'Drug' Tag

• Impax Labs challenges Vytorin patents – BusinessWeek

  August 21, 2010

  Impax Labs challenges Vytorin patentsBusinessWeekLLC’s patents on the cholesterol drug Vytorin. Impax has asked for Food and Drug Administration approval to make a generic version of the drug. …Impax Laboratories Confirms Patent Challenge Relating to VYTORIN(R), 10 mg/80 mgMarketWatch (press release)Impax challenges cholesterol drug patentsSan Francisco Business TimesImpax Laboratories Confirms Patent Challenge Relating to VYTORIN(R), [...]

  posted in Uncategorized by admin

• Gilead receives Notice Letter of Sigmapharms ANDA submission for generic Hepsera

  August 20, 2010

  [Story ID: 3442] Gilead Sciences, Inc. today announced receipt of a Paragraph IV Certification Notice Letter advising that Sigmapharm Laboratories, LLC submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) requesting permission to manufacture and market a generic version of Hepsera® (adefovir dipivoxil).

  posted in Uncategorized by admin

• Generic drug industry bemoans limits on patent settlements – The Hill (blog)

  July 31, 2010

  Town HallGeneric drug industry bemoans limits on patent settlementsThe Hill (blog)The Generic Pharmaceutical Association (GPhA) said in a statement that “patent settlements create competition and competition means more savings and greater …GPhA responds to split vote over branded-generic drug settlementsDrug Store NewsEditorial: Senate panel can end ‘pay for delay’ drug tacticsDaily RepublicGENERICS CAN OFFER SIGNIFICANT [...]

  posted in Uncategorized by admin

• Study on interactions between new antitubercular drug candidates SQ109 and TMC207

  July 27, 2010

  [Story ID: 3276] Sequella, Inc., a clinical-stage biopharmaceutical company developing drugs for treatment of life-threatening infectious diseases, announced today the publication of studies in the scientific journal Antimicrobial Agents and Chemotherapy on synergy between SQ109, its lead drug candidate for the treatment of TB, and TMC207, Tibotec lead TB drug candidate:

  posted in Uncategorized by admin

• AHF bans pharmaceutical sales representatives of Bristol Myers Squibb

  July 27, 2010

  [Story ID: 3275] Today AIDS Healthcare Foundation (AHF) announced that it has banned pharmaceutical sales representatives from Bristol-Myers Squibb (BMS) from calling on AHF’s medical providers and staff in its sixteen U.S. healthcare centers. The decision is based on BMS’ refusal to lower the price of its key AIDS drug Reyataz for cash-strapped AIDS Drug [...]

  posted in Uncategorized by admin

• FDA grants marketing approval of ANDA for enoxaparin sodium for injection

  July 26, 2010

  [Story ID: 3213] Momenta Pharmaceuticals, Inc., a biotechnology company specializing in the characterization and engineering of complex drugs, today announced that the U.S. Food and Drug Administration has granted marketing approval of the Abbreviated New Drug Application for enoxaparin sodium for injection filed by Sandoz. Developed under a collaboration agreement between Momenta and Sandoz, this [...]

  posted in Uncategorized by admin

• FDA approves Mylans ANDA for generic Solodyn ER 45 mg, 90 mg and 135 mg tablets

  July 23, 2010

  [Story ID: 3159] Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited received final approval on July 20 from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Minocycline Hydrochloride Extended Release Tablets (Minocycline ER), 45 mg, 90 mg and 135 mg, the generic version of Solodyn® ER, [...]

  posted in Uncategorized by admin

• FDA approves Impaxs ANDA for generic OPANA ER 30mg tablet

  July 23, 2010

  [Story ID: 3163] Impax Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted final approval of the Company’s Abbreviated New Drug Application (ANDA) for the generic version of OPANA® ER (oxymorphone hydrochloride) Extended Release 30mg tablet. In June 2010, the Company was granted final approval for the 5mg, 10mg, 20mg, [...]

  posted in Uncategorized by admin

• FDA accepts MannKinds resubmission of AFREZZA NDA, sets PDUFA action date

  July 21, 2010

  [Story ID: 3077] MannKind Corporation today announced that it has submitted, and the U.S. Food and Drug Administration has accepted, MannKind’s resubmission of its New Drug Application for AFREZZA’

  posted in Uncategorized by admin

• Teva Agrees To End IP Suit Over Aricept Patent – Forbes (blog)

  July 21, 2010

  Teva Agrees To End IP Suit Over Aricept PatentForbes (blog)Generics maker Teva Pharmaceuticals USA Inc. has agreed to suspend litigation over a compound patent for Eisai Co. Ltd.’s popular Alzheimer’s drug Aricept, …Japan’s Eisai to make key drug in India – NikkeiReuters(Repeats to fix technical glitch)Reuters all 5 news articles

  posted in Uncategorized by admin