Pharmaceutical News

RSS

Analysis of diabetes drugs

Most oral medications prescribed for type 2 diabetes are similarly effective for reducing blood glucose, but the drug metformin is less likely to cause weight gain and may be more likely than other treatments to decrease so-called bad cholesterol, according to a report funded by HHS Agency for Healthcare Research and Quality.

17 Jul 2007

Tackling counterfeit Chinese pharmaceuticals

Agencies worldwide are cracking down on counterfeit pharmaceuticals, and much of the focus has been on China, where an official was recently executed for approving fake medicines.

17 Jul 2007

NDA for Lubiprostone to treat irritable bowel syndrome with constipation

Sucampo Pharmaceuticals, Inc., has announced that it has submitted a supplemental New Drug Application to the U.S. Food and Drug Administration to seek market approval of a lower strength of lubiprostone (8 mcg) to treat irritable bowel syndrome with constipation (IBS-C).

13 Jul 2007

Roche statement on offer for Ventana Medical Systems

Roche released the following statement in response to the announcement by Ventana Medical Systems, Inc. ("Ventana").

12 Jul 2007

Caraco Pharmaceutical Labs announces FDA approval to market generic Tenormin

Caraco Pharmaceutical Laboratories has announced that the US Food and Drug Administration (FDA) has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Atenolol Tablets USP (atenolol).

12 Jul 2007

Baxter receives FDA approval for new dosage of Advate for hemophilia A

Baxter Healthcare Corporation announced that the U.S. Food and Drug Administration (FDA) has approved a new 3000 IU (5mL) dosage strength of ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method].

12 Jul 2007

Ajinomoto to market Capsiate Natura in the U.S.

Ajinomoto has announced plans to introduce Capsiate Natura, a capsinoid dietary supplement, into the United States market.

12 Jul 2007

Ranbaxy receives approval to manufacture and market Amlodipine Besylate tablets

Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), has announced that RLL has received final approval from the U.S. Food and Drug Administration to manufacture and market Amlodipine Besylate Tablets, 2.5 mg (base), 5 mg (base) and 10 mg (base).

11 Jul 2007

CMS issues final rule for Medicaid prescription drug reimbursements

CMS on Friday released a final rule that will change the Medicaid prescription drug reimbursement formula for pharmacies from being based on the average wholesale price to being based on the average manufacturer price, CongressDaily reports (Edney, CongressDaily, 7/10).

11 Jul 2007

Abiogen licenses RFB4 antibody from Cancer Research Technology

Cancer Research Technology Limited (CRT), the oncology-focused development and commercialisation company, today announces it has agreed an exclusive worldwide licence with Abiogen Pharma S.p.A. (Italy).

11 Jul 2007

Roxane Laboratories announces launch of Amlodipine Besylate tablets

Roxane Laboratories, Inc. has announced the approval of its Abbreviated New Drug Application (ANDA) for Amlodipine Besylate Tablets, 2.5mg, 5mg, and 10mg by the U.S. Food and Drug Administration.

10 Jul 2007

Pharmaxis files for Korean marketing approval of its lung function test Aridol

Pharmaxis has announced its first step into the Asian market, filing for Korean marketing approval of its lung function test Aridol.

10 Jul 2007

Peregrine licenses worldwide rights to a novel anti-angiogenesis technology

Peregrine Pharmaceuticals, Inc. has announced that it has licensed worldwide exclusive rights to a novel anti-angiogenesis technology from The University of Texas M. D. Anderson Cancer Center.

10 Jul 2007

Novavax licenses virus-like particle from Wyeth

Novavax, Inc. has announced that is has signed a non-exclusive, worldwide license agreement with Wyeth, to obtain rights to a patent application covering virus-like particle (VLP) technology for use in human vaccines in certain fields of use.

10 Jul 2007

MacroGenics investigational new drug for West Nile vrus monoclonal antibody is active

MacroGenics has announced that the company's investigational new drug (IND) application to the U.S. Food and Drug Administration for its monoclonal antibody targeted to West Nile Virus is now active.

10 Jul 2007

Bio-adhesive vaginal foam

Foamix Ltd. has announced that the Company has been selected to present at the 34th Annual Meeting of the Controlled Release Society.

10 Jul 2007

Calypte begins U.S. initiative

Calypte Biomedical Corporation has announced that it has leased an 11,000+ square foot site located in Portland, Oregon.

10 Jul 2007

Approval of generic Dostinex

Barr Pharmaceuticals, Inc. has announced that its subsidiary Barr Laboratories, Inc. has received final U.S. Food & Drug Administration (FDA) approval for its application to manufacture and market a generic version of Pharmacia and Upjohn Company's Dostinex (cabergoline) tablets, 0.5 mg.

10 Jul 2007

Actavis launches Terbinafine hydrochloride tablets in the U.S.

Actavis Group has announced that it has launched Terbinafine hydrochloride tablets in the U.S. Distribution of the product will commence immediately.

10 Jul 2007

FDA designates Carbaglu for treatment of NAGS deficiency as a Fast Track product

The Food and Drug Administration (FDA) in the USA has concluded that Carbaglu (carglumic acid) for treatment of N-acetylglutamate synthase (NAGS) deficiency meets the criteria for fast track designation.

10 Jul 2007