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Genomic research could help doctors better target oxaliplatin drug to treat colorectal cancer patients: Study

Genomic research could help doctors better target a drug widely used to treat colorectal cancer patients, according to a study by Genomic Health Inc. and the Translational Genomics Research Institute.

13 Jan 2011

Pfizer initiates rolling submission of crizotinib NDA for ALK-positive advanced NSCLC

Pfizer Inc. announced today that it has initiated the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for crizotinib (PF-02341066), an oral first-in-class anaplastic lymphoma kinase (ALK) inhibitor for the treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors are ALK-positive. Pfizer expects to complete the submission in the first half of 2011.

13 Jan 2011

FDA accepts to review Fibrocell Science's azficel-T drug

Fibrocell Science, a biotechnology company focused on the development of autologous cell therapies for aesthetic, medical and scientific applications, announced today that the U.S. Food & Drug Administration has accepted for review the Company's complete response submission for azficel-T, proposed brand name laViv, for the treatment of moderate to severe nasolabial folds and wrinkles.

12 Jan 2011

K-V Pharmaceutical provides update on FDA review of NDA for Gestiva

K-V Pharmaceutical Company today issued an update on the status of the U.S. Food and Drug Administration's review of Hologic, Inc.'s New Drug Application for Gestiva as a treatment for the prevention of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.

12 Jan 2011

FDA panel rejects new pancreatic enzyme replacement drug

Eli Lilly & Co did not win the support of the U.S. advisory panel on Wednesday for its one-of-its kind drug not made from pig enzymes to help certain pancreatic patients digest food. A Food and Drug Administration panel of outside experts in a 7-4 vote said they were not convinced the experimental medicine, known chemically as liprotamase, worked well enough for patients to absorb enough needed nutrients. One member of the panel abstained.

12 Jan 2011

US most susceptible to brand erosion post patent expiry

On average, small molecule brands in the US experienced the greatest degree of brand erosion following patent expiry and exposure to direct generic competition, according to a new report from independent market analyst, Datamonitor.

12 Jan 2011

Study highlights importance of independent evaluation of Tamiflu drug

Tom Jefferson and colleagues from the Cochrane Group argue that the current system for assessing the safety and effectiveness of drugs, based on published trial data only, is "wholly inadequate" and "ethically dubious."

12 Jan 2011

Study shows delivering cancer drug in hydrophobic nanoparticle is a safe and effective prostate cancer therapy

Researchers at MIT and Brigham and Women's Hospital have shown that they can deliver the cancer drug cisplatin much more effectively and safely in a form that has been encapsulated in a nanoparticle targeted to prostate tumor cells and is activated once it reaches its target.

12 Jan 2011

New research identifies nutrition inadequacy among Americans

At a time when the country is facing an obesity epidemic, the problem of nutrition inadequacy is often overlooked. Yet, many Americans are overweight and undernourished, concludes a new study called "What America's Missing."

12 Jan 2011

Study: 23% of doctors have negative perceptions on quality, effectiveness of generic drugs

A new study by researchers at Harvard, Brigham and Women's Hospital and CVS Caremark finds that 23 percent of doctors' have negative perceptions of the effectiveness and quality of generic drugs and that may lead to doctors prescribing unnecessarily expensive medications.

12 Jan 2011

56% of respondents have still not received flu shots

As we enter peak flu season, flu activity is steadily increasing in the United States, with eight states now reporting widespread outbreaks of influenza cases according to the most recent Centers for Disease Control and Prevention (CDC) report.

12 Jan 2011

Apixaban drug raises hope for DVT prevention in patients undergoing hip replacement surgery

A worldwide research consortium that includes the University of Oklahoma Health Sciences Center has proven that a new drug is more effective and easier to use than current medicines in the prevention of blood clots following hip replacement surgery.

12 Jan 2011

Herpes zoster vaccine reduces risk of developing shingles by 55%

Receiving the herpes zoster vaccine was associated with a 55 percent reduced risk of developing shingles, according to a Kaiser Permanente study of 300,000 people that appears in the current issue of the Journal of the American Medical Association.

12 Jan 2011

Coventry Health Care offers new medicare plans for employer group

Coventry Health Care of Florida is first to the greater Tampa market with a portfolio of hybrid PPO health care plans that blend the best features of traditional co-pay based plans with the freedom and affordability of consumer-directed plans.

12 Jan 2011

BPH, hair loss prevention drugs may produce adverse side effects in men

Researchers from Boston University School of Medicine, in collaboration with colleagues at Lahey Clinic and from Denmark and Germany, have found that 5a-reductase inhibitors, while improving urinary symptoms in patients with benign prostatic hyperplasia and possible hair loss prevention, produces significant adverse effects in some individuals including loss of libido, erectile dysfunction, ejaculatory dysfunction and potential depression.

12 Jan 2011

FDA accepts Merck's JANUMET extended-release formulation NDA for type 2 diabetes

Merck today announced that the New Drug Application (NDA) for the Company's investigational extended-release formulation of JANUMET for type 2 diabetes has been accepted for standard review by the U.S. Food and Drug Administration (FDA). The Company is also moving forward as planned with regulatory filings in countries outside the United States.

12 Jan 2011

Patients who consume painkillers may face cardiovascular risk

The drugs include traditional non-steroidal anti-inflammatory drugs as well as new generation anti-inflammatory drugs, known as COX-2 inhibitors. The researchers say that doctors and patients need to be aware that prescription of any anti-inflammatory drug needs to take cardiovascular risk into account.

12 Jan 2011

Zogenix, Desitin receive MAA approval for SUMAVEL DosePro in Germany and the UK

Aradigm Corporation today announced that Zogenix, Inc. and Desitin Pharmaceuticals GmbH were granted approval of the Marketing Authorization Application for SUMAVEL® DosePro™ (sumatriptan injection) needle-free delivery system for the acute treatment of migraine attacks, with or without aura, and the acute treatment of cluster headache by the Federal Institute for Drugs and Medical Devices of Germany (BrArM) and the Medicines and Healthcare products Regulatory Agency of the United Kingdom (MHRA).

11 Jan 2011

ESHRE Annual Meeting addresses latest breakthroughs in reproductive medicine

Reproductive medicine is one of today's most exciting scientific and clinical areas. Every month there are announcements of medical 'firsts', new rulings by regulatory bodies or ethical controversies. These often spark a heated debate among practitioners in the field, ethicists, legislators, the media and the public. ESHRE's Annual Meeting is the forum where more than 9,000 of the world's leading experts in reproductive medicine gather to give a public presentation of their latest research findings.

11 Jan 2011

Genzyme provides update on discussions with Sanofi-Aventis

Genzyme Corp. (NASDAQ: GENZ) reported today that discussions between its financial advisors and financial advisors for Sanofi-Aventis are continuing and have expanded to include representatives of both companies.

11 Jan 2011