Blog
RSS FeedPosted by Michael Wonder on 02 Mar 2018
Biogen and AbbVie announce the voluntary worldwide withdrawal of marketing authorisations for Zinbryta (daclizumab) for relapsing multiple sclerosis
2 March 2018 - Patient safety is the top priority for Biogen and AbbVie. ...
Posted by Michael Wonder on 02 Mar 2018
FDA to review Dupixent (dupilumab) as potential treatment for moderate-to-severe asthma
2 March 2018 - The U.S. FDA has accepted for review the supplemental biologics license application of Dupixent (dupilumab) as an ...
Posted by Michael Wonder on 01 Mar 2018
Under Trump, the pace of FDA regulations slowed to a trickle
28 February 2018 - As the Trump administration settled in last year, the White House insisted on fewer regulations — ...
Posted by Michael Wonder on 01 Mar 2018
FibroGen granted fast track designation by U.S. FDA for pamrevlumab treatment of patients with locally advanced unresectable pancreatic cancer
1 March 2018 - FibroGen today announced that the U.S. FDA has granted fast track designation for the company’s anti-CTGF antibody, ...
Posted by Michael Wonder on 01 Mar 2018
Allergan announces FDA has extended the ulipristal acetate NDA review period to August 2018
1 March 2018 - Allergan today announced that it was notified by the U.S. FDA that the review of the new ...
Posted by Michael Wonder on 01 Mar 2018
Sorrento Therapeutics subsidiary, Scilex, receives US FDA approval for non-opioid ZTlido (lignocaine topical system) 1.8% for PHN pain
28 February 2018 - ZTlido uses novel technology demonstrating 12 hour wear for efficient lignocaine delivery, even during exercise. ...
Posted by Michael Wonder on 01 Mar 2018
Galera Therapeutics receives FDA breakthrough therapy designation for GC4419 for the reduction of severe oral mucositis
28 February 2018 - Designation based on positive results of Phase 2b trial of GC4419. ...
Posted by Michael Wonder on 01 Mar 2018
Friction in the path to use of biosimilar drugs
1 March 2018 - Enactment of the Biologics Price Competition and Innovation Act in 2010 raised expectations that new competition would ...
Posted by Michael Wonder on 28 Feb 2018
How bad is Celgene's FDA foul-up? Two decades of biotech history say it can't be good.
28 February 2018 - Past performance doesn't guarantee future results. But in the biotechnology business, history tends to rhyme. ...
Posted by Michael Wonder on 28 Feb 2018
Drug makers lobby for antibiotic incentives in pandemic preparedness bill
27 February 2018 - A big legislative package due for renewal later this year could include hundreds of millions of ...
Posted by Michael Wonder on 28 Feb 2018
Novo Nordisk files for regulatory approval of long-acting factor VIII (N8-GP) in the US and the EU for treatment of haemophilia A
28 February 2018 - Novo Nordisk today announced the submission of a biologics license applications to the US FDA and ...
Posted by Michael Wonder on 28 Feb 2018
Celgene provides regulatory update on ozanimod for the treatment of relapsing multiple sclerosis
27 February 2018 - Celgene today announced that it has received a refusal to file letter from the United States ...
Posted by Michael Wonder on 27 Feb 2018
Tetraphase Pharmaceuticals announces FDA acceptance for filing of its NDA submission for eravacycline for the treatment of complicated intra-abdominal infections
27 February 2018 - PDUFA date set for 28 August 2018. ...
Posted by Michael Wonder on 27 Feb 2018
Shionogi announces FDA new drug application and EMA marketing authorisation application acceptances for lusutrombopag (S-888711)
26 February 2018 - Shionogi announced today that the new drug application for lusutrombopag (S-888711), an investigational, once-daily, orally administered, ...
Posted by Michael Wonder on 27 Feb 2018
Lilly receives additional FDA approval for Verzenio (abemaciclib), as initial treatment for advanced breast cancer
26 February 2018 - New indication based on MONARCH 3 trial can help more women living with HR+, HER2- advanced breast ...