Generics Industry News Search
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February 2015 News Archive |
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The European Medicines Agency has accused an Indian contract research organisation of systematic fraud, and has recommended suspending sales of hundreds of generic drug formulations in Europe because their approval is based on questionable clinical trial data...
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Pharma major Lupin announced today that it has received final approval for its Vancomycin hydrochloride capsules, 125 mg and 250 mg from the FDA to market a generic version of ANI Pharmaceuticals' Vancocin capsules 125 mg and 250mg strengths. Lupin Pharmaceuticals, the company's US subsidiary would commence marketing the product shortly...
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Teva announced the launch of Dexmethylphenidate HCl extended-release capsules in a new 10mg strength, the generic version of Novartis' Focalin XR extended-release capsules...
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The Delhi High Court has ruled that India's patent office failed to follow proper procedures in evaluating Gilead's patent application...
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Amgen today announced a Phase 3 study evaluating the efficacy and safety of biosimilar candidate ABP 501 compared with Humira (Adalimumab) in patients with moderate-to-severe rheumatoid arthritis met its primary and key secondary endpoints...
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From July 1, you can walk up to a chemist and ask for a 'Jan Aushadhi' brand for your medicine, with the government set to launch its own brand to sell low cost generic medicines...
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Cosmo Pharmaceuticals informs that Santarus, a wholly owned subsidiary of Salix Pharmaceuticals, and its subsidiary, Cosmo Technologies, the licensor, commenced a lawsuit against generic drug maker Par Pharmaceutical, for Par's infringement of six patents listed in the FDA's Orange Book as covering Uceris and its use...
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Galena Biopharma today announced that its partner, Orexo AB, has filed a patent infringement lawsuit in United States District Court for the District of New Jersey, against Actavis...
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Indian generic drug manufacturer Cipla urged the Delhi High Court on Thursday to consider public interest and set aside an order restraining it from manufacturing and selling Indacaterol, used for the treatment of chronic obstructive pulmonary disorder...
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Mylan today confirmed that it and its subsidiary Mylan Pharmaceuticals have been sued by Bayer Healthcare and Onyx Pharmaceuticals in connection with the filing of an ANDA with the FDA for Sorafenib Tablets, 200 mg...
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Global health charity Medecins du Monde (MdM) launched a legal challenge on Tuesday to a European patent held by U.S. drugmaker Gilead Sciences which it accused of charging "exorbitant" prices for a hepatitis C drug...
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Advisors to the FDA will meet next month to review Celltrion's biosimilar of Johnson & Johnson and Merck & Co's anti-inflammatory blockbuster Remicade...
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Upsher-Smith today announced that is has receive an AB rating from the FDA for its previously-approaved Vogelxo (testosterone) gel 1% unit-dose tubes and packets...
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Natco Pharma announced today that it has filed ANDAs for Fingolimod, 0.5mg capsules and Cabazitaxel, 60mg/1.5ml injection, with the FDA, through its respective marketing partners in the USA...
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Good news for Teva when it comes to Mylan's generic version of AstraZeneca's Nexium: It won't be around for a little while...
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Novartis and its Neupogen biosimilar are steamrolling toward the U.S. market. But Amgen hasn't given up stopping the product in its tracks. The biotech last week urged a California court to block the biosimilar launch, with FDA approval expected as soon as March 9...
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Sucampo Pharmaceuticals, a global biopharmaceutical company, today announced that Sucampo and R-Tech Ueno, have entered into a stipulation and license agreement with Par Pharmaceutical...
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Breckenridge Pharmaceutical announced today that it has filed an ANDA with a Paragraph IV certification for Cabazitaxel solution; IV (infusion) in 60 mg/1.5 mL strength, a generic version of Jevtana by Sanofi...
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Pharma major Cipla plans to name its hepatitis C drug with Gilead Sciences as Hepcvir, its chairman Yusuf K Hamied said on Wednesday...
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Teva UK and a number of other generic companies have launched their versions of Sanofi's Renvela (Sevelamer carbonate) following the expiry of the drug's patent in the country...
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Cipher Pharmaceuticals today announced that the Beteflam patch has been accepted for review by Health Canada...
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AstraZeneca today announced that the US District Court for the District of New Jersey ruled US Patent No. 7,524,834 ("the '834 patent"), protecting Pulmincort respules in the US, is invalid...
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Actavis today announced that it has launched its generic version of AstraZeneca's Pulmicort respules (Budesonide inhalation suspension) 0.25 and 0.5 mg vials following a ruling from the United States District Court for the District of New Jersey...
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Teva, a leading global pharmaceutical company, today announced the launch of the generic equivalent of Lovenox (Enoxaparin sodium injection) in seven dosage strengths in the United States...
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Acino announces the achievement of another judicial success in the ongoing German intellectual property litigation proceedings regarding it generic Rivastigmine patch...
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Actavis today confirmed that the United States Court of Appeals for the Federal Circuit has issued a temporary injunction to prevent Actavis from further distribution of its generic version of Pulmicort respules 0.25, 0.5 mg pending its consideration of AstraZeneca's request for an injunction pending appeal...
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Lupin and Celon Pharma announced today that they have entered into a definitive agreement under which the companies will jointly develop Fluticasone/Salmeterol dry powder inhaler (DPI) product which is a generic version of GlaxoSmithKline's Advair Diskus...
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Hospira a world leader in the development of biosimilar therapies, today announced the launch of the first biosimilar monoclonal antibody, Inflectra (Infliximab), in major European markets...
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Apotex, a rising competitor in the global biosimilars market, announced today that, as of February 13th, 2015, the FDA has accepted for filing the company's application for Filgrastim (Grastofil), a biosimilar version of Amgen's Neupogen...
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Actavis today announced that it has received final approval from the FDA on its ANDA for a generic version of Reckitt Benckiser's Subutex (Buprenorphine 2 mg and 8 mg sublingual tablets)...
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The FDA has told private registered medical practitioners to use the generic name of the drug used to treat swine flu...
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Confirmation that 2015 will be a watershed year for biosimilars came with data on Remsima presented at the European Crohn's and Colitis Organisation meeting held in Barcelona...
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Ahmedabad-based Intas Pharmaceuticals becomes the first Indian company to launch a biosimilar in highly regulated markets like the EU, US and Japan...
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TWi today announced that TWi and Teva have reached an agreement that will transfer the US sales and distribution rights of TWi's generic versions of Megace ES and Lidoderm from Teva to TWi...
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Lupin announced today that is has received final approval for its Bimatoprost ophthalmic solution, 0.03% from the FDA to market a generic version of Allergan's Lumigan ophthalmic solution, 0.03%...
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Sagent Pharmaceuticals today announced the voluntary nationwide recall Atracurium Besylate injection single-dose vials manufactured by Emcure Pharmaceuticals and distributed by Sagent...
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Cosmo informs that Santarus a wholly owned subsidiary of Salix Pharmaceuticals and its subsidiary, Cosmo Technologies, the licensor, commenced a lawsuit against generic drug maker Actavis...
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Celltrion Healthcare has today announced the launch of Remsima (Infliximab) in 12 European markets: Austria, Belgium, Denmark, France, Germany, Greece, Italy, Luxembourg, the Netherlands, Spain, Sweden and the UK...
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Jubilant Life Sciences, has received ANDA final approval from the FDA for Irbesartan tablets and Cetirizine hydrochloride tablets...
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A consumer safety group is calling on the FDA to pull certain antifungal tablets off the market, saying there are safer medicines that do not carry risks of liver damage...
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VANC Pharmaceuticals, a pharmaceutical company focused on the Canadian generic drug and OTC markets, is pleased to announce that it has received confirmation from the British Columbia Ministry of Health approving 14 of the Company's generic molecules under the low cost alternative program...
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Napp Pharmaceuticals has launched Celltrion's Remicade biosimilar Remsima (Infliximab) in the UK, potentially offering significant savings to the National Health Service while increasing patient access to this kind of therapy...
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The federal court has dismissed a case against Pfizer Australia which claimed the pharmaceutical giant misused its market power and engaged in anti-competitive conduct in the way it supplied one of its blockbuster drugs to pharmacists...
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Glenmark Generics USA, the subsidiary of Glenmark generics today announced that US market approval and introduction of Ashlyna extending-cycle oral contraceptive tablets...
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Heritage today announced the voluntary nationwide recall of ten lots of Colistimethate for injection, USP, 150 mg single-dose vial and three lots of Rifampin for injection, USP, 600 mg single-dose vial manufactured by Emcure Pharmaceuticals and distributed by Heritage...
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The FDA has postponed a crucial meeting of an advisory committee to consider a cheap version of a top-selling drug for rheumatoid arthritis and Crohn's disease, which had been scheduled for March 17...
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Glenmark Generic announced the US market approval and introduction of Trandolapril and Verapamil hydrochloride extended release tablets, the generics equivalent of AbbVie's TARKA...
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A US federal judge has denied Indian generic drug maker Ranbaxy Laboratories bid to reinstate approvals granted to it to launch the first copies of the heartburn drug Nexium and the antiviral Valcyte, a court document showed...
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