Business Wire

  1. Teva Provides Update On Generic Temodar®
    3/17/2010
    Teva Pharmaceutical Industries Ltd., announced recently that the parties to the patent litigation regarding Barr's U.S. generic version of Schering's Temodar® have entered into an agreement pending resolution of Schering's appeal to the Federal Circuit of the U.S. District Court's decision holding the ‘291 Patent unenforceable.
  2. Mannatech Vigorously Defends Ambrotose® Product Patents With Latest Legal Action Against Multiple Companies
    3/17/2010
    Mannatech, Incorporated, a global pioneer in the development of high-quality health, weight and fitness and skin care solutions based on nutritional science, announced it has filed a complaint against seven independent companies for infringement on Mannatech's patents (U.S. Patents 6,929,807; 7,157,431; 7,199,104; and 7,202,220).
  3. TRADE NEWS: Agilent Technologies Introduces BioHPLC Columns For Characterization Of Bio-Molecules
    3/15/2010
    Agilent Technologies Inc. (NYSE:A) today announced the availability of new ion exchange and size exclusion columns specifically designed for the analysis of bio-molecules including monoclonal antibodies, recombinant proteins, peptides, vaccine products and DNA/RNA. The columns provide robust, reproducible and high-resolution solutions for biopharmaceutical manufacturers to effectively monitor the safety, efficacy and stability of their products. "With the addition of these new bio-columns, we can now offer our customers significant improvements in charge-based and size-based
  4. Impax Laboratories Confirms Patent Challenge Relating To TRILIPIX® Delayed-Release Capsules, 135 mg And 45 mg
    3/15/2010
    Impax Laboratories, Inc. (NASDAQ: IPXL) today confirms that it has initiated a challenge of the patent listed by Abbott Laboratories and Fournier Laboratories Ireland Ltd. in connection with its TRILIPIX® (choline fenofibrate) delayed-release capsules, 135 mg and 45 mg. Impax filed its Abbreviated New Drug Application ("ANDA") containing a paragraph IV certification for a generic version of TRILIPIX® with the U.S. Food & Drug Administration ("FDA"). Following receipt of the notice from the FDA
  5. FDA Requests Additional Information Regarding AFREZZA™ In Complete Response Letter To MannKind
    3/15/2010
    MannKind Corporation recently announced that it has received a Complete Response letter from the U.S. Food & Drug Administration (FDA) regarding the New Drug Application (NDA) for AFREZZA™ (insulin human [rDNA origin]) Inhalation Powder for the treatment of adult patients with type 1 and type 2 diabetes mellitus for the control of hyperglycemia.
  6. Portola Pharmaceuticals And Merck Announce That Phase 2 Study Showed Investigational Factor Xa Inhibitor, Betrixaban, Reduced Incidence Of Bleeding Compared To Warfarin In Patients With Atrial Fibrillation
    3/15/2010
    Portola Pharmaceuticals and Merck today announced the results of EXPLORE-Xa, a Phase 2 exploratory, dose finding study of betrixaban, an investigational oral direct Factor Xa inhibitor. Results showed that a once-daily dose of oral betrixaban, given to patients with non-valvular atrial fibrillation or atrial flutter and at least one risk factor for stroke, reduced the incidence of major and clinically relevant non-major (CRNM) bleeds* compared to dose-adjusted warfarin. The data were presented during a
  7. BioSante Announces FDA Orphan Drug Designation for GVAX Pancreatic Cancer Vaccine
    3/15/2010
    BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced BioSante's receipt of Orphan Drug designation from the FDA's Office of Orphan Products Development for GVAX Pancreas Vaccine in the treatment of pancreatic cancer. "The Orphan Drug designation of GVAX Pancreas Vaccine for the treatment of pancreatic cancer is BioSante's first GVAX regulatory submission and response from the FDA since acquiring this portfolio of cancer vaccines last October," said Stephen M. Simes, BioSante's president & CEO. "It
  8. Patient Advocacy Group Asks FDA To Enhance Its Enforcement Of Unapproved Drugs Initiative
    3/12/2010
    The National Minority Quality Forum (The Forum) is launching a new public information campaign aimed to help educate consumers, physicians, and policymakers about the risks associated with prescribing and taking unapproved drugs that have not been subjected to the rigorous Food and Drug Administration's (FDA) review and approval process. Unapproved drugs can be dangerous – or even deadly – to patients as a result of the lack of testing, unknown or unregulated ingredients, improper
  9. AutekBio, Suma Ventures And Beijing E-Town To Invest In The Largest CMO Project In Asia
    3/10/2010
    AutekBio, Inc., SUMA Ventures and Beijing E-Town Harvest International Capital Management Corporation, a venture capital group from Beijing Municipal Government announced a joint investment of more than US$100m to develop a new contract manufacturing organization (CMO) for biopharmaceutical industry in China.
  10. Rexahn Pharmaceuticals Issued Japanese Patent For Anti-cancer Compound Archexin
    3/8/2010
    Rexahn Pharmaceuticals, Inc., a clinical stage pharmaceutical company commercializing potential best in class oncology and CNS therapeutics, recently announced that the Japanese Patent Office has issued a patent for its novel anti-cancer compound, Archexin.

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