Protocols

SEC subpoenaes BioMarin in drisapersen probe; Job hunting? The FDA has hundreds of open positions

BioMarin $BMRN has more headaches to contend with on its Duchenne muscular dystrophy drug drisapersen. The company says in its newly posted quarterly report with the SEC that it is cooperating with an SEC investigation into the drug, which was rejected by the FDA and the EMA. BioMarin has been rethinking its decision to bury the drug, pondering an appeal of the FDA’s position. Its statement on the SEC: In August 2016, we received a subpoena from the staff of the SEC requesting that we produce documents in connection with a non-public, fact-finding inquiry related to our former drisapersen program. The letter enclosing the subpoena states that the investigation and the subpoena do not mean that the Company or anyone else has broken the law, or that the SEC has a negative opinion of any person, entity or security. We intend to cooperate fully with the SEC in this matter. We are not able to predict whether any proceeding may be instituted in connection with the subpoena, or the outcome of any proceeding that may be instituted.

Looking for a job in drug development? Consider a career at the FDA. The agency has 700 unfilled positions in the new drugs division. Of course, reports Kaiser Health News, you’d have to be willing to accept considerably less than what industry is paying. A booming biotech field has created quite a competition for the best and the brightest, meaning many of those jobs may go unfilled for some time.

Basel-based NBE Therapeutics has raised $20.5 million in a Series B round for its antibody-drug conjugate work. PPF Group led the round with participation from Boehringer Ingelheim Venture Fund and all other existing private investors, including a new private investor. “The proceeds from this financing round and the expertise provided by our shareholders will allow NBE to progress to a clinical stage company and advance our ADC platform and products to clinical proof-of-concept,” says CEO Ulf Grawunder.

AstraZeneca spinout Albireo has completed its deal, announced last May, to acquire Biodel and start trading under the $ALBO symbol.

Endo is recalling 1,365,559 subpotent birth control pills manufactured by CMO Patheon at its plant in Ontario, Canada. The Class III voluntary recall began in September but was only recently posted by the FDA.

Palatin Technologies, a penny stock company $PTN that recently claimed positive data on a new drug to spur the female libido, is now rumored to be looking for a buyer.


The best place to read Endpoints News? In your inbox.

Full-text daily reports for those who discover, develop, and market drugs. Join 17,000+ biopharma pros who read Endpoints News by email every day.

Free Subscription

RAPS Regulatory Convergence 2017