Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 26 Feb 2018
Statement from FDA Commissioner on FDA’s ongoing efforts to help improve effectiveness of influenza vaccines
26 February 2018 - The current influenza season has been especially difficult, causing widespread illness that has affected all fifty ...
Posted by Michael Wonder on 26 Feb 2018
Taking new steps to meet the challenges of rare diseases — FDA marks the 11th Rare Disease Day
26 February 2018 - Today 30 million people in the United States – or one out of every 10 Americans – ...
Posted by Michael Wonder on 26 Feb 2018
Contribution of NIH funding to new drug approvals 2010–2016
12 February 2018 - This report shows that NIH funding contributed to published research associated with every one of the 210 ...
Posted by Michael Wonder on 25 Feb 2018
Patients eagerly awaited a generic drug. Then they saw the price.
23 February 2018 - When Teva Pharmaceuticals announced recently that it would begin selling a copycat version of Syprine — ...
Posted by Michael Wonder on 24 Feb 2018
Mallinckrodt receives FDA acceptance of stannsoporfin new drug application filing
23 February 2018 - Action date set for 22 August 2018. ...
Posted by Michael Wonder on 24 Feb 2018
FDA accepts Shire’s biologics license application and grants priority review for lanadelumab for the prevention of attacks in hereditary angioedema patients
23 February 2018 - Lanadelumab, the first long-acting investigational monoclonal antibody in hereditary angioedema, is being evaluated for the prevention of ...