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Roche receives FDA approval for Zelboraf to treat BRAF mutation-positive metastatic melanoma

Genentech, a member of the Roche Group, today announced that the U.S. Food and Drug Administration (FDA) approved Zelboraf (vemurafenib) for the treatment of BRAF V600E mutation-positive, inoperable or metastatic melanoma, as determined by an FDA-approved test.

18 Aug 2011

New gout drug may help severely affected: Study

A new drug for gout could help very sick gout patients who don't get better with usual treatment, according to a new study. The research was designed and funded by the pharmaceutical company Savient, which markets the drug, called Krystexxa (pegloticase).

17 Aug 2011

Zelboraf receives FDA approval for treatment of metastatic melanoma

The U.S. Food and Drug Administration today approved Zelboraf (vemurafenib), a drug to treat patients with late-stage (metastatic) or unresectable (cannot be removed by surgery) melanoma, the most dangerous type of skin cancer.

17 Aug 2011

FDA accepts Protalix taliglucerase alfa NDA resubmission for review

Protalix BioTherapeutics, Inc., announced today that the U.S. Food & Drug Administration (FDA) has accepted for review the resubmission of the taliglucerase alfa New Drug Application (NDA) following the Company's receipt of a Complete Response Letter (CRL) in February 2011.

17 Aug 2011

Mylan confirms Frova patent challenge

Mylan Inc. today confirmed that the company and its subsidiary Mylan Pharmaceuticals Inc. have been sued by Endo Pharmaceuticals in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Frovatriptan Succinate EQ, 2.5 mg base tablets.

17 Aug 2011

FDA, USP co-sponsors OTC drug products workshop

Updated public standards incorporating new tests for impurities as well as more modern technologies to help ensure the quality of over-the-counter (OTC) ingredients and products will be key areas of focus for a September 8-9, 2011, workshop co-sponsored by the U.S. Food & Drug Administration (FDA) and the U.S. Pharmacopeial Convention.

17 Aug 2011

PAREXEL recognized as Company of the Year for the Pharmaceutical Industry

PAREXEL International Corporation, a leading global biopharmaceutical services provider, has been named Company of the Year for the Pharmaceutical Industry in The Eighth Annual International Business Awards, the only global, all-encompassing business awards program honoring great performances in business.

From Parexel 17 Aug 2011

Bayer Healthcare to provide over 600,000 moxifloxacin tablets to fight MDR-TB in China

Bayer Healthcare announced on Monday it "has agreed to support the World Health Organization (WHO) and the Stop TB Partnership in the fight against multidrug-resistant tuberculosis (MDR-TB) by making 620,000 tablets of the antibiotic moxifloxacin available to WHO," according to a Bayer press release.

17 Aug 2011

Study finds broadest immune response from LAIV nasal spray vaccines for children

Children younger than 3 years old receive the same protective antibody response from the recommended two doses of licensed seasonal influenza vaccines regardless of whether the two doses are injected by needle, inhaled through a nasal spray or provided through one dose of each in any order, according to researchers funded by the National Institutes of Health.

17 Aug 2011

FDA approves two new strengths of Lupron Depot-PED for central precocious puberty

Abbott announced today that the U.S. Food and Drug Administration has approved two new strengths for three-month administration of Lupron Depot-PED (leuprolide acetate for depot suspension) for the treatment of children with central precocious puberty (CPP).

17 Aug 2011

Inflammation linked with RA increases patients risk of heart disease

Rheumatoid arthritis (RA) sufferers are at an increased risk of dying due to cardiovascular disease. A new five year study published in BioMed Central's open access journal Arthritis Research & Therapy showed that the risk of cardiovascular disease for people with RA is due to disease-related inflammation as well as the risk factors which affect the general population.

16 Aug 2011

Scientists demonstrate how Modified Citrus Pectin enhances immune function

Groundbreaking research demonstrates the ability of a specific form of Modified Citrus Pectin (MCP) to greatly enhance immune function.

16 Aug 2011

AHRQ's new Spanish-language guide on heart medications

A free, illustrated easy-to-read pamphlet that compares drugs for preventing heart attacks, heart failure or strokes in people with stable coronary heart disease is one of six new Spanish-language publications from HHS' Agency for Healthcare Research and Quality that help patients compare treatments for common illnesses.

16 Aug 2011

Combination immunotherapy more effective for patients with Sezary Syndrome

A three-pronged immunotherapy approach nearly doubles five-year survival among patients with rare leukemic form of cutaneous T-cell lymphoma, reports a new study by dermatologists from the Abramson Cancer Center and Perelman School of Medicine at the University of Pennsylvania.

16 Aug 2011

Starpharma starts bacterial vaginosis prevention study of VivaGel

Starpharma Holdings Limited today announced the commencement of its Phase 2 study of VivaGel for the prevention of bacterial vaginosis (BV), following receipt of ethics approval.

15 Aug 2011

NAI reaches settlement with VPX over beta-alanine patent litigation

Natural Alternatives International, Inc., a leading formulator, manufacturer and marketer of customized nutritional supplements, today announced that it reached a settlement with one of the defendants to litigation pending before the U.S. District Court for the District of Delaware, Vital Pharmaceutical, Inc..

12 Aug 2011

Thorne acquires global rights to Q-Cell, an advanced formulation Coenzyme Q10

Thorne Research, Inc., a leader in developing and manufacturing pure, high quality nutritional supplements marketed through licensed healthcare practitioners, has acquired exclusive global rights to market Q-Cell, an advanced formulation Coenzyme Q10 (CoQ10) supplement formerly marketed under the brand name Q-Best.

12 Aug 2011

Fibrate drugs may not prevent heart attacks in diabetes patients with elevated cholesterol

Type 2 diabetes patients, who face higher risk of cardiovascular disease, often take a combination of medications designed to lower their LDL or "bad" cholesterol and triglyceride levels while raising their HDL or "good" cholesterol because doctors long have thought that taken together, the drugs offer protection from heart attacks and improve survival.

12 Aug 2011

Benefits of nanoparticle sunscreens outweigh risks

The most personal encounter that many consumers have had so far with the much-heralded field of nanotechnology is the topic of an article in the current edition of Chemical & Engineering News (C&EN), the American Chemical Society's weekly newsmagazine.

12 Aug 2011

Advaxis completes ADXS-PSA prostate cancer construct pre-IND meeting with the FDA

Advaxis, Inc.,, a leader in developing the next generation of immunotherapies for cancer and infectious diseases, has completed a pre-IND (Investigational New Drug) meeting with the FDA on August 10 to discuss the development plan for ADXS-PSA, a construct for the treatment of prostate cancer.

12 Aug 2011