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RSS FeedPosted by Michael Wonder on 19 Jan 2017
U.S. FDA approves Imbruvica (ibrutinib) as first treatment specifically indicated for relapsed/refractory marginal zone lymphoma - a rare type of non-Hodgkin's lymphoma
19 January 2017 - Imbruvica will be a chemotherapy-free option for patients with marginal zone lymphoma who failed prior therapies. ...
Posted by Michael Wonder on 19 Jan 2017
Boehringer Ingelheim biosimilar candidate to Humira accepted for EMA and FDA regulatory review
18 January 2017 - BI 695501 EMA and FDA applications are first biosimilar regulatory filings for Boehringer Ingelheim. ...
Posted by Michael Wonder on 18 Jan 2017
FDA grants fast track designation for aTyr's Resolaris to treat limb girdle muscular dystrophy 2B and removes partial clinical hold for Resolaris
18 January 2017 - First reported fast track designation for LGMD2B treatment. ...
Posted by Michael Wonder on 18 Jan 2017
FDA issues long-awaited biosimilar interchangeability guidance
17 January 2017 - The US FDA has finally released for public consultation its long-awaited draft guidance detailing the agency's ...
Posted by Michael Wonder on 18 Jan 2017
Teva receives FDA approval for Vantrela ER (hydrocodone bitartrate) extended release tablets formulated with proprietary abuse deterrence technology
18 January 2017 - Vantrela ER label describes the product’s abuse-deterrent properties against abuse in the three most common routes—oral, ...
Posted by Michael Wonder on 18 Jan 2017
FDA approves a generic of Xyrem with a REMS Program
17 January 2017 - The U.S. FDA has approved the first generic version of Xyrem (sodium oxybate) Oral Solution, to treat ...
Posted by Michael Wonder on 18 Jan 2017
FDA Advisory Committees: independent, informed, essential and evolving
18 January 2017 - One of the most common concerns raised when I meet with medical leaders is the need ...
Posted by Michael Wonder on 18 Jan 2017
Statement from FDA Commissioner announcing new draft guidances on medical product communications
18 January 2017 - We recognise that there is a high level of interest regarding FDA’s views on communications about ...
Posted by Michael Wonder on 18 Jan 2017
Will cardiovascular outcomes data on newer diabetes drugs bury the older agents?
17 January 2017 - Patients with type 2 diabetes are treated with many drugs other than insulin. In 2014, Medicare paid ...
Posted by Michael Wonder on 17 Jan 2017
CTD Holdings receives FDA fast track designation for development of Trappsol Cyclo to treat Niemann-Pick Disease Type C
17 January 2017 - CTD Holdings today announced that the U.S. FDA has granted fast track designation to Trappsol Cyclo for ...
Posted by Michael Wonder on 17 Jan 2017
Introducing IMEDS, a public-private resource for evidence generation
17 January 2017 - The FDA has been working to establish a national resource for FDA-approved medical products that can ...
Posted by Michael Wonder on 17 Jan 2017
Drug makers manipulate orphan drug rules to create prized monopolies
17 January 2017 - More than 30 years ago, Congress overwhelmingly passed a landmark health bill aimed at motivating pharmaceutical ...
Posted by Michael Wonder on 13 Jan 2017
RedHill Biopharma announces QIDP fast track designation granted by FDA to RHB-104 for non-tuberculous Mycobacteria infections
11 January 2017 - RedHill Biopharma today announced that RHB-104 has been granted Qualified Infectious Disease Product designation by the ...
Posted by Michael Wonder on 13 Jan 2017
Two Silicon Valley insiders meet with Trump about heading FDA
12 January 2017 - Two critics of the FDA met with President-elect Donald Trump Thursday to discuss running the agency. ...
Posted by Michael Wonder on 13 Jan 2017
U.S. FDA extends review period for baricitinib
13 January 2017 - Eli Lilly and Incyte announced today that the U.S. FDA has extended the review period for ...