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Lucentis receives Health Canada approval to treat vision loss from DME

Health Canada has approved Lucentis (ranibizumab) as a treatment for vision loss resulting from diabetic macular edema, one of the major causes of adult vision loss and an important complication of the growing epidemic of diabetes.

14 Sep 2011

Cohera's TissuGlu Surgical Adhesive receives CE Mark approval

Cohera Medical, Inc., a rapidly growing medical device company, announced today that it has received CE Mark approval for its lead product, TissuGlu® Surgical Adhesive. CE Mark approval allows TissuGlu to be sold in the European Union.

14 Sep 2011

Celecoxib inhibits GSK3 enzyme in lung cancer cells

Several clinical studies have shown that taking the anti-inflammatory drug celecoxib can reduce the risk of developing polyps that lead to colon cancers, at the cost of increasing the risk of heart disease. But what if this tradeoff was not necessary?

14 Sep 2011

Reminder packaging improves adherence to long-term hypertension medications

People with chronic illnesses are more likely to take long-term medications according to doctors' instructions if the packaging includes a reminder system, according to a new review of evidence.

14 Sep 2011

FDA grants Orphan Drug Designation for Accentia's Revimmune to prevent GVHD

Accentia Biopharmaceuticals, Inc. and its majority-owned subsidiary, Biovest International, Inc., today jointly announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Revimmune, the Company's proprietary system-of-care based on high-dose administration of Cytoxan, for the prevention of graft-versus-host disease (GVHD) following bone marrow transplant.

14 Sep 2011

Biotica, Buck Institute collaborate to investigate polyketides in diseases of aging

The Buck Institute for Research on Aging and Biotica Technology Ltd. today announced a three-year collaboration to investigate polyketides in diseases of aging. Building on observations that rapamycin extends healthy lifespan in various species, the collaborators will evaluate rapamycin analogs and other polyketides in a broad range of age-related disease models to identify novel therapeutics.

14 Sep 2011

Natural S-equol supplement does not increase risk of estrogen-sensitive breast cancer

Consuming the soy germ-based compound Natural S-equol and the supplement SE5-OH containing Natural S-equol did not increase the risk of estrogen-sensitive breast cancer, according to a study in the September issue of the peer-reviewed journal Food and Chemical Toxicology.

14 Sep 2011

Merck issues statement on GARDASIL human papillomavirus vaccine

Merck, known as MSD outside the United States and Canada, issued the following statement on GARDASIL, Merck's vaccine to protect against certain diseases caused by human papillomavirus (HPV) types 6, 11, 16 and 18.

14 Sep 2011

Prescription drugs expensive in Australia and likely to increase

According to experts Australians are facing some of the highest ‘out-of-pocket’ costs in the industrialized world for prescription medicines and the problem is likely to worsen

14 Sep 2011

Avedro acquires proprietary and patent pending transepithelial ParaCel riboflavin formulation

Avedro, Inc announced today that it has acquired all the intellectual property rights to produce, market, and distribute a breakthrough transepithelial riboflavin formulation based on the research of Roberto Pinelli, MD at the Istituto Laser Microchirurgia Oculare (ILMO) in Brescia, Italy.

14 Sep 2011

Health Canada approves Afinitor for treatment of brain tumours caused by TSC in children

Families with children suffering from brain tumours caused by an uncommon genetic disorder known as Tuberous Sclerosis Complex (TSC) have new hope with Health Canada's recent conditional approval of a new therapeutic use for the drug Afinitor (everolimus). Afinitor is the first drug therapy approved in Canada for the treatment of brain tumours caused by TSC in patients three years of age and older.

14 Sep 2011

Kremers Urban reaches settlement agreement with ALZA over Concerta patent litigation

Kremers Urban Pharmaceuticals Inc. is pleased to announce that it has reached a settlement dismissing all pending litigation arising from its Abbreviated New Drug Application (ANDA) to market an extended release methylphenidate hydrochloride product, for which Concerta is the reference listed drug product. The ANDA is currently under review with FDA.

14 Sep 2011

FDA’s response to Tobacco company’s allegations on graphic cigarette labels

The Food and Drug Administration (FDA) has replied to the claims from cigarette makers that new graphic-warning labels due to take effect next year violate tobacco companies’ free speech rights.

13 Sep 2011

Older drugs may be better than newly approved ones

It is a common belief that drugs given the okay by the Food and Drug Administration (FDA) are safer and more effective than they have to be to win approval, according to a new study. Especially in the first few years after a drug becomes available, researchers note, there are still questions about how well it will work and whether it will have any serious side effects warn experts. For example FDA-approved painkiller Vioxx was pulled off the market in 2004 after longer-term evidence showed that it may increase the risk of heart attack and stroke.

13 Sep 2011

FDA announces organizational changes within CDER's Office of Oncology Drug Products

Today, the U.S. Food and Drug Administration announced organizational changes within the office responsible for reviewing all drug and biologic applications for cancer therapies.

13 Sep 2011

New drug combination may treat two aggressive cancers

Researchers at Brigham and Women's Hospital (BWH) have identified a new combination of targeted therapies that, together, may treat two aggressive tumor types that until now have not had effective treatments. These findings are published in Cancer Cell on September 13, 2011.

13 Sep 2011