Generics Industry News Search
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March 2011 News Archive |
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Genentech Inc allegedly colluded with Celltech R&D; Ltd to fraudulently extend the life of a disputed patent and reaped more than a $1 billion in royalties, according to a lawsuit by rival drugmaker Human Genome Sciences Inc...
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Elan Corporation plc and Celgene Corporation, today announced that Elan subsidiary Elan PharmaInternational Limited has entered into a settlement and license agreement with Celgene Corporation resolving the patent infringement litigation involving ABRAXANE(R)...
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Daiichi Sankyo Company, Limited, today announced that it has concluded an agreement to acquire Plexxikon Inc., a privately held pharmaceutical company based in Berkeley, California with a late-stage oncology product, PLX4032, as well as a promising pipeline and technology platform...
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Pfizer Inc. today announced that it has combined operations with King Pharmaceuticals, Inc. On February 28, 2011, Pfizer completed its acquisition of King through the merger of its wholly owned subsidiary, Parker Tennessee Corp., with and into King...
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Mylan Inc. today confirmed that the company has been sued by Vivelle Ventures LLC, Noven Pharmaceuticals Inc. and Novartis Pharmaceuticals Corporation in connection with the filing of an Abbreviated New Drug Application with the U.S. Food and Drug Administration for Estradiol Transdermal System, USP (Twice-Weekly), 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day and 0.1 mg/day...
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Stanford University faces off against the pharmaceutical company Roche this week before the U.S. Supreme Court. The case addresses the question of who owns the rights to university research funded by the federal government...
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Teva Pharmaceutical Industries Ltd. today announced that the United States District Court for the Southern District of New York has set a trial date of September 7, 2011 in the Company's ongoing patent infringement litigation against Momenta Pharmaceuticals, Inc./Sandoz Inc. and Mylan Pharmaceuticals, Inc./Mylan Inc./Natco Pharma Ltd. regarding their purported generic versions of COPAXONE (glatiramer acetate injection)...
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GenericsWeb, the leader in established pharmaceutical patent analysis and searching, recently published an article that analyses opportunities in launching generic versions of Olanzapine....
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Generic drugs are expected to enjoy a banner year in 2011, prompting some investment pros to reformulate their portfolios to get a jump on the transition
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Patents are about to expire on more than a dozen of the most-used drugs, and cheaper generics are on the way, Channel 4 Action News' Michelle Wright reported...
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Roche announced today that the European Commission confirmed that Avastin (bevacizumab) in combination with paclitaxel will remain a treatment option for women with metastatic breast cancer in Europe...
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Handa Pharmaceuticals, LLC, a specialty pharmaceutical company based in Fremont, California, today confirmed that its Abbreviated New Drug Application for Dexlansoprazole Delayed Release Capsules, 60 mg, a generic version of Takeda's DEXILANT, has been accepted for review by the U.S. Food and Drug Administration...
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Patients battling cancer, infections and mental illness joined a rally here today beseeching the government to reject a trade pact with the European Union that they fear will threaten the availability of inexpensive generic medicines in India...
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Amneal Pharmaceuticals, LLC is pleased to announce that it received U.S. FDA approval for Indomethacin Extended Release capsules, USP in the 75 mg strength effective December 1, 2010...
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Eisai Co. forecast sales will be little changed for the next five years after losing patent protection on its Aricept pill, the world's bestselling treatment for Alzheimer's disease...
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According to pharmaceutical analyst Sophia Snyder at research firm IBISWorld, generics now average about 30 percent of the price of the brand-name originals
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Qualitest Pharmaceuticals today announced that the U.S. Food and Drug Administration has approved Emoquette (Desogestrel and Ethinyl Estradiol Tablets. 0.15mg/0.03mg, generic Ortho-Cept) for the prevention of pregnancy in women who elect to use oral contraceptives for the prevention of pregnancy...
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Harris & Harris Group, Inc. notes that Amgen and BioVex Group, Inc., today announced the completion of the acquisition of BioVex Group, Inc...
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ISTA Pharmaceuticals, Inc., announced it filed a Citizen Petition (CP) with the U.S. Food and Drug Administration (FDA) on March 1, 2011. The CP requests the FDA refrain from granting tentative or final approval of any abbreviated new drug application (ANDA) for bromfenac sodium ophthalmic solution 0.09% that utilizes the labeling for discontinued XIBROM (bromfenac ophthalmic solution)(R) 0.09% or omits any portion of the BROMDAY label relating to the once-per-day dosing...
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In a CNBC-TV18 exclusive Dr Reddy's chairman Anji Reddy says the pharmaceutical major's goal is to sell USD 1 billion branded generics in three years...
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The board of directors of Hospira, Inc., a global specialty pharmaceutical and medication delivery company, today announced the election of F. Michael Ball as the company's new chief executive officer and a member of the board, effective March 28, 2011...
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The U.S. Supreme Court on Monday rejected a challenge to a 1997 settlement in which Bayer AG paid Barr Pharmaceuticals Inc. to drop an early bid to market a generic version of Cipro, an antibiotic drug...
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On March 7th, the U.S. Supreme Court denied yet another Petition for Writ of Certiorari concerning whether patent settlement agreements (what opponents call "pay-for-delay" agreements or "reverse payments") are unlawful and violate the antitrust laws...
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Banning patents on biological materials will harm Australian patients, destroy Australian jobs and stall medical research, Medicines Australia has told a Senate Committee
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The European Commission welcomes the delivery today of the opinion of the Court of Justice of the EU on the compatibility of the envisaged agreement on the European and EU Patent Court with the EU Treaties. Now that the opinion is available, the Commission will analyse it very carefully with a view to identifying appropriate solutions...
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The U.S. Senate gave its near-unanimous support Tuesday to the first major overhaul of patent law in more than 50 years, voting 95-5 to approve the wide-reaching legislation and send it to the U.S. House of Representatives...
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On Monday, the U.S. Supreme Court on Monday let stand a ruling allowing drug companies to pay competitors to delay the production of generic drugs, the San Francisco Business Times reports...
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"Novartis v Actavis: ruling on the merits confirms scope of SPC" is the title of this blog's first note from Norway -- and also one of the first full hearings on the merits of any litigation relating to Novartis' compound valsartan...
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Doctors are being contacted to organize a clinical trial for a copy of Teva Pharmaceutical Industries Ltd.'s multiple sclerosis medicine Copaxone, a Teva executive said...
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Hospira Inc won approval for the first U.S. generic version of Sanofi-Aventis SA's big-selling Taxotere cancer drug, sending Hospira shares up 2 percent...
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There could soon be some good news for consumers weary of soaring health care costs: The patents for several best-selling medications will expire this year, clearing the path for lower-cost generics to take their place...
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Home-grown pharma major Dr Reddy's Laboratories may launch three new drugs in the US market next fiscal after the settlement of disputes with foreign players over the rights to two of them and a favourable court ruling in a third case...
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A federal private member's bill that would make it possible for Canadian generic-drug companies to supply developing countries with affordable medication will go to a vote tonight in the House of Commons....
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The average cost of brand-name prescription drugs in upstate New York rose 93 percent between 2004 and 2010 and 11 percent between 2009 and 2010, according to a new report by the Rochester region's largest health insurer, Excellus BlueCross BlueShield....
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Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received final approval from the U.S. Food and Drug Administration under the President's Emergency Plan for AIDS Relief for its New Drug Application for Zidovudine Tablets, 100 mg...
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Since 2009, we have been tracking the story surrounding Genzyme's enzyme replacement drug Fabrazyme, which started with a problem at Genzyme's manufacturing facilities and led to nationwide shortages of the drug...
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Canadian lawmakers approved a bill aiming to ease the process that lets generic drug manufacturers produce patented medicines for export to poor nations at cheaper prices in a move the pharmaceutical industry says could undermine intellectual property rights....
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Big Pharma faces a host of well-known problems, most notably that its blockbuster drugs are coming off patent at the same time that its pipeline of new drugs has turned into a drip...
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About Court Report: Each week we will report briefly on recently filed biotech and pharma cases...
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Watson Pharmaceuticals, Inc. today announced that the United States District Court for the District of Delaware has ruled that Watson's generic version of Fentora does not infringe United States Patent Nos. 6,200,604 or 6,974,590...
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Glenmark Pharmaceuticals has received the maximum number of approvals to sell lowcost medicines in the US this fiscal, ahead of bigger peers such as Sun Pharma, Ranbaxy Laboratories and Dr Reddy's, that will support its revenue growth in the coming quarters. ...
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Today, Senate Health, Education, Labor and Pensions Committee Chairman Tom Harkin, along with Senators Jay Rockefeller, Charles Schumer, Debbie Stabenow and Sherrod Brown sent a letter to Food and Drug Administration Commissioner Dr. Margaret Hamburg urging the FDA to help ensure Americans have access to affordable generic drugs as soon as possible by making timely regulatory decisions...
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Cephalon Inc., maker of the painkiller Fentora, asked a federal judge to block the sale of a competitor's generic version of the drug, alleging it is potentially dangerous...
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M&As;, like that between Pfizer and Wyeth, and joint ventures have been increasingly common over the past several years as companies seek to replace revenue loss associated with the impending patent cliff for their blockbuster products....
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Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, today announced the signing of a global settlement agreement among Alnylam, Max Planck Society, the Whitehead Institute for Biomedical Research and the University of Massachusetts resolving their ongoing litigation regarding the Tuschl patents...
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Optimer Pharmaceuticals, Inc. announced today that the United States Patent and Trademark Office has issued U.S. Patent 7,906,489 which covers methods of Clostridium difficile infection treatment with fidaxomicin...
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Gilead Sciences Inc. and units of patent-partner Roche Holding AG sued Indian generic drugmaker Natco Pharma Ltd. for allegedly infringing a U.S. patent for the Tamiflu influenza medication...
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India's Dr. Reddy's Laboratories has filed an abbreviated new drug application with the U.S. Food and Drug Administration to sell a generic version of Pozen Inc.'s osteoarthritis drug, Vimovo, according to an SEC filing...
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AstraZeneca lawyers went to court in France on Thursday to defend the company's blockbuster heartburn and stomach ulcer drug Nexium from generic competition in Europe's biggest market for the product...
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National Pharmaceutical Pricing Authority has invoked the public interest clause in the Drugs Price Control Order to fix the price of an epileptic drug of Abbott Healthcare, the wholly owned subsidiary of the US pharmaceutical giant which sells the branded generic drugs it acquired from Piramal Healthcare in India...
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GenericsWeb, the leader in established pharmaceutical patent analysis and searching, recently published an article that analyses opportunities in launching generic versions of Remifentanil....
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Astellas Pharma Inc. today announced that it has exercised a buy-out option to acquire all of the ownership interest of Maxygen, Inc. in Perseid Therapeutics LLC, the joint venture between Maxygen and Astellas...
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Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, is reporting the filing of a complaint by Tekmira Pharmaceuticals Corporation in the Business Litigation Session of the Massachusetts Superior Court...
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Astellas Pharma Inc. said its OSI Pharmaceuticals subsidiary, along with Roche Holding AG's Genentech and Pfizer Inc., will terminate a case against Teva Pharmaceutical Industries Ltd. relating to patents for the cancer drug Tarceva...
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Elite Pharmaceuticals, Inc. announces the settlement of a lawsuit filed in the Superior Court of New Jersey, Chancery Division: Bergen County entitled ThePharmaNetwork, LLC v. Elite Pharmaceuticals, Inc...
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Depomed will regain from Abbott Laboratories the rights to its drug Gralise, it said Thursday, and will receive a $40 million from the company...
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Eli Lilly & Co.'s patent- infringement claim over Hospira Inc.'s generic version of the cancer treatment Gemzar will be investigated by a U.S. trade agency with the power to block imports of the copycat drug...
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The U.S. government and Johnson & Johnson each filed patent-infringement lawsuits against Teva Pharmaceutical Industries Ltd. TEVA to block sales of a generic version of the HIV medicine Prezista...
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Drugmaker Eli Lilly, which faces plunging sales due to competition and lapsing patents, will not merge with another peer to ride out any rough times ahead, chief executive John Lechleitr said on Saturday...
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Should generic drugmakers be liable for labeling errors made by brand-name companies?
It's a question the U.S. Supreme Court will examine March 30 when it hears arguments in the case of Mensing v. Pliva Inc. Gladys Mensing sued the generic drug company Pliva in 2005, claiming she developed the neurological disorder tardive dyskinesia after using metoproclamide to treat a gastric ailment...
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Gilenya approved in the EU for people with highly active relapsing-remitting multiple sclerosis despite treatment with beta interferon, or in patients with rapidly evolving severe RRMS...
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Cephalon, Inc. announced today that it has signed a definitive merger agreement under which it will acquire all of the outstanding capital stock of Gemin X Pharmaceuticals, Inc., a privately-held biopharmaceutical company developing first-in-class cancer therapeutics, for $225 million cash on a cash-free, debt-free basis. Gemin X stockholders could also receive up to $300 million in cash payments upon the achievement of certain regulatory and sales milestones...
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Watson Pharmaceuticals today confirmed that its subsidiary, Watson Laboratories, Inc. has launched Famciclovir tablets, 125 mg, 250 mg and 500 mg, the generic version of Novartis' Famvir following approval of its Abbreviated New Drug Application by the U.S. Food and Drug Administration...
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Mylan Inc. sued the U.S. Food and Drug Administration, seeking to block India's Ranbaxy Laboratories Ltd. exclusive rights to sell a generic version of Pfizer Inc. cholesterol pill Lipitor, the world's best- selling medicine...
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Novartis announced today that it completed the transaction to acquire an 85 percent stake in the Chinese vaccines company Zhejiang Tianyuan Bio-Pharmaceutical Co., Ltd....
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POZEN Inc., a pharmaceutical company committed to transforming medicines that transform lives, today announced that it has filed a motion for a preliminary injunction seeking to prevent Par Pharmaceuticals, Inc. from launching a generic version of Treximet (sumatriptan and naproxen sodium)...
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Drug firm Aurobindo Pharma today said it has received final approval from the US health regulator to market Famciclovir tablets, used for treating herpes simplex infections in HIV-infected patients, in the American market...
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Glenmark remains the only Indian company to be granted an ANDA approval for an oral contraceptive product in the US. Today's approval marks the fourth female hormonal product authorised for distribution in the US...
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The Procter & Gamble Company and Teva Pharmaceutical Industries Ltd. today announced the signing of a master agreement to create a partnership in consumer health care by bringing together both companies' existing over-the-counter medicines and complementary capabilities to accelerate growth...
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Portola Pharmaceuticals and Merck, known as MSD outside the United States and Canada, today announced that Merck plans to return to Portola all rights for betrixaban, an investigational oral Factor Xa inhibitor anticoagulant being evaluated for the prevention of stroke in patients with atrial fibrillation (SPAF)...
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Cephalon, Inc. announced that today the United States District Court in Delaware upheld the validity of Cephalon's U.S. Patent Number6,264,981 patent and found that Watson Pharmaceuticals, Inc.'s proposed generic version of FENTORA(R) (fentanyl buccal tablet) infringes that patent...
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Bayer AG, Europe's biggest drug and chemical maker, won a U.K. court ruling upholding the validity of two patents for its birth-control pill Yasmin after a challenge by Hungary's Gedeon Richter Nyrt...
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Qualitest Pharmaceuticals today announced that the U.S. Food and Drug Administration has approved Toresmide tablets (generic Demadex)in 5 mg, 10 mg, 20 mg and 100 mg strengths...
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Watson Pharmaceuticals, Inc. today confirmed that its subsidiaries, Andrx Labs, LLC and Watson Laboratories, Inc. -- Florida, filed Abbreviated New Drug Applications with the U.S. Food and Drug Administration seeking approval to market Oxycodone Hydrochloride Extended-Release tablets in the 10,15, 20, 30, 40, 60 and 80 mg strengths...
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Watson Pharmaceuticals, Inc., a leading integrated global pharmaceutical company, today confirmed that it has received a favorable decision from the U.S. Court of Appeals for the Federal Circuit related to its ongoing patent challenge in connection with Watson's Abbreviated New Drug Application seeking FDA approval to market a generic version of Teva Women's Health, Inc.'s SEASONIQUE (levonorgestrel/ethinyl estradiol (0.15 mg/0.03 mg) and ethinyl estradiol (0.01 mg))...
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Dr. Reddy's Laboratories has launched Levocetirizine tablets, a bioequivalent generic version of Xyzal tablets in the US market...
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Dr Reddy's Laboratories Limited has launched Levocetirizine tablets (5mg), a bioequivalent generic version of Xyzal tablets in the USA market, the company said today....
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Andrx Labs and Watson Laboratories, subsidiaries of Watson Pharmaceuticals, have submitted abbreviated new drug applications for marketing Oxycodone Hydrochloride extended-release tablets in the 10, 15, 20, 30, 40, 60 and 80mg strengths with the US Food and Drug Administration....
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Cephalon, Inc. and ChemGenex Pharmaceuticals Limited today jointly announced that Cephalon's wholly-owned subsidiary, Cephalon CXS Holdings Pty Ltd, intends to make a takeover bid for ChemGenex...
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Actavis has received approval from the FDA to market Valacyclovir Hydrochloride Tablets...
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Valeant Pharmaceuticals International, Inc. today announced that it had made a proposal to the Board of Directors of Cephalon, Inc., to acquire Cephalon for $73.00 per share in cash...
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India today ruled out sharing test data of drugs, or data exclusivity, of Indian pharma firms with developed countries and multi-national companies, and stressed that the provision will not form part of any free trade agreements pursued by the country...
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GlaxoSmithKline, which has the marketing rights for Lovaza (omega 3 acid ethyl esters) in the US and Puerto Rico, confirmed today that Pronova BioPharma Norge AS, which owns the patents for Lovaza, has entered into an agreement with Apotex Corp. and Apotex Inc. (collectively 'Apotex'), to settle their patent litigation in the United States related to Lovaza. ...
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Pharmacies can continue to compound generic hydroxyprogesterone caproate for reducing the risk for preterm delivery despite warnings from KV Pharmaceutical which sells a costly, branded version of the drug not to do so, the US Food and Drug Administration announced today....
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Pronova BioPharma announced today that it has entered into an agreement with Apotex Corp. and Apotex Inc. to settle patent litigation regarding Apotex's proposed generic version of Lovaza yesterday...
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