Alkermes picked up FDA approval for a long-acting version of Otsuka's now-generic Abilify, planning to launch its injection as a treatment for schizophrenia.
Venture-backed Ark Biosciences has successfully completed a Phase I clinical trial of work on anti-respiratory syncytial virus (RSV) candidate AK0529, hitting a key milestone for the respiratory viral infection and viral hepatitis focused company.
The three manufacturers that market duodenoscopes in the U.S. have all been required by the FDA to submit postmarket surveillance plans to the agency within 30 days. This comes after all three received warning letters from the agency in August and an FDA committee panel took up the same issue in May.
Negotiators from the 12 countries making up the Trans-Pacific Partnership (TPP) have negotiated deal terms relating to biologic drugs. But no one, other than perhaps the trade reps who made the deal, appears to be happy with the final outcome.
St. Jude Medical revealed in an SEC filing that it has been hit by a FDA warning letter for nonconformance with the agency's Good Manufacturing Practice regulations at the Atlanta facility that makes the CardioMEMS heart failure monitor.
Trade officials from the 12 countries hammering out the final details on the Trans Pacific Partnership in Atlanta appear to have reached a compromise on biologic drugs that will allow the pact to move forward while potentially setting a higher IP bar on the most promising area of drug discovery.
Sometimes it seems that the FDA has a scattershot approach to policing pharma marketing, with warning letters few and far between--and some of them lobbed from left field. But there's one tried-and-true way to invite unwanted attention from the agency's marketing police: Leave side effects out of drug promos, according to an analysis presented at a recent conference.
As part of a multifaceted effort to combat antibiotics resistance, the FDA is distributing a survey to veterinarians who specialize in treating horses, cows and other ruminants, which are animals that obtain most of their nutrients by grazing.
EBR Systems' WiSE leadless pacemaker just earned a CE mark, becoming the first device in the class approved for improving left ventricular function. Medtronic and St. Jude Medical also offer leadless pacemakers, but they are implanted in the heart's right ventricle.
India may house drug testing laboratories in each state under an INR17.5 billion ($270 million) plan to shore up quality.