Generics Industry News Search
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August 2013 News Archive |
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Pharma Major Lupin announced today that its U.S. subsidiary, Lupin Pharmaceuticals, has received final approval for its Ranolazine Extended-release tablets, 500 mg and 1000 mg from the United States FDA...
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India's patent appeals board has revoked a patent granted to GlaxoSmithKline Plc's breast cancer drug Tykerb, which is a salt form of the original compound, Lapatinib...
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Pfizer sued two units of rival Wockhardt in Delaware federal court Friday, alleging its planned generic version of overactive-bladder medication Toviaz infringes a handful of patents covering the drug...
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German generic drug maker Stada Arzneimittel AG today said that it is in exclusive talks to acquire British over-the-counter drug manufacturer Thornton & Ross...
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Oncobiologics and inVentiv Health today announced a broad strategic partnership around clinical development for all assets in Oncobiologic's pipeline...
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Pfizer Inc. must pay about $1.8 million in punitive damages to a Connecticut woman who developed breast cancer after taking the company's Prempro menopause drug, a judge concluded...
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Supernus Pharmaceuticals, Inc. announced that earlier today it sued generic drug makers Actavis Inc., Watson Laboratories, Inc. for infringement of two patents covering its anti-epileptic drug Oxtellar XR...
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Teva announced today that the European Commission has granted marketing authorisation for Lonquex (Lipegfilgrastim). This approval provides the regulatory framework for the commercialisation of Lonquex in all twenty eight countries of the European Union plus Norway, Iceland and Liechtenstein...
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India revoked patents on two of Allergan Inc's eye drugs on Thursday, the latest in a series of intellectual property setbacks suffered by Western drug makers...
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Actavis and Warner Chilcott today announced that they have received approval from the French competition authority for Actavis' pending acquisition of Warner Chilcott...
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Drug firm Sun has said it will pay its dues of Rs 2,517.41 crore soon as part of settlement agreement with Wyeth (now a division of Pfizer) and Altana Pharma(now known as Takeda)...
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Perrigo today announced that it has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug applications for Fluocinolone acetonide scalp oil, 0.01%, the generic equivalent to Derma-Smoothe/FS scalp oil, and Fluocinolone acetonide topical oil, 0.01%, the generic equivalent to Derma-Smoothe/FS body oil...
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Teva and Perrigo today announced the launch of the generic equivalent to Temodar (Temozolomide)...
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Glenmark Generics USA has been granted final abbreviated new drug approval from the United States Food and Drug Administration for Acamprosate calcium delayed release tablets its generic version of Forest Laboratories' Campral delayed release tablets...
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GlaxoSmithKline scored a win Friday when a Delaware federal judge upheld its patent for the prostate reduction pill Avodart, saying Banner Pharmacaps, Mylan and other generic-drug makers hadn't shown that the patent was invalid...
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AstraZeneca on Monday asked the Federal Circuit to block four generic-drug makers from launching no-name versions of its Pulmicort Respules pediatric asthma medication, saying a lower court relied too heavily on expert testimony in finding one of its patents as obvious and anticipated...
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Dainippon Sumitomo Pharma and Takeda today jointly announced that on August 12th, Swiss local time, Takeda obtained the approval of the marketing authorisation application by Swissmedic for atypical antipsychotic medication Lurasidone hydrochloride for the treatment of patients with schizophrenia...
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Indian Intellectual Property Appellate Board revoked two composition patents of US-based Allergan...
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Avanir Pharmaceuticals Inc. announced that it has entered into a settlement agreement with Sandoz Inc. to resolve pending patent litigation in response to Sandoz's ANDA seeking approval to market generic versions of Avanir's NUEDEXTA capsules...
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Swiss drug major Roche has decided not to pursue its patent for anti-cancer drug Herceptin, the patent which had come up for extension till 2019, paving the way for generic drug makers to manufacture this drug...
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The Patent and Trademark Office is no different from a district court in the requirement to assess objective indicia of nonobviousness in a patent reexamination proceeding, the U.S. Court of Appeals for the Federal Circuit ruled Aug. 12 (Leo Pharm. Prods., Ltd. v. Rea, Fed. Cir., No. 2012-1520, 8/12/13)...
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Teva on Friday sued rival Perrigoin Delaware federal court, alleging a planned generic version of asthma treatment ProAir HFA infringes on several patents covering the drug and its dispenser...
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Indonesian pharmaceutical firm Soho has inked a deal to team up with German counterpart Fresenius Kabi in a bid to boost the local company's generic products business, Soho chief executive Marcus Pitt said on Monday...
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Roche announced last week that it is allowing the Indian patent covering its breast cancer treatment Trastuzumab to expire...
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Mallinckrodt announced today that it has entered into an agreement with Amneal to distribute to addiction treatment centers its Buprenorphine HCl and Naloxone HCl dihydrate sublingual tablets (CIII), a generic version of Suboxone, manufactured in Amneal's Hauppauge, New York, facility...
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Eli Lilly is banking on a simple vitamin recommendation to defend long-term patent protection on its second-best-selling drug, the cancer treatment Alimta...
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Allergan has asked the U.S. Food and Drug Administration to revise the agency's draft guidelines for firms seeking to produce generic versions of its chronic dry eye disease treatment, Restasis...
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The Federal Trade Commission has asked the U.S. District Court for the District of New Jersey to accept an amicus brief that addresses the application of the U.S. Supreme Court's recent ruling in FTC v. Actavis to a patent settlement containing a "no-authorised-generic" commitment...
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Par today announced that it has received approval from the U.S. Food and Drug Administration for its supplemental Abbreviated New Drug Application for Bupropion hydrochloride extended-release tablets USP, 300 mg...
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Japan's Ministry of Health Labor and Welfare (MHLW) approved 367 items of generic drugs last week...
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India's fast growing research-based pharmaceutical company, Venus Pharma received marketing authorisation approval from France for its generic broad spectrum antibiotic injectable, Meropenem...
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Sandoz, the generic pharmaceuticals division of Novartis, has launched Nexmezol...
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Mylan today confirmed that the company has received approval from the U.S. Food and Drug Administration for its supplemental Abbreviated New Drug Application providing bioequivalence study results requested by FDA for Bupropion hydrochloride Extended-release tablets USP (XL), 300 mg...
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Horizon Pharma, Inc. today announced that it has entered into settlement and license agreements with Par Pharmaceutical Companies, Inc. and its subsidiary Par Pharmaceutical, Inc., to resolve pending patent litigation involving Duexis (ibuprofen and famotidine) tablets...
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Dr. Reddy's announced today that it has launched Divalproex Sodium extended - release tablets, USP (250 mg and 500 mg), a therapeutic equivalent generic version of Depakote ER (Divalproex sodium) tablet, extended release in the US market on August 19, 2013...
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Concerns about potential microbial contamination have led to a recall for several lots of generic Zantac sold by Dr. Reddy's, which were sold at Wal-Mart, Walgreens and Supervalu store...
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Amgen and Onyx today announced that their Boards of Directors have unanimously approved a transaction under which Amgen will acquire all of the outstanding shares of Onyx for $125 per share in cash...
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Amgen Canada et al. v. Teva et al. (T-989-12) is the first case in which the Federal Court will consider whether the Minister of Health should be prohibited from authorising the sale of a subsequent-entry biologic (SEB) (or biosimilar) drug in Canada...
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Actavis today confirmed that it has filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration seeking approval to market Prednisone Delayed-release Tablets, 1 mg, 2 mg and 5 mg...
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A closely watched campaign to create state laws for biosimilar substitution, which has so far been rejected in 10 states and gained little traction elsewhere, took a controversial step forward when a bill was overwhelmingly approved by a California assembly committee...
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Endo Health Solutions today announced that its Qualitest subsidiary has reached a definitive agreement to acquire privately held Boca Pharmacal, a specialty generics company, for $225 million in cash...
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BD Rx Inc., a wholly-owned subsidiary of leading global medical technology company BD (Becton, Dickinson and Company), announced today that the U.S. FDA has approved the third drug to be offered in the new BD Simplist line of ready-to-administer prefilled generic injectables...
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Upsher-Smith today announced its Morphine sulfate extended-release capsules, CII will be commercially available on September 4, 2013...
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Eisai announced that the company has recently entered into a non-exclusive licensing agreement in the United States with a manufacturer of generic pharmaceuticals that grants certain rights, including the right to market and offer for sale a generic version of Donepezil hydrochloride 23 mg and a non-exclusive license to Eisai Intellectual Property covering Donepezil hydrochloride 23 mg, including U.S. Patent No. 8,481,565...
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Gilead, the world's largest maker of HIV medicines, sued Merck seeking a court order that the experimental hepatitis C drug Sofosbuvir won't infringe patents...
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