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   January 2015 News Archive news archive  


02/01/2015  Torrent Pharm and Reliance Life Sciences partner to market IBD biosimilars news archive
Torrent Pharmaceuticals has signed a licensing agreement with Reliance Life Sciences for the marketing of three biosimilar products in India...
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05/01/2015  PL Developments receives its first ANDA approval to manufacture Ibuprofen 200 mg tablets and caplets news archive
PL Developments announced today that they have received FDA approval to manufacture Ibuprofen...
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05/01/2015  Mylan launches generic Diovan tablets news archive
Mylan today announced the U.S. launch of its Valsartan tablets...
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05/01/2015  Jubilant Life Sciences receives ANDA approvals for Mycophenolate mofetil and Rizatripta news archive
Jubilant Life Sciences, an integrated Pharmaceuticals and Life Sciences Company, has received ANDA final approval from the U.S. FDA for Mycophenolate mofetil...
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06/01/2015  Lupin launches generic Diovan tablets news archive
Lupin announced today that it has launched its Valsartan tablets...
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06/01/2015  Teva launches generic Diovan in the United States news archive
Teva Pharmaceuticals announces the FDA approval and the launch of the generic equivalent to Diovan (Valsartan) Tablets in the United States...
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06/01/2015  Patent office sets aside earlier order granting patent to Abbott's Humira news archive
The Patent Office has set aside its earlier order granting patent to Abbott Biotechnology Ltd's rheumatoid arthritis drug Humira...
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06/01/2015  Teva launches generic versions of 2 antibiotics in US news archive
Teva Pharmaceutical has launched generic versions of two antibiotics in the US...
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06/01/2015  Jubilant Life Sciences receives ANDA approvals for Valsartan tablets news archive
Jubilant Life Sciences, an integrated Pharmaceuticals and Life Sciences Company, announced today that it has received ANDA final approval from the...
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06/01/2015  Aurobindo Pharma receives U.S. FDA approval for Valsartan tablets news archive
Aurobindo Pharma is pleased to announce that the company has received final approval from the U.S. FDA to manufacture and market Valsartan tablets...
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07/01/2015  Hospira Japan receives approval for two new generic oncology products news archive
Hospira Japan, announced today the approval of two new generic oncology drugs...
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07/01/2015  FDA panel unanimously backs Novartis' copy of Amgen's Neupogen news archive
A panel to the U.S. Food and Drug Administration unanimously backed the approval of Novartis AG's copy of Amgen's blockbuster cancer drug Neupogen...
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09/01/2015  Hikma to launch Colchicine 0.6mg capsules news archive
Hikma today notes that Takeda has been unsuccessful in appealing the decision...
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10/01/2015  High Court stops Cipla's generic drug sales news archive
In a move that may be a damper for patients suffering from lung and respiratory diseases, the Delhi high court has decided in favour of drug MNC Novartis...
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12/01/2015  Perrigo launches AB therapeutic equivalent Testosterone gel 1.0% news archive
Perrigo today announced that it has launched its AB therapeutic equivalent Testosterone gel...
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12/01/2015  Perrigo launches the generic version Of Clobex spray, 0.05% news archive
Perrigo today announced that it has launched Clobetasol propionate spray...
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12/01/2015  Hospira submits new Biologics License Application to FDA for proposed Epoetin alfa biosimilar news archive
Hospira today announced that it has submitted a Biologics License Application to the FDA for Retacrit...
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12/01/2015  Prasco and Takeda enter into agreement to market authorised generic of Colcrys in the United States news archive
Prasco, Takeda, and Takeda's wholly-owned subsidiary, Takeda Pharmaceuticals U.S.A. announced today that Prasco and TPUSA have entered into a distribution and supply agreement for the rights to distribute Colchicine Tablets...
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12/01/2015  Helsinn reaches settlement agreement regarding patent dispute on Aloxi news archive
Helsinn Healthcare announces that it has entered into a settlement agreement with Sandoz to resolve their patent litigations relating to Helsinn Healthcare...
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12/01/2015  Takeda update regarding Colcrys litigation news archive
Takeda Pharmaceutical Company, and its wholly-owned subsidiary, Takeda Pharmaceuticals U.S.A. (TPUSA) stated today that TPUSA will continue its patent infringement litigation against Hikma Pharmaceuticals...
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12/01/2015  Bristol-Myers Squibb, Natco Pharm settle patent dispute news archive
The patent dispute between US-based pharma major Bristol Myers Squibb (BMS) and Indian pharma company Natco Pharm over Entecavir...
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13/01/2015  Cipla moves Delhi High Court against restraint on its Indacaterol-based drug news archive
Cipla today moved the Delhi High Court challenging its order temporarily restraining it from manufacturing or selling any drug containing the chemical Indacaterol...
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13/01/2015  Actavis launches U.S. generic specialty injectable portfolio news archive
Actavis announced the launch of a leading portfolio of generic specialty injectable medications to be marketed to hospitals across the United States...
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13/01/2015  Pfizer warns UK docs about patent infringement over a generic Lyrica news archive
In an unusual move, Pfizer has written to physician groups in the U.K. to warn that prescribing generic versions of its Lyrica medicine - specifically, for treating pain - would violate its patent...
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14/01/2015  AstraZeneca loses German court appeal over Seroquel drug patent news archive
In November 2012, the federal patent court in Germany ruled a key patent on Seroquel, the extended-release version of Seroquel...
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14/01/2015  U.S. District Court sets briefing schedule in Veloxis litigation news archive
Veloxis today confirmed that the U.S. District Court for the District of Columbia has set a briefing schedule...
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14/01/2015  India rejects Gilead's hepatitis C drug patent request news archive
India's patent office has rejected an application from Gilead for its hepatitis C drug Sovaldi...
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14/01/2015  Duke seeks to stop generic drug incursions news archive
After a federal appeals court ruled in June that its existing patents for an eyelash growth treatment were invalid...
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15/01/2015  Mylan launches generic Epivir-HBV tablets news archive
Mylan today announced the U.S. launch of its Lamivudine tablets, 100 mg, which is the generic version of GlaxoSmithKline's Epivir-HBV...
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15/01/2015  Novartis patent case: Delhi HC refuses interim relief to Cipla news archive
In another disappointment for Mumbai- based drug maker Cipla, Delhi High Court division bench has refused to give any interim relief to the company against a recent order by Delhi High Court barring the company to sell cheaper generic of Novartis' respiratory drug Onbrez...
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15/01/2015  Elite Pharmaceuticals announces first shipment of generic Isradipine capsules news archive
Elite Pharmaceuticals today announced the first shipments of generic Isradipine 2.5 mg and 5.0 mg capsules. Isradipine is a calcium channel blocker prescribed for hypertension...
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15/01/2015  Akorn confirms generic Durezol patent challenge news archive
Akorn today confirmed that it has filed an ANDA with the U.S. FDA seeking approval to market Difluprednate ophthalmic emulsion 0.05%...
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15/01/2015  Orexo receives Paragraph IV notice letter concerning Abstral in the US news archive
Orexo today announced that it has, together with its partner Galena Biopharma, received a "Paragraph IV"...
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16/01/2015  Supernus sues Par for infringement of Trokendi XR patents news archive
Supernus Pharmaceuticals announced that it sued generic drug makers Par Pharmaceutical Companies for infringement of four patents covering its antiepileptic drug Trokendi...
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19/01/2015  Europe to boost international cooperation on generics news archive
The EMA is ready to share its assessments of applications for generic medicines in real time with collaborating regulatory agencies outside the EU...
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20/01/2015  Fresenius Kabi approved for Neostigmine methylsulfate injection news archive
Fresenius Kabi announced it has received approval from the FDA to market Neostigmine methylsulfate injection, the generic version of Eclat's Bloxiverz...
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20/01/2015  Actavis recalling 65,000 bottles of generic seizure drug news archive
Actavis has another drug recall to deal with, this one involving nearly 65,000 bottles of the generic version of the seizure drug Neurontin that it manufactures at a plant in India...
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20/01/2015  Teva announces U.S. Supreme Court decision to reverse Federal Circuit Court's judgment on Copaxone 20 mg/mL case and remand for further review news archive
Teva today announced the U.S. Supreme Court's decision in Teva Pharmaceuticals USA, Petitioners v. Sandoz that reversed the Federal Circuit Court's judgment of invalidity of Teva's '808 patent for Copaxone 20 mg/mL...
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20/01/2015  Strides Arcolab Limited has entered into a licensing agreement with Gilead Sciences news archive
Strides Arcolab Limited has entered into a licensing agreement with Gilead Sciences, under which Gilead has extended non-exclusive rights to the Indian firm to manufacture and distribute Tenofovir Alafenamide, both as a single agent product and in combination with other drugs, as per a company release....
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20/01/2015  Delhi High Court asks Glenmark to stop making Linezolid drug news archive
The Delhi High Court on Monday restrained Mumbai-based generic drug maker Glenmark Pharmaceuticals from manufacturing and selling, directly or indirectly, Linezolid, manufactured through the process patented by the Hyderabad-based pharma company Symed Laboratories...
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21/01/2015  European Medicines Agency accepts Samsung Bioepis' Enbrel biosimilar candidate, SB4, for regulatory review news archive
Samsung Bioepis today announced that the marketing authorisation application for its Enbrel biosimilar candidate, SB4 has been validated and accepted for review by European Medicines Agency...
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21/01/2015  Australian regulator hits restart on plan to name biosimilars news archive
Australia's medicines regulator, the TGA, has announced it will no longer implement a planned update to the way in which it names biosimilar products following a proposal by WHO to change a naming standard on which Australia relied for its policy...
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21/01/2015  Supernus sues TWi for infringement of Oxtellar XR patents news archive
Supernus Pharmaceuticals announced that it sued generic drug makers TWi Pharmaceuticals for infringement of four patents covering its antiepileptic drug Oxtellar XR...
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22/01/2015  China's Innovent banks $100M to cash in on the biosimilar boom news archive
Innovent Biologics has raised $100 million in venture cash in hopes of becoming the premier maker of biotech drugs in its native China, advancing a pipeline of biosimilars and proprietary treatments...
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23/01/2015  Hanwha Chemical to export generic arthritis drug tech to Germany news archive
Hanwha Chemical is exporting the technology to make generic drugs for arthritis treatments...
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26/01/2015  Teva receives FDA approval for first generic Nexium delayed-release capsules in the United States news archive
Teva Pharmaceutical Industries today announced the FDA's approval of the first generic equivalent to Nexium delayed-release capsules in the United States...
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26/01/2015  Impax receives FDA approval for a generic version of Lamictal orally disintegrating tablets news archive
Impax Laboratories announced today that the FDA has approved generic Lamictal orally disintegrating tablets, 25mg, 50mg, 100mg and 200mg in blister packaging...
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26/01/2015  Antares Pharma provides regulatory update on Sumatriptin injection news archive
Antares Pharma, today announced that the FDA has issued a complete response letter regarding the ANDA for Sumatriptan Injection for the acute treatment of migraine...
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26/01/2015  Supreme Court sends patent cases back to appeals court news archive
The Supreme Court on Monday sent three patent cases, including one dispute over Shire Plc's Lialda drug, back to a lower court for further proceedings in light of a ruling the justices issued last week...
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27/01/2015  Copaxone's patent remains in force at least until the Federal Circuit Appeals Court reconsiders the case. news archive
The rivals of Teva Pharmaceutical Industries who are developing a generic version of multiple sclerosis treatment Copaxone, have urged the US Supreme Court to expedite sending the case back to the appellate court...
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28/01/2015  Ranbaxy forfeits 180 days exclusivity for generic Nexium news archive
Ranbaxy Laboratories has lost the opportunity to exclusively market in the United States for six months, the first generic version of Astra Zeneca's heartburn drug Nexium, the Delhi-based company said in a filing to the stock exchange on Tuesday...
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30/01/2015  Patent dispute: Novartis objects to Wockhardt filing fresh documents news archive
Swiss pharma company Novartis has raised objections to Wockhardt filing additional documents in a revocation petition by the latter against the former's patent for anti-diabetes drug Vildagliptin...
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30/01/2015  ANI Pharmaceuticals announces the launch of Etodolac 300mg capsules news archive
ANI Pharmaceuticals today announced the launch of Etodolac 300mg oral capsules, indicated for use in the management of the signs and symptoms of osteoarthritis, rheumatoid arthritis, and acute pain...
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30/01/2015  Teva launches Metoclopramide Injection news archive
Teva announced the launch of Metoclopramide Injection, the generic version of Baxter's Reglan injection...
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