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ACT Biotech files SPA with FDA for telatinib combination Phase 3 trial for stomach cancer

ACT Biotech, Inc., a biopharmaceutical company focused on the development of highly targeted, oral therapeutics for the treatment of cancer, announced today that it has filed a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA) related to a randomized Phase 3 trial of telatinib in combination with chemotherapy for the first-line treatment of patients with advanced stomach cancer.

28 Feb 2011

Dialogue with children about healthy habits very important

Health is a hot topic amongst adults. But, dialoguing with children about healthy habits is equally important. Kids, today, need to be as proactive as adults in managing their health by making wholesome choices--whether for food or for their daily activities.

28 Feb 2011

Endo fourth quarter total revenues increase 31% to $511 million

Endo Pharmaceuticals today reported financial results for the fourth quarter 2010.

28 Feb 2011

Regeneron's ARCALYST meets primary, secondary endpoints in second Phase 3 gout flare study

Regeneron Pharmaceuticals, Inc. announced that in a second Phase 3 study (PRE-SURGE 2) in gout patients initiating allopurinol therapy, ARCALYST (rilonacept) met the primary and all secondary study endpoints. The primary endpoint was the number of gout flares per patient over the 16-week treatment period.

28 Feb 2011

Exactech fourth quarter total revenue increases 7% to $51.8 million

Exactech, Inc., a developer and producer of bone and joint restoration products for hip, knee, extremities, spine and biologic materials, announced today that revenue for 2010 increased 7% to $190.5 million from $177.3 million in 2009. Diluted earnings per share for the year was $0.80 based on net income of $10.5 million.

28 Feb 2011

Celgene's ISTODAX sNDA granted FDA Priority Review classification for progressive/relapsed PTCL

Celgene Corporation today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review classification to its Supplemental New Drug Application (sNDA) regarding ISTODAX (romidepsin) for injection for the treatment of peripheral T-cell lymphoma (PTCL) in patients who have received at least one prior therapy.

28 Feb 2011

FDA grants 510(k) clearance for Derma Sciences MEDIHONEY Gel Wound and Burn Dressing

Derma Sciences, Inc., a medical device and pharmaceutical company focused on advanced wound care, today announced receipt of 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Company's patent-pending MEDIHONEY® Gel Wound and Burn Dressing.

28 Feb 2011

FDA approves Matrix Labs generic Neurontin ANDA

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Gabapentin Capsules USP, 100 mg, 300 mg and 400 mg, the generic version of Pfizer's Neurontin® Capsules used to treat a painful complication of shingles.

28 Feb 2011

Hotspur Technologies announces first clinical use of its Keeper Embolectomy Catheter

Hotspur Technologies announced today that Dr. Thomas DiBartholomeo of Fairfield, CT, performed the first clinical use of its Keeper Embolectomy Catheter. The Keeper Catheter enables physicians to clear clot formation within arteries, while also incorporating the capability of injecting physician-specified fluids directly through the balloon catheter.

28 Feb 2011

Seattle Genetics submits brentuximab vedotin BLA to FDA for treatment of ALCL, Hodgkin lymphoma

Seattle Genetics, Inc. announced today that it has submitted a Biologics License Application to the U.S. Food and Drug Administration for the use of brentuximab vedotin in relapsed or refractory Hodgkin lymphoma and relapsed or refractory systemic anaplastic large cell lymphoma.

28 Feb 2011

FDA clears Ascom's ClinicalConneX | Cardiomax medical device

Ascom Inc., a leading supplier of mission critical on-site wireless communications, is pleased to announce ClinicalConneX as its new integration suite powered by Ascom's Unite Professional Messaging and Alarm Application.

28 Feb 2011

U.S. food prices could rise up to 4%, USDA says

U.S. food prices will "rise as much as 4% this year, more than the 2% to 3% estimated last month, after a surge in prices for farm goods, the U.S. Department of Agriculture" forecast Thursday during the agency's outlook conference in Washington, Bloomberg/Los Angeles Times reports.

28 Feb 2011

Despite FDA action, Deston still believes Auralgan as a safe and effective drug product

Deston Therapeutics LLC announced today that it is currently exploring its options to respond to a recent seizure of its Auralgan Otic Solution by the Federal Government and that it still believes that Auralgan is a safe and effective drug product.

28 Feb 2011

Temporary budget compromise would not defund health law

News outlets covered the ongoing saga of whether Congress and the president will avert a government shutdown.

28 Feb 2011

Pharming, Santarus receive FDA refusal to file letter for RHUCIN BLA

Specialty biopharmaceutical company Santarus, Inc.and biotech company Pharming Group NV today announced the receipt of a "refusal to file" letter from the U.S. Food and Drug Administration for the RHUCIN Biologics License Application submitted by Pharming.

28 Feb 2011

Visualization techniques and action plan can improve food habits

If you want to improve the way you eat, the best way to do so is to both make an action plan and visualize yourself carrying it out, according to McGill researchers.

28 Feb 2011

Menthol cigarette makers & FDA in a legal debate over ban

Tobacco companies have decided to sue the U.S. Food and Drug Administration (FDA) over a decision that has been made in regards to cigarettes. The companies include the R.J. Reynolds Tobacco Co. as well as Lorillard, Inc., have sued the FDA over a decision that would potentially ban all cigarettes that contain a chemical known as menthol.

28 Feb 2011

FDA approves GSK's PROMACTA to treat rare blood disorder

GlaxoSmithKline today announced that the United States Food and Drug Administration granted full approval for PROMACTA, an oral tablet that can raise platelet counts in patients with the rare blood disorder chronic immune thrombocytopenic purpura who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy.

27 Feb 2011

Experts offer myth-busting advice to fight against spring allergies

Millions of Americans sneeze and wheeze March through June when they use misinformation to manage their spring allergies.

27 Feb 2011

Scientists discover killer protein that protects against development of cancer

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.

27 Feb 2011