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Bioalliance Pharma's anti-emetic drug Setofilm receives European approval

BioAlliance Pharma SA, a company dedicated to the treatment and supportive care of cancer and AIDS patients, today announced approval for Setofilm® in 16 European countries.

24 Mar 2010

New study shows leptin treatment may help reduce type 1 diabetes

Using leptin alone in place of standard insulin therapy shows promise in abating symptoms of type 1 diabetes, UT Southwestern Medical Center researchers report.

24 Mar 2010

Medicare steps up efforts to monitor seniors' prescriptions

Writing for Kaiser Health News in collaboration with USA Today, Susan Jaffe reports on how Medicare is expanding a program to make sure that some older adults use the right drugs and take them correctly to prevent harmful side effects or interactions.

24 Mar 2010

WHO advises continued use of GSK's rotavirus vaccine in developing countries

The WHO on Monday advised developing countries to continue administering GlaxoSmithKline's Rotarix vaccine - which offers protection to children against the diarrhea-causing rotavirus - after the FDA advised doctors in the U.S. to temporarily stop using the vaccine following the discovery that it was "contaminated with an apparently harmless pig virus," Reuters reports

24 Mar 2010

FDA grants Orphan Drug Designation for anti-diabetic drug

The FDA has granted Orphan Drug Designation of Diamyd Medical´s lead drug candidate Diamyd®. Orphan drugs qualify for seven years of market exclusivity from the date of US marketing approval, tax credits for clinical research and a waiver for FDA user fees.

24 Mar 2010

Renowned leaders to discuss latest findings in early-stage drug development for cancer

When people think of cancer treatment, chemotherapy infusions, injections and pills often come to mind. These treatments result from extensive research and testing in drug development. But how does the process begin?

24 Mar 2010

Arginine supplements can improve exercise capacity in older people

Taking arginine supplements can improve the cycling ability of over-50s. Researchers writing in BioMed Central's Journal of the International Society of Sports Nutrition tested a combination of the amino acid and an antioxidant in sixteen cyclists, finding that it enhanced their anaerobic threshold - the amount of work done before lactic acid begins to accumulate in the blood

24 Mar 2010

Celladon Corporation receives USPTO notice of allowance covering MYDICAR for advanced heart failure

Celladon Corp. announced today that the United States Patent and Trademark Office (USPTO) has granted a notice of allowance for a broad patent covering the company's lead drug candidate MYDICAR®, a genetically targeted enzyme replacement therapy for advanced heart failure. The patent will be issued to The Regents of the University of California and licensed exclusively to Celladon.

23 Mar 2010

EMA validates InterMune's pirfenidone MAA for IPF

InterMune, Inc. today announced that the company's Marketing Authorization Application (MAA), submitted on March 2 seeking approval of pirfenidone for the treatment of idiopathic pulmonary fibrosis (IPF) in adults, was validated by the European Medicines Agency (EMA). Validation of the MAA by the EMA indicates that the application is complete and that the review process will begin on March 24. The proposed trade name for pirfenidone in both the United States and Europe is Esbriet®.

23 Mar 2010

BioSante Pharmaceuticals receives FDA Orphan Drug designation for GVAX AML Vaccine

BioSante Pharmaceuticals, Inc. today announced positive GVAX AML Vaccine results and BioSante’s receipt of Orphan Drug designation from the FDA’s Office of Orphan Products Development for GVAX AML Vaccine in the treatment of acute myeloid leukemia. This Orphan Drug designation is the second GVAX cancer vaccine from BioSante to secure FDA orphan drug designation.

23 Mar 2010

5% increase in tobacco taxation needed to account for high cost of smoking to society

A leading think tank has recommended a five per cent rise in tobacco taxation in the next Budget to reflect the high cost of smoking to society.

23 Mar 2010

Clinical Data completes NDA submission for vilazodone

Clinical Data, Inc., today announced that the Company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for vilazodone for the treatment of major depressive disorder (MDD). Vilazodone is a dual-acting potent and selective serotonin reuptake inhibitor and a 5-HT1A receptor partial agonist. The Company expects that the NDA submission, if accepted, will be subject to a standard review.

23 Mar 2010

SAMHSA study shows how psychiatric drugs prescribed for medical conditions

A new study sponsored by the Substance Abuse and Mental Health Services Administration outlines the conditions that physicians around the country reported treating with psychiatric drugs such as antipsychotics, antidepressants, and anti-anxiety drugs.

23 Mar 2010

Pfizer's Neurontin to earn 50% patient share in treatment of postherpetic neuralgia: Survey

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that a novel formulation of Pfizer's Neurontin that is dosed once a day would earn a 50 percent patient share in the treatment of postherpetic neuralgia, according to surveyed U.S. neurologists.

23 Mar 2010

Adrenal fatigue: Vitamins, supplements may do more harm than good

Taking vitamins or supplements to treat “adrenal fatigue” may do more harm than good, says Todd Nippoldt, M.D., a Mayo Clinic expert in hormone disorders affecting the adrenal glands.

23 Mar 2010

Sir James Black inventor of beta-blockers passes away

Sir James Black passed away on Monday after a long illness, he was 85. Sir James Black is credited as the inventor of the beta-blocker drugs in 1962. These are drugs which play an important role in the treatment of angina and heart attacks. They are regarded as one of the major medical breakthroughs of the 20th Century in Pharmacology. Born in Uddingston, Lanarkshire, Sir James Black studied medicine at St. Andrews University.

23 Mar 2010

Temporary suspension of Rotarix – a rotavirus vaccine for kids

The US FDA after deliberation has come up with a warning to the nation’s pediatricians to stop giving children a vaccine that prevents diarrhea causing Rotavirus vaccine. There is reportedly a contamination with a harmless pig virus in this vaccine called Rotarix and manufactured by GlaxoSmithKline.

23 Mar 2010

ChemGenex shares falter as FDA requests more data on new leukemia drug

ChemGenex Pharmaceuticals Ltd. Shares fell most in the last 16 years to AUD$0.44 following a concern raised by the US drug regulators – US FDA. The FDA requested on Monday for more uniform clinical test data before they review and consider approval of the company’s new leukemia drug.

23 Mar 2010

Ipsen, GTx expand partnership for toremifene 80 mg

Ipsen today announced the expansion of their partnership for the development and commercialization of toremifene 80 mg for the reduction of fractures in men with advanced prostate cancer on androgen deprivation therapy (ADT) and toremifene 20 mg for the prevention of prostate cancer in high risk patients with High Grade Prostatic Intraepithelial Neoplasia lesions (HGPIN).

23 Mar 2010

WHO H1N1 vaccine shipments headed to more developing countries

The WHO on Friday announced "it had delivered the first doses of H1N1 [swine flu] vaccine to Cuba, and a dozen countries in Africa would receive millions of doses in coming weeks," Reuters reports.

23 Mar 2010