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Takeda receives FDA approval for EDARBI to treat hypertension in adults

Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc., today announced that the U.S. Food and Drug Administration approved EDARBI for the treatment of hypertension, or high blood pressure, in adults.

27 Feb 2011

Avastin debate spills over until June FDA hearing

The U.S. Food and Drug Administration have granted Roche a hearing in June to defend the cancer treatment Avastin. The hearing would examine the effectiveness of the drug in breast cancer.

27 Feb 2011

Viewpoints: WSJ on Medicare Advantage, Texas Gov. Perry on 'Fed inroads,' Med students' health policy ignorance

The White House has apparently decided that it won't enforce the unpopular parts of its health-care plan until after the 2012 election. The latest evidence is its decision not to slash Medicare Advantage, the program that Democrats hate because it lets seniors choose private insurance options. ... Would this be the same Medicare Advantage that candidate Barack Obama vowed to eliminate, saying in 2007 that "We shouldn't be rewarding the insurance industry for deceiving and defrauding our seniors"? (2/25).

25 Feb 2011

FDA approves variance for sale of KODAK Systems using KODAK Laser Projection Technology

The Food and Drug Administration (FDA) has approved a variance that allows for the sale of KODAK Laser Projector Systems using KODAK Laser Projection Technology to cinema exhibitors without the need for individual site or show operator variances. This is an important step forward in delivering brighter 2D and 3D images that provide higher dynamic range and a wider color gamut to theaters.

25 Feb 2011

New policy research brief examines patients at risk of losing care under health center spending cuts

A new policy research brief released today by the Geiger Gibson/RCHN Community Health Foundation Research Collaborative at The George Washington University School of Public Health and Health Services examines the characteristics of patients whose access to health center services is at risk because of a potential $1.3 billion in direct spending cuts for community health centers.

25 Feb 2011

Warner Chilcott fourth quarter revenue increases 1% to $694.4 million

Warner Chilcott plc today announced its results for the quarter and year ended December 31, 2010. As discussed more fully below, our financial position and results of operations in the quarter ended December 31, 2010 as compared to the prior year quarter were significantly impacted by several important transactions in 2009 and 2010.

25 Feb 2011

Discovery highlights unexpected role for killer protein in 'autophagy'

Scientists at Trinity College Dublin have made an important discovery concerning how fledgling cancer cells self-destruct, which has the potential of impacting on future cancer therapies. The Trinity research group, led by Smurfit Professor of Medical Genetics, Professor Seamus Martin and funded by Science Foundation Ireland, has just published their findings in the internationally renowned journal, Molecular Cell.

25 Feb 2011

AMAG fourth quarter total revenues increase to $17.2 million

AMAG Pharmaceuticals, Inc. a biopharmaceutical company focused on the development and commercialization of a therapeutic iron compound to treat iron deficiency anemia, today reported unaudited consolidated financial results for the fourth quarter and year ended December 31, 2010.

25 Feb 2011

Savient launches KRYSTEXXA in the U.S.

Savient Pharmaceuticals, Inc. announced the official full U.S. commercial launch of KRYSTEXXA™ (pegloticase), which has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of chronic gout in adult patients refractory to conventional therapy. KRYSTEXXA is now the first and only therapy available to address this unmet medical need.

25 Feb 2011

Protalix receives FDA CRL for taliglucerase alfa NDA for Gaucher disease

Protalix BioTherapeutics, Inc., announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the Company's New Drug Application (NDA) for taliglucerase alfa for the treatment of Gaucher disease. Taliglucerase alfa is a plant-cell expressed form of glucocerebrosidase (GCD).

25 Feb 2011

Media examine effects, outlook of food price increases worldwide

"A rush by farmers to expand plantings in many parts of the world is raising expectations that food prices may retreat as early as the second half of this year if weather conditions remain favorable," the Wall Street Journal reports in a story examining how recent global developments could affect food price spikes.

25 Feb 2011

Radioactive tracing agent can identify tumor-draining sentinel nodes in breast cancer, melanoma patients

Researchers say a new kind of tracing agent is more accurate than current methods in helping identify tumor-draining sentinel lymph nodes in breast cancer and melanoma patients. That's the finding in a new study that appears in the online version of the Annals of Surgical Oncology.

25 Feb 2011

The Lancet journal publishes XGEVA Phase 3 study results against prostate cancer, bone metastases

Amgen today announced the publication of results from a Phase 3 head-to-head trial that compared XGEVA to Zometa in preventing bone complications called skeletal-related events in 1,901 men with prostate cancer and bone metastases.

25 Feb 2011

Role of serotonin in autism spectrum disorders

Mouse models are yielding important clues about the nature of autism spectrum disorders, which impact an estimated one in 110 children in the U.S. In labs at the UT Health Science Center San Antonio, researchers are studying strains of mice that inherently mimic the repetitive and socially impaired behaviors present in these disorders.

25 Feb 2011

Longer looks: Best health policy picks from thought-provoking publications

Last week, in the largest nationwide bust of its kind ever, more than 700 federal agents fanned out from Miami to Los Angeles and rounded up 111 doctors, nurses, physical therapists and health company executives in nine cities.

25 Feb 2011

Salix anticipates receipt of FDA's CRL for XIFAXAN 550 mg sNDA

Salix Pharmaceuticals, Ltd. today announced that based on a telephone conversation with the U.S. Food and Drug Administration held last evening, the Company anticipates receiving a Complete Response Letter on or before the March 7, 2011 PDUFA goal date for the supplemental New Drug Application for XIFAXAN 550 mg tablets for the proposed indication of treatment of non-constipation irritable bowel syndrome and IBS-related bloating.

25 Feb 2011