While the plodding government shutdown has thus far left the biotech industry largely unmarred, the furlough-weakened FDA has now postponed an advisory committee hearing, leaving Merck and Stallergenes in limbo with their allergy drugs.
A worker at an Aesica plant in the U.K. was severely burned after being doused with 7 liters of bromine as he worked on a storage tank, landing him in the hospital and the company in court. The company will pay a £100,000 ($161,000) fine for the 2007 incident.
Delcath's year of disappointment lumbers on as the New York company axes 21 of its 60 employees, looking to cut costs as it figures out just what to do with an FDA-rejected device.
The Supreme Court has rejected Medtronic's effort to overturn a heart valve patent loss, meaning Edwards Lifesciences gets to keep its U.S. market dominance and an $83.6 million award.
Delcath's year of disappointment lumbers on as the New York company has canned 21 of its 60 employees, looking to cut costs as it figures out just what to do with an FDA-rejected device.
Despite the government shutdown, Medtronic and CardioMEMS will proceed with key FDA meetings scheduled for this week intended to advance approval processes for their medical devices, the agency confirmed.
Atossa Genetics is voluntarily recalling its signature breast cancer test and related products from the market to address the FDA's allegations that they lacked clearance for their promoted uses.
Government shutdown or no, the FDA kept its PDUFA word for Pfizer and Ligand's treatment for hot flashes, approving a long-delayed drug that'll enter the crowded market for hormone therapies.
Arzerra has not yet been approved anywhere for a first-line use, but the companies believe that new data will boost its chances. It is asking for it to be used in combination with an alkylator-based therapy in patients for which a fludarabine-based therapy is not appropriate.
The deep divisions in U.S. politics have been more apparent than ever this week, but there was also evidence everyone can pull together. Both Houses of Congress and political parties got behind a bill to set a 10-year deadline for a track-and-trace system that has database implications for drugmakers.