What do you think? Would a buyer rather pay $200 for a prescription of AstraZeneca's heartburn medicine Nexium, or $620? Seems pretty simple, but that math is at the heart of a court battle in Maine over whether governments and companies are going to buy drugs from Canadian pharmacies at lower prices than they can get in the U.S.
Medtronic's push to expand the treatment options for its cardiac resynchronization therapy pacemakers and defibrillators have won the backing of a crucial FDA advisory panel. The Minnesota device giant wants to use its CRT devices for patients who have atrioventricular block and left ventricular systolic dysfunction.
Just hours after Bayer laid out some ambitious plans to accelerate development of a new wave of cancer and cardiovascular therapies, the FDA came through with a key new approval of riociguat--to be sold as Adempas--for a devastating lung disease.
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.