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RSS FeedPosted by Michael Wonder on 09 Dec 2016
US Solicitor General calls on Supreme Court to review six-month delays to biosimilar launches
8 December 2016 - With the timing of all future US launches of biosimilars at stake, the US Solicitor General ...
Posted by Michael Wonder on 08 Dec 2016
Interpreting geographic variations in results of randomised, controlled trials
7 December 2016 - Clinical triallists generally accept the premise that surprising results in subgroups of a randomised, controlled trial most ...
Posted by Michael Wonder on 08 Dec 2016
Real world evidence — what is it and what can it tell us?
7 December 2016 - The FDA is developing guidance on the use of “real-world evidence” — health care information from atypical ...
Posted by Michael Wonder on 08 Dec 2016
1 patient, 7 tumours and 100 billion cells equal 1 striking recovery
7 December 2016 - The remarkable recovery of a woman with advanced colon cancer, after treatment with cells from her ...
Posted by Michael Wonder on 08 Dec 2016
Trump team said to consider Thiel associate O’Neill for FDA
8 December 2016 - In speech, said FDA could approve drugs without efficacy data. ...
Posted by Michael Wonder on 08 Dec 2016
Neovacs obtains FDA “fast track” designation for IFNα kinoid in lupus (SLE)
7 December 2016 - Neovacs today announced that the U.S. FDA has granted “fast track” status to IFNα kinoid in ...
Posted by Michael Wonder on 08 Dec 2016
US Senate clears bill to ease FDA drug and device approvals
7 December 2016 - Measure includes money for NIH, cancer moonshot, precision medicine initiative. ...
Posted by Michael Wonder on 07 Dec 2016
FDA approves Genentech’s Avastin (bevacizumab) plus chemotherapy for a specific type of advanced ovarian cancer
6 December 2016 - In the United States, Avastin is now approved for nine distinct uses across six different types ...
Posted by Michael Wonder on 07 Dec 2016
Novo Nordisk files for regulatory approval of once-weekly semaglutide in the US and EU for the treatment of type 2 diabetes
5 December 2016 - Novo Nordisk today announced the submission of a new drug application to the US FDA and ...
Posted by Michael Wonder on 07 Dec 2016
Theravance Biopharma receives FDA fast track designation for velusetrag (TD-5108) for idiopathic and diabetic gastroparesis
6 December 2016 - Results from ongoing phase 2b study in gastroparesis expected in mid 2017. ...
Posted by Michael Wonder on 06 Dec 2016
Failure of investigational drugs in late-stage clinical development and publication of trial results
5 December 2016 - Many investigational drugs fail in late-stage clinical development. A better understanding of why investigational drugs fail can ...
Posted by Michael Wonder on 06 Dec 2016
Kite Pharma initiates rolling submission of U.S. biologics license application for KTE-C19, its investigational anti-CD19 CAR-T therapy, for the treatment of patients with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma
4 December 2016 - First CAR-T therapy BLA filing initiated with the U.S. FDA. ...
Posted by Michael Wonder on 06 Dec 2016
Kite Pharma receives FDA breakthrough therapy designation for KTE-C19 for the treatment of refractory, aggressive non Hodgkin lymphoma
7 December 2015 - Kite Pharma today announced that the U.S. FDA has granted breakthrough therapy designation status to the Company's ...
Posted by Michael Wonder on 05 Dec 2016
Merck CEO says drug maker is ‘restrained’ on price increases
1 December 2016 - CEO isn’t interested in big mergers, seeks value in the labs. ...
Posted by Michael Wonder on 04 Dec 2016
Immune system, unleashed by cancer therapies, can attack organs
3 December 2016 - As Chuck Peal lay in a Waterbury, Connecticut, emergency room one Sunday in early September, doctors ...