Generics Industry News Search
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December 2010 News Archive |
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Endo Pharmaceuticals announced today the completion of its acquisition of Qualitest Pharmaceuticals. Endo announced Sept. 28 that it entered into a definitive agreement to acquire Qualitest Pharmaceuticals, a leading, privately held generics company in the U.S., for approximately $1.2 billion in cash...
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Eurand N.V., a global specialty pharmaceutical company, and Axcan Holdings, Inc., a leading pharmaceutical company focused on the treatment of gastrointestinal disorders, today announced that they have entered into a definitive agreement under which Axcan will acquire all the outstanding shares of Eurand for $12.00 per share in cash...
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Adamis Pharmaceuticals Corporation, announced the signing of a strategic manufacturing, supply, and product development agreement with Beximco Pharmaceuticals Ltd...
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Teva Pharmaceutical Industries Ltd. has agreed not to sell a generic version of the sleep medicine Lunesta until at least 2013, settling a patent suit brought by the drug's manufacturer Dainippon Sumitomo Pharma Co.'s Sunovion Pharmaceuticals Inc...
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Teva Pharmaceutical Industries Ltd. commented today on the patent infringement lawsuit filed by Momenta Pharmaceuticals, Inc. and Sandoz Inc...
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Kadmon Pharmaceuticals announced today that Three Rivers Pharmaceuticals, a Kadmon Company, has received approval from the US Food and Drug Administration to market Topotecan Hydrochloride for Injection, 4 mg (base)/vial, the generic version of GlaxoSmithKline's Hycamtin...
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Fasken Martineau LLP's intellectual property team headed by Julie Desrosiers has won a drug patent case launched against an international pharmaceutical company by three generic drug manufacturers...
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J B Chemicals & Pharmaceuticals today said it has received US health regulator's nod to market a generic version of diclofenac sodium tablets, an anti-inflammatory drug, in the American market....
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Momenta Pharmaceuticals Inc. said Thursday it is suing rival Teva Pharmaceutical Industries Ltd. in a patent dispute over generic versions of the anti-clotting drug Lovenox...
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In encouraging news for generic drug industry and public health, the Supreme Court on Wednesday dismissed German MNC Bayer Corporation's appeal against the Delhi high court's decision on its plea for "patent linkage" ....
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Sagent Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company, today announced U.S. FDA approval and launch of its topotecan hydrochloride for injection, a chemotherapy agent, in conjunction with the innovator's patent expiry...
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Sagent Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company, today announced U.S. FDA's approval of four presentations of midazolam injection, USP, a general anesthetic...
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Shire plc announced that its subsidiary Shire LLC has filed a lawsuit in the U.S. District Court for the Northern District of California against Impax Laboratories, Inc. and Watson Pharmaceuticals...
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Impax Laboratories, Inc. today confirms that it has initiated a challenge of patents listed by Shire Development Inc. in connection with INTUNIVTM (guanfacine hydrochloride), 4 mg...
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Aurobindo Pharma Limited is pleased to announce that the company has received tentative approval from the US Food & Drug Administration to manufacture and market Duloxetine Hydrochloride Delayed-Release Capsules 20mg (base), 30mg (base) and 60mg (base)....
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AstraZeneca, which makes the best-selling heartburn drug Nexium, has been raided by EU antitrust regulators investigating suspected collusion to block the sale of cheaper generic medicines...
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AstraZeneca Plc, the U.K.'s second- biggest drugmaker, and Nycomed A/S were raided by European Union antitrust officials as part of a probe into whether companies colluded to keep cheaper copies of medicines off the market. ...
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BIOPHARMA analyzes the U.S. Biopharmaceuticals Market and its growth factors, with special emphasis on the top companies in the field and their product pipeline...
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Drug maker Glenmark today said it along with its US-based partner has got the US health regulator's nod to manufacture and market two oxycodone products, used for treating moderate to severe pain, in the American market....
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Several different generic formulations of clopidogrel sold in India and Europe contain significant levels of methyl chloride, a known toxin and mutagen....
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A federal judge has order Watson CEO Paul Bisaro to comply with an FTC subpoena for a case involving a patent settlement between the generic drugmaker and Cephalon over the narcolepsy drug Provigil....
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A generic form of the fibromyalgia drug Cymbalta (duloxetine) has received tentative approval from the U.S. FDA. Impax Laboratories sought approval for delayed-release 20, 30 and 60 mg duloxetine capsules...
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A panel of drug experts has advised that the FDA issue warnings concerning a rate and debilitating condition caused by Dilantin and generic phenytoin intravenous equivalents...
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AstraZeneca announced today that the European Commission has granted marketing authorisation to BRILIQUE (ticagrelor tablets) for the prevention of atherothrombotic events in adult patients with Acute Coronary Syndromes...
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Maruho Co., Ltd. and Astellas Pharma Inc. announced that the companies have agreed that Astellas will assign detailing/promotional activities for Protopic (tacrolimus hydrate) in Japan to Maruho on April 1, 2011 and thereafter will transfer its distribution right in Japan to Maruho on April 1, 2014...
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Anchen Pharmaceuticals, Inc. announced today that U.S. FDA has granted final approval for the Company to market the 12.5mg strength of Zolpidem Tartrate ER Tablets...
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Watson Pharmaceuticals, Inc. and Natco Pharma Limited today confirmed an exclusive, U.S. development and license agreement, to develop and commercialize lenalidomide 5, 10, 15 and 25 mg tablets...
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Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration under the President's Emergency Plan for AIDS Relief for its New Drug Application for Abacavir Sulfate Tablets, 60 mg...
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Cytori Therapeutics and Astellas Pharma Inc. have entered into a strategic equity agreement to evaluate the potential of adipose derived stem and regenerative cells for the treatment of serious illnesses for which there is no fundamental treatment...
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GlaxoSmithKline plc today announced that it has entered into an agreement to acquire Nanjing MeiRui Pharma Co., Ltd for a cash consideration of approximately $70 million...
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The European Medicines Agency has been formally notified by Sanofi Pasteur of its decision to withdraw its application for a centralised marketing authorisation for Emerflu, a pandemic influenza vaccine...
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Caraco Pharmaceutical Laboratories, Ltd. reports receipt of a proposal from Sun Pharmaceutical Industries Ltd. and Sun Pharma Global, Inc for a going private transaction by which Sun, Sun Global, and/or one or more of their affiliates would acquire all of the outstanding shares of Caraco common stock not held by Sun or Sun Global for a per share consideration of $4.75 in cash...
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Intellipharmaceutics International has submitted an abbreviated new drug application with the US Food and Drug Administration for approval to market a generic of the 30mg strength of Focalin XR (dexmethylphenidate hydrochloride)...
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Avid Bioservices, Inc., a leading provider of integrated biomanufacturing services and a subsidiary of Peregrine Pharmaceuticals, Inc. today announced an agreement to provide services for a privately held U.S. and China-based biopharmaceutical company focused on developing biosimilars for global commercialization...
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U.S. drugmaker Cephalon has announced that it will take a 20 percent stake in Australian biotechnology company Mesoblast as part of an alliance to develop and market stem cell treatments for degenerative conditions of the cardiovascular and central nervous systems...
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Ranbaxy Laboratories and Teva Pharmaceutical Industries have won FDA approval to market generic versions of Eisai's blockbuster Alzheimer's drug Aricept and will share 180-day exclusivity on the drug...
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On the back of government support, Brazil generics market will post a CAGR of nearly 19% during 2010 - 2012, says RNCOS....
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Strides Arcolab Limited today announced that it has entered into an agreement to acquire 70% stake in Bangalore-based biotechnology firm, Inbiopro Solutions. The acquisition marks Strides' foray into biologics, strengthening the Company's offering in the Specialty segment...
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Amneal Pharmaceuticals, LLC is pleased to announce that Robert Loewenstein, Esq. has joined the company as General Counsel/Senior Vice President...
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Biogen Idec Inc. is likely to produce generic versions of biologic drugs as that niche industry develops and patents expire, marking a new foray for the biotech company, Chief Executive George Scangos said...
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On August 2, patients with the rare Fabry disease petitioned the Department of Health and Human Services to exercise the "march-in" powers under the federal Bayh-Dole Act, and issue an open license to use patents needed to manufacture Genzyme's enzyme replacement drug Fabrazyme...
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Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Nifedipine Extended-release Tablets USP, 30 mg, 60 mg and 90 mg, the generic version of Bayer's Adalat CC Tablets, a treatment for hypertension...
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Strides Arcolab Limited today announced that it has received USFDA approval for Lidocaine Hydrochloride Injection USP, 0.5% (5 mg/mL), 1% (10 mg/mL), Multi-dose vials...
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On December 9, 2010, the Federal Court of Appeal upheld the data protection provision of the Food and Drug Regulations: Canadian Generic Pharmaceutical Association v. Canada (Health), 2010 FCA 334...
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The free trade agreement currently under negotiation between India and European Union threatens the production of generic medicines which will among others affect HIV patients, a top UN official said on Friday...
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In October, when AstraZeneca announced its most recent financial results, the drug giant said cheaper generic competition was beginning to erode sales on some key drugs...
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The US Supreme Court has said that it would decide whether generic drug companies could be sued under state law over allegations they failed to provide adequate label warnings about potential side effects...
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Teva Pharmaceutical Industries Ltd. today announced that the company has filed a Citizen Petition with the U.S. Food and Drug Administration requesting that the FDA refuse to approve any abbreviated new drug application for a purported generic version of COPAXONE (glatiramer acetate injection)...
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Brazil, one of the major emerging powers of the world, is marking its presence in almost every dimension of the global economy, including the generic drugs industry. The generics industry has registered a significant growth rate over the last few years...
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The U.S. Supreme Court has decided to hear an appeal filed by generic drug makers, who say that federal laws requiring their labels to match those of the original medication should allow them to escape liability from product liability lawsuits that allege they failed to properly warn about dangerous drug side effects...
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Reckitt Benckiser Group plc today announces that it has agreed to buy Paras Pharmaceuticals Limited for INR 32.6 billion (approximately GBP 460 million) from the current shareholders, including the Patel family and Actis, the emerging markets private equity investor. RB will finance the transaction from existing facilities...
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Sanofi-aventis announced today that it has extended its tender offer for all outstanding shares of common stock of Genzyme Corporation at $69.00 per share, net to the seller in cash, without interest and less any required withholding taxes...
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Luitpold Pharmaceuticals, Inc. a New York based U.S. subsidiary of Daiichi Sankyo Co., Ltd. announced today that it has signed a binding merger agreement with ROXRO PHARMA, Inc., a privately held U.S. specialty pharmaceutical company, developing products for the treatment of acute pain conditions. The financial terms of the acquisition were not disclosed...
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Handa Pharmaceuticals, LLC, a specialty pharmaceutical company based in Fremont, California, today announced that the U.S. Food and Drug Administration has granted tentative approval of the Company's Abbreviated New Drug Application for Quetiapine Fumarate Extended-Release Tablets, 50 mg., 150 mg., 200 mg., 300 mg., and 400 mg., a generic version of AstraZeneca's SEROQUEL XR...
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Watson Pharmaceuticals and its CEO, the targets of some seemingly heavy-handed investigation tactics by Federal Trade Commission (FTC) officials this year, suffered another setback last week to their forceful efforts to oppose the Commission...
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Gedeon Richter Plc and Mochida Pharmaceutical Co. Ltd. today announce that the two companies have entered into a comprehensive and long term license and collaboration agreement in respect of development and marketing of Richter's biosimilar product portfolio...
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Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc. - Florida, filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration seeking approval to market Hydromorphone Hydrochloride Extended-release Tablets, 8 mg, 12 mg, and 16 mg...
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Aspen ARV tender bid is successfulFollowing the announcement of the Anti-Retroviral Tender results by the South African National Treasury Department, Aspen Pharmacare Holdings Limited is pleased to announce that its South African operating company has been successful in winning a number of key products in the tender, including Efavirenz and Tenofovir, in spite of strong competition. The tender is effective for a period of two years, commencing 01 January 2011...
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Watson Pharmaceuticals Inc. said Covidien Plc's Mallinckrodt unit sued the company to block a generic version of the painkiller Exalgo...
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Aceto Corporation, a global leader in the sourcing, quality assurance, regulatory support, marketing and distribution of pharmaceuticals, nutraceuticals, specialty chemicals and crop protection products, today announced that it has signed a definitive purchase agreement for its wholly-owned subsidiary to acquire certain assets of Rising Pharmaceuticals, Inc...
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Household products group Reckitt Benckiser has been fined 10.2m pounds after admitting abuse of a dominant position in the market for the supply of its heartburn medicines to the NHS...
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Novartis announced today that it has entered into a definitive agreement with Alcon, Inc. to merge Alcon into Novartis for Novartis shares and a Contingent Value Amount...
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Cypress Bioscience, Inc., a pharmaceutical company engaged in the development of innovative drugs to treat central nervous system disorders, announced today that it has entered into a definitive merger agreement with Ramius V&O; Acquisition LLC, an affiliate of Ramius LLC and affiliates of Royalty Pharma, providing for the acquisition of Cypress by Ramius and Royalty Pharma...
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As talks for the free trade agreement between India and the European Union came to an end on December 10, several questions were raised about its impact on the Indian generic drugs market...
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AstraZeneca Plc, maker of the cholesterol pill Crestor, can't use patents expiring in 2018 and 2022 to block generics planned by companies including Mylan Inc. and Teva Pharmaceutical Industries Ltd., a U.S. judge ruled...
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Mylan Inc. today confirmed that the company and its subsidiary Mylan Pharmaceuticals Inc. have been sued by Shionogi Pharma Inc. and CIMA LABS INC. in connection with the filing of an Abbreviated New Drug Application with the U.S. Food and Drug Administration for Prednisolone Sodium Phosphate Orally Disintegrating Tablets, 10 mg, 15 mg and 30 mg. This product is the generic version of Orapred ODT, a corticosteroid indicated as an anti-inflammatory or immunosuppressive agent for the treatment of certain endocrine conditions and for palliation of certain neoplastic conditions...
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I have already written about the investigation launched last October by the Italian antitrust authority on an alleged abuse of a dominant position by Pfizer in relation to the manner in which Pfizer enforced or attempted to enforce its patent rights...
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Generic-drug companies, led by Teva Pharmaceutical Industries, would face fewer factory inspections and save as much as a year developing products in exchange for paying fees for the first time under a Food and Drug Administration proposal...
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About Court Report: Each week we will report briefly on recently filed biotech and pharma cases...
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Generics Limited, today announced they have been granted final approval from the United States Food and Drug Administration for Felodipine extended-release tablets, the generic version of Astrazeneca Pharmaceuticals LP, Plendil...
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Sonke Pharmaceuticals Ltd, a marketer and distributor of generic anti-retroviral medication, has been awarded R913.5mn of the R4.28bn national ARV tender. Sonke will supply the South African Government with ARVs for the next two years...
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Undettered by American drug regulator USFDA's no to an earlier request, Lupin Pharma has requested it to cancel acceptance of any generic drug application of anti-cholesterol drug Antara, if the generic product does not have the same dosage...
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Gilead Sciences, Inc. and Arresto Biosciences, Inc., a privately-held, development-stage biotechnology company focused on medicines to treat fibrotic diseases and cancer, today announced the signing of a definitive agreement pursuant to which Gilead will acquire Arresto...
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Biogen Idec and Neurimmune Holding AG today announced that Biogen Idec has acquired a subsidiary of Neurimmune, which includes the world-wide rights to three pre-clinical immunotherapy programs...
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Eli Lilly and Company today announced that it has completed the acquisition of Avid Radiopharmaceuticals, Inc., a privately held company developing novel molecular imaging compounds intended for the detection and monitoring of chronic human diseases...
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Swiss drugmaker Hoffmann-La Roche and Warner Chilcott Company have sued Sun Pharma Global Inc, an arm of Sun Pharmaceutical Industries, in the US for alleged patent infringement of Actonel (risedronate sodium tablets in 150 mg form), used for treating bone disorder disease osteoporosis...
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Based on its proprietary Pipeline Patent Intelligence, GenericsWeb reveals that the patent protection for the Docetaxel molecule in US and European countries expired in November 2010, however the innovator, Sanofi-Aventis now relies mainly on key formulation patents to protect its Taxotere market from generic erosion. ...
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Genmed Holding Corp. is announcing its entry into the European generic drug market with the receipt of its first marketing and distribution license for paracetamol....
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Teva Pharmaceutical Industries Ltd. announced today that it has entered into an agreement with Takeda Pharmaceutical Company Limited to settle patent litigation related to Teva's generic versions of Takeda's ACTOS (pioglitazone HCl) and ACTOplus met (pioglitazone HCl and metformin HCl) for the United States....
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Takeda Pharmaceutical Company Limited today announced that Takeda and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc., have completed settlements with all defendants in patent litigation brought against the companies in response to their Abbreviated New Drug Applications for generic ACTOS (pioglitazone HCl), ACTOplus met (pioglitazone HCl and metformin HCl), and duetact (pioglitazone HCl and glimepiride)...
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Teva Pharmaceutical Industries Ltd. said Tuesday it will start selling a generic version of the diabetes drug Actos after settling a patent infringement lawsuit brought by the company that makes Actos, Takeda Pharmaceutical Co...
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Intellipharmaceutics International Inc., today announced that it has notified the U.S. Food and Drug Administration that it has not received notification, as provided for under the Hatch-Waxman Act, of any patent infringement proceedings by the brand owner, Wyeth Pharmaceuticals, Inc., a wholly-owned subsidiary of Pfizer, Inc., for its application to market a generic of Wyeth's Protonix (delayed-release pantoprazole sodium) tablets...
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Abbott announced today that Abbott and AstraZeneca will discontinue their joint collaboration for the development of CERTRIAD (rosuvastatin / fenofibric acid delayed release) capsules...
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Biogen Idec and Elan Corporation, plc announced that the companies have submitted a supplemental Biologics License Application to the U.S. Food and Drug Administration and a Type II Variation to the European Medicines Agency to request review and approval to update the respective TYSABRI Prescribing Information and Summary of Product Characteristics...
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PDL BioPharma, Inc. today announced that on December 15, 2010, the U.S. Patent and Trademark Office terminated its interference proceeding between certain claims of the Company's Queen et al...
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Teva Pharmaceutical Industries Ltd. announced today that it has received a complete response letter from the U.S. Food and Drug Administration for its supplemental New Drug Application for a lower-volume (0.5mL) injection of glatiramer acetate...
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Sanofi-Aventis SA lost an appeals court ruling that overturned an order barring generic versions of its cancer drug Eloxatin...
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Drug firm Taj Pharmaceuticals today said it has received tentative approval from US health regulator to sell a generic version of Topiramate Tablets, used in treating central nervous system diseases, in the American market...
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Stride Arcolab's wholly owned subsidiary Linkace Investments Pty Ltd is set to acquire outstanding minority shares in Ascent Pharmahealth Ltd, Australia for a total consideration of $100 million after necessary approvals...
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Cephalon Inc. asked a U.S. judge Wednesday to order the Federal Trade Commission to release confidential documents regarding drug patent-litigation settlements throughout the pharmaceutical industry...
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Glenmark Generics Inc., USA , the United States subsidiary of Glenmark Generics Ltd, today announced that they have been granted approval for three Abbreviated New Drug Applications by the United States Food and Drug Administration...
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Sawai Pharmaceutical Co., the nation's second-largest generic drug maker, is pressing midsize pharmaceutical company Kyorin Co. to reconsider its merger proposal after the latter spurned the overture...
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As more scientific data becomes available linking the drug Reglan (Metoclopramide) with a serious neurological disorder called tardive dyskinesia (TD), new products liability cases are being filed by former users of the drug around the country...
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Last week, in Sanofi-Aventis v. Sandoz, Inc., the Federal Circuit vacated the entry of a consent judgment and an injunction by the District Court for the District of New Jersey, which enjoined Defendants-Appellants Sun Pharmaceutical Industries, Ltd. and Caraco Pharmaceutical Laboratories, Ltd. from manufacturing and selling a generic version of the colorectal cancer drug oxaliplatin...
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The vast majority of court rulings on oxycodone (original product: Oxycontin / Oxygesic by Mundipharma) in the patent dispute between Mundipharma and Acino's licensees have been in favor of Acino and its marketing partners....
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Market Publishers Ltd and GenericsWeb Pty Ltd signed partnership agreement for quality market research promotion on Internet. MarketPublishers.com is now authorized to distribute and sell GenericsWeb research reports...
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Glenmark Generics Inc., USA, the United States subsidiary of Glenmark Generics Ltd, today announced that they have been granted final Abbreviated New Drug Application approval by the United States Food and Drug Administration for Lithium Carbonate 300 mg extended-release tablets...
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Impax Laboratories, Inc. today announced that the U.S. Food and Drug Administration has granted final approval of the Company's Abbreviated New Drug Application for the generic version of Doryx (doxycyline hyclate delayed-release) 75 and 100mg tablets...
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Akorn, Inc., a niche generic pharmaceutical company, today reported that its Akorn-Strides LLC joint venture has entered into a purchase agreement with Pfizer Inc. to sell 16 Abbreviated New Drug Approvals and 6 filed ANDAs. For its portion, Akorn, Inc. will receive $35 million in cash. Akorn-Strides LLC will continue to manufacture and distribute the approved products until April 30, 2011...
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Sun Pharmaceutical Industries announced that USFDA has granted a tentative approval for an Abbreviated New Drug Application a generic version of Boniva, Ibandronate Sodium Injection, 1 mg(base)/ml, packaged in 3 ml single-dose vials...
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