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   July 2014 News Archive news archive  


01/07/2014  More MSF patients with DR-TB gain access to dramatically cheaper version of life-saving drug news archive
After a three-year long struggle, Medecins Sans Frontieres (MSF) has received approval from the South African Medicines Control Council (MCC) to import a dramatically more affordable version of an antibiotic, Linezolid...
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02/07/2014  AZ sues to block generic Saxagliptin from Mylan news archive
AstraZeneca has filed a lawsuit against Mylan in the US after it filed for approval of a generic version of diabetes drug Onglyza...
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02/07/2014  Upsher-Smith announces launch of the first and only generic transdermal Testosterone gel available in three convenient configurations news archive
Upsher-Smith Laboratories today announced the launch of Testosterone gel (1%), the generic of the newly FDA approved Vogelxo (testosterone) gel 1%, for topical use...
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02/07/2014  Impax acquires two products from Actavis news archive
Impax Laboratories today announced that it has acquired from Actavis two generic products for cash consideration pursuant to a Purchase Agreement and a Supply Agreement...
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03/07/2014  Teva files citizen petition with the FDA regarding the complexity of Copaxone news archive
Teva today announced that the company has filed a citizen petition regarding the approvability of purported generic versions of Copaxone...
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03/07/2014  Sun Pharma recalls 200 vials of cancer drug news archive
Sun Pharmaceutical is recalling 200 vials of the chemotherapy drug Gemcitabine in the US due to a lack of assurance of sterility...
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03/07/2014  Beximco Pharma Receives GMP Approval from Taiwan FDA as the First Bangladeshi Company news archive
Beximco Pharmaceuticals Limited today announces that it has received GMP from Taiwan FDA as the first Bangladeshi company...
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07/07/2014  Sanofi sues to block Unimark's generic Multaq news archive
The U.S. subsidiary of French pharmaceutical company Sanofi has slapped Indian drugmaker Unimark Remedies with a lawsuit in Delaware federal court seeking to block the manufacture and sale of a generic version of Multaq...
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07/07/2014  Nippon Kayaku announces marketing approval in Japan of Infliximab biosimilar monoclonal antibody news archive
Nippon Kayaku today announced that Nippon Kayaku has obtained the marketing approval of Infliximab BS for I.V. infusion 100mg which was developed jointly with Celltrion and Celltrion Healthcare...
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07/07/2014  NeuClone signs biosimilar deal with Serum Institute news archive
Sydney-based biotech NeuClone has signed a major licensing agreement and joint development partnership with The Serum Institute of India covering the manufacturing of 10 biosimilar drugs...
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08/07/2014  Mylan launches generic Micardis tablets news archive
Mylan today announced that it has launched Telmisartan tablets...
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08/07/2014  Actavis confirms generic Ampyra patent challenge news archive
Actavis today confirmed that it has filed an ANDA with the FDA seeking approval to market Dalfampridine extended-release tablets...
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08/07/2014  Glenmark Generics receives final ANDA approval for Telmisartan tablets news archive
Glenmark Generics has been granted final ANDA from the FDA for Telmisartan tablets...
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08/07/2014  Perrigo announces FDA final approval for the store brand equivalent to Advil congestion relief tablets news archive
Perrigo today announced that it was the first to receive final approval from the FDA for its ANDA for Ibuprofen and Phenylephrine hydrochloride tablets...
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08/07/2014  Sandoz launches authorised generic version of Diovan in the U.S. news archive
Sandoz today announced the U.S. introduction of an authorised generic version of Diovan (Valsartan) tablets for the treatment of high blood pressure...
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08/07/2014  Sanofi sues Eli Lilly over insulin rival to Lantus news archive
Sanofi SA has filed a lawsuit accusing Eli Lilly and Co of infringing seven patents related to insulin and devices used to deliver it...
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08/07/2014  Delhi HC doesn't stop Natco from exporting Copaxone generic news archive
The Delhi HC has stopped short of restraining Natco from exporting the generic version of Copaxone to the U.S...
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08/07/2014  Roche, Helsinn sue Dr. Reddy's over generic Aloxi news archive
Roche and Helsinn hit Dr. Reddy's with a complaint in New Jersey federal court on Monday, alleging that the generic-drug maker's proposed version of the anti-nausea drug Aloxi would infringe one of their patents...
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08/07/2014  The first-to-file drug Prasugrel: HEC Pharm was sued by Eli Lilly news archive
HEC Pharm received a complaint from United States District Court Southern District of Indiana about Eli Lilly and Company...
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09/07/2014  Par Pharmaceutical begins shipment of Fluphenazine Decanoate injection, USP news archive
Par Pharmaceutical Companies today announced that it has received final approval from the U.S. FDA for its ANDA for Fluphenazine Decanoate injection, USP 25 mg/mL...
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11/07/2014  Actavis confirms generic Diclegis patent challenge news archive
Actavis today confirmed that it has filed an ANDA with the FDA seeking approval to market Doxylamine succinate and Pyridoxine hydrochloride delayed-release tablets...
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11/07/2014  Sun Pharma recalls over 40,000 bottles of antidepressant news archive
Sun Pharmaceutical is recalling 41,127 bottles of antidepressant Venlafaxine hydrochloride...
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12/07/2014  Merck seeks to settle patent row with Glenmark news archive
In the long-winding patent battle on a widely-prescribed diabetes drug, Januvia (Sitagliptin), Merck has sought a settlement to end the dispute with generic company, Glenmark...
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14/07/2014  Medac Pharma secures FDA approval of Rasuvo injection for rheumatoid arthritis, poly-articular-course juvenile idiopathic arthritis and psoriasis news archive
Medac Pharma, announced that the U.S. FDA has approved Rasuvo, a subcutaneous injectable methotrexate...
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14/07/2014  Upsher-Smith announces immediate availability of a generic equivalent to Qudexy XR extended-release capsules news archive
Upsher-Smith today announced the launch of Topiramate extended-release capsules...
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14/07/2014  Sandoz launches authorised generic version of Tobi news archive
Sandoz today announced the US market introduction of Tobramycin inhalation solution, an authorised generic version of Tobi, currently marketed by Novartis Pharmaceuticals...
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15/07/2014  Natco pleased with Bombay High Court decision to uphold compulsory license on Nexavar issued to the company news archive
Natco is pleased to inform that the Bombay High Court upheld the compulsory license (CL) granted to the Company on Nexavar (Sorafenib tosylate)...
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15/07/2014  Glenmark gets final nod from US FDA for skin infection cream news archive
Glenmark Pharmaceuticals has received final approval from the US health regulator for its generic Fluocinonide cream used for treating a variety of skin infections...
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15/07/2014  Fifth Circuit backs shield against branded pharma's liability for generic harms news archive
The court fight over Pfizer's stomach drug Reglan (Metoclopramide) has yielded another ruling in Big Pharma's favor...
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17/07/2014  Depomed announces district court order in ANDA litigation news archive
Depomed today announced that the U.S. District Court for the District of New Jersey entered an order preliminarily enjoining Actavis Elizabeth and Actavis from marketing a generic version of Gralise prior to the Court's issuance of an opinion in the matter...
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17/07/2014  Mylan wins motion to enjoin Glaxosmithkline from providing Paroxetine CR to Apotex; Apotex can no longer supply authorised generic product news archive
Mylan today announced that the U.S. District Court for the District of New Jersey granted its motion for a permanent injunction against GlaxoSmithKline in relation to Paroxetine CR...
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17/07/2014  The Medicines Patent Pool signs a record seven new sub-licences to speed the availability of generic HIV medicines to developing countries news archive
Three days before the start of the 20th International AIDS Conference in Melbourne, Australia, the Medicines Patent Pool (MPP) announced seven new sub-licensing agreements for the manufacture of generic HIV medicines...
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17/07/2014  Lannett signs agreement to be exclusive U.S. distributor of authorised generic of hypertension drug, Aceon news archive
Lannett announced that it has signed an agreement with Symplmed, to be the exclusive distributor in the United States of an authorised generic version of Aceon (Perindopril erbumine tablets) in 2 mg, 4 mg and 8 mg dosage strengths...
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18/07/2014  Acorda Therapeutics sues Mylan over plan to copy MS drug news archive
Acorda Therapeutics, which makes the drug Ampyra to improve multiple sclerosis patients' walking, sued Mylan, accusing the company of attempting to sell a generic of the drug before its patents expire...
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20/07/2014  Intas launches cheaper generic blood cancer drug news archive
Homegrown drug maker Intas Pharmaceuticals has launched a generic version of blood cancer drug Azacitidine at one-fifth of the price of currently available drug for the disease...
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21/07/2014  Strides Arcolab acquires Raricap and India branded generic business of Bafna news archive
Strides Arcolab today entered into an agreement with Bafna Pharmaceuticals to acquire majority stake of their India branded generics business...
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21/07/2014  Arena Pharmaceuticals enters into marketing and supply agreement for Belviq in Israel news archive
Arena today announced that its wholly owned subsidiary, Arena Pharmaceuticals GmbH, has entered into an exclusive marketing and supply agreement for Belviq...
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21/07/2014  FDA grants Genentech's Avastin priority review for recurrent platinum-resistant ovarian cancer news archive
Genentech today announced that the U.S. FDA has accepted the company's supplemental Biologics License Application (sBLA) and granted Priority Review for Avastin (Bevacizumab) plus chemotherapy for the treatment of women with recurrent platinum-resistant ovarian cancer...
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21/07/2014  Gilead litigation says claims by Merck, AbbVie on Sovaldi are patently wrong news archive
Gilead Sciences got to the market first with an interferon-free oral hepatitis C fighter, a category projected to hit $20 billion in sales by 2020...
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22/07/2014  India's Lupin, U.S. firms weigh bids for GSK's mature drugs news archive
Indian generics firm Lupin, some U.S. drugmakers looking for a tax-saving deal in Europe and private equity funds are planning to bid for a range of older drugs being auctioned by GlaxoSmithKline...
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23/07/2014  Strides Arcolab gets U.S. FDA approval for Tacrolimus capsules news archive
Pharma firm, Strides Arcolab announced that it has received approval from the U.S. FDA for marketing of Tacrolimus capsules, used as immuno-suppressant...
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23/07/2014  Mylan wins motion for temporary restraining order against Apotex for authorised generic of Paxil news archive
Mylan announced that the U.S. District Court for the District of New Jersey granted its motion for a temporary restraining order against Apotex and Apotex in litigation relating to Paroxetine, the authorised generic of GlaxoSmithKline's Paxil...
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23/07/2014  Abuse of U.S. generic-drug rules costs billions news archive
U.S. rules that ensure prescription medicines are not misused have been manipulated by brand-name drug companies to fight off generic competitors, costing consumers billions of dollars...
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23/07/2014  Cubist strikes agreement with competitor to delay generic Cubicin news archive
A competitor of antibiotics maker Cubist Pharmaceuticals has agreed not to launch a generic version of its flagship drug for skin infections until at least Dec...
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24/07/2014  FDA accepts Sandoz application for biosimilar Filgrastim news archive
Sandoz announced today that the FDA has accepted its Biologics License Application for Filgrastim...
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24/07/2014  Perrigo confirms AB therapeutic equivalent rating from the FDA for its Testosterone gel 1.0% news archive
Perrigo today announced that it has received an AB therapeutic equivalent rating from the FDA for its previously approved NDA for Testosterone gel 1.0%...
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28/07/2014  Indian generic drugmakers set to score from MPP deals on HIV drugs news archive
Seven new sub-licensing agreements for the manufacture of generic HIV medicines and two new generation drugs, Atazanavir and Dolutegravir, by the MPP, is set to usher in a new era of innovative production...
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28/07/2014  Aurobindo, Lupin being sued on generics plans news archive
Multinational drugmakers Pfizer and Forest Laboratories have filed lawsuits against Indian generic company Aurobindo, as it wants to manufacture copycat versions of drugs of which they have patents...
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28/07/2014  Testing an Accelerated Path for Biosimilars news archive
Since the passage of the Affordable Care Act in 2010, a streamlined regulatory path has been available in the U.S. for biosimilars: generic versions of biologic drugs, such as proteins and RNA complexes, manufactured through living systems like bacteria or viruses...
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29/07/2014  Hikma acquires Ben Venue generic injectables manufacturing facility in Ohio news archive
Hikma Pharmaceuticals announced in a press release that it has acquired the Ben Venue Laboratories manufacturing facility in Bedford, OH...
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29/07/2014  More pharma firms trying to settle patent rows via talks news archive
Indian generics or copycat drug makers and multinational pharma companies are increasingly resorting to mediation to resolve patent fights...
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29/07/2014  IDT executes binding Memorandum of Understanding with Mayne Pharma for exclusive distribution of Temozolomide in the US news archive
IDT Australia is pleased to announce that it has entered into a binding Memorandum of Understanding (MOU) with Mayne Pharma's US Products division to distribute IDT's generic Temozolomide product in the US...
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30/07/2014  InnoPharma announces launch of Olanzapine for injection, 10 mg/vial in Canada news archive
InnoPharma today announced the first generic launch of Olanzapine for injection...
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30/07/2014  Perrigo confirms first to file patent challenge for generic version of Topicort topical spray 0.25% news archive
Perrigo announced that it has filed with the FDA an ANDA for Desoximetasone topical spray 0.25%...
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