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FDA takes legal action against dietary supplement manufacturer in Pennsylvania

The FDA today took legal action against a dietary supplement maker and owner for substituting ingredients and products without noting the changes on the final product labels. The permanent injunction, filed on behalf of the FDA by the U.S. Department of Justice, would stop the defendants from making and distributing more than 400 products for being in violation of the Federal Food, Drug, and Cosmetic Act.

24 Nov 2011

Advaxis completes ADXS-HER2 pre-IND meeting with FDA

Advaxis, Inc., a leader in developing the next generation of immunotherapies for cancer and infectious diseases, completed a pre-IND meeting with the FDA on November 22, 2011 to discuss the development plan for ADXS-HER2, an immunotherapy for the treatment of HER2 expressing cancers.

23 Nov 2011

Transcept receives FDA approval for Intermezzo to treat insomnia

The U.S. Food and Drug Administration today approved Intermezzo (zolpidem tartrate sublingual tablets) for use as needed to treat insomnia characterized by middle-of-the-night waking followed by difficulty returning to sleep.

23 Nov 2011

Cancer medicine component could prevent heart attacks

A substance in medicines for cancer and epilepsy could also prevent heart attacks, according to researchers at the Sahlgrenska Academy at the University of Gothenburg, Sweden, who have been using it to stimulate the body's own defence system against blood clots.

23 Nov 2011

University of Rochester receives U.S. patent for HPV vaccine research

The University of Rochester has been awarded a U.S. patent for research essential to both human papillomavirus vaccines on the market.

23 Nov 2011

Study reveals principal mechanism of action for paracetamol

Researchers at King's College London have discovered how one of the most common household painkillers works, which could pave the way for less harmful pain relief medications to be developed in the future.

23 Nov 2011

Medicare to cover infusion costs for prostate cancer vaccine, company says

In Medicare news, the drug maker Dendreon says federal officials have said they will pay doctors to administer the drug. Also, policymakers are studying Medigap to see if curbs on those policies could help cut Medicare costs.

23 Nov 2011

Families with chronically ill member less likely to benefit from employer-sponsored insurance

Benefits paid out under employer-sponsored health care plans are less generous to families covering a member with a chronic illness than to families without a chronically ill member, according to a trio of university researchers. The difference is due primarily to higher out-of-pocket expenses for prescription drugs.

23 Nov 2011

USPTO issues patent to BioFactura's StableFast platform

BioFactura, Inc. was awarded a US patent covering the core technologies of its proprietary StableFast Biomanufacturing Platform. The US Patent and Trademark Office allowed 32 claims broadly covering composition of matter, methods, commercial kits, and media formulations.

23 Nov 2011

Oral antibiotics might treat Buruli ulcer

It might be possible to treat Buruli ulcer, a crippling and deforming disease, with only oral medicines, which would make treatment easier. And even the current treatment can in many cases be given in an outpatient regimen.

23 Nov 2011

FDA accepts Regeneron's ARCALYST sBLA for review

Regeneron Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company's supplemental Biologics License Application (sBLA) for ARCALYST Injection for Subcutaneous Use for the prevention of gout flares in patients initiating uric acid-lowering therapy.

22 Nov 2011

Naltrexone for problem gamblers

According to new practice guidelines Australian doctors treating gambling addicts now can consider prescribing an anti-heroin drug, naltrexone, to help problem gamblers control their impulses. Australia has one of the world’s highest rates of problem gamblers, with about 2.1 per cent of Australians experiencing some form of gambling problem.

22 Nov 2011

Merck agrees to pay $950 million in Vioxx safety probe

Merck & Co. will pay $950 million and one of its units will plead guilty to a criminal charge to resolve a U.S. probe of its illegal marketing of the painkiller Vioxx.

22 Nov 2011

Essence Healthcare, CompCare sign new multi-service agreement

Comprehensive Care Corporation announced today it has signed a new multi-service agreement with Essence Healthcare to provide managed behavioral health and pharmacy management services to the Medicare Advantage population serviced by Essence Healthcare in Missouri, Washington and Illinois.

22 Nov 2011

Eating fish before age of nine months reduces risk of pre-school wheeze in children

Children who started eating fish before nine months of age are less likely to suffer from pre-school wheeze, but face a higher risk if they were treated with broad spectrum antibiotics in the first week of life or their mother took paracetamol during pregnancy.

22 Nov 2011

New way to exploit expression of BRAF by papillary carcinomas for therapeutic purposes

Papillary carcinoma is the most common form of thyroid cancer. Approximately one quarter of these carcinomas have mutations in the BRAF gene. The prevalence of such mutations is even greater in high-grade carcinomas, particularly those that are refractory to standard treatment, which is radioactive iodine.

22 Nov 2011

Medicare will still cover Avastin for breast cancer, despite revocation of FDA approval

The FDA announced that Avastin, while still approved for other cancers, is more harmful than helpful to breast cancer patients.

22 Nov 2011

Decanoic acid can modulate glucose control

A Van Andel Research Institute (VARI) study published recently in the Journal of Biological Chemistry reveals that a natural fatty acid can serve as a regulator of blood sugar levels, which may have important applications in designing better and safer drugs for diabetes treatment.

22 Nov 2011

FDA accepts Otsuka's aripiprazole depot formulation NDA for review

Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S announced today that the U.S. Food and Drug Administration has determined that a new drug application (NDA) for Otsuka's investigational once-monthly aripiprazole depot formulation for the indication of maintenance treatment of schizophrenia in adults is sufficiently complete to permit a substantive review.

22 Nov 2011

New way to enhance effects of anandamide in the body

UC Irvine and Italian researchers have discovered a new means of enhancing the effects of anandamide - a natural, marijuana-like chemical in the body that provides pain relief.

22 Nov 2011