Washington Week: Stem Cell Ruling Tops News

WASHINGTON (MedPage Today) — Congress may be out of town, but Washington came alive this week when a federal judge put a hold on NIH funding for embryonic stem cell research.

CDC, FDA Warn About Fingerstick Devices

WASHINGTON (MedPage Today) — A joint warning from the FDA and CDC cautioned against reusing fingerstick and point-of-care (POC) blood testing devices because of the potential for transmission of bloodborne illnesses.

Anti-HER2 Drug Fails to Win FDA Fast Track

WASHINGTON (MedPage Today) — The Food and Drug Administration turned down a request for accelerated approval of Roche-Genentech’s trastuzumab-DM1 for treatment of HER2-positive breast cancer.

FDA Issues Long List of Harmful Tobacco Components

(MedPage Today) — Forget tar and nicotine — the FDA is proposing to list as harmful or potentially harmful more than 100 chemicals found in tobacco and tobacco smoke, paving the way for tighter regulation of commercial tobacco products.

Maker Recalls Replacement Hip Devices

(MedPage Today) — The maker of an artificial hip system issued a voluntary recall of its ASR product line after data indicated a higher than expected need for device replacement surgery five years after the initial procedure.

FDA: Give Time Out to TimeOut Capsules

WASHINGTON (MedPage Today) — The FDA has issued a warning against yet another product marketed as an “all-natural sexual enhancement” dietary supplement — this one called TimeOut — that contains a potentially dangerous analogue of the prescription drug sildenafil, the active ingredient in Viagra.

CDC, FDA Warn About Fingerstick Devices

WASHINGTON (MedPage Today) — A joint warning from the FDA and CDC cautioned against reusing fingerstick and point-of-care (POC) blood testing devices because of the potential for transmission of bloodborne illnesses.

Maker Recalls Replacement Hip Devices

(MedPage Today) — The maker of an artificial hip system issued a voluntary recall of its ASR product line after data indicated a higher than expected need for device replacement surgery five years after the initial procedure.

FDA: Give Time Out to TimeOut Capsules

WASHINGTON (MedPage Today) — The FDA has issued a warning against yet another product marketed as an “all-natural sexual enhancement” dietary supplement — this one called TimeOut — that contains a potentially dangerous analogue of the prescription drug sildenafil, the active ingredient in Viagra.

Hypertension Drug Tekamlo (Aliskiren And Amlodipine) Approved By FDA

Novartis’ single pill combination of aliskiren and amlopidine - Tekamlo - has been approved by the Food and Drug Administration (FDA) for the treatment of hypertension. Data revealed that Tekamlo significantly reduced blood pressure compared to amlodipine or aliskiren (Tekturna) alone. The medication has been approved in tablet form…