A voluntary recall was issued Friday after there was a report of a single visible glass particle in a vial in a lot that was produced for Genco Pharmaceutical Services.
BioMarin Pharmaceuticals nabbed the FDA's blessing for Vimizim, the only drug ever approved to treat a rare enzyme disorder called Morquio A syndrome, although it will wear a boxed warning about the risk of anaphylaxis. The FDA nod could set the M&A rumor mill to work again.
Boston Scientific nabbed a new CE mark that allows one of its esophageal stents to be used to treat narrowing of the esophagus caused by benign scar tissue--another win as the company seeks to restore steady revenue expansion after a years-long slump.
Clinical trial data collection has evolved slowly over the past two decades from site visits and paper questionnaires to telemedicine and electronic patient reported outcomes. The transition is far from complete though, with the likes of CamNtech and Medidata now looking to bring wearable computers to clinical trials.
Medtronic launched a new crossing catheter in Europe to treat peripheral artery disease. The device recently received a European CE mark, but has yet to win FDA clearance, the company said in a statement.
Ariosa Diagnostics won certification from the New York Department of Health to begin selling its Harmony prenatal and reporting test results to New York healthcare providers, a big step in the company's efforts to grow its market for the test.
Anyone reading the news this week knows what a stray remark from a CEO can do. But pharma executives don't have to mention "distressed babies"--or something equally telegenic--to get themselves in trouble.
FDA Commissioner Margaret Hamburg is in India this week trying to build rapport with regulators and drugmakers in her ongoing quest to stress quality manufacturing in a country that produces a huge amount of the generic drugs used by U.S. consumers. But back home, questions of quality are brewing as Congress prepares to look deeper into whether generic drugs manufactured outside the U.S. are making the grade.
Blood Purification Technologies won FDA clearance to begin human clinical trials of its Wearable Artificial Kidney. Testing will be conducted at several academic medical centers, the company said in a statement. Specific trial dates were not disclosed.
The FDA has rejected Durect's pain therapy Posidur, telling the biotech that investigators didn't provide sufficient data to prove that it could be safely administered. And regulators sent Durect back to the drawing board, instructing the company to do additional safety studies if it still wants to seek an approval for the drug, intended to ease postsurgical pain.