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Anti-frailty pill for seniors in the pipeline

An 'anti-frailty' pill for seniors could be in the pipeline - the pill which increases muscle mass in arms and legs of older adults is the brainchild of researchers at the University of Virginia Health System.

5 Nov 2008

Mylan receives final approval for generic version of antiepileptic Keppra

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Levetiracetam Tablets, 250 mg, 500 mg and 750 mg. Levetiracetam Tablets are the generic version of UCB Pharma's Keppra.

4 Nov 2008

SurModics acquires drug delivery assets of PR Pharmaceuticals

SurModics, Inc. announced today that it has acquired a portfolio of intellectual property and collaborative drug delivery projects from PR Pharmaceuticals, Inc., a drug delivery company specializing in injectable, biodegradable sustained release formulations.

4 Nov 2008

Call to explore broader use of human papillomavirus vaccines

A call to explore a broader use of HPV (human papillomavirus) vaccines and the validation of a simple oral screening test for HPV-caused oral cancers are reported in two studies by a Johns Hopkins Kimmel Cancer Center investigator.

4 Nov 2008

Anti-VEGF drugs for retinal diseases could have serious side effects

Scientists at Schepens Eye Research Institute have found that reducing the levels of vascular endothelial growth factor (VEGF), which is best known as a stimulator of new blood vessel growth, in adult mice causes the death of photoreceptors and Muller glia -- cells of the retina that are essential to visual function.

3 Nov 2008

Genentech submits application to FDA for Avastin in the most aggressive form of brain cancer

Genentech has announced that the company submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Avastin (bevacizumab) as a therapy for people with previously treated glioblastoma. If accepted by the FDA, the application would be considered for an accelerated approval that allows provisional approval of medicines for cancer or other life-threatening diseases based on preliminary evidence suggesting clinical benefit.

3 Nov 2008

FDA accepts Arana's anti-inflammatory IND

Biotechnology company Arana Therapeutics Limited today announced that lead anti-inflammatory compound, ART621 has successfully passed review of its rheumatoid arthritis Investigational New Drug (IND) application by the US Food and Drug Administration (FDA).

2 Nov 2008

Pfizer's Toviaz (fesoterodine fumarate) receives FDA approval for the treatment of overactive bladder

Pfizer Inc has announced that the U.S. Food and Drug Administration (FDA) approved Toviaz (fesoterodine fumarate) extended release tablets for the treatment of overactive bladder (OAB) symptoms.

2 Nov 2008

GlaxoSmithKline believes there is no liver safety issue with Avandia (rosiglitazone maleate)

GlaxoSmithKline today issued the following response to a petition filed by Public Citizen to the U.S. Food and Drug Administration (FDA) on Avandia (rosiglitazone maleate), a highly effective therapy for treating type 2 diabetes when used in the appropriate patient population.

31 Oct 2008

GSK to acquire Genelabs Technologies

GlaxoSmithKline and Genelabs Technologies, Inc announced today that they have entered into a definitive agreement pursuant to which GSK will acquire Genelabs for approximately $57 million (pounds Sterling 35 million) through a tender offer of $1.30 per share in cash. This strategic acquisition will strengthen GSK's effort to develop and deliver novel therapies against the hepatitis C virus (HCV).

29 Oct 2008

FDA grants tentative approval for 75th generic anti-retroviral drug

The Food and Drug Administration within the U.S. Department of Health and Human Services (HHS) has reached the milestone of the 75th anti-retroviral generic drug approved or tentatively approved as part of President Bush's Emergency Plan for AIDS Relief (PEPFAR).

29 Oct 2008

FDA warns Bayer HealthCare on over-the-counter aspirin product

The U.S. Food and Drug Administration today sent Warning Letters to Bayer HealthCare concerning two unlawful, over-the-counter (OTC) aspirin products - Bayer Women's Low Dose Aspirin + Calcium (Bayer Women's) and Bayer Aspirin with Heart Advantage (Bayer Heart Advantage).

28 Oct 2008

New tuberculosis vaccine safer, more effective than BCG vaccine for HIV-positive people

A new tuberculosis vaccine could be safer and more effective than the currently available BCG vaccine, particularly for HIV-positive people, according to a study to be published in the November issue of Infection and Immunity, IANS/Times of India reports (IANS/Times of India, 10/24).

28 Oct 2008

How drug companies covertly promote off-label drug use

Off-label prescription of a drug is generally legal, but promotion of off-label uses by a drug manufacturer is illegal. In an article in this week's PLoS Medicine, two physician researchers describe the techniques that drug companies use to covertly promote off-label use, even when such promotion is illegal.

28 Oct 2008

Expensive new diabetes drugs don't necessarily produce better outcomes

The annual cost of prescription diabetes drugs nearly doubled to $12.5 billion between 2001 and 2007, according to a study by researchers at the Stanford University School of Medicine and the University of Chicago. The researchers say the findings raise questions about whether the higher cost actually translates into improved care and better outcomes.

28 Oct 2008

Sedative propofol could be fatal

Patients treated for their prolonged seizures with the sedative propofol may be at high risk for complications and even death. New research presented at CHEST 2008, the 74th annual international scientific assembly of the American College of Chest Physicians (ACCP), shows that the use of propofol as an antiepileptic agent in patients with refractory status epilepticus (RSE), prolonged seizures that do not respond to initial treatment, was associated with significant mortality and morbidity.

28 Oct 2008

Improved communication about medications reduces complications among patients using common blood thinner

Patients who report receiving written and verbal instructions on the proper way to take the blood thinner warfarin are significantly less likely to suffer the serious gastrointestinal and brain bleeding problems that are associated with misuse of the drug, according to new research from the University of Pennsylvania School of Medicine.

27 Oct 2008

New gout drug offers hope for those who have exhausted treatment options

Researchers in the U.S. say a new drug effectively treats serious cases of gout - the drug called pegloticase mimics a blood-clearing enzyme missing in humans and helps remove the build up in uric acid, which causes the painful, needle-like crystals to collect around fingers, toes and other joints.

27 Oct 2008

New drugs the next casualty of the credit crunch

Scientists at an international conference have been warned that the next casualty of the credit crunch could be new drugs.

27 Oct 2008

Gardasil safety questioned, CDC urged to back up statement with data

The National Vaccine Information Center (NVIC) is calling on the Centers for Disease Control (CDC) and Food and Drug Administration (FDA) to publicly release the study design, data and names of principal investigators involved in a statement this week maintaining that Gardasil vaccine is safe with no serious side effects.

26 Oct 2008