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Green Cross seeks regulatory approval for peramivir in S.Korea

BioCryst Pharmaceuticals, Inc. today announced that it has been informed by its partner, Green Cross Corp., that Green Cross has filed a New Drug Application (NDA) in South Korea to seek regulatory approval for intravenous (i.v.) peramivir to treat patients with influenza.

9 Jan 2010

Centron receives agency of record assignments for FRAGMIN and GLIADEL Wafer medicines

HealthSTAR's Centron, a medical communications company, is pleased to announce that they have been awarded agency of record assignments for FRAGMIN® and GLIADEL® Wafer from Eisai Inc.

9 Jan 2010

Watson Pharmaceuticals files ANDA with FDA seeking approval to market LoSeasonique

Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, today confirmed that its subsidiary, Watson Laboratories, Inc., has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market its levonorgestrel and ethinyl estradiol (0.10 mg/0.02 mg) oral contraceptive product prior to the expiration of U.S. Patent No. 7,615,545, which is owned by Duramed Pharmaceuticals, Inc., a subsidiary of Teva Pharmaceutical Industries, Ltd.

9 Jan 2010

Genentech's ACTEMRA approved to treat RA

Genentech, Inc., a wholly owned member of the Roche Group, today announced that the U.S. Food and Drug Administration (FDA) approved ACTEMRA® (tocilizumab) for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.

8 Jan 2010

CDC encourages public to receive H1N1 vaccine; PBS examines arrival of vaccine in developing countries

During a media briefing Thursday, Anne Schuchat, director of the National Center for Immunization and Respiratory Diseases at the CDC, warned against complacency over the H1N1 (swine flu), and encouraged Americans who had not yet received the H1N1 vaccine to do so, CNN reports.

8 Jan 2010

ESF-UB Conference to concentrate on potentially clinically relevant polymorphisms

Pharmacogenetics started in the fifties with the discovery of primaquine-related haemolysis among glucose-6-phosphate deshydrogenase deficient patients. At the end of the century, it progressively evolved into Pharmacogenomics, investigating simultaneously multiple gene targets till covering the whole genome in relation with altered drug response.

8 Jan 2010

Prolia drug expected to garner blockbuster sales in 2018

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, despite the U.S. Food and Drug Administration's (FDA) recent request for postmarketing surveillance of Amgen's Prolia, the drug's expected launch this year in the United States and Europe for the treatment of osteoporosis will drive Prolia to garner blockbuster sales in 2018..

8 Jan 2010

Chinese researchers become the world's fifth most prolific contributors to regenerative medicine

Chinese researchers have become the world's fifth most prolific contributors to peer-reviewed scientific literature on clock-reversing regenerative medicine even as a skeptical international research community condemns the practice of Chinese clinics administering unproven stem cell therapies to domestic and foreign patients.

8 Jan 2010

Amira Pharmaceuticals achieves another development milestone in its FLAP program

Amira Pharmaceuticals, Inc. announced today that it has achieved another development milestone in its FLAP program, which is partnered with GlaxoSmithKline. This milestone is related to the successful development of a solid dose formulation, which is critical for future development and commercialization activities.

8 Jan 2010

3Sbio submits registrational clinical trial application for Feraheme injection

3SBio Inc., a leading biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products primarily in China, today announced that it has submitted its application for a registrational clinical trial to the Chinese State Food and Drug Administration ("SFDA") for Feraheme (ferumoxytol) Injection for intravenous use.

8 Jan 2010

Pharmaceutical companies working on nearly 100 life-changing medicines for HIV/AIDS

Medical News Today recently reported that America's pharmaceutical research and biotechnology companies are working on nearly 100 life-changing medicines for diseases affecting people with HIV/AIDS, according to a new report released by the Pharmaceutical Research and Manufacturers of America (PhRMA).

8 Jan 2010

Sciele Pharma announces the U.S. availability of Adrenaclick

Sciele Pharma, Inc., a Shionogi company, today announced the U.S. availability of Adrenaclick™, a single-dose, epinephrine auto-injector for the emergency treatment for severe allergic reactions (Type I) such as anaphylaxis.

8 Jan 2010

Laureate Pharma and Iconic Therapeutics complete manufacturing hI-con1 recombinant Fc-Factor VII fusion protein

Laureate Pharma, Inc., a full-service biopharmaceutical development and protein production company specializing in the development and GMP manufacture of monoclonal antibodies, fusion proteins and other therapeutic protein products, and Iconic Therapeutics, a company focused on the development of treatments for wet adult macular degeneration (wet AMD) and other ophthalmic diseases, today announced the completion of the manufacture of the first GMP lot of hI-con1(TM) recombinant Fc-Factor VII fusion protein.

8 Jan 2010

Hi-Tech Pharmacal receives clearance from FDA to market Tropazone lotion

Hi-Tech Pharmacal Co., Inc. announced today that it received clearance from the FDA to market Tropazone™ lotion, a prescription dermatological product which will be promoted by Hi-Tech’s branded marketing subsidiary, ECR Pharmaceuticals Co., Inc. The product is indicated for the treatment of various dermatological conditions including atopic dermatitis, allergic contact dermatitis, and radiation dermatitis.

8 Jan 2010

Murad launches new line of Anti-Aging Acne products for adults struggling with acne

Murad, Inc. has announced the launch of a new line of Anti-Aging Acne products for adults struggling with acne. The new Anti-Aging Acne line is the first comprehensive approach designed to restore a smooth, youthful complexion by addressing acne breakouts while diminishing the appearance of fine lines and wrinkles.

8 Jan 2010

Kyowa Hakko Kirin receives exclusive rights to develop and commercialize bardoxolone methyl

Reata Pharmaceuticals, Inc. (Reata) and Kyowa Hakko Kirin Co., Ltd. (Kyowa Hakko Kirin) announced today that they have entered into a licensing agreement that provides Kyowa Hakko Kirin with the exclusive rights to develop and commercialize Reata’s lead compound, bardoxolone methyl (bardoxolone), in Japan and other selected Asian markets.

8 Jan 2010

Biovest International receives Orphan Drug Designation for its personalized lymphoma vaccine

Biovest International, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to BiovaxID®, Biovest’s personalized lymphoma vaccine. BiovaxID represents a new class of active immunotherapy and is one of the few select late-stage patient-specific cancer vaccines vying to be among the first to reach market.

8 Jan 2010

UCLA: Metformin can be used to treat patients with diabetes and advanced heart failure

A new study has shown that metformin, a drug often used in the treatment of diabetes mellitus, is safe for use in treating patients who have both diabetes and advanced heart failure.

7 Jan 2010

UAB issues updated guidelines for childhood and teen immunization schedule

The co-director of the University of Alabama at Birmingham (UAB) Division of Pediatric Infectious Diseases is a member of the committee that this week issued updated guidelines for childhood and teen immunizations to include formal recommendations that children older than 6 months get the H1N1 influenza vaccine to guard against swine flu, and that combination vaccines are generally preferred over separate injections.

7 Jan 2010

Carolinas MED-1 to house a clinic for residents to get H1N1 Flu shots

Carolinas MED-1 - the first mobile hospital of its kind in the world - will be serving the people of Charlotte and Mecklenburg County when it is deployed this Saturday for an H1N1 vaccine clinic.

7 Jan 2010

Pharmaceutical News

Green Cross seeks regulatory approval for peramivir in S.Korea

Centron receives agency of record assignments for FRAGMIN and GLIADEL Wafer medicines

Watson Pharmaceuticals files ANDA with FDA seeking approval to market LoSeasonique

Genentech's ACTEMRA approved to treat RA

CDC encourages public to receive H1N1 vaccine; PBS examines arrival of vaccine in developing countries

ESF-UB Conference to concentrate on potentially clinically relevant polymorphisms

Prolia drug expected to garner blockbuster sales in 2018

Chinese researchers become the world's fifth most prolific contributors to regenerative medicine

Amira Pharmaceuticals achieves another development milestone in its FLAP program

3Sbio submits registrational clinical trial application for Feraheme injection

Pharmaceutical companies working on nearly 100 life-changing medicines for HIV/AIDS

Sciele Pharma announces the U.S. availability of Adrenaclick

Laureate Pharma and Iconic Therapeutics complete manufacturing hI-con1 recombinant Fc-Factor VII fusion protein

Hi-Tech Pharmacal receives clearance from FDA to market Tropazone lotion

Murad launches new line of Anti-Aging Acne products for adults struggling with acne

Kyowa Hakko Kirin receives exclusive rights to develop and commercialize bardoxolone methyl

Biovest International receives Orphan Drug Designation for its personalized lymphoma vaccine

UCLA: Metformin can be used to treat patients with diabetes and advanced heart failure

UAB issues updated guidelines for childhood and teen immunization schedule

Carolinas MED-1 to house a clinic for residents to get H1N1 Flu shots

Achieving and maintaining ISO 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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