Generics Industry News Search
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May 2007 News Archive |
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NEW YORK--(BUSINESS WIRE) April 30, 2007 --Pfizer Inc reported today that the Federal Court of Appeal of Canada has reversed a lower court ruling that would have permitted generic manufacturer Novopharm to launch a competitor product to Celebrex. The appellate court issued an order prohibiting regulatory approval of Novopharm’s product in Canada until Celebrex’s compound patent expires in November 2014....
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/FTC/ WASHINGTON, April 30, 2007 -- The Commission has approved publication of a Federal Register Notice regarding the agency’s planned study of authorized generic pharmaceuticals, which was first announced last year. The Commission proposes to undertake a study to examine both the likely short-term competitive effects of authorized generic drug entry and, to the extent possible, its likely long-term impact on competition by generic drug manufacturers....
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PITTSBURGH, April 30 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. (NYSE: MYL) today announced that the U.S. District Court for the District of Columbia issued a decision denying all requests for preliminary injunction related to Amlodipine Besylate Tablets and supporting the U.S. Food and Drug Administration's (FDA) position concerning Mylan's current status as the only approved ANDA for all strengths of this product....
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/Beximco/ LONDON, April 30, 3007--Beximco Pharmaceuticals Ltd. (BPL), the leading pharmaceutical manufacturer and the largest pharmaceutical exporter in Bangladesh, today announces that it has signed an agreement with Gulf Generics, a widely renowned and highly accredited pharmaceutical distributor in the Gulf region. Gulf Generics is owned by the members of the Kuwait Royal Family....
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FRANKLIN LAKES, N.J., April 30, 2007 /PRNewswire-FirstCall/ -- As more Americans turn to medications for a good night's sleep, the introduction of a generic version of Ambien (zolpidem tartrate) presents multi-million dollar savings for consumers and health plan sponsors, helping to offset spending growth in what has become one of the fastest growing categories of prescription drugs....
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/Orange Book Blog/ April 30, 2007 -- In an April 18 decision, the FDA determined that Pfizer is entitled to 6 months of pediatric exclusivity on Norvasc (amlodipine besylate), that Mylan may continue to sell its generic version of Norvasc, that FDA will approve Apotex's generic Norvasc ANDA if and when the Federal Circuit issues a mandate from its March 22 decision, and that no other Norvasc generics will be approved unless Pfizer's Norvasc patent is removed from the Orange Book....
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/Orange Book Blog/ April 30, 2007 -- In a unanimous decision released this morning, the Supreme Court reversed the Federal Circuit's decision
in KSR v. Teleflex and ruled that Teleflex's patent is invalid a
s obvious. ...Pharmaceutical patent owners are likely relieved that the Supreme Court did not reject the TSM test outright and replace it with a much more stringent standard, such as "Synergism" (as applied in a 1976 Supreme Court case) or "Extraordinary Level of Innovation" (as suggested by the Solicitor General)....
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/Orange Book Blog/ April 29, 2007 -- Last month the Federal Circuit invalidated three key claims of Pfizer's Norvasc patent and currently a district court in Washington, D.C. is deciding whether to allow a flood of Norvasc generics on the market. But the news for Pfizer hasn't been all bad lately. Though it might be small consolation, a district court in Virginia recently awarded Pfizer $3.2 million in attorney's fees and costs in a case in which Synthon (who is also one of the Norvasc generic applicants) accused Pfizer of infringing its patent on a process for making amlodipine, the active ingredient in Norvasc....
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/Business Standard/ New Delhi - April 30, 2007 --Ranbaxy Laboratories, the country’s biggest drugmaker, is all set to focus its energies in developing and marketing niche products where price erosion is minimal. The company’s move is aimed at beating the pricing pressure in key generics markets of the US and Europe.
The company had identified a basket of high-value medicines that come under the category of “limuses and penams” to strengthen its revenues from key export markets...
Click here to read full article (www.business-standard.com)...
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/Times News Network/ Mumbai: May 01, 2007 -- Here’s the big break Indian pharma majors have been looking for in their global game. Raj Jain, Wal-Mart’s chief executive designate for India operations, has opened a world of opportunity for them. The global retail behemoth is in advanced stages of negotiations with top Indian companies for direct sourcing of generic drugs for global supply...
Click here to read full article (economictimes.indiatimes.com)...
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/Times News Network/ NEW DELHI 30 Apr, 2007 -- An underdeveloped generics market, aging population and greater liberalisation have made Japan an attractive destination for Indian pharmaceutical majors. Japan will become the next happening place for generic opportunity, feel major pharma firms like Ranbaxy and Zydus Cadila, who have invested in the world's second largest pharmaceutical market after US. Japanese pharma market is around $64 billion...
Click here to read full article (timesofindia.indiatimes.com)...
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/Business Standard/ Mumbai April 30, 2007 -- Competing with established biotech companies in India such as Wockhardt, Biocon and Reliance Life Sciences, small biotech companies such as Zenotech, BV Biocorp and Intas Biopharma are likely to emerge as major Indian players in the field of biogeneric drugs, copycat versions of off-patent biotech drugs. The biogenerics market is expected to grow to $25 billion in Europe and $30 billion in the US by 2015 as many existing blockbuster biotech drugs are going off-patent in the coming years.
Click here to read full article (www.business-standard.com)...
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/Business Standard/ Mumbai May 1, 2007 -- As the Indian pharmaceutical companies aggressively pursue research and development to capture the market for drugs going off-patent, a dozen companies led by Aurobindo Pharma, Wockhardt, Ranbaxy, Dr Reddy’s Lab and Sun Pharma have bagged almost one-fourth of generic drug approvals in the US in the four-and-a-half month from December 2006. Out of the 186 original abbreviated new drug application (ANDA) approvals granted by the US Food and Drug Administration (FDA) during the period, about a dozen Indian companies bagged 43 approvals...
Click here to read full article (www.business-standard.com)...
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/IP Law & Business/ May 2007 -- Bruce Downey of Barr Pharmaceuticals is leading the charge to create a legal framework for copies of biotech drugs. So far, the generic industry has gotten its wish list inscribed in a bill sponsored by congressional heavyweights . But the political battle abouut lowering the price of biotech drugs is far from over. ... These days, the 58-year-old is adding to his dangerous reputation by taking aim at a faster-growing target: the $60 billion biotech industry.
Click here to read full article (www.ipww.com)...
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LONDON (Reuters) May 2, 2007 -- The world's top drugmakers face the loss of $140 billion (70 billion pounds) in annual sales by 2016 as key product patents expire and cheap generic versions of their blockbuster medicines hit the market, according to a report on Wednesday. Independent market analysis firm Datamonitor said that the huge patent "cliff" meant manufacturers of branded products could expect to face a decade of unrelenting generic competition.
Click here to read full article (uk.reuters.com)...
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WASHINGTON--(BUSINESS WIRE)--May 2, 2007 - Drs. Kevin A. Hassett of the American Enterprise Institute and Robert J. Shapiro of Sonecon, LLC., released a new study today refuting claims that the prospect of competition from authorized generics has reduced either patent challenges by other generic manufacturers or the development of new generic products. Their study also found that the additional competition from authorized generics during the 180-day exclusivity period produces lower prices for American consumers....
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WOODCLIFF LAKE, N.J., May 02, 2007 /PRNewswire-FirstCall/ -- Barr Laboratories, Inc., a subsidiary of Barr Pharmaceuticals, Inc. , today announced that it received final U.S. Food & Drug Administration (FDA) approval for its application to manufacture and market a generic version of Bayer Pharmaceuticals Corporation's Nimotop(R) (nimodipine) Capsules, 30 mg. The Company will launch its product later this month....
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RICHMOND, Va.--(BUSINESS WIRE)--May 2, 2007 - Insmed Inc. (Nasdaq:INSM) President and Chief Executive Officer Geoffrey Allan, Ph.D., testified today at a congressional hearing, "Assessing the Impact of a Safe and Equitable Biosimilar Policy in the United States."
...He, along with other industry and regulatory experts, shared views on the ability of biotech companies to produce safe and affordable versions of currently approved recombinant protein products....
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WASHINGTON, May 02, 2007 /PRNewswire-USNewswire/ -- Citizens Against Government Waste (CAGW) released today its report Biogenerics: What They Are, Why They Are Important, and Their Economic Value to Taxpayers and Consumers. The report estimates that if the Food and Drug Administration (FDA) was provided with the appropriate statutory framework to approve generic forms of biotech drugs for the marketplace, these drugs could save taxpayers and consumers $43.2 billion between 2011 and 2020....
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ARLINGTON, Va., May 02, 2007 /PRNewswire-USNewswire/ -- The following is a statement from Generic Pharmaceutical Association (GPhA) President and CEO Kathleen Jaeger on today's House Energy and Commerce Subcommittee on Health hearing on biogenerics: "Today's hearing is another opportunity for Congress to hear from current and former FDA officials that the science exists to approve safe, effective and affordable biogenerics...
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ARLINGTON, Va., April 30, 2007 /PRNewswire/ -- The Generic Pharmaceutical Association (GPhA) today released the following statement in response to the Biotechnology Industry Organization's (BIO) white paper on biologics: "It's a shame that BIO is still trying to delay patients' access to affordable, life-saving medicines even though the Food and Drug Administration (FDA) has stated that it has the scientific ability to review biogenerics for safety and efficacy...
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/Associated Press/ Washington May 2, 2007 -- Executives from the generic and biotech drug industries are expected to spar on Capitol Hill Wednesday over the potential risks and benefits of allowing generic drug companies to market cheaper versions of biotech drugs. Representatives from generic drug makers are among the panelists scheduled to testify. At stake is whether the government should allow generic versions of biotech drugs, which are some of the most costly medical treatments. A leading Food and Drug Administration official also is scheduled to speak.
Click here to read full article (www.businessweek.com)...
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/Patent Baristas/ May 2nd, 2007 -- It is clear that the Supreme Court’s ruling in KSR Int’l Co. v. Teleflex Inc. (Opinion 04-1350; Decided April 30, 2007) was meant to make it easier to challenge a patent on the grounds that the idea was obvious or showed no real innovation. The question is, does this mean bad news for pharmaceutical and biotech companies?...
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/Orangebook Blog/ May 01, 2007 -- On Wednesday, May 2nd, two subcommittees of the House Committee on Energy and Commerce will hold hearings of importance to pharmaceutical companies: first, on legislation to establish an abbreviated pathway for FDA approval of follow-on biologics; second, on a pending bill to ban "reverse payment" settlements of Hatch-Waxman litigation....
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/Orangebook Blog/ May 01, 2007 -- American Conference Institute is planning another "FDA Boot Camp" conference for May 15-16 in San Francisco. Prior versions of this conference in New York and Chicago were very popular. According to ACI, "FDA Boot Camp has been designed to give product or patent litigators, as well as patent prosecutors and life sciences investment and securities experts, a strong working knowledge of core FDA regulatory competencies."...
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/Times News Network/ May 01, 2007 -- New Delhi: Swiss pharma-major Novartis’s fight against certain provisions in the Indian patent laws — which do not allow patenting of incremental innovations — has taken an interesting turn with Norway’s minister of international development Erik Solheim asking the company to withdraw its case against India.
Click here to read full article (economictimes.indiatimes.com)...
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DUBLIN, Ireland--(BUSINESS WIRE)--May 1, 2007 - Research and Markets (http://www.researchandmarkets.com/reports/c55531) has announced the addition of Thailand Pharmaceuticals & Healthcare Report Q4 2006 to their offering. The Thailand Pharmaceuticals & Healthcare Report provides independent forecasts and competitive intelligence on Thailand's pharmaceuticals & healthcare industry....
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/Business Wire/ May 1 2007, 6:00 AM EST -- Research and Markets (http://www.researchandmarkets.com/reports/c55441) has announced the addition of Switzerland Pharmaceuticals & Healthcare Report Q4 2006 to their offering. The Switzerland Pharmaceuticals & Healthcare Report provides independent forecasts and competitive intelligence on Switzerland's pharmaceuticals & healthcare industry. ...
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/Reuters/ 01 May 2007 -- Merck, Germany's drugs and chemicals group, received four final bids for its generics drugs business, sources familiar with the situation said on Monday. Actavis Group, Mylan Laboratories and Teva Pharmaceutical Industries submitted bids, while private equity firms Bain Capital and Apax Partners submitted a joint offer, sources said.
Click here to read full article (www.cnbc.com)...
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/CNNMoney/ May 2 2007 -- NEW YORK (CNNMoney.com) -- The waves from a Supreme Court decision that undermines patents on gas pedals could hit Big Pharma like a truck, say some experts.
The financial health of the name-brand drug industry, dominated by giants, is heavily dependent on protecting the patents of multi-billion dollar blockbuster drugs. As the result of Monday's Supreme Court ruling in KSR International v. Teleflex, patents on name-brand drugs might become more vulnerable to generic drugmakers, say some experts.
Click here to read full article (money.cnn.com)...
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/Duke University/ May 2 , 2007 | DURHAM, N.C. –- Generic versions of a class of medicines called "biologics" would not be significantly cheaper than brand-name versions of the medicines, according to research from professors at Duke University's Fuqua School of Business....
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/Bloomberg/ May 2 2007 New York: Dr. Reddy’s Laboratories Ltd, India’s third-biggest drug maker, said its version of Roche Holding AG’s rituximab will be 50% cheaper than the original, allowing more access to the cancer therapy. Rituximab treats non-Hodgkin’s lymphoma, a blood malignancy. Reddy’s released Reditux on the weekend in Hyderabad, where the company is based. The generic-drug maker will also seek to sell the treatment elsewhere, including the US, spokeswoman Mythili Mamidanna said.
Click here to read full article (www.livemint.com)...
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/Antitrust & Competition Policy Blog/ May 1, 2007 -- The FTC is considering conducting a study to analyze the use and likely short- and long-run competitive effects of authorized generic drugs in the prescription drug marketplace. Before investigating these issues, the FTC is seeking public comments on its proposed information requests to firms in the prescription drug industry....
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/Glenmark/ Mumbai, March 28, 2007: Glenmark Pharmaceuticals Limited (NSE:GLENMARK.NS) confirmed that Schering Corporation and MSP Singapore Company LLC ("Schering") filed suit on March 22, 2007 in the U.S. District Court for the District of New Jersey seeking to prevent Glenmark from proceeding with the commercialization of its Ezetimibe product. Ezetimibe is currently marketed by Schering as Zetia®....
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/Orange Book Blog/ April 30, 2007 -- In an April 18 decision, the FDA determined that Pfizer is entitled to six months of pediatric exclusivity on Norvasc (amlodipine besylate), that Mylan may continue to sell its generic version of Norvasc, that FDA will approve Apotex's generic Norvasc ANDA if and when the Federal Circuit issues a mandate from its March 22 decision, and that no other Norvasc generics will be approved unless Pfizer's Norvasc patent is removed from the Orange Book....
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NEW YORK (CNNMoney.com) April 30 2007 -- Lawmakers are pushing forward with legislation that could help create generic competition for Big Biotech, drastically lowering the costs of expensive biotech drugs and changing the landscape in the pharmaceutical industry forever.
The Senate is expected to vote Wednesday on a bill that would extend the 15-year-old process of requiring drug companies to pay fees to the Food and Drug Administration to help fund the drug review process. ...so that it takes months instead of years to get lifesaving drugs approved for the market...
Click here to read full article (money.cnn.com)...
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/Financial Times/ April 30, 2007 -- Aggressive competition for the generic drugs arm of Merck of Germany pushed offers beyond €4bn at the close of a revised round of bids on Monday. Four rivals - Actavis of Iceland, Teva of Israel, Mylan of the US and a joint private equity offer from Apax Partners and Bain Capital - all stayed in the auction after completing due diligence in recent weeks...
Click here to read full article (www.msnbc.msn.com)...
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/Kaiser Network/ Apr 30, 2007 -- Prescription drugs increasingly are being offered as combination therapies, in which two or more medications are combined in a single dose, the Los Angeles Times reports. According to the Times, the trend in part is being driven by drug manufacturers facing patent expirations and competition from generic drug makers...
Click here to read full article (www.kaisernetwork.org)...
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WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--May 4, 2007 - Merck & Co., Inc. issued the following statement today on the Government of Brazil's decision to issue a compulsory license for STOCRIN(TM) (efavirenz):
"Merck is profoundly disappointed by the decision of the Government of Brazil (GOB) to issue a compulsory license for STOCRIN(TM) (efavirenz), which would break Merck & Co., Inc.'s patent and make it possible for efavirenz to be produced by a generic manufacturer....
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DUBLIN, Ireland--(BUSINESS WIRE)--May 4, 2007 - Research and Markets has announced the addition of the Decision Resources, Inc. report: Generics Erosion Patterns in the U.S. Market to their offering.
...In a data-rich report that employs analyses of 34 branded drugs facing generics competition between January 2002 and December 2006, we highlight the most effective strategies employed by pharmaceutical companies in their effort to ward off the threat of generics competition....
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WASHINGTON--(BUSINESS WIRE)--May 3, 2007 - As the House of Representatives' Committee on Energy and Commerce holds a hearing today on follow-on biologics, the Biotechnology Industry Organization (BIO) issued a statement of facts in response to misleading public statements on follow-on biologics made by the Generic Pharmaceutical Association (GPhA) and others....
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PITTSBURGH, May 3 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. (NYSE: MYL) today announced that Mylan Pharmaceuticals Inc. has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Letrozole Tablets USP, 2.5 mg...
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WASHINGTON, May 02, 2007 /PRNewswire-USNewswire/ -- Today, the Coalition for a Competitive Pharmaceutical Market (CCPM) welcomed two actions on both sides of Capitol Hill that are essential steps to ensuring that consumers and businesses can look forward to generic competition for biological medications. First, key Senators reached a bipartisan agreement today to produce legislation authorizing the Food and Drug Administration (FDA) to review and approve safe and effective biogeneric drugs,...
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/Patent Docs Blog/ May 02, 2007 -- There is a growing trend in developing countries (such as Brasil, China, India, and Thailand) for their governments to avail themselves of the ability under prevailing international trade agreements to grant compulsory licenses or permit so-called "parallel imports" of generic drugs in the face of national patents procured by the innovator drug company. This tendency threatens to overturn progress in intellectual property protection and harmonization hoped to be achieved by passage of the General Agreement on Tariffs and Trade (GATT) and the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)....
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NEW YORK (CNNMoney.com) -- India's fast-growing biotech business has the potential to be one of the driving forces behind its enviable 8 percent GDP growth, and a government estimate ...projected in an open letter that the biotech industry could surge to $25 billion in annual sales by 2015, ...But for now India's biotech elephant won't grow to its full potential unless it can attract more foreign investments and partnerships. In order to do that, the country's patent laws need to become more palatable for outside investors, experts say...
Click here to read full article (money.cnn.com)...
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/FDA/ May 2, 2007 -- The U.S. Food and Drug Administration (FDA) today issued the "Critical Path Opportunities for Generic Drugs" report identifying many of the unanswered scientific questions that impede the development of generic versions of commonly used drugs.
The report is part of FDA's Critical Path Initiative, established in 2004 to discern what challenges exist in moving a promising drug, biologic or device along the critical path from discovery, or proof of concept, to a marketable product....
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/Patent Docs Blog/ May 04, 2007 -- The ink is barely dry on the U.S. Supreme Court's decision in KSR Int'l Co. v. Teleflex Inc., perhaps the most anticipated patent law decision of the year, and pundits and practitioners are trying to assess the impact of the decision on patent law and practice. It is clear from the Supreme Court's language that different technologies will be differentially affected by the application of the Court's obviousness rubrics. The question (at least for Patent Docs) is how can this decision be expected to impact biotechnology patent claims (both in prosecution and litigation)?...
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/Patently-O Blog/ May 03, 2007 -- "We do not believe that too much guessing is needed to see what the new patent environment will be like, since we already have the benefit of Chief Judge Michel’s March 23, 2007 decision in the Norvasc case, in which he identified the likely changes in the court’s obviousness jurisprudence. . . . A few of the principles reflected in Judge Michel’s opinion are as follows:...
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Links to stories and case reports of interest to the Pharmaceutical community....
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/Patent Docs Blog/ May 07, 2007 -- About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring. In this week:
Shire v. Teva (carbamazepine), Janssen v. Sandoz (galantamine), Merck v. Ranbaxy (imipenem & cilastatin)...
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/IPKat Blog/ 07 May 2007 -- A recent decision from the High Court illustrates how it might be overambitious to claim patent rights over a new product when all you have done is show one way of making it. In Generics (UK) Ltd & Ors v H Lundbeck A/S, decided last Friday by Justice Kitchin at the High Court, Lundbeck's patent covering Cipralex (citalopram) was partially revoked on application by the claimants under section 72 for being insufficiently disclosed. The patent claimed not only a novel way of making the more active (+) enantiomer of citalopram, but effectively all ways of making it....
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/IPFrontline/ May 07, 2007 -- The Supreme Court of Canada’s decision in AstraZeneca has now been judicially interpreted by the Federal Court of Canada, for the first time. The implications are far-reaching ... (and) include the following: • Generic manufacturers may not be obligated to address all patents listed on the Patent Register.
• In certain circumstances, Health Canada may issue Notices of Compliance (NOC) for generic products when prohibition proceedings have been commenced.
• Health Canada may not necessarily alert innovator drug companies before it issues NOCs to generic manufacturers (on the basis that certain listed patents do not have to be addressed)...
Click here to read full article (www.ipfrontline.com)...
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/Times News Network/ May 09, 2007 -- MUMBAI: Indian generic pharma companies may now find it easier to challenge patents in the US. In another twist in the battle between innovators and generic companies, the US Supreme Court last week wrote new rules that will make it harder to obtain and defend patents in the US.
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“This is a very positive move for the Indian pharma industry,” said Dilip G Shah, secretary general, Indian Pharma Alliance (IPA). “The decision may make it harder to obtain a United States patent, and existing United States patents will be subject to an immediate enhanced threat by re-examination.”
Click here to read full article (economictimes.indiatimes.com)...
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JERUSALEM--(BUSINESS WIRE)--May 8, 2007 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Eli Lilly and Co's cancer treatment Gemzar(R) (Gemcitabine) for injection, 200 mg base/vial....
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HAYWARD, Calif.--(BUSINESS WIRE) May 09, 2007 --IMPAX Laboratories, Inc. (OTC: IPXL) today announced that the U.S. Food and Drug Administration (FDA) has granted final approval of the Company's Abbreviated New Drug Application (ANDA) for generic versions of Ditropan® XL, (Oxybutynin Chloride) 5 mg and 10 mg Extended-release Tablets....
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BALTIMORE, May 8 /PRNewswire/ -- Lupin Pharmaceuticals, Inc. announced today that it was granted final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application for Cefdinir for Oral Suspension, 250 mg/5mL. ...Commercial shipment in the U.S. has already commenced....
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/Bloomberg News/ May 8, 2007 FRANKFURT: Teva Pharmaceutical Industries is bidding more than €4.5 billion to acquire the generic drugs unit of Merck KGaA, two people with direct knowledge of the process said. Teva, the world's biggest generic-drug maker, and Mylan Laboratories are the remaining contenders for the Merck unit after Apax Partners Worldwide and Bain Capital dropped out of the running last week, ... A decision on the winning offer will be announced in the next two weeks, they said. Teva's bid is worth $6 billion.
Click here to read full article (www.iht.com)...
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/Globes/ 13 May 07 -- IBI Investment House Ltd. analyst Noa Weisberg says that the acquisition of the generic business of Germany’s Merck KGaA for $6.7 billion by Mylan Laboratories Inc. will “balance out” for Teva Pharmaceutical Industries Ltd. On one hand, Teva will now face a stronger rival with a broad geographical deployment (Merck’s generics business has a presence in 90 countries) in the generic inhaler market, but Mylan will “struggle financially”...
Click here to read full article (www.globes.co.il)...
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TOKYO, Japan, and WOODCLIFF LAKE, N.J., May 11 /PRNewswire/ -- Eisai Co., Ltd. and its U.S. subsidiary Eisai Inc. (collectively "Eisai") today announced that the United States District Court for the Southern District of New York has ruled in Eisai's favor with respect to Eisai's patent infringement lawsuit against Teva Pharmaceuticals and Dr. Reddy's Laboratories concerning Aciphex(R) (generic name: rabeprazole sodium, Product Name in Japan: Pariet(R))....
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WOODCLIFF LAKE, N.J., May 11 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. (NYSE: BRL) today announced that its subsidiary, Barr Laboratories, Inc., has received tentative approval from the U.S. Food and Drug Administration (FDA) for its generic version of Janssen Pharmaceutica Products, L.P.'s Razadyne(R) (Galantamine Hydrobromide), 4mg, 8mg and 12mg Tablets....
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WASHINGTON, May 09, 2007 /PRNewswire-USNewswire/ -- The Pharmaceutical Care Management Association (PCMA) issued the following statement today regarding H.R. 1956, "The Patient Protection and Innovative Biologic Medicines Act." PCMA is the national association representing America's pharmacy benefit managers (PBMs), which administer prescription drug plans for more than 210 million Americans with health coverage provided through Fortune 500 employers, health insurance plans, labor unions, and Medicare Part D:...
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LOS ANGELES--(BUSINESS WIRE)--May 10, 2007 - Abraxis BioScience, Inc. (NASDAQ:ABBI), an integrated, global biopharmaceutical company, today announced that it has received two approvals from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Applications (ANDAs) for Clindamycin Injection, 300mg, 600mg, 900mg and 9g, USP, the generic equivalent of Pfizer's Cleocin(R) Phosphate Injection....
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JERUSALEM--(BUSINESS WIRE)--May 10, 2007 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted approval for the Company's Abbreviated New Drug Applications (ANDA) to market its generic versions of Abbott's antibiotic Omnicef(R) (Cefdinir) Capsules, 300 mg, and for Oral Suspension, 125 mg/5 mL and 250 mg/5 mL. Teva has commenced shipment of these products....
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May 10 (Bloomberg) -- Icelandic billionaire Bjorgolfur Thor Bjorgolfsson made a preliminary bid for control of Actavis Group hf, a generic-drug maker that's spent more than $1.5 billion on acquisitions since 2005. The stock jumped to an all-time high. Bjorgolfsson's Novator investment group is bidding 85.23 Icelandic kronur per Class A share of Actavis, valuing the company at 3.3 billion euros ($4.5 billion).
Click here to read full article (www.bloomberg.com)...
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/Patent Docs Blog/ May 13 2007 -- About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring. In this week:
Purdue v. Par (tramadol), Abbott v. Teva (divalproex), Bioglan v. Novartis (diclofenac)...
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/New York Times/ May 11, 2007 -- Bristol-Myers Squibb said yesterday that it would plead guilty to criminal charges that it made false statements to the government, a move meant to end a federal antitrust investigation of the drug maker’s botched efforts last year to preserve a lucrative monopoly for the anti-clotting medicine Plavix. ...The investigation involved allegations that the company reached a secret agreement with the Canadian drug maker Apotex to keep a generic copy of Plavix off the market.
Click here to read full article (www.nytimes.com)...
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/Orange Book Blog/ May 10, 2007 -- Guest Post by Prof. Christopher M. Holman, UMKC School of Law: Much of the current discussion surrounding the proposed follow-on biologics bills assumes that a "statutory path" is necessary before FDA can implement an abbreviated biologics license application (BLA) process for biotechnology-derived therapeutic proteins. In fact, FDA probably already has the authority to create such a process by regulation, but so far has declined to do so....
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/Patent Docs Blog/ May 09, 2007 -- The crisis regarding the pricing of patented drugs in poor and developing countries continues this week, with actions by current and former U.S. chief executives contributing to the situation. The U.S. Trade Representative issued a "Special 301 Report" on Monday, pursuant to the provisions of the Trade Act of 1974. This report on the state of intellectual property rights worldwide identifies twelve countries on a "priority watch list"...
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/Glenmark/ Mumbai, 16 May 2007 -- Glenmark Pharmaceuticals Ltd, a research- based company headquartered in Mumbai (India) received US FDA approval to market Pravastatin Sodium oral tablets, a generic version of Bristol Myers Squibb brand Pravachol ... Glenmark also received US FDA approval to market Naproxen Sodium oral tablets EQ, a generic version of Roche's brand Anaprox and Naproxen oral tablets...
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/GenericsWeb/ Sydney, Australia, May 17th, 2007 -- Following the grant of a divisional patent in Europe which effectively reinstates previously-revoked patent protection of the Fosamax (Alendronic Acid sodium) once-a-week formulation, an analysis conducted by Generic Pharmaceutical Patent Information specialists GenericsWeb reveals that a similar threat remains in Australia.
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PRINCETON, N.J., May 17 /PRNewswire/ -- Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that RLL has received tentative approval from the U.S. Food and Drug Administration to manufacture and market the antihistamine Fexofenadine Hydrochloride Tablets, 30 mg, 60 mg, and 180 mg. Total annual market sales for Fexofenadine Hydrochloride Tablets were $931 million (IMS - MAT: March 2007)....
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BALTIMORE, May 15 /PRNewswire/ -- Lupin Pharmaceuticals, Inc. announced today that it has received final approval from the US FDA for its Abbreviated New Drug Application (ANDA) for Simvastatin Tablets 10mg, 20mg, 40mg and 80mg. Lupin's Simvastatin Tablets are the AB-rated generic equivalent of Merck's Zocor(R) tablets. Simvastatin is indicated for the treatment of high cholesterol....
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MONTGOMERY, Ala.--(BUSINESS WIRE)--May 15, 2007 - Midlothian Laboratories, a Montgomery, Ala.-based distributor of generic pharmaceuticals, announced today that in continuing its efforts in supporting humanitarian relief organizations, it has made another significant donation of pharmaceutical products....
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/Merck/ Darmstadt, Germany May 13, 2007 – Merck KGaA announced today that it will sell its Generics business to Mylan Laboratories Inc, Canonsburg, PA USA. Merck and Mylan have signed a share purchase agreement whereby Mylan will acquire all Merck Generics companies throughout the world for EUR 4.9 billion....
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St. Louis, MO, May 18, 2007 – KV Pharmaceutical Company (NYSE: KVa/KVb) announced today that it has received final approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application to market its 100 mg and 200 mg strengths of metoprolol succinate extended-release tablets. This product is a generic version of AstraZeneca’s branded product, Toprol-XL®....
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/Pharmaceutical Business Review/ 18th May 2007 -- A study from the National Audit Office has suggested that the UK National Health Service could save as much as GBP200 million a year by prescribing cheaper, generic drugs. The National Audit Office (NAO) study, which included a survey of 1,000 general practitioners and prescribing advisers in Primary Care Trusts (PCTs), concluded that generic drugs offer scope for improving the efficiency of prescribing in primary care without affecting clinical outcomes...
Click here to read full article (www.pharmaceutical-business-review.com)...
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/www.globalinsight.com/ 17 May 2007 -- India's Torrent Pharmaceuticals and Zydus Cadila today announced the launch of generic versions of Sanofi Aventis's Acomplia/Zimulti (rimonabant) in the Indian market. Zydus Cadila is branding the drug as Slimona, priced at 5.50 rupees (US$0.13) per tablet, while Torrent has priced it at slightly higher level of 8 rupees per tablet, calling it Rimoslim. ...The move suggests a new wave of potential introductions by other leading Indian pharma firms, resulting in an expansion of the small segment...
Click here to read full article (www.globalinsight.com)...
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/Patent Docs Blog/ May 18, 2007 -- The economic and political realities (both at home and abroad) are beginning to be felt with regard to intellectual property protections for Western companies in poor and developing nations, as evidenced by changes to American trade policies announced recently (see "Worldwide Drug Pricing Regime in Chaos"). Specifically, the Bush administration has agreed with Congressional negotiators to reduce the extent to which the U.S. government uses its influence in international trade to encourage (some would say coerce) foreign governments to enforce patent protection for drugs protected by patents in their home countries....
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/Orange Book Blog/ May 18, 2007 -- Links and summaries of the latest big news in Pharma as seen by Aaron Barkoff of the Orange Book Blog....
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/Globes Online/ 15 May 07 -- The acquisition by Mylan Laboratories Inc. of the generics division of German company Merck KGaA is not a blow to Teva Pharmaceutical Industries Ltd. Moreover, I do not believe that it will have any affect on Teva's business in the immediate and longer-term future. The acquisition has put Mylan in a position of having to swallow up a company that is much larger than itself, and one with an entirely different culture and structure. It looks good on paper, but...
Click here to read full article (www.globes.co.il)...
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/Boehringer Ingelheim/ Germany, 15 May 2007 - In order to further improve access to its anti-HIV drug Viramune® (nevirapine) in developing countries Boehringer Ingelheim has amended its policy of voluntary licences for generic producers. The company now issues short, non-assert declarations which can be given to all generic producers worldwide, prequalified by the WHO, that will supply nevirapine to developing countries. These agreements, which practically mean that patents on nevirapine will not be enforced by Boehringer Ingelheim in developing countries, are free of licence fees or other charges....
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Jerusalem, Israel, May 20, 2007 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announces that on May 18, 2007 the U. S. Food and Drug Administration granted to Teva final approval of its amlodipine besylate/ benazepril products in 2.5 mg/ 10 mg, 5 mg/ 10mg; 5 mg/ 20 mg and 10 mg/ 20 mg dosage strengths, AB rated to Novartis' Lotrel ® and Teva immediately commenced shipping the product....
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/The Hankyoreh/ Korea May.16,2007 -- A group of multinational drug makers has filed patent-infringement lawsuits against Korean pharmaceutical companies ... The U.S. drug maker Pfizer is suing nine local pharmaceutical firms, claiming they violated its patents related to the production of its Detrusitol SR, an incontinence treatment medicine. ...[these] drugs will soon be put on sale in the Korean market.
Click here to read full article (english.hani.co.kr)...
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/Haaretz/ 17.5.07 -- The Indian company Natco Pharma today announced the launch of a generic version of Copaxone (glatiramer acetate), which is Teva's biggest earner. Global sales of the drug run at about $1.4 billion a year. Natco, the first company to launch a generic version of the drug, says it will sell glatimir at 60% below the price of the original drug...
Click here to read full article (www.haaretz.com)...
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/The Yomiuri Shimbun/ Japan May. 18, 2007 -- The nation's use of low-priced generic medicines is much lower than in other industrial nations, and is keeping medical costs in Japan excessively high, according to the Finance Ministry. The finding was presented to the Fiscal System Council, an advisory body to the finance minister, on Wednesday at a meeting examining the adverse impact on state finances of high medical costs...
Click here to read full article (www.yomiuri.co.jp)...
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/NDTV Profit/ May 16, 2007 (New Delhi) -- A bitter pill for the pharmaceutical companies, the government may finally cap trade margins on generic medicines as drug makers failed to do so on their own...
Click here to read full article (www.ndtvprofit.com)...
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MUMBAI, India | May 16, 2007 | Glenmark Pharmaceuticals Ltd [Glenmark], a research-based company headquartered in Mumbai (India) received US FDA approval to market Pravastatin Sodium oral tablets 10 mg, 20 mg and 40 mg, a generic version of Bristol Myers Squibb brand Pravachol....
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/Kaisernetwork/ May 16, 2007 -- Thai Health Minister Mongkol Na Songkhla on Tuesday said that Thailand will not issue compulsory licenses to produce reduced-cost versions of patented drugs if pharmaceutical companies offer prices lower than those charged by generic drug makers, Reuters AlertNet reports...
Click here to read full article (www.kaisernetwork.org)...
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Toronto, Ontario CANADA, May 16, 2007 /FSC/ - Orbus Pharma Inc. (ORB - TSX), today announced that patent applications for its extended release formulation of the drug Metoprolol Succinate has been published ... formulation is a generic version of Astra Zeneca's Beloc-ZOK(r) (metoprolol CR/XL) which had reported 2005 annual sales of US$1.7 billion....
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/Orange Book Blog/ May 15, 2007 -- Detailed examination of the Aciphex judgement by Aaron Barkoff...
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May 18, 2007 - Wilmington, DE - AstraZeneca (NYSE: AZN) today announced that the U.S. Food and Drug Administration (FDA) has approved SEROQUEL XR™ (quetiapine fumarate) Extended-Release Tablets, a once-daily medicine for the treatment of schizophrenia in adult patients. ...
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/Orange Book Blog/ May 20, 2007 -- ...Teva announced in a press release today that the FDA granted final approval to Teva's ANDA for generic Lotrel on Friday, Teva began shipping the product immediately, and the U.S. District Court for the District of New Jersey granted Novartis's motion for a temporary restraining order on Saturday, halting Teva's shipments....
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/Patent Docs Blog/ May 20, 2007 -- About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring. In this week: Merck Sharp & Dohme v. Teva (montelukast), Smithkline Beecham v. Teva (rosiglitazone) , Abbott v. Wockhardt (divalproex), Sanofi-Aventis v. Mutual (zolpidem)...
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/Sun Pharma/ Mumbai, India : May 21, 2007 : Sun Pharmaceutical Industries Ltd., together with its subsidiaries, has signed definitive agreements to acquire Taro Pharmaceutical Industries Ltd., a multinational generic manufacturer with established subsidiaries, manufacturing and products across the U.S., Israel, Canada. North America represents more than 90% of Taro's sales....
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CORONA, Calif., May 21, 2007 /PRNewswire/ -- Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, announced today that pursuant to an agreement with Sandoz, a subsidiary of Novartis AG, Watson has relinquished its rights to a 180-day period of marketing exclusivity for its 50 mg strength of metoprolol succinate extended-release tablets (the generic equivalent to AstraZeneca PLC's Toprol XL(R) 50 mg product)....
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TORONTO, May 21 /CNW/ -- Ranbaxy Pharmaceuticals Canada Inc. (RPCI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that RLL has received approval in Canada to manufacture and market Ran(R)-Pravastatin Tablets, from Health Canada, Therapeutic Products Directorate (TPD)....
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TOTOWA, N.J., May 21, 2007 /PRNewswire-FirstCall/ -. Actavis Group (OMX: ACT), the international generic pharmaceuticals company, today announced that it has received approval from the U.S. Food & Drug Administration to market Finasteride Tablets, USP 5 mg. Distribution of the product will begin immediately....
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JERUSALEM--(BUSINESS WIRE)--May 21, 2007 - Teva announced today that the United States District Court for the District of New Jersey has vacated a temporary order restraining Teva's launch of its amlodipine besylate/benazepril products, AB rated to Novartis' Lotrel(R). Instead, the Court has ordered Teva and Novartis not to sell or offer further generic product, beyond what has already been commercialized....
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PRINCETON, N.J., May 21, 2007 /PRNewswire/ -- Sandoz announced today that the US Food and Drug Administration has granted final approval to its abbreviated new drug application for metoprolol succinate 50 mg extended release tablets, a generic equivalent of Toprol XL(R)....
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Baltimore, MD, May 22, 2007: Lupin Pharmaceuticals, Inc. announced today that on May 16, 2007 it received tentative approval from the US FDA for its Abbreviated New Drug Application (ANDA) for Ziprasidone Hydrochloride Capsules 20mg, 40mg, 60mg and 80mg....
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/Orange Book Blog/ May 21, 2007 -- This afternoon, the Federal Circuit denied Pfizer's petition for rehearing and rehearing en banc of Pfizer v. Apotex, in which the court invalidated claims 1-3 of Pfizer's U.S. Patent No. 4,879,303. The '303 patent covers amlodipine besylate, the active ingredient in Norvasc....
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/Manila Standard Today/ 21 May 2007 -- Local pharmaceutical giant United Laboratories Inc. is challenging the patent of several branded drugs in its bid to reduce the cost of medicines by 50 percent. Jose Maria Ochave, Unilab’s head of legal services and business development, told reporters that the company would contest at least four patents before the courts, including that of Lipitor, Seretide, Unasyn and Plavix...
Click here to read full article (www.manilastandardtoday.com)...
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/Ranbaxy/ Gurgaon, India, London, UK, and Princeton, NJ - May 29, 2007 -- Ranbaxy Laboratories Limited (RLL) announced that the Norwegian Appeals Court today handed down a favorable decision for Ranbaxy in its case against Pfizer, involving key Norwegian patents on Atorvastatin in Norway....
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May 29, 2007 HAYWARD, Calif.--(BUSINESS WIRE)--IMPAX Laboratories, Inc. (OTC:IPXL) today announced that the U.S. Food and Drug Administration (FDA) has granted final approval of the Company's Abbreviated New Drug Application (ANDA) for generic versions of Xanax® XR, (Alprazolam)....
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MUMBAI (Thomson Financial) 05.29.07 - India's mid-sized drug maker Aurobindo Pharma Ltd said it has received approval from the US Food and Drug Administration for its antibiotic Cefprozil tablets in 250 mg and 500 mg strengths.
Click here to read full article (www.forbes.com)...
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/Novartis/ Basel, May 29, 2007 - A US federal court judge has extended a temporary restraining order stopping Teva Pharmaceutical Industries Ltd. from shipping any further supplies of a generic version of the high blood pressure medicine Lotrel...
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NEW YORK--(BUSINESS WIRE) May 29, 2007 --Pfizer Inc. said today that it will immediately seek to appeal a ruling by the Borgarting Court of Appeal in Oslo, Norway that four of Pfizer’s patents covering Lipitor are either invalid or not infringed by a proposed generic atorvastatin calcium product from Ranbaxy Laboratories....
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May 25, 2007 - HAYWARD, Calif.-- (BUSINESS WIRE) -- IMPAX Laboratories, Inc. today announced that patent infringement litigation pertaining to its generic version of Purdue Pharma?s OxyContin® (oxycodone HCl extended-release) Tablets has been dismissed by the United States District Court...
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Mobor, Goa, India, Wednesday, May 23, 2007 -- (Business Wire India) India's leading drug manufacturers are becoming global players, utilizing both organic growth through the gradual development of their business and mergers and acquisitions (M&A;), as they seek to boost their presence in existing markets and open up new ones....
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/Orange Book Blog/ May 23, 2007 -- Last month (as we reported then), the U.S. District Court for the District of Delaware granted Merck's motion to dismiss the patent suit Merck filed against Apotex concerning generic Fosamax. The court indicated at the time that an opinion would "follow at the court's earliest convenience." On Monday, the court issued the promised opinion....
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Weston, FL (May 24, 2007) — Apotex Corp. announced today that it has launched amlodipine besylate tablets (2.5 mg, 5 mg, and 10 mg), the generic equivalent of Pfizer’s Norvasc®....
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/Asia Times/ May 24, 2007 -- The current dispute over Thailand and Brazil licensing generic versions of patented medicines severely tests global health and health-care-access policy. It also tests key US trade relations with Asia and the functionality of the global trade system itself. ...we have a dysfunctional battle between pharmaceutical giants and governments of developing countries, each side claiming to champion the world's health needs and accusing the other of exploitation.
Click here to read full article (www.atimes.com)...
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/Live Mint/ New Delhi: May 24 2007 -- The debate on the safety of Avandia, an anti-diabetes drug of Glaxosmithkline Plc’s, is finding repurcussions in the Indian pharmaceuticals industry. Worries have surfaced on the business viability of Dr Reddy’s Laboratories Ltd’s challenge of the patent on Avandia in the wake of a study that said the Glaxosmithkline drug raised the risk of death caused by heart attacks and stroke by nearly two-thirds.
Click here to read full article (www.livemint.com)...
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/Managing IP/ April 2007 -- Pending before the Philippine Congress and certified as urgent by President Gloria Macapagal Arroyo are two bills or proposed laws: House Bill No. 6035 and Senate Bill No. 2263. Both have the objective of providing cheaper medicines, and are expected to be approved... One common subject matter tackled in these bills is the amendment of Section 74 of the Intellectual Property Code (IP Code, RA 8293) referring to compulsory licensing of a patented invention by the government.
Click here to read full article (www.managingip.com)...
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/RealMoney/ 5/23/2007 -- The current cutthroat competition among generic-drug companies will likely lead to a consolidation phase in the industry. Consider, for instance, the generics acquisition Mylan Laboratories made last week. ...In light of that deal and of the potential for more, Stockpickr offers a list of the Generic-Drug Manufacturers that could be next in line to get acquired.
Click here to read full article (www.thestreet.com)...
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/Managing IP/ May 2007 - The Intellectual Property Office of New Zealand (IPONZ) recently released a decision of particular significance to the pharmaceutical industry. The decision follows a hearing at IPONZ on the patentability of Swiss claims where the novelty of the claimed subject matter resides in a dosage regime, rather than the active ingredient or the disease to be treated.
Click here to read full article (www.managingip.com)...
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/Orange Book Blog/ May 24, 2007 -- Via the Antitrust Review and Pharmalot, the Solicitor General has recommended that the Supreme Court deny certiorari in Joblove v. Barr Labs, the most recent "reverse payments" case to be appealed to the Court. Last year, the Solicitor General advised the Court not to take the FTC v. Schering case. At the time, many observers thought this case might better present the reverse payments issue....
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/Times News Network/ May 25, 2007 - Mumbai: It’s not just Ranbaxy and Dr Reddy’s Laboratories which have decided to challenge pharma giants’ blockbuster drugs patents in the US. In a significant move, Mumbai-based Wockhardt Pharma has just got into the game, with the company challenging one of Abbott Lab patent on blockbuster epilepsy drug, Depakote...
Click here to read full article (economictimes.indiatimes.com)...
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/Zimulti Acomplia Report/ 24 May 2007 -- Sanofi-Aventis, developer of diet drug rimonabant (Acomplia / Zimulti), said on May 24th it was "examining all legal options" in light of the emergence of three different companies offering generic versions of rimonabant in India.
Click here to read full article (www.acompliareport.com)...
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/Seeking Alpha/ May 25th, 2007 -- Teva (TEVA) investors are anxiously awaiting Tuesday’s court decision regarding the patent infringement charge brought against it by Novartis (NVS). Novartis claims that its drug Lotrel has valid patent rights until 2017 and Teva’s generic version of the high blood pressure drug infringes on that patent...
Click here to read full article (healthcare.seekingalpha.com)...
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/Globes Online/ 27 May 07 -- A week ago, Teva Pharmaceutical Industries Ltd. CFO Dan Suesskind said after losing the bid to acquire Merck KGaA's generics division "We didn’t want to buy at yesterday’s price what will cost a lot less tomorrow." Last Friday, it was the turn Robert J. Coury, CEO at Teva's US rival Mylan Laboratories Inc...
Click here to read full article (www.globes.co.il)...
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/Business Standard/ New Delhi May 28, 2007 -- After making big-ticket acquisitions abroad, leading Indian pharmaceutical companies like Dr Reddy’s Laboratories, Ranbaxy Laboratories, and Aurobindo Pharma are rapidly shifting production to their Indian facilities. Dr Reddy’s, for instance, will soon feed the entire product pipeline of Betapharm, the fourth-largest generic (off patent) drug company in Germany that it acquired last year for $572 million, from India.
Click here to read full article (www.business-standard.com)...
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/Wockhardt/ Mumbai, 21 May,2007 -- Pharmaceutical and biotechnology major Wockhardt received USFDA approval for marketing Zolpidem tablets (the generic version of brand Ambien) in the US....
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Tuesday, May 22, 2007 -- Today in Pfizer, Inc. v. Apotex, Inc., __ F.3d __ (Fed. Cir. 2007)(en banc)(order), panel proceedings, 480 F.3d 1348 (2007)(Michel, C.J.), the court refused to grant rehearing en banc in one of the most controversial chemical patent opinions in the history of the court in conflict with, inter alia, the leading case, In re Papesch, 315 F.2d 381 (CCPA 1963)...
Click here to read full article (www.ipfrontline.com)...
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/Patent Docs Blog/ May 28 -- About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring. In this week:
Allergan Inc. v. Apotex (Alphagan)
Takeda Pharmaceuticals North America, Inc. et. al. v. Sandoz, Inc (Actos)...
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/AP/ May 28 2007 Bangkok -- The Thai government, which has clashed with Western pharmaceutical giants over expensive patented drugs, said on Monday it is considering approving more cheap generic versions of pricey medicines. "We are considering imposing compulsory licences on two more drugs," said Health Minister Mongkol Na Songkhla.
Click here to read full article (www.iol.co.za)...
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/Gannett News Service/ 28 May 2007, WASHINGTON — A Democratic senator who wants to control drug prices through generic competition and re-importation of prescriptions from Canada is not the most likely recipient of campaign contributions from the pharmaceutical industry.
But when voters switched congressional majorities from Republican to Democrat, Eli Lilly and Co. followed suit...
Click here to read full article (www.usatoday.com)...
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DETROIT, May 30 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical Laboratories, Ltd., announced today that the US Food and Drug Administration (FDA) has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) for Cetirizine HCL...
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/RTT News/ 5/30/2007 7:02:23 PM Wednesday, the Department of Justice announced that Bristol-Myers Squibb Co. (BMY), agreed to plead guilty to two counts of making false statements to the Federal Trade Commission, related to its botched Plavix settlement negotiations with a privately held Canadian firm, Apotex Inc. Bristol-Myers has also agreed to pay an aggregate statutory maximum fine of $1 million...
Click here to read full article (www.rttnews.com)...
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PITTSBURGH, May 30 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. (NYSE: MYL) announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its supplemental Abbreviated New Drug Application (ANDA) for Fluoxetine Capsules USP, 40 mg....
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PITTSBURGH, May 31, 2007 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. announced today that the United States District Court for the Southern District of New York has ruled that Mylan's 10 mg and 20 mg omeprazole delayed-release capsules, which are the generic versions of AstraZeneca LP's Prilosec (R), do not infringe patents asserted against it by AstraZeneca. The Court also found that omeprazole products from Apotex and Impax do infringe the same patents asserted against Mylan....
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PITTSBURGH, May 31, 2007 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. today announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Applications (ANDAs) for Azithromycin Tablets...
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PITTSBURGH, May 31, 2007 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. today announced that Mylan Pharmaceuticals Inc. has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Paroxetine Hydrochloride Extended-release Tablets...
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/The Wall Street Journal/ May 31 2007 New Delhi: In what appears to be a response to growing criticism of drug companies globally over patents, German drug maker Boehringer Ingelheim GmbH has decided not to enforce patents on its anti-HIV drug, Nevirapine, in 78 low-income African and Asian countries, including India. Industry watchers see the move as an olive branch, if not a savvy public relations exercise...
Click here to read full article (www.livemint.com)...
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/FDA news/ May 31, 2007 -- The Department of Justice (DOJ) is recommending that the Supreme Court refuse to hear a case that would determine whether reverse-payment agreements are prohibited under federal antitrust law. The plaintiffs alleged that the companies’ patent settlement over AstraZeneca’s breast cancer drug Nolvadex (tamoxifen citrate) was anticompetitive.
Click here to read full article (fdanews.com)
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/Patent Docs Blog/ May 31, 2007 -- On Thursday, the California Healthcare Institute (CHI), an independent organization comprising more than 250 biomedical companies, academic and research institutions, and companies involved in supporting the biomedical community, released a white paper entitled "Impact of Patent Law Changes on Biomedical Investment and Innovation." The CHI white paper analyzes the implications of recent patent law developments on the biomedical industry, and concludes that a handful of Supreme Court decisions, Congress' attempt to enact patent reform legislation, and the Patent Office's push for new patent rules have combined to reduce the value of life sciences patents will have a "chilling effect on biomedical investment and innovation."
Click here to read full article (patentdocs.typepad.com)...
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/TheStreet.com/ 5/31/2007 -- When Barr Pharmaceuticals (BRL) went to court last week against Johnson & Johnson (JNJ) , it wasn't a typical patent battle. That's because the contest over J&J;'s Razadyne, a drug for mild to moderate Alzheimer's disease, will serve as an early test of how a recent Supreme Court ruling may improve the efforts of generic-drug makers to challenge patents...
Click here to read full article (www.thestreet.com)...
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BENTONVILLE, Arkansas (Reuters) May 31, 2007 - Wal-Mart Stores Inc. said on Thursday that just six months after completing the roll-out of its $4 generic prescription drug program, 37.8 percent of all prescriptions it fills are $4 prescriptions.
Click here to read full article (www.nytimes.com)...
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