Latest Headlines

Latest Headlines

Alkermes wins an FDA nod for its monthly schizophrenia drug

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.

Shanghai-based biotech Ark Biosciences successfully completes PhI on RSV candidate

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.

FDA orders postmarket studies from trio of duodenoscope makers as 'superbug' scare continues

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 look to be only ones happy about TPP pharma deal

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 hit by FDA warning letter on CardioMEMS manufacturing

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.

TPP negotiators said to reach compromise on biologics

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.

Want to get a warning letter from OPDP? Omit drug risks from your promos

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.

FDA seeks veterinarians' input on antibiotics resistance

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.

Europe grants its first CE mark for leadless pacemaker to treat left ventricle

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 considers drug testing labs in each state

India may house drug testing laboratories in each state under an INR17.5 billion ($270 million) plan to shore up quality.