Sipuleucel-T in prostate cancer: Indication of added benefit – Sipuleucel-T (trade name Provenge) has been approved since September 2014 for men with metastatic prostate cancer who have few or no symptoms and do not yet require chemotherapy. In the dossier assessment conducted by the German Institute for Quality and Efficiency in Health Care (IQWiG) in January 2015, no added benefit could be derived for sipuleucel-T.
170 reportedly sickened by mold in Chobani yogurt – Complaints double from people attributing sickness to Chobani yogurt – As of September 13, the FDA received a total of 170 complaints associated with Chobani. The various issues reported continue to be cramps, nausea, headache and diarrhea. The complaints were submitted by individuals in Arizona, Delaware, New York, Maryland, Ohio, Pennsylvania, California, Indiana and Florida.
High school athletes say concussions won’t sideline them — Survey of football players shows many would not report symptoms to a coach – Many high school football players say it’s OK to play with a concussion even though they know they are at risk of serious injury. The study of 120 high school football players in the Cincinnati area also found that one-quarter had suffered a concussion, and more than half acknowledged they would continue to play with symptoms of a concussion.
American Academy of Neurology (AAN) Issues Updated Sports Concussion Guideline: Athletes with Suspected Concussion Should Be Removed from Play – With more than one million athletes now experiencing a concussion each year in the United States, the American Academy of Neurology (AAN) has released an evidence-based guideline for evaluating and managing athletes with concussion. This new guideline replaces the 1997 AAN guideline on the same topic.
US FDA approves new treatment for late-stage breast cancer – Kadcyla (ado-trastuzumab emtansine) – a new therapy for patients with HER2-positive, late-stage (metastatic) breast cancer is approved by US FDA. Breast cancer is the second leading cause of cancer-related death among women. Almost 20 percent of breast cancers have increased amounts of the HER2 protein.
US FDA approves new orphan drug Kynamro to treat inherited cholesterol disorder – Kynamro – mipomersen sodium – injection approved as an addition to lipid-lowering medications and diet to treat patients with a rare type of high cholesterol called homozygous familial hypercholesterolemia (HoFH). Kynamro is approved by the U.S. Food and Drug Administration.
US FDA approves new seasonal influenza vaccine made using novel technology – The U.S. Food and Drug Administration announced that it has approved Flublok, the first trivalent influenza vaccine made using an insect virus (baculovirus) expression system and recombinant DNA technology. Flublok is approved for the prevention of seasonal influenza in people 18 through 49 years of age.