierce Pharmahttp://www.fiercepharma.com/story/gsk-pay-4075msettle-case-involving-pr-plant/2011-0623?utm_medium=nl&utm_source=internal GlaxoSmithKline and its SB Pharmco Puerto Rico unit have agreed to pay $40.75 million to 37 states and the District of Columbia over allegations of violating drug manufacturing standards. In a statement, Illinois

Organisation of Pharmaceutical Producers of India


Pharma SpectrumDIFICID, Optimer is initiating a Patient Assistance Program to help eligible uninsured and underinsured patients gain access to this important treatment option. http://www.news-medical.net/news/20110628/454Life-Sciences-launches-new-GS-FLX2b-System-for-highthroughput-sequencing.aspx 454 Life Sciences, a Roche Company (SWX:RO)(SWX:ROG)(Pink Sheets:RHHBY), announced today the launch and immediate availability of the new GS FLX+ System, an instrument capable of generating extra-long sequencing reads up to 1,000 by in length. This new level of performance presents a major milestone in the life science's industry, making it the first high-throughput sequencing technology to deliver millions of bases from reads with accuracy and lengths that are comparable to Sanger-based methods.

Daiichi Sankyo Launches LIXIANA In JapanJuly 19, 2011, BioSpectrum Asiahttp://www.biospectrumasia.com/Content/190711JPN1 6667.asp?nl=%5b%5bforstats Building on its cardiovascular portfolio, Daiichi Sankyo, a pharmaceuticals company with its head office in Tokyo, announced the launch of LIXIANA in Japan. It received the first marketing approval for the edoxaban 15 mg and 30 mg tablets by the Japanese Ministry of Health, Labour and Welfare in April 2011. This is the first time edoxaban will be commercially available to patients in any global market. Edoxaban is a once-daily, oral anticoagulant that specifically, reversibly and directly inhibits the enzyme, Factor Xa, a clotting factor in the blood. Results from clinical studies supported the approval of edoxaban for the prevention of venous thromboembolism (VTE) in patients with total knee arthroplasty, total hip arthroplasty and hip fracture surgery. VTE is the term for the generation of a blood clot and the obstruction of a vein or a pulmonary artery by a blood clot.

R&D/Clinical TrialsApprovals For New Pharma Products In 2011 Could Exceed Previous Year, Reports Fitch; Citeline Says Ph IIIs Up 13%June 28, 2011, Pharma Letterhttp://www.thepharmaletter.com/file/105393/approval s-for-new-pharma-products-in-2011-could-exceedprevious-year-reports-fitch-citeline-says-ph-iiis-up13.html?utm_source=2009_11_06Pharma+Clean&utm_campaign=27af5a7c21RSS_EMAIL_CAMPAIGN&utm_medium=email The pharmaceutical R&D pipeline for new pharmaceutical products remains strong for the remainder of 2011, according to a new Fitch Ratings report, titled Global Pharmaceutical R&D Pipeline - First Quarter 2011, which expects that drug developers will be actively introducing a full range of new medicines to both the specialty and primary care markets before yearend. Fitch-rated pharmaceutical companies have applications for 18 New Molecular Entities (NMEs) filed with the drug regulatory agencies in Europe or the USA with anticipated near-term review deadlines.

Abbott Plans New Formulations Of HIV MedicinesJuly 18, 2011, BioSpectrum Asiahttp://www.biospectrumasia.com/Content/180711OTH1 6650.asp?nl=%5b%5bforstats Global Pharma company Abbott has announced that it plans to develop two new formulations of its HIV medicines, Kaletra (lopinavir/ritonavir) and Norvir (ritonavir), to offer new formulation options for people living with HIV-1. The company is currently investigating a new powder formulation of Norvir as well as a coformulation of three HIV medicines lopinavir, ritonavir and 3TC (lamivudine). The Norvir powder formulation is planned to make it easier to store the medicine. The investigational fixeddose combination of lopinavir, ritonavir and 3TC combines three established HIV medicines and could reduce the daily number of tablets taken by a patient. Additionally, this tablet may offer a more cost-effective treatment option to patients.

New Studies Raise Hopes For Pfizer, J&J Alzheimer's TreatmentJuly 20, 2011, Fierce Biotechhttp://www.fiercebiotech.com/story/new-studies-raisehopes-pfizer-jj-alzheimers-treatment/2011-07-20 New studies are raising hopes that bapineuzumab, an experimental Alzheimer's drug, may be safer than researchers for Pfizer and J&J had expected after cases of brain swelling were reported among the patients

454 Life Sciences Launches New GS FLX+ System For High-Throughput SequencingJune 28, 2011, News Medical

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Pharma Spectrumtaking the drug. The condition could decrease over time, according to scientists. "It looks like we can treat people for a number of years safely," Dr. Steven Salloway of Butler Hospital and Brown University in Providence, RI, told the Alzheimer's Association International Conference in Paris. Since a dozen Alzheimer's patients had a brain-swelling condition in a 2008 study of bapineuzumab........ http://online.wsj.com/article/SB10001424052702303678 704576442901100190640.html Two studies released Wednesday show AIDS drugs can sharply reduce the risk of heterosexuals acquiring HIV, adding to a growing number of new methods to slow the spread of the virus world-wide. A bottle of antiretroviral drug Truvada, the brand name of emtricitabine, is shown at a California pharmacy in November 2010. Researchers found that couples in Africa, in which one partner had HIV but the other didn't, had an average of 73% fewer infections when given daily doses of that drug and another medication. Many researchers now believe science has developed sufficient tools to contain the pandemic, which is thought to infect about 2.6 million people annually. But tight budgets may limit deployment of these methods.

Merck Chief Stands By His Big R&D SpendJuly 18, 2011, Fierce Biotechhttp://www.fiercebiotech.com/story/merck-chiefstands-his-big-rd-spend/2011-07-18 Don't expect Merck CEO Ken Frazier to offer any apologies for the company's big R&D budget. "Science and innovation are in the DNA of the company," he told reporters for the Wall Street Journal. "The science will lead us to another big breakthrough. "Sure, he adds, investors and analysts may throw a few "brickbats" in his direction as steep R&D costs bite into the bottom line, but that's a burden he's willing to bear. "I'm trying to run the company in a way that I can satisfy the short- and intermediate-term needs of investors without sacrificing really what we're about."

Report Highlights Urgent Need For Rethink On Biopharma Industry InnovationJuly 13, 2011, Pharma Letterhttp://www.thepharmaletter.com/file/105751/reporthighlights-urgent-need-for-rethink-on-biopharmaindustry-innovation.html Life sciences companies with very effective innovation programs typically produce twice as many new products as those without effective programs. This was a key finding of a new Economist Intelligence Unit survey sponsored by Quintiles, which highlights the urgent need for biopharmaceutical industry innovation. The survey comes as the biopharma sector reaches the patent cliff - this year and next, seven of the worlds 15 top-selling drugs, accounting for nearly $50 billion in sales in 2009, will go off-patent.

India, Denmark To Promote Research In Stem Cell, Traditional MedicinesJuly 15, 2011, Pharmabiz, Joseph Alexanderhttp://www.pharmabiz.com/NewsDetails.aspx?aid=6393 3&sid=1 India and Denmark will launch joint strategic research programme in the areas of biotechnology and life sciences, especially in the emerging sectors like stem cells and cell therapy with a view to strengthen the research efforts and work developing leads. The joint programme, to be launched by early 2012, will be in accordance with the Memorandum of Understanding (MoU) signed in 2004 between the Department of Biotechnology (DBT) and the Danish Ministry of Science, Technology and Innovation (MSTI) aimed at further developing and strengthening the IndoDanish research collaboration within health science biotechnology.

OHE Report Recommends Prize System To Boost R&D In Fight Against SuperbugsJuly 8, 2011, Pharma Letterhttp://www.thepharmaletter.com/file/105649/ohereport-recommends-prize-system-to-boost-rd-in-fightagainst-superbugs.html A new report today by the Office of Health Economics (OHE), which is linked with the Association of the British Pharmaceutical Industry (ABPI), has called for a shake up in the way future antibiotics are to be rewarded in Europe so that biopharmaceutical companies can spend more to fight superbugs.

AIDS Drugs Can Prevent Infection, Studies ShowJuly 14, 2011, Wall Street Journal

Organisation of Pharmaceutical Producers of India


Pharma Spectrum Ex-Pfizer R&D Chief Lamattina Criticizes Short-Term Pharma StrategyJuly 7, 2011, Fierce Biotechhttp://www.fiercebiotech.com/story/ex-pfizer-rd-chieflamattina-criticizes-short-term-pharma-strategy/201107-06 John LaMattina has some advice for Pfizer, where he worked for 30 years before retiring as the head of research. Once the pharma giant finishes chopping the R&D budget to around $6.5 billion, he says, Pfizer will only be committing 10% to 11% of its 2012 estimated revenue to R&D. And by shortchanging R&D now to satisfy the short-term profit demands of analysts and investors, he adds, Pfizer will likely be haunted by the anemic funding in years to come. "This industry historically has spent anywhere from 15% to 20% of top-line sales in R&D," LaMattina told Reuters. "It's their lifeblood. If you don't have new products you don't have a business anymore." Added LaMattina: "In the short term, I guess that's OK in terms of delivering for shareholders. But four, five, 10 years out, I'm not sure that is going to be a very good position to be in." With diabetes on the rise all over the world, especially in developing countries like India, the pharmaceutical industry is shifting its focus to developing drugs that help ease the lifestyles of sufferers of the disease. The number of medicines under development for diabetes by member companies of PhRMA (Pharmaceutical Research and Manufacturers of America, a consortium of all major research based pharmaceutical companies in the world) has increased from 95 in 2008 to over 230 in 2010. These medicines are in different stages of FDA approval and for treatment of the different types of diabetes. More than half of the drugs under development are for type 2 diabetes, which is the most common type of diabetes in India. These developments would therefore, help contribute to a decrease in the overall burden of diabetes in India, according to a spokesman for the PhRMA.

Novel Approach For Multiple Sclerosis Treatment Identified By Biogen IdecJuly 4, 2011, Pharma Letterhttp://www.thepharmaletter.com/file/105524/novelapproach-for-multiple-sclerosis-treatment-identified-bybiogen-idec.html?utm_source=2009_11_06Pharma+Clean&utm_campaign=815c7171c6RSS_EMAIL_CAMPAIGN&utm_medium=email US biotech firm Biogen Idec (Nasdaq: BIIB) has revealed results from a study that suggest that inhibiting death receptor-6 (DR6) function may represent a novel approach in the treatment of multiple sclerosis by blocking autoimmune response while promoting remyelination. Data from in vitro and in vivo models were published online today and will be published in the July print issue of Nature Medicine. Biogen is already well represented in the current $10 billion a year MS sector, with Avonex and Tysabri (natalizumab), the latter co-marketed with Irelands Elan.

Roche Tarceva Progression-Free Chemotherapy

Nearly Doubles Survival Vs

July 7, 2011, Pharma Letterhttp://www.thepharmaletter.com/file/105579/rochetarceva-nearly-doubles-progression-free-survival-vschemotherapy.html?utm_source=2009_11_06Pharma+Clean&utm_campaign=c41bc1f70cRSS_EMAIL_CAMPAIGN&utm_medium=email In a trial dubbed EURTAC, the first Phase III study to include Western lung cancer patients first-line treatment with erlotinib, Swiss drug major Roches (ROG: SIX) blockbuster Tarceva, nearly doubled progression-free survival compared with chemotherapy, according to research presented at the 14th World Conference on Lung Cancer in Amsterdam, Netherlands, hosted by the International Association for the Study of Lung Cancer (IASLC). Erlotinib is a tyrosine kinase inhibitor (TKI) that targets the epidermal growth factor receptor (EGFR).

EU Commission's Research Funding Plans Slammed By Scientists And NGOsJuly 4, 2011, Pharma Letterhttp://www.thepharmaletter.com/file/105513/eucommissions-research-funding-plans-slammed-byscientists-and-ngos.html?utm_source=2009_11_06Pharma+Clean&utm_campaign=ac7893fac8RSS_EMAIL_CAMPAIGN&utm_medium=email In an open letter sent last week to the President and Members of the European Commission, as well as the European Parliament and the European Union member states, 98 civil society and research organisations from 22 European countries warned that the Commission's draft proposals for the next Research funding framework (2014-2020) fail to address the real challenges faced by

As Many As 230 Drugs Targeting Diabetes Under Development By PhRMA Member CompaniesJuly 5, 2011, Pharmabiz, Joseph Alexanderhttp://www.pharmabiz.com/NewsDetails.aspx?aid=6378 6&sid=1

Organisation of Pharmaceutical Producers of India


Pharma SpectrumEuropean societies and call for a research agenda geared towards the needs of society and the environment rather than those of big business. Under the Canada-India Agreement for Scientific and Technological Cooperation aimed at fostering joint Research and Development (R&D) projects, the two sides will launch R&D projects in all areas of biotechnology including life sciences and medical devices. The Ontario-India programme has now called for proposals for collaborative projects with a view to develop innovative products and products, especially in the life science and medical devices sectors.

India Behind China, Innovation Efficiency



July 4, 2011, Business Standardhttp://business-standard.com/india/news/india-behindchina-pakistaninnovation-efficiency/441440/ India has improved its position to ninth this year from 101st in 2010 in an index that ranks countries on their innovative outcomes compared to the inputs available, but Pakistan and China are ahead of us. The Innovation Efficiency Index, compiled in a report by business school INSEAD and industry chamber CII, highlights those counties that achieve more on innovations from less conditions. Cote d'lvoire tops the list on this index, released in Geneva, followed by Nigeria, China and Pakistan. The Innovation Efficiency Index is part of an overall global innovation index. India's position on this latter, more comprehensive, index slipped to 62nd this year from 56th in 2010.

Lilly Outlines Turnaround Strategy As CEO Calls Research Cuts "Nuts"June 30, 2011, Fierce Biotechhttp://www.fiercebiotech.com/story/lilly-outlinesturnaround-strategy-ceo-calls-research-cuts-nuts/201106-30 You have to give Eli Lilly CEO John Lechleiter credit for consistency. In a fast-changing biopharma world in which some of its top rivals are scrambling to create new R&D models, he's sticking with his research team and refusing to budge on investor pressure to hack at its multibilliondollar R&D budget--despite a string of setbacks in the clinic. "I never thought I'd live to see this, but investors are actually thinking to cut R&D--that's the hot topic of the day," he told Reuters in an exclusive interview at BIO's big confab in Washington, D.C. "This is kind of nuts, but this is what's being talked about." And he wasn't finished.

Sanofi Enters Research Pact With Weill Cornell Medical College To Discover New Treatments For TuberculosisJuly 1, 2011, Pharmabiz, P.A. Francishttp://www.pharmabiz.com/NewsDetails.aspx?aid=6371 9&sid=2 Sanofi announced that it entered into a research collaboration with Weill Cornell Medical College to identify new anti-infectives that aim to shorten the course of treatment of tuberculosis (TB) and could provide effective therapies against drug-susceptible and drug-resistant strains of TB. Under the terms of the collaboration, Sanofi will provide 80,000 chemical compounds to Dr Carl Nathans laboratory at Weill Cornell, where the compounds will be screened to assess their ability to inhibit growth of Mycobacterium tuberculosis.

Clinical Trial Drug Dropouts Reach Unsustainable Levels, Says Thomson Reuters RepoJune 28, 2011, Pharma Letterhttp://www.thepharmaletter.com/file/105390/clinicaltrial-drug-dropouts-reach-unsustainable-levels-saysthomson-reuters-repo.html The pharmaceutical industry spent less on drug R&D last year than at any time in the last three years, according to data released today from the 2011 Pharmaceutical R&D Factbook compiled by CMR International, a Thomson Reuters business. Overall expenditure on discovering and developing new medicines amounted to an estimated $68 billion last year, down nearly 3% on the $70 billion spent in both 2008 and 2009, according to the data release released yesterday.

India, Canada To Launch Collaborative R&D Projects In Biotech, Medical Devices SectorsJuly 1, 2011, Pharmabiz, Joseph Alexanderhttp://www.pharmabiz.com/NewsDetails.aspx?aid=6371 6&sid=1

Organisation of Pharmaceutical Producers of India


Pharma Spectrum 347mn People Have Worldwide, Says StudyJune 27, 2011, Indian Expresshttp://www.indianexpress.com/news/347-mn-peoplehave-diabetes-worldwide--says-study/809028/ An estimated 347 million people are suffering from diabetes worldwide, said an international study published in The Lancet medical journal. Researchers from Imperial College London and Harvard University analysed data from 2.7 million people, aged 25 and over, across every continent, using statistical techniques to project a worldwide figure, to estimate diabetes prevalence. They claim the total number of people with diabetes which can be fatal has risen from 153 million to 347 million in the past three decades, considerably higher than a 2009 estimate of 285 million....


that the companies have signed a definitive agreement under which Bristol-Myers Squibb will acquire privately held Amira Pharmaceuticals, a small-molecule pharmaceutical company focused on the discovery and early development of new drugs to treat inflammatory and fibrotic diseases. Under the terms of the agreement, Bristol-Myers Squibb will acquire all of Amira Pharmaceuticals issued and outstanding shares of capital stock and stock equivalents in an all-cash transaction for a purchase price of $325 million upfront and potential additional milestone payments totalling $150 million.

Astellas Licenses Vical Vax For $130MJuly 21, 2011, Fierce Vaccineshttp://www.fiercevaccines.com/story/astellas-licensesvical-vax-130m/2011-07-21 Japan's Astellas will pay up to $130 million to license a vaccine to prevent cytomegalovirus (CMV) reactivation in transplant recipients. The disease is typically dormant in those who are healthy but can cause illness in immunocompromised people. A Phase III trial of TransVax in hematopoietic stem cell transplant recipients and a Phase II study in solid organ transplant patients are slated to begin in 2012.

Mergers & Acquisitions / CollaborationsDr Reddys Acquires JB Chems UnitJuly 23, 2011, The Times of Indiahttp://articles.timesofindia.indiatimes.com/2011-0723/india-business/29807309_1_cis-prescription-portfoliorussia-market Dr Reddy's announced on Friday that it has entered into an agreement with JB Chemicals & Pharmaceuticals to acquire their pharmaceutical prescription portfolio in the Russia and other CIS regions, for $34.85 million (around Rs 155 crore). The agreement involves acquisition of 20 brands, including key ones like Metrogyl and Jocet. Dr Reddy's has also entered into a supply agreement with JB Chemicals for the continued manufacturing and supply of these products associated with the acquired brands, says a company statement.

Pfizer To Acquire IcagenJuly 21, 2011, BioSpectrum Asiahttp://www.biospectrumasia.com/Content/210711OTH1 6692.asp?nl=%5b%5bforstats Pfizer and Icagen announced that they have entered into a definitive merger agreement. Pfizer, which currently owns approximately 11 percent of Icagens fully diluted shares, will acquire the remaining 8.3 million shares at a price of $6 per share. The aggregate transaction value, including the value of the shares currently owned by Pfizer, is approximately $56 million. In 2007, Pfizer and Icagen entered into a worldwide collaboration for the discovery, development and commercialization of compounds that modify three specific sodium ion channels as new potential treatments for pain and related disorders.

Bristol-Myers Squibb To Acquire Amira PharmaceuticalsJuly 22, 2011, BioSpectrum Asiahttp://www.biospectrumasia.com/Content/220711OTH1 6695.asp?nl=[[forstats Bristol-Myers Squibb, a global pharmaceutical company, and US-based Amira Pharmaceuticals have announced

Merck & Co Expands Collaboration With Roche On Hep C Drug VictrelisJuly 21, 2011, Pharma Letterhttp://www.thepharmaletter.com/file/105969/merckco-expands-collaboration-with-roche-on-hep-c-drugvictrelis.html US drug giant Merck & Co has signed a new non-exclusive agreement with Swiss major Roche (ROG: SIX) for the global promotion, upon appropriate marketing approvals,

Organisation of Pharmaceutical Producers of India


Pharma Spectrumof Victrelis (boceprevir) as part of a triple combination therapy regimen with peginterferon alfa and ribavirin (peg/riba). Under the terms of the deal, Roche and Merck will work together in global markets, including Europe, Asia and Latin America, to educate physicians and patients about hepatitis C virus (HCV). http://www.fiercebiotech.com/story/allergan-scoopsfledgling-vicept-275m-buyout-pact/2011-0719?utm_medium=nl&utm_source=internal Flush with Botox bucks, Allergan has struck a deal to buy Vicept Therapeutics for $75 million upfront and up to $200 million in milestones, snaring an mid-stage topical treatment for rosacea. Adding to its R&D pipeline for dermatology, Allergan gains V-101, Vicept's lead therapy, along with two early-stage programs. Malvern, PA-based Vicept was founded back in 2009 with backing from Vivo Ventures, Fidelity Biosciences and Sofinnova Ventures. A year ago the trio of VCs invested $16 million in Vicept's Series A. They stand to come out well ahead in the buyout. Dr. Neal Walker, Vicept's president and chief executive officer and a board certified dermatologist, founded the company.

Novartis' Interest In Buying Gen-Probe Fizzles, WSJ ReportsJuly 20, 2011, Fierce Pharmahttp://www.fiercepharma.com/story/novartis-interestbuying-gen-probe-fizzles-wsj-reports/2011-07-20 Novartis' appetite for deals is expected to grow in the near future, but the Swiss drug giant may no longer be interested in gobbling up diagnostic test provider GenProbe. After speculation that Novartis' interest in GenProbe had waned, sources with knowledge of the deal told the Wall Street Journal that the drug company was no longer seeking a buyout of the San Diego-based diagnostic test maker. The news yesterday put a dent in Gen-Probe's stock price, which fell 2.47% to $62.41 per share. Novartis drops out of the picture as a likely buyer of Gen-Probe-which makes diagnostic tests for HIV and other infectious diseases--after the drug maker's CEO Joe Jimenez revealed earlier this month....

Granules-Omnichem To Put $20 Mn In Mfg FacilityJuly 14, 2011, Business Standardhttp://www.businessstandard.com/india/news/granules-omnichem-to-put-20mn-in-mfg-facility/442729/ City-based pharmaceutical company Granules India is setting up a bulk drugs and intermediaries manufacturing facility in Visakhapatnam with an investment of $20 million (around Rs 90 crore) in joint venture with Belgian pharmaceutical firm Ajinomoto OmniChem. The JV, equally owned by the two companies, is targeted to offer high-value active pharmaceutical ingredients (APIs) and intermediaries to pharmaceutical players. "We are excited to enter the contract manufacturing sector through a partnership with OmniChem, which is a highly reputed company with an established track record in the sector.

US, India To Develop Data Access PlatformJuly 20, 2011, Minthttp://www.livemint.com/2011/07/19221506/US-Indiato-develop-data-acce.html?atype=tp India and the US are collaborating on the development of a technology platform to enable local state agencies to reorganize data, some of which is restricted, in a format accessible on the Web. The move is aimed at improving transparency in governance by the United Progressive Alliance (UPA) government, which has been facing charges of corruption in recent times. This (platform) will be similar to an existing initiative by the United States government called data.gov and will be developed completely free of cost, said Aneesh Chopra, chief technology officer, office of science and technology in the US and an adviser to President Barack Obama.

Sandoz Expands Strategic Alliance With Nipro In Japan; Shionogi Licenses Drug To IldongJuly 14, 2011, Pharma Letterhttp://www.thepharmaletter.com/file/105793/sandozexpands-strategic-alliance-with-nipro-in-japan-shionogilicenses-drug-to-ildong.html Sandoz, a generics subsidiary of US drug major Novartis has entered into a strategic alliance with Japans Nipro Corp, which will focus on a broad range of cross-licensing and co-development opportunities for the Japanese generics market. Sandoz and Nipro, who have been working together on various product licensing deals since 2007, will now expand their cooperation to include a wider affiliation

Allergan Scoops Up Fledgling Vicept In $275M Buyout PactJuly 19, 2011, Fierce Biotech

Organisation of Pharmaceutical Producers of India


Pharma Spectrumwith respect to the development, production and commercialization of generic pharmaceutical products in Japan. http://www.thepharmaletter.com/file/105618/bristolmyers-squibb-in-up-to-465-million-deal-with-innatepharma-for-cancerantibody.html?utm_source=2009_11_06Pharma+Clean&utm_campaign=d79d516109RSS_EMAIL_CAMPAIGN&utm_medium=email US drug major Bristol-Myers Squibb (NYSE: BMY) has signed a global agreement with French biotech firm Innate Pharma (Euronext Paris: FR0010331421 IPH) for the development and commercialization of IPH2102, a novel antibody in Phase I development for the treatment of cancer.

Pharma Execs Expect Aggressive M&A Strategy To Develop Products, Spur Growth: KPMG SurveyJuly 13, 2011, Pharma Letterhttp://www.thepharmaletter.com/file/105763/pharmaexecs-expect-aggressive-ma-strategy-to-developproducts-spur-growth-kpmgsurvey.html?utm_source=2009_11_06Pharma+Clean&utm_campaign=e02dc5d1caRSS_EMAIL_CAMPAIGN&utm_medium=email On the hunt for new therapies and new customers to drive growth, pharmaceutical executives will step up acquisition activity in the coming year, according to a recent survey by KPMG, a US audit, tax and advisory services firm, which surveyed around 100 drug industry execs in the USA. In the KPMG survey, 83% of executives said it is likely their company will be involved in a merger or acquisition as a buyer or seller in the next two years.

Jubilant Pharma





June 29, 2011, Financial Expresshttp://www.financialexpress.com/news/Quickview/809956/ Drug firm Jubilant Life Sciences on Tuesday said its USbased arm has entered into an agreement with Janssen Pharmaceutica NV to deliver pre-clinical candidates in the area of neuroscience to the Belgium-based firm. The pact will span an initial period of three years and focus on multiple targets in the area of neuroscience, Jubilant Life Sciences said in a statement. The agreement was signed between Jubilants US arm Jubilant Discovery Services and Janssen Pharmaceutica, it said. As per the deal, Janssen will transfer ongoing efforts on selected drug discovery targets to Jubilant, it added.

Cant Beat? Join. Innovator Gilead In Novel Generics DealJuly 13, 2011, DNA Moneyhttp://www.dnaindia.com/money/report_cant-beatjoin-innovator-gilead-in-novel-generics-deal_1565138 US-based biopharmaceuticals maker Gilead Sciences Inc has entered into agreements with four Indian generic drug makers Hetero Drugs, Matrix Laboratories, Ranbaxy Laboratories and Strides Arcolab for manufacturing and marketing three of its new HIV drugs, marking a new model in out-licensing of intellectual property. The three drugs are still in Phase III development and are expected to come out of trials sometime in the first quarter next year. Subsequently, the molecules will go through the approval process. By tying up with the generic companies ahead of the completion of trials, Gilead is preparing to launch the drugs on its own as an innovator along with the generic makers.

Glenmark Receives $25 Sanofi As Upfront Payment



June 28, 2011, The Economic Timeshttp://economictimes.indiatimes.com/news/news-byindustry/healthcare/biotech/pharmaceuticals/glenmarkreceives-25-mn-from-sanofi-as-upfrontpayment/articleshow/9013692.cms Glenmark Pharma today said its USD 613 million (over Rs 2,745 crore) outlicensing deal with Sanofi has been approved by the US authorities and has also received an upfront payment of USD 25 million (over Rs 110 crore) from the French drug-maker. Last month Glenmark Pharmaceuticals SA, a whollyowned subsidiary of Glenmark Pharmaceuticals, had outlicensed its novel monoclonal antibody ' GBR 500' aimed at treating digestive system disorders, to French drug-maker Sanofi for as much as USD 613 million.

Bristol-Myers Squibb In Up To $465 Million Deal With Innate Pharma For Cancer AntibodyJuly 7, 2011, Pharma Letter

Organisation of Pharmaceutical Producers of India


Pharma Spectrum

PricingStudy: MS Drugs' Benefits Carry A Steep PriceJuly 21, 2011, Fierce Pharmahttp://www.fiercepharma.com/story/study-ms-drugsbenefits-carry-steep-price/2011-0721?utm_medium=nl&utm_source=internal A new study on the pricing of multiple sclerosis drugs-which found, essentially, that they're too expensive, at least in the U.S.--tags a few issues that people like to chat about casually. But what if they were seriously addressed? That would only raise all sorts of political, ethical and philosophical questions. The Neurology study analyzed the cost-benefit data of four drugs using U.S. prices: Biogen Idec's Avonex, Teva Pharmaceutical's Copaxone, Bayer's Betaseron and Merck KGaA's Rebif. Although the numbers on each drug varied, the general conclusion was that it costs more than $800,000 for each patient to gain a year's worth of quality of life.

Following the intensive efforts of the Secretariat General of the Greek Ministry of Health, which is responsible for the pricing of medicines in the country, and the respective Directorate for Medicines and Pharmacies, the new Price Bulletin has now been uploaded on the web sites of the Ministry of Health and the Greek pharmaceutical industry association, the SFEE. Last year, the Greek government introduced draconian drug price cuts of 25% (The Pharma Letters passim. The Ministry of Health implemented the law and more specifically Article 14 of Law 3840/2010, according to which the prices of medicines in Greece may not be lower than the average of the three lowest prices in the 22 European Union countries, said the SFEE in a press statement.

Trade & OthersWith EU, US Out Of Reach, Biocons Drivers Are ClearJuly 22, 2011, DNA Moneyhttp://www.dnaindia.com/money/report_with-eu-usout-of-reach-biocons-drivers-are-clear_1568111 Homegrown biotech company Biocon is turning focus to the emerging markets as headwinds blow in the US and Europe. Markets in Latin America, Asia, Africa and the Middle East will be the new growth triggers, said Kiran Mazumdar Shaw, CMD, Biocon. The regulated markets have not yet opened up, so opportunity will be sought in other geographies, Shaw said in a conference call. The domestic branded formulations business, which includes insulin (diabetes), statin (cardiology), nephrology, oncology and immunodermatology businesses, will also see renewed focus.

German Pharma Counts Cost Of Drug Price Controls, Calls For ReviewJuly 18, 2011, Pharma Letterhttp://www.thepharmaletter.com/file/105828/germanpharma-counts-cost-of-drug-price-controls-calls-forreview.html?utm_source=2009_11_06Pharma+Clean&utm_campaign=cb8882873cRSS_EMAIL_CAMPAIGN&utm_medium=email The clamour against the recent drug pricing reforms in Germany has grown steadily louder. Last week Eli Lillys chief executive called for an overhaul of AMNOG, the complex new vetting procedure that determine whether a new drug provides an additional benefit, and, consequently, its market price (The Pharma Letters July 11, January 28). In addition, the German Pharma Association VFA has highlighted the cost of the price freeze and increase in the mandatory discount pharma firms are obliged to offer the state health insurance system, and called for a review of the policy.

Fonda Upshot: Reddys Finds Complex Generics A Good BetJuly 21, 2011, DNA Moneyhttp://www.dnaindia.com/money/report_fonda-upshotdr-reddys-finds-complex-generics-a-good-bet_1567777 Egged on by the US Food and Drugs Administrations (FDA) approval for its limited-competition generic Arixtra (fondaparinux sodium), Dr Reddys Laboratories is altering its generics strategy to focus more on complex molecules for all future launches. The idea? Gain from minimum competition in the US. We will work on more complex molecules and to that effect we may not see a high number of filings (with the FDA) as well. This would also add to the increase in the R&D cost, GV Prasad, the companys CEO, said.

New Greek Drug Price Bulletin Now Published, Despite Industry ArgumentsJuly 11, 2011, Pharma Letterhttp://www.thepharmaletter.com/file/105682/newgreek-drug-price-bulletin-now-published-despiteindustry-arguments.html?utm_source=2009_11_06Pharma+Clean&utm_campaign=a74df6b220RSS_EMAIL_CAMPAIGN&utm_medium=email

Organisation of Pharmaceutical Producers of India


Pharma Spectrum Healthcare To Add 4M Jobs Through 2018July 19, 2011, Fierce Healthcarehttp://www.fiercehealthcare.com/story/healthcareadd-4m-jobs-through-2018/2011-0719?utm_medium=nl&utm_source=internal The healthcare industry will experience some of the fastest job growth through 2018, with home health aides and personal and home care aides leading the pack at 460,900 new jobs and 375,800 new jobs, respectively. In fact, half of the 20 fastest growing occupations are in healthcare, according to Bureau of Labor Statistics (BLS) data. The BLS also predicts that roughly 26 percent of all new jobs created in the U.S. economy will be in the healthcare and social assistance industry. Thanks to an aging population and longer life expectancies, public and private hospitals, nursing and residential care facilities, and individual and family services are expected to grow by a total of 4 million new jobs, notes the BLS. Metoclopramide is the generic copy of Wyeths Reglan, which has been sued by patients in the US now known as Reglan Litigation after being found to have side effects, including serious irreversible body movement disorder.

How Will The Generics Biz Cure Its Blockbuster Hangover?July 18, 2011, Fierce Pharmahttp://www.fiercepharma.com/story/how-will-genericsbiz-cure-its-blockbuster-hangover/2011-0715?utm_medium=nl&utm_source=internal Anyone who's been watching pharma knows that the number of big new drugs has been dropping. That's obviously a problem for Big Pharma. But it's going to become a problem for branded drugmakers' major nemesis: the generics industry. Makers of copycat meds like to knock off blockbusters because they stand to deliver more return on the upfront investment. As branded drugmakers increasingly turn out smaller, more specialized meds, there will be fewer big drugs to copy.

Asia, Africa, S America To Be Fastest Growing Pharma Markets: Kiran DasJuly 19, 2011, Pharmabiz, Nandita Vijayhttp://www.pharmabiz.com/NewsDetails.aspx?aid=6401 2&sid=1 Asia, Africa and Latin America are the fastest growing pharma markets in the world today. Generics globally and speciality drugs in developed markets are tipped to be the most sought-after growth drivers for companies across the world, according to Kiran Das, executive vice president, Sven Genetech Limited, a Jupiter Bioscience Group Company. Major growth driver in the medium term will be 'pharmemerging' markets, where the growth would result primarily through generics and biosimilars. Key focus would be on specific therapies covering oncology, central nervous system, diabetes, respiratory, cardiology and nephrology. Speciality medicines will continue to grow owing to increased usage, newer indication approvals and expanding user base.

Merck Job Cuts Set To AccelerateJuly 14, 2011, Fierce Pharmahttp://www.fiercepharma.com/story/merck-job-cutsset-accelerate/2011-0714?utm_medium=nl&utm_source=internal Merck's long-planned job cuts are set to accelerate. The company announced its intent to shed some 15,000 jobs by 2012 last year, but thousands of those jobs have yet to go. Sources tell Pharmalot that Merck plans to amp up its layoff process soon, probably early next month. Merck announced the cuts in the wake of its 2009 merger with Schering-Plough. The idea was to save some $3.5 billion by slashing the payroll by 10% and shuttering facilities. Such an enormous restructuring plan takes time, of course, and as of March, Merck still had about 8,000 jobs remaining to be cut, Pharmalot figures

US Drugstore Chain Rite Aid Sues RanbaxyJuly 19, 2011, Hindu Business Linehttp://www.thehindubusinessline.com/companies/articl e2247749.ece US-based drugstore chain Rite Aid Corporation has sued Ranbaxy Laboratories to recover the litigation cost spent in lawsuits involving the Indian firms generic drug metoclopramide used to treat vomiting and nausea but found to have adverse side effects.

PhRMA: U.S. Drug Discounts Could Cost 260K JobsJuly 12, 2011, Fierce Pharmahttp://www.fiercepharma.com/story/phrma-us-drugdiscounts-could-cost-260k-jobs/2011-07-12 While President Barack Obama and congressional leaders jockey for position in the U.S. debt reduction talks, the pharma industry is doing some negotiating of its own. That's because lawmakers are proposing billions in additional cuts in drug spending, provided via discounts from drugmakers.

Organisation of Pharmaceutical Producers of India


Pharma SpectrumThe pharma industry already agreed to increased drug discounts as part of Obama's healthcare reform package. But with budget shortfalls forcing cuts to state spending-and deficit-minded politicians digging in for federal cuts--pharma is once again in the firing line. http://www.fiercepharma.com/story/nine-10-bigpharmas-cut-sales-reps-2010/2011-07-08 While worldwide spending on sales reps and other drug marketing grew slightly last year to roughly $91 billion, the sources of that growth lay in China, Japan and Latin America. In the U.S. and Europe, companies made major cuts. The slight global growth in spending on sales reps depended on double-digit increases in sales-force spending in those three emerging markets. Many major drugmakers added significantly to their sales forces in those markets, according to the analysis by market research firm Cegedim Strategic Data.

Biopharma Should Be Part Of Transatlantic Trade And Economic Discussions, Lilly CEO UrgesJuly 12, 2011, Pharma Letterhttp://www.thepharmaletter.com/file/105714/biophar ma-should-be-part-of-transatlantic-trade-and-economicdiscussions-lilly-ceo-urges.html?utm_source=2009_11_06Pharma+Clean&utm_campaign=5ed5a361a9RSS_EMAIL_CAMPAIGN&utm_medium=email John Lechleiter, chairman, president and chief executive of US drugs major Eli Lilly (NYSE: LSE) has urged that biopharmaceuticals be included in transatlantic trade and economic discussions. Dr Lechleiter, who last week slammed German health care reform (The Pharma Letter July 11), participated in the American Council on Germany's conference on "The Transatlantic Partnership in the 21st Century," joining US Federal Reserve Bank Chairman Paul Volcker; German State Secretary in the Federal Finance Ministry Jorg Asmussen; and Handlesblatt editor-in-chief Gabor Steingart in a panel discussion. "Biopharmaceutical innovation has enormous global economic and social benefits," said Dr Lechleiter, noting that "new medicines are one of the most cost-effective investments we can make to improve health care and enable more efficient use of health care budgets.

Domestic Generic Exports Get A Boost With Bar-CodingJuly 8, 2011, The Times of Indiahttp://timesofindia.indiatimes.com/business/indiabusiness/Domestic-generic-exports-get-a-boost-with-barcoding/articleshow/9144926.cms Domestic generic exports are expected to get a further boost once bar-coding is implemented in phases over the next year, as a result of which drug consignments would be better tracked and monitored. With consignments carrying a unique identification code, origin of exports can now be traced. This would also help in establishing India as a quality supplier of drugs, industry experts say-. The government recently decided to stagger the implementation of bar-coding on export consignments, with barcodes on 'primary level' packaging such as medicine strips, vials or bottles becoming mandatory from July 2012.

Chinese Docs Trade Up To Jobs In Pharma SalesJuly 11, 2011, Fierce Pharmahttp://www.fiercepharma.com/story/chinese-docstrade-jobs-pharma-sales/2011-07-11 What's a low-paid Chinese doctor to do? Become a pharma rep. As Bloomberg reports, physicians in China are abandoning medical practice for jobs in drug sales, finding that they can better their $300-a-month doctors' salary by marketing drugs, rather than prescribing them. The human resources firm Aon predicts that as many as 14,000 Chinese doctors will join foreign drugmakers over the next 5 years. Such is one unintended consequence of Big Pharma's Chinese gold rush.

Ranbaxy Recalls Skin Care Drug From UKJuly 7, 2011, Business Standardhttp://wap.businessstandard.com/storypage.php?id=5&autono=441855 Ranbaxy Ltd has been asked by the UK Medicines and Healthcare products Regulatory Agency (MHRA), the largest drug regulator in Europe, to recall its drugs used to treat skin infections. Ranbaxy (UK) Ltd was recalling all unexpired stock of Isotretinoin 20mg capsules due to a potential issue with bio-equivalence in comparison with the originator product, UK MHRA said in its notification. The European Commission has also decided to suspend marketing authorisation for Isotretinoin as a temporary measure. A company spokesperson refused to comment.

Nine Of 10 Big Pharmas Cut Sales Reps In 2010July 8, 2011, Fierce Pharma

Organisation of Pharmaceutical Producers of India


Pharma Spectrum GSK Launches Next Revamp Of SalesRep PayJuly 7, 2011, Fierce Pharmahttp://www.fiercepharma.com/story/gsk-launches-nextrevamp-sales-rep-pay/2011-07-06 GlaxoSmithKline made news last year by announcing it would overhaul sales-rep compensation. The aim: Aligning reps' performance goals with company values, GSK said. Transparency and integrity, for two. The company didn't say so directly, but the implication was that the usual sales quotas and bonuses incentivized behavior that didn't exactly conform to those values. In January, GSK got rid of individual sales goals, and now, the second stage of that plan is coming to fruition. Instead of earning bonuses based on sales goals, reps will now have their incentive pay determined by three things: their own selling skills, evaluations from doctors and the performance of their business units as a whole. Millions of people dependent on life-saving generic drugs to treat HIV/AIDS will die if India stops producing cheap drugs for the disease due to its trade deal with the European Union, the head of UNAIDS warned on Tuesday. The EU and India are currently negotiating a free-trade agreement, which campaigners say will restrict India's ability to produce anti-retroviral (ARV) drugs, preventing the world's poor from accessing cheap drugs for their treatment.

Drugs Cos Eye US Entry After FDA CheeksJuly 5, 2011, Economic Times (epaper Page No. 5)http://lite.epaper.timesofindia.com/getpage.aspx?pagei d=5&pagesize=&edid=ET&edlabel=ETM&mydateHid=0507-2011&pubname=Economic+Times++Mumbai&edname=Mumbai&publabel=ET The US drug regulator has inspected manufacturing plants of at least half a dozen Indian drugmakers in the past few weeks, raising hopes among some of these companies that they will shortly be able to export medicines from their units to the worlds largest drug market. Several industry executives said teams of inspectors of the US Food and Drugs Administration (FDA) did not find any major deficiency during their inspection of facilities of Ranbaxy Laboratories, Orchid Chemicals & Pharmaceuticals, Emcure Pharma, Nectar LifeSciences and Ind Swift Laboratories over the course of the past four weeks.

Harvard Docs Punished For Undisclosed Pharma TiesJuly 5, 2011, Fierce Pharmahttp://www.fiercepharma.com/story/harvard-docspunished-undisclosed-pharma-ties/2011-07-05 Three Harvard Medical School psychiatrists who made headlines for their ties to the pharma industry are now being sanctioned by the school and its affiliated Massachusetts General Hospital. According to the Harvard Crimson, Joseph Biederman, Thomas Spencer and Timothy Wilens are barred from paid, industrysponsored work for one year. And for two years after that, they will have to get upfront approval from Harvard and Mass General for any industry-paid activities. The three men sent a letter of apology to their colleagues, saying Harvard and Mass General determined they had violated conflicts of interest policies, the Crimson reports. The actual violations weren't listed, but a U.S. Senate investigation found in 2008 they had failed to report some $4.2 million in payments from drug companies as required by university policy.

Tough UK Bribery Act To Cover Indian CompaniesJuly 3, 2011, The Economic Timeshttp://articles.economictimes.indiatimes.com/2011-0701/news/29726132_1_foreign-public-official-britishcompanies-bribery-act Indian companies with offices in the UK and British companies operating in India will be covered by a tough new act that seeks to prosecute companies and individuals who not only offer or receive bribes but also fail to prevent bribery. The Bribery Act 2010, which comes into force today, overhauls existing British laws dating back to 1889 and creates offences in the UK or abroad that carry prison terms of up to 10 years and unlimited fines. Failure to prevent bribery has also been made an offence under the act.

Millions Will Die If India Stops AIDS Drugs: U.N.July 5, 2011, Reutershttp://uk.reuters.com/article/2011/07/05/us-indiaaids-drugsidUKTRE7643U120110705?feedType=RSS&feedName=heal thNewsMolt

Organisation of Pharmaceutical Producers of India


Pharma Spectrum Japan Ushers In Big Meds From AZ, GSK, MerckJuly 1, 2011, Fierce Pharmahttp://www.fiercepharma.com/story/japan-ushers-bigmeds-az-gsk-merck/2011-07-01 Japanese health regulators spread some happiness yesterday, granting marketing approval to several major Big Pharma products. AstraZeneca, GlaxoSmithKline, and Merck each got the nod for a key drug that's already marketed elsewhere, but still awaiting launch in Japan. In each case, as the world's second largest drug market, Japanese approval could be a boon. In AstraZeneca's case, in fact, the drug is Nexium, and its Japanese approval will offer a tailwind just as it's nearing the end of its patent life in other markets. Daiichi Sankyo has signed on to co-promote and distribute the stomach drug, while AZ will manufacture the product. Might Bayer be a potential buyer for Pfizer's animal health business? The German drugmaker wants to grow its animal health unit, research exec Andreas Busch tells Dow Jones. Part of that growth would be through acquisition, with another chunk coming from converting human treatments for use in cats and dogs. Busch wouldn't say just where Bayer might be looking for animal-health buys. But he said the company is definitely scouting the territory. "It would be stupid not to be looking in the present environment for assets in animal health, and we continue to look at attractive assets as they become available," Busch told the news service, "because we believe the animal health business could be a very important pillar of our overall diversified health care strategy."

Pfizer To Shed Vet Unit, Keep GenericsJuly 7, 2011, Fierce Pharmahttp://www.fiercepharma.com/story/pfizers-spinverdict-generics-yes-vet-drugs-no/2011-0707?utm_medium=nl&utm_source=internal Deep into its reassessment of non-pharma business units, Pfizer has signaled its intentions. It's looking at selling its animal health and nutrition businesses. Offloading the units would help the company refocus on segments of its business that promise more growth, for instance, its offpatent drugs unit. That's a business the company intends to keep, Pfizer said in a statement. The consumer healthcare business will also stay. The potential animal health and nutrition sales would be a trade: $5.5 billion in annual revenues in return for greater focus on pharma and sale proceeds that could be returned to shareholders.

Animal HealthLilly Eyes Vet Assets; Pfizer Says All Or NothingJuly 22, 2011, Fierce Pharmahttp://www.fiercepharma.com/story/lilly-eyes-vetassets-pfizer-says-all-or-nothing/2011-0722?utm_medium=nl&utm_source=internal Might Eli Lilly emerge as a buyer for Pfizer's animal health business? CFO Derica Rice told Lilly investors that the company is keeping an eye on Pfizer's plans for the unit, which may be sold or spun off. If Lilly likes any of the available assets, it would pursue them, Rice said. When asked about that pledge, Pfizer said that it doesn't envision selling off the animal health business in pieces. The whole unit would be sold or spun off, spokeswoman Joan Campion told Bloomberg. "While we are evaluating a variety of options including a sale, spin-off or other transaction, we believe we will favor one overall option rather than dividing assets and business operations," Campion told the news service.

BiotechnologyPakistan Can Emerge As Biotechnology LeaderJuly 22, 2011, Pharma Letterhttp://www.thepharmaletter.com/file/105978/pakistan -can-emerge-as-biotechnology-leader.html Lahore?Provincial Minister for Agriculture, Malik Ahmad Ali Aulakh has said that 21 century is the century of Biotechnology and Pakistan has tremendous potential to emerge as Biotechnology leader. Speaking at a seminar on Bio-technology at Lahore ...

Note To Pfizer: Bayer Shopping For Vet BuysJuly 13, 2011, Fierce Pharmahttp://www.fiercepharma.com/story/note-pfizer-bayershopping-vet-buys/2011-0713?utm_medium=nl&utm_source=internal

Organisation of Pharmaceutical Producers of India


Pharma Spectrum Indian Drug Makers Bet Big On Local Biosimilar MarketJuly 8, 2011, Business Standardhttp://www.business-standard.com/india/news/indiandrug-makers-bet-biglocal-biosimilar-market/442020/ Indian pharmaceutical players, who want to reap a pie of the global biosimilar (copies of biological drugs) markets, are trying their luck at regional markets first. Players, including Dr Reddys, Cipla and Lupin are strengthening their presence in the regional markets such as India and South East Asia with new biosimilar launches. According to statistics released by Datamonitor, the Indian biosimilars market is expected to grow to $580 million by 2012. Biosimilars are generic versions of innovative biotech drugs. The absence of clear regulatory norms for biosimilars, especially in regulated markets like the US, is a hurdle for generic drug makers. for their discovery of the Helicobacter pylori bacterium and its role in gastritis and peptic-ulcer disease.

Eli Lilly Plans Investment To Boost Its Biotech CapabilitiesJune 29, 2011, Pharma Letterhttp://www.thepharmaletter.com/file/105423/eli-lillyplans-investment-to-boost-its-biotech-capabilities.html US drug major Eli Lilly (NYSE: LLY) yesterday revealed plans for a multi-million dollar investment to expand its existing biotechnology capabilities, at the BIO International Convention taking place in Washington DC. The amount of the investment was not disclosed.

GAVI Funds Pneumococcal Vaccines To Reduce Childhood MortalityJuly 2, 2011, Pharmabizhttp://www.pharmabiz.com/NewsDetails.aspx?aid=6374 3&sid=1 Global Alliance for Vaccines and Immunisation (GAVI), has funded the Pneumococcal vaccines to reduce childhood mortality. The Governments of Central African Republic, Benin and Cameroon will introduce vaccines in the coming weeks to combat pneumonia, one of the biggest killers of children worldwide. The roll-outs of the pneumococcal vaccines in countries such as CAR, Cameroon and Benin have been made possible through an innovative finance mechanism pioneered by GAVI called the Advance Market Commitment (AMC).

Medical Diagnostics / DevicesResearchers Incorporate Cellavista System In Cell PlatformJuly 21, 2011, MDBR Newshttp://invitrodiagnostics.medicaldevices-businessreview.com/news/researchers-incorporate-rochecellavista-system-in-cell-culture-platform-210711 A research team from the Institute of Chemistry and Biological Chemistry at Zurich University of Applied Sciences has used Roche's high-throughput Cellavista Imaging System in the development of an automated liquid-handling cell culture platform for isolating, expanding and characterizing human primary cells. Roche's Cellavista Imaging System is used for noninvasively measuring of cell expansion and fluorescence measurement of cell quality, The Cellavista Imaging System uses brightfield and fluorescence detection with multiwell plates, chamber slides or RoboFlasks.

Roche Culture

Nobel Prize Winner To Transform Cancer Bug To Flu VaccineJune 29, 2011, Fierce Biotechhttp://www.fiercebiotech.com/story/nobel-prizewinner-transform-cancer-bug-flu-vaccine/2011-0629?utm_medium=nl&utm_source=internal Australian scientist Barry Marshall continues to make hay with the cancer-making stomach bacterium that won him a Nobel Prize. He's planning to use the bug in a drinkable flu vaccine that's slated to begin trials next year. Marshall, founder of Ondek, shows that his business acumen rivals his scientific expertise. "We're focusing on flu because we think that would be attractive to investors," he says in a Bloomberg report. He and J. Robin Warren won the 2005 Nobel Prize in Medicine with

Chinese Market To Drive Firm's Business In AsiaJuly 21, 2011, China Daily


http://www.chinadaily.com.cn/bizchina/201107/21/content_12951555.htm Multinational healthcare devices manufacturer Cook Medical Inc expects to almost triple its business in the Asia-Pacific region by 2015 on the back of continuing strong growth in China, according to the company's senior executives.

Organisation of Pharmaceutical Producers of India


Pharma Spectrum"Cook's annual sales growth in China will continue to exceed 60 percent this year, and we forecast this growth momentum continuing in the coming years," Philip Nowell, vice-president of US-based Cook Medical, told China Daily.

DomesticIPRCipla Wins Pre-Grant Opposition Against Novartis For Dispersible Tabs Containing DeferaciroxJune 30, Shirodkar 2011, Pharmabiz, Suja Nairhttp://www.pharmabiz.com/NewsDetails.aspx?aid=6369 6&sid=1 The Chennai patent office has granted a pre-grant opposition in favour of Cipla for dispersible tablets containing 'deferacirox'. Out of the four grounds under which Cipla had filed for the pre grant opposition, the Patent office upheld two of it. Novartis had filed an application for patent for their invention titled, dispersible tablets containing deferacirox in 2007 with the Chennai patent office. Cipla had subsequently filed a pre-grant opposition through their Attorney Gopakumar Nair Associates under section 25(1) of the Patents Act.

Medical Device Investment Boost



July 20, 2011, North Jersey.comhttp://www.northjersey.com/news/business/125871543 _Medical_device_investments_up.html New Jersey's medical device start-up companies received $25 million in venture capital funding during the second quarter, despite investor apprehension of tighter government regulations in that sector. In Bergen and Passaic counties, hundreds of firms, both small and large, compete in the marketplace. There are roughly 250 registered medical device companies in the two counties, about 30 percent of New Jersey companies in that industry, according to data from the Food and Drug Administration.

New AppointmentsMajor Changes At US FDA, With New Posts And AppointmentsJuly 19, 2011, Pharma Letterhttp://www.thepharmaletter.com/file/105901/majorchanges-at-us-fda-with-new-posts-andappointments.html The world of FDA regulation is changing rapidly and, in an effort to keep current, US Food and Drug Administration Commissioner Margaret Hamburg has announced a major reorganization The structure of the Office of the Commissioner that I inherited was created in 1970, when the FDA consisted of three centers and a field office, Dr Hamburg said in an e-mail to agency staff. By 2011, we had grown to seven centers, and a Commissioners Office with more than 1,600 staff.

RegulatoryCDSCO Issues Guidance Document For Import & Registration Of APIs, FormulationsJuly 25, 2011, Pharmabiz, Ramesh Shankarhttp://www.pharmabiz.com/NewsDetails.aspx?aid=6411 4&sid=1 The Central Drugs Standard Control Organization (CDSCO) has issued Guidance document on common submission format for import and registration of Active Pharma Ingredients (APIs) and finished formulations in India. The main purpose of the document is to provide guidance for submission of application in Form 40 to the CDSCO for registration certificate and issuing license for import of drugs into India. The document is intended to provide non-binding guidance for use in the import and registration of bulk drugs and finished formulations in India.

Organisation of Pharmaceutical Producers of India


Pharma Spectrum DoP Moots National Authority For Drugs & Therapeutics With CDSCO Under ItJuly 25, 2011, Pharmabiz, Jospeh Alexanderhttp://www.pharmabiz.com/NewsDetails.aspx?aid=6411 5&sid=1 Even as the move to set up a Central Drug Authority (CDA) by the Health Ministry with a view to centralising the operations of the pharmaceutical sector is stuck for three years now, the Department of Pharmaceuticals (DoP) is now mooting a proposal to set up the National Authority for Drugs and Therapeutics (NADT). The Department is learnt to have made a draft proposal in this regard, though it is yet to make the proposal public or consult the stakeholders on the formation of the new authority. Sources said, the proposal was still in the draft stage and details would be disclosed for consideration and comments by all concerned after finalisation. mandatory for corporates to earmark part of their profit for corporate social responsibility (CSR) initiatives. India Inc, the Minister said, needs to develop a culture of voluntary CSR ... CSR cannot be considered only as a charity it is more of a social business ... As my predecessor has said that 2 per cent mandatory provision (for CSR spend in the Companies Bill 2009), will stay.

DoP Takes Steps To Assess Current Status Of Regulatory Matters Relating To ExportsJuly 20, 2011, Pharmabiz, Joseph Alexanderhttp://www.pharmabiz.com/NewsDetails.aspx?aid=6403 3&sid=1 The Department of Pharmaceuticals (DoP) has launched an exercise to assess the current status of regulatory matters regarding exports, such as IPR, TRIPS, patent linkage, free trade agreements and data exclusivity, with purpose of getting a comprehensive view about the problems and then take up the issues with concerned departments and agencies. The DoP has asked the Pharmaceutical Export Promotion Council (Pharmexcil) to submit the current status report on all issues concerning the exports, especially exports to the European Union. The issues related to compliance with standards in other countries will also be covered. The DoP has set up a panel for taking up the studies and making the report.

DCGI Stops Attending Office After Madras HC Order On July 20 Against His ExtensionJuly 23, 2011, Pharmabiz, Ramesh Shankarhttp://www.pharmabiz.com/NewsDetails.aspx?aid=6410 3&sid=1 The Madras High Court's recent interim order, staying the 9-month extension given to Drugs Control General of India (DCGI), has virtually made the Central Drugs Standard Control Organisation (CDSCO) without a functioning head, as the DCGI Dr Surinder Singh stopped attending the office after the court order on July 20. Sources said that ever since the court order, the DCGI has proceeded on leave as the court has stayed until further orders the union health ministry's recent order in which it had given nine months extension to Dr Singh to continue in the position of DCGI. The court held that the extension order given to Dr Sigh by the government without the permission of the court was in contravention of the laws of the land as the issue was sub judice as a case on the appointment of the DCGI was pending with the court.

National Pharmacovigilance Programme To Be Extended To 20 More CentresJuly 20, 2011, Pharmabiz, Ramesh Shankarhttp://www.pharmabiz.com/NewsDetails.aspx?aid=6403 2&sid=1 The national pharmacovigilance programme (PvPI), launched late last year at 20 centres across the country with an aim to ensure that the benefits of use of medicine outweighs the risks thus safeguarding the health of Indian population, will be extended to 20 more centres soon. Some of the centres which have been selected for the expansion of the PvPI included: Grant Medical College & Sir J J Group of Hospital, Byculla, Mumbai; Lokmanya Tilak Municipal Medical College & General Hospital, Mumbai; Godavari Foundation's Dr Ulhas Patil Medical College, Jalgaon, Maharashtra; Padamashree Dr D Y Patil Medical College Hospital & Research Centre, Pimpri, Pune.............

Voluntary CSR Not Working, To Be Made Mandatory, Says MoilyJuly 21, 2011, Indian Expresshttp://www.indianexpress.com/news/voluntary-csr-notworking-to-be-made-mandatory-says-moily/820275/ Regretting that the concept of voluntary

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