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FDA approves Cymbalta for maintenance treatment of major depressive disorder

Eli Lilly and Company has announced that the U.S. Food and Drug Administration (FDA) has approved Cymbalta (duloxetine HCl) for the maintenance treatment of major depressive disorder (MDD) in adults.

2 Dec 2007

Bionovo describes a new class of therapeutic compounds

Bionovo, Inc. has announced the publication of a groundbreaking paper in the journal Molecular and Cellular Endocrinology covering the isolation, identification and description of a pure chemical compound, liquiritigenin, which represents a new class of therapeutic compounds showing promise for the safe treatment of menopausal symptoms.

2 Dec 2007

Sirtris Pharmaceuticals unveils promising, novel SIRT1 activators for treating diseases of aging

Sirtris Pharmaceuticals has announced that findings in the journal Nature demonstrate that Sirtris has developed novel drug candidates that offer a promising, new approach to treating diseases of aging, including Type 2 Diabetes, by targeting SIRT1, a gene that controls the aging process.

29 Nov 2007

New anti-infective drug aims to fight drug-resistant bacteria at source

Deadly methicillin-resistant Staphylococcus aureus - MRSA - a bacterium that responds poorly to conventional antibiotic treatment, infects 90,000 Americans per year and causes 19,000 deaths, most in hospital settings.

29 Nov 2007

Innovative drug production project secures funding from Technology Strategy Board

PolyTherics, a biopharmaceutical spin-out company from Imperial College London and the London School of Pharmacy, has announced that it has secured funding from the Technology Strategy Board.

29 Nov 2007

Strange behaviours linked to popular sleeping pill Zolpidem

The Therapeutic Goods Administration (TGA) in Australia has updated warnings on a popular sleeping drug.

29 Nov 2007

FDA to review Champix/Chantix side effects

A drug which was designed to help people quit smoking is causing concern following a number of reports that it induces suicidal feelings and aggressive and erratic behaviour.

29 Nov 2007

Watson Pharmaceuticals receives FDA approval for generic Combunox

Watson Pharmaceuticals, Inc. has announced that it has received final approval from the United States (U.S.) Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for Oxycodone Hydrochloride and Ibuprofen Tablets (CII) in the 5 mg/400 mg strength.

27 Nov 2007

Ikaria's INOmax approved in Australia

Ikaria Holdings, Inc., through its subsidiary INO Therapeutics LLC, announced today that it has received approval from Australia's regulatory body, the Therapeutic Goods Administration (TGA), for INOmax (nitric oxide) for inhalation.

27 Nov 2007

Drug safety experts call for increased patient involvement

National drug safety experts, including representatives from the Center for Medicine in the Public Interest (CMPI) and the Critical Path Institute (CPI), will gather at the National Press Club and call for an improved approach to providing consumers with real time and individualized information about the risks and benefits of drugs on the market.

27 Nov 2007

BioMarin files investigational NDA for PEG-PAL for the treatment of phenylketonuria

BioMarin Pharmaceutical Inc. has announced that it has filed an investigational new drug application (IND) with the U.S. Food and Drug Administration (FDA) for PEG-PAL (Poly Ethylene Glycol-Phenylalanine Ammonia Lyase), formerly known as Phenylase, for the treatment of phenylketonuria (PKU).

27 Nov 2007

FDA extends comment period for proposed sunscreen regulation

The Food and Drug Administration has announced that it will be extending the comment period on the agency's proposed sunscreen regulation to Dec. 26, 2007.

27 Nov 2007

Wyeth receives European approval for TORISEL

Wyeth Pharmaceuticals, a division of Wyeth, has announced that the European Commission has approved TORISEL (temsirolimus) for the first-line treatment of patients with advanced renal cell carcinoma (RCC) who have at least three of six prognostic risk factors. TORISEL is the only approved cancer therapy that specifically inhibits the mTOR (mammalian target of rapamycin) kinase, an important regulator of cell proliferation, cell growth and cell survival.

27 Nov 2007