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FDA asks Guided Therapeutics to provide additional information on LuViva PMA

Guided Therapeutics, Inc., developer of a rapid and painless biophotonic testing platform for the early detection of cancer, today announced that, after a series of meetings with the U.S. Food and Drug Administration (FDA), and after reviewing draft responses, the FDA has asked the company to provide additional information in the company's response to one remaining question.

15 Jul 2011

Women with current major depression more likely to use crack

Women who are clinically depressed at the time they enter drug court have a substantially higher risk of using crack cocaine within four months, according to a new study.

15 Jul 2011

Neuralstem receives U.S. patent allowance for three new neurogenic compounds

Neuralstem, Inc. announced that it has received notice of allowance for U.S. Patent Applications 12/939,897 and 12/939,914 entitled: "Compositions to Effect Neuronal Growth."

15 Jul 2011

Transcept receives FDA Complete Response Letter for Intermezzo NDA

Transcept Pharmaceuticals, Inc. announced today that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) regarding the resubmitted New Drug Application (NDA) for Intermezzo.

15 Jul 2011

Teva commends U.S. Senators for introducing Affordable Medicines Utilization Act of 2011

Teva commends Senators Scott Brown, Ron Wyden and John McCain for introducing the Affordable Medicines Utilization Act of 2011.

15 Jul 2011

Oxytocin does not boost prospects for normal births

A new Cochrane review says that oxytocin, a medication often used to quicken slow-paced labor in its early stages, doesn't boost the prospects for normal births. Riskier births that required cesarean section or the use of forceps didn't become less common.

15 Jul 2011

Tocotrienol could help reduce stroke damage

Preventive supplementation with a natural form of vitamin E called tocotrienol could help reduce brain damage caused by strokes, researchers reported today at the 2nd International Conference on Tocotrienols and Chronic Diseases.

15 Jul 2011

Partially hydrolysed whey formula does not prevent allergies in high-risk infants

Despite the formula being recommended in public health guidelines set out by the Australasian Society of Clinical Immunology and Allergy, the new study, published online in the Journal of Allergy and Clinical Immunology, found there was no benefit in using hypoallergenic formula to prevent allergies in high-risk infants up to seven years of age, compared to a conventional cow's milk based formula.

15 Jul 2011

FDA needs more oversight power to protect increasingly globalized drug supply, Pew report says

"The Food and Drug Administration needs much more power to protect the U.S. supply of drugs as more and more are made in other countries," according to a report released Tuesday by the Pew Health Group, National Journal reports.

15 Jul 2011

CVS Caremark adds Access' MuGard to pharmacy benefit network

ACCESS PHARMACEUTICALS, INC., a biopharmaceutical company leveraging its proprietary drug-delivery platforms to develop treatments in areas of oncology, cancer supportive care and diabetes, announced that its lead product for oral mucositis, MuGard, has been added to CVS Caremark's pharmacy benefit network.

15 Jul 2011

Yervoy, a new melanoma drug approved in Australia

Australia has approved the world’s first drug to prolong the lives of people with advanced melanoma. The drug Yervoy received the nod from the Therapeutics Good Association (TGA) on Friday amid hopes it could add two years to the life of people with the deadliest form of skin cancer but for whom other treatments have failed.

14 Jul 2011

Seattle Genetics lymphoma drug gets FDA panel nod

Seattle Genetics Inc. has finally obtained the U.S. Food and Drugs Administration (FDA) nod for a second type of blood cancer drug. The FDA advisory committee voted 10-0 on Thursday to recommend accelerated approval of the drug, under the proposed trade name Adcetris, for anaplastic large cell lymphoma (ALCL). The panel earlier unanimously approved the drug for Hodgkin's lymphoma, another type of blood cancer.

14 Jul 2011

USPTO awards patent for Convergen LifeSciences' CNVN202 to treat lung cancer

Convergen LifeSciences, Inc. announced today that another United States Patent 7,977,468 has been awarded by the U.S. Patent and Trademark Office jointly to The University of Texas System Board of Regents and The Secretary, U.S. Department of Health and Human Services.

14 Jul 2011

Studies show AIDS drugs can prevent heterosexuals from acquiring HIV

Two new studies released early Wednesday show that AIDS drugs can prevent heterosexuals from acquiring HIV, adding to a growing number of new methods to slow the spread of the virus world-wide.

14 Jul 2011

EC grants marketing authorization for BENLYSTA to treat SLE

GlaxoSmithKline and Human Genome Sciences, Inc. announced today that the European Commission has granted marketing authorization for BENLYSTA 10mg/kg as an add-on therapy in adult patients with active autoantibody-positive systemic lupus erythematosus, with a high degree of disease activity, despite standard therapy.

14 Jul 2011

RXi expands intellectual property portfolio with additional NeuVax patents

RXi Pharmaceuticals Corporation, a biotechnology company focused on discovering, developing and commercializing innovative therapies addressing major unmet medical needs using targeted biotherapeutics, announced today that it expanded its patent portfolio with additional patents covering worldwide rights to develop and commercialize NeuVax.

14 Jul 2011

EC approves YERVOY for treatment of previously-treated advanced melanoma

Bristol-Myers Squibb today announced that the European Commission has approved YERVOY for the treatment of adult patients with previously-treated advanced melanoma.

14 Jul 2011

Humira's early-line growth threatens Enbrel's future uptake in psoriatic arthritis

Decision Resources, one of the world's leading research and advisory firms focusing on pharmaceutical and healthcare issues, finds that while Amgen/Pfizer's Enbrel was the most widely used tumor necrosis factor (TNF)-alpha inhibitor for recently treated psoriatic arthritis patients in the fourth quarter of 2010, Abbott's Humira has superseded Enbrel as an early-line TNF-alpha inhibitor for newly diagnosed psoriatic arthritis patients. Humira's early-line growth threatens Enbrel's future uptake in psoriatic arthritis.

14 Jul 2011

New Tamiflu anti-viral flu medication in lower concentration

When flu season arrives this fall, a liquid form of Tamiflu—the most widely used anti-viral flu medication—will be available in a new, lower concentration to reduce the possibility of medication errors.

14 Jul 2011

Scientists discover new mechanism of drug resistance in hospital microbes

Hospitals struggle to prevent the infections that complicate treatment for cancer, joint replacement, heart surgery and other conditions. Hospital-acquired infections are often resistant to multiple antibiotics, leading to approximately 100,000 deaths and more than $30 billion in additional health care costs yearly.

14 Jul 2011