Generics Industry News Search
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October 2012 News Archive |
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Pozen, a pharmaceutical company committed to transforming medicines that transform lives, today announced that the United States Court of Appeals for the Federal Circuit has affirmed the August 5, 2011 decision of the United States District Court for the Eastern District of Texas that had issued a favourable verdict in the litigation between Pozen and several generic pharmaceutical companies which had filed Abbreviated New Drug Applications (ANDAs) seeking approval from the U.S. Food and Drug Administration (FDA) to market generic copies of Treximet (Sumatriptan/Naproxen sodium)...
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Celgene (CELG) has a good chance of prevailing against generic drug developers in the ongoing litigation over its cancer blockbuster, Revlimid (Lenalidomide), intellectual property attorneys told BioPharm Insight...
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Watson Pharmaceuticals today announced that on September 28, 2012, the United States District Court for the Northern District of Georgia granted summary judgment in favor of Watson, and all other defendants, on all remaining claims in the pending antitrust lawsuit related to settlements of patent litigation concerning Androgel 1% Testosterone gel. ...
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Sanofi further expands its leadership in affordable pharmaceuticals and its existing capabilities in Latin America...
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U.S. antitrust regulators found no wrongdoing in a deal made four years ago between German drugmaker Bayer AG and a division of Teva Pharmaceuticals to end patent litigation over the popular Yasmin birth control pill....
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Sanofi and Bristol-Myers Squibb today announced they have restructured their successful long-term alliance following the loss of exclusivity of Plavix and Avapro/Avalide in many major markets....
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Mylan sued the U.S. Food and Drug Administration for approval to sell a generic version of Novartis's heart pill Diovan after a competitor failed to get the drug on the market in time...
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Breckenridge Pharmaceutical announced today that it has entered into an agreement with Ajanta Pharma to market its Abbreviated New Drug Application (ANDA) for Risperidone Tablets, the generic version of Risperdal Tablets by Janssen Pharma. ...
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The highest strength of a generic version of the antidepressant Wellbutrin, marketed by a unit of Teva Pharmaceuticals, will be taken off the U.S. market after tests showed it didn't work as well as the brand-name drug...
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Mylan Specialty, a subsidiary of Mylan, a generic pharmaceutical company, and Pfizer have announced a license agreement, under which Pfizer will obtain the exclusive rights to market and sell EpiPen Injection 0.3/0.15mg in Japan...
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Mayne Pharma is pleased to announce that it has entered into a binding agreement to acquire Metrics...
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BioSante Pharmaceuticals (BPAX) and ANIP Acquisition Company d/b/a ANI Pharmaceuticals announced today that they have entered into a definitive merger agreement by which the companies will merge in an all-stock transaction, with BioSante as the surviving company...
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The move to reverse a 2007 decision granting patent protection on the drug to treat kidney cancer follows tough decisions in recent years by local authorities and courts in rejecting patents on expensive cancer medicines, including on Novartis' Glivec...
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Folotyn (Pralatrexate injection) is the first therapeutic to have been approved for peripheral T-cell lymphoma (PTCL), in September 2009...
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Impax Laboratories was sued by Avanir Pharmaceuticals for allegedly infringing a new patent for the drug Nuedexta, used to control abnormal emotional outbursts...
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Ranbaxy has launched the authorized generic Cevimeline hydrochloride 30 mg. capsules in the U.S. market, under an agreement with Daiichi Sankyo....
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Mylan today announced that it has entered into a settlement agreement with Shionogi and CIMA Labs that will resolve patent litigation related to Prednisolone sodium phosphate orally disintegrating tablets (ODT) 10 mg, 15 mg and 30 mg....
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Cambridge-based Alnylam Pharmaceuticals said that key claims in a patent that covers molecules that mediate its RNA interference technology have been upheld in a challenge by a Japanese company.
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The Federal Trade Commission filed an amicus brief in the U.S. District Court for the District of New Jersey stating that an agreement by a branded drug company not to launch an authorised generic (AG) drug "provides a convenient method for branded drug firms to pay generic patent challengers for agreeing to delay entry." ...
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Actavis today announced that it has received approval from the US Food & Drug Administration to market Diltiazem hydrochloride extended-release capsules, in all available strengths: 120mg, 180mg, 240mg, 300mg, 360mg, and 420mg....
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Perrigo today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Applications (ANDA) to market over-the-counter nicotine polacrilex mini lozenge, 2 mg (mint flavor) and 4 mg (mint flavor)....
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The US Food and Drug Administration (FDA) has granted regulatory approval to Actavis' Diltiazem hydrochloride (HCL) extended-release capsules...
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Watson Pharmaceuticals (WPI) today announced that its subsidiary Watson Laboratories-Florida has received approval from the U.S. Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for Trospium chloride extended-release capsules, the generic equivalent to Allergan's Sanctura XR...
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Watson Pharmaceuticals (WPI) today announced that its subsidiary Watson Laboratories has received approval from the U.S. Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for Irbesartan tablets USP, 75 mg, 150 mg and 300 mg, the generic equivalent to Sanofi's Avapro...
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Elite Pharmaceuticals today announced that Elite received approval as of September 28th from the U.S. Food and Drug Administration for generic Phentermine capsules 15 mg and 30 mg...
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Perrigo today announced that it has received tentative approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application to market over-the-counter Omeprazole and sodium bicarbonate capsules 20mg/1100mg, the store brand equivalent to Merck & Co.'s Zegerid OTC....
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In their iPolitics article entitled "Controlling drug costs... one lawsuit at a time", Tim Gilbert and Nathaniel Lipkus argue that "current Canadian drug policy is thwarting our ability to achieve the savings necessary to afford the drugs of tomorrow."...
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Acorda Therapeutics (ACOR) today announced that the U.S. Patent and Trademark Office (USPTO) has determined that U.S. Patent No. 5,540,938 ("the '938 patent") is entitled to a full five year patent term extension under the patent restoration provisions of the Hatch Waxman Act...
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The Australian Government is taking practical steps to ensure that the patent system is delivering effective outcomes for consumers and industry with the appointment of an expert panel to review pharmaceutical patents. The Panel will seek public comment before submitting a final report to Government in April 2013....
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Mylan has agreed to buy an Indian drug manufacturing plant for about $32.5 million, the Cecil-based company said on Wednesday....
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Court instructs FDA to approve Watson's ANDA...
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I see big risks ahead for United Therapeutics (UTHR)...
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Mylan today announced that it has filed an expedited motion in the U.S. District Court for the District of Columbia to stay the Court's order related to Watson's abbreviated new drug application (ANDA) for Pioglitazone, pending appeal....
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Akorn, a niche specialty pharmaceutical company, today announced that its manufacturing and development partner, Sofgen Pharmaceuticals, LLC, has received approval of its abbreviated new drug application (ANDA) for Progesterone capsules, 100mg and 200mg....
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Fujifilm Kyowa Kirin Biologics, a joint venture between Fujifilm and Kyowa Hakko Kirin, announced today that it will endeavor to develop a biosimilar version of Bevacizumab, an anti-VEGF humanized monoclonal antibody which has impressive therapeutic effects for cancers such as colorectal cancer and non-small cell lung cancer....
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Changes to patent rules are being considered that could make it easier for British pharmaceutical companies to develop new drugs....
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Actavis today announced the launch of Riluzole film-coated tablets on a number of major European markets immediately following patent expiry....
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Watson Pharmaceuticals today announced that Watson has launched a generic version of Actos (Pioglitazone hydrochloride 15mg, 30mg and 45mg tablets) after receiving final approval today from the U.S. Food and Drug Administration (FDA)...
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Forest Laboratories and Forest Laboratories Holdings announced today that they have entered into a settlement agreement with Hetero Labs and Hetero USA in patent infringement litigation brought by Forest in response to Hetero's ANDA seeking approval to market generic versions of Forest's Bystolic (Nebivolol) tablets...
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The Food and Drug Administration said it was looking more closely at the way generic companies made extended-release drugs after it found one such medicine failed to work as well as its brand-name counterpart...
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Watson today announced that it has completed the acquisition of the Actavis Group for EUR 4.25 billion...
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