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RSS FeedPosted by Michael Wonder on 29 Nov 2017
Trump backs bipartisan fixes to ObamaCare markets
28 November 2017 - President Trump at a closed-door meeting with GOP senators on Tuesday said he would support two ...
Posted by Michael Wonder on 29 Nov 2017
GSK submits US regulatory application for single-dose tafenoquine for Plasmodium vivax malaria
29 November 2017 - Regulatory milestone affirms GSK's strong commitment and scientific capabilities to fighting infectious diseases. ...
Posted by Michael Wonder on 29 Nov 2017
Trump health nominee set to be grilled about ties to drug industry
29 November 2017 - Azar lists competition, patent fixes as ways to lower costs. ...
Posted by Michael Wonder on 29 Nov 2017
U.S. FDA grants fast track designation for Idera Pharmaceuticals’ IMO-2125 in combination with ipilimumab for treatment of PD-1 refractory metastatic melanoma
29 November 2017 - Phase 3 trial initiation planned for first quarter 2018. ...
Posted by Michael Wonder on 29 Nov 2017
Is the FDA withholding data about a controversial drug to protect its manufacturer?
29 November 2017 - In the case of Sarepta, it sure looks that way. ...
Posted by Michael Wonder on 29 Nov 2017
BioMarin sells second priority review voucher for 125 million dollars
27 November 2017 - BioMarin today announced that it has entered into a definitive agreement to sell the rare paediatric disease ...
Posted by Michael Wonder on 28 Nov 2017
Dova Pharmaceuticals announces FDA acceptance of the avatrombopag new drug application with priority review
27 November 2017 - Dova Pharmaceuticals today announced the new drug application for avatrombopag has been accepted for filing and has ...
Posted by Michael Wonder on 28 Nov 2017
Stealth BioTherapeutics granted fast track designation for the treatment of Barth syndrome
27 November 2017 - Stealth BioTherapeutics today announced that the U.S. FDA has granted fast track designation for its lead ...
Posted by Michael Wonder on 28 Nov 2017
Pharma's paradox: cure a deadly childhood disease and then get attacked on price
28 November 2017 - It’s a diagnosis that no parents want to hear - their child has acute lymphoblastic leukaemia. ...
Posted by Michael Wonder on 28 Nov 2017
Kyowa Hakko Kirin announces FDA acceptance for filing and priority review designation of mogamulizumab’s biologics license application
28 November 2017 - Kyowa Hakko Kirin today announces that the U.S. FDA has accepted for review the biologics license ...
Posted by Michael Wonder on 28 Nov 2017
FDA issues guidance that could make it easier for EpiPen rivals to come to market
28 November 2017 - FDA issued guidance that says generic copies with some design differences may be approved as substitutable products. ...
Posted by Michael Wonder on 27 Nov 2017
As health care changes, insurers, hospitals and drugstores team up
27 November 2017 - They seem like odd couples: Aetna, one of the nation’s largest health insurers, is in talks ...
Posted by Michael Wonder on 27 Nov 2017
He raised drug prices at Eli Lilly. Can he lower them for the U.S.?
26 November 2017 - Alex M. Azar II, President Trump’s nominee to lead the Department of Health and Human Services, ...
Posted by Michael Wonder on 23 Nov 2017
Alkermes’ new drug application for investigational product designed for initiation onto Aristada accepted for filing by U.S. FDA
16 November 2017 - FDA action expected by 30 June 2018. ...
Posted by Michael Wonder on 23 Nov 2017
GSK submits landmark IMPACT data to US regulatory authority to support expanded label for Trelegy Ellipta
23 November 2017 - GlaxoSmithKline and Innoviva today announced the filing of a supplemental new drug application with the US FDA ...