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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

Mylan receives tentative FDA approval for generic versions of Benicar and Uroxatral

Mylan Inc. today announced that its subsidiary, Mylan Pharmaceuticals Inc., received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 20 mg/12.5 mg, 40 mg/12.5 mg and 40 mg/25 mg.

22 Oct 2008

CytoDyn files new IND for Cytolin

CytoDyn, Inc. has filed a new IND for a study to reconfirm dose ranging and to "prove the principle" with a randomized, double-blind placebo controlled study of Cytolin, the Company's first-in-class drug for treating HIV/AIDS. This comes 13 years after the first IND was issued for the drug.

22 Oct 2008

Aires Pharmaceuticals signs license agreement with NIH

Aires Pharmaceuticals Inc. today announced the signing of an exclusive license agreement with the U.S. National Institutes of Health for the patented use of a nitric oxide prodrug to treat cardiopulmonary conditions.

22 Oct 2008

Trius Therapeutics awarded $28 million to develop novel drugs targeting bacterial DNA Gyrase and Topoisomerase IV

Trius Therapeutics, Inc., today announced the award of a $28 million contract from the National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health, for the development of novel antibiotics directed against multiple Gram-negative bacterial pathogens.

22 Oct 2008

FDA grants orphan drug status to new 'Trojan Horse' like Ewing's Sarcoma drug

The Cure Our Children Foundation, a nonprofit charitable foundation dedicated to children, announced today that the U.S. Food and Drug Administration (FDA) has approved the Orphan Drug Designation of the foundation's unique drug product for children with Ewing's Sarcoma cancer. The efforts to develop this drug were made possible by the generous volunteers and researchers in private industry and at two universities.

20 Oct 2008

Teva granted FDA approval for Fentanyl transdermal system

Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has granted approval for the Company's Abbreviated New Drug Application (ANDA) for Fentanyl Transdermal System, 25 mcg/hour, 50 mcg/hour, 75 mcg/hour and 100 mcg/hour, the AB-rated generic equivalent of Ortho McNeil's chronic pain treatment Duragesic. Shipment of this product has commenced.

20 Oct 2008

Better TB vaccine in the pipeline

Scientists in the U.S. believe they have a vaccine in the pipeline that offers better protection from tuberculosis (TB).

20 Oct 2008

FDA approves Astepro, new formulation of Astelin

The U.S. Food and Drug Administration (FDA) has approved Astepro - the new formulation of Astelin. Astepro Nasal Spray is an improvement over the marketed Astelin Nasal Spray and is better tolerated by patients using the new spray.

19 Oct 2008

FDA approves new labeling for psoriasis drug Raptiva

The U.S. Food and Drug Administration today announced labeling changes, including a Boxed Warning, to highlight the risks of life-threatening infections, including progressive multifocal leukoencephalopathy (PML), with the use of Raptiva (efalizumab). The labeling changes are based on the FDA's post-market surveillance.

19 Oct 2008

FDA grants orphan drug status to Reata's pancreatic cancer drug

Reata Pharmaceuticals, Inc. has announced that RTA 402 has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer. RTA 402 is currently being studied in a Phase 1/2 trial in patients with pancreatic cancer, and is also in Phase 2 development for chronic kidney disease.

16 Oct 2008

Vioxx heart risks confirmed in long-term study

The study, an analysis of people who took the arthritis drug carried out by Dr. Robert Bresalier of the M.D. Anderson Cancer Center at the University of Texas, has found Vioxx doubles the risk of strokes and heart attacks.

14 Oct 2008

TB Alliance enters into collaboration with sanofi-aventis to fight tuberculosis

The Global Alliance for TB Drug Development (TB Alliance) and sanofi-aventis announced today that they have entered into a collaboration agreement to accelerate the discovery, development and clinical use of drugs against tuberculosis (TB). The TB Alliance is a not-for-profit, product development partnership, whose goal is the development of new TB drugs.

14 Oct 2008