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RSS FeedPosted by Michael Wonder on 12 Jul 2017
FDA grants full approval for Blincyto (blinatumomab) to treat relapsed or refractory B-cell precursor acute lymphoblastic leukaemia in adults and children
11 July 2017 - Data from the phase 3 TOWER study support conversion from accelerated to full approval. ...
Posted by Michael Wonder on 11 Jul 2017
The Donald piles on the pressure for health reform bill
12 July 2017 - President Donald Trump heaped pressure on legislators yesterday to pass a health care reform bill before ...
Posted by Michael Wonder on 11 Jul 2017
Two recent scientific advances underscore an encouraging future for precision medicine at FDA
11 July 2017 - FDA helps bring precision medicine – in the form of targeted therapies — to people living ...
Posted by Michael Wonder on 11 Jul 2017
First gene therapy — ‘a true living drug’ — on the cusp of FDA approval
11 July 2017 - When doctors saw the report on Bill Ludwig’s bone-marrow biopsy, they thought it was a mistake ...
Posted by Michael Wonder on 11 Jul 2017
Health reform, both real and conservative
11 July 2017 - The American health care system has two core problems. It’s the world’s most expensive, and it ...
Posted by Michael Wonder on 11 Jul 2017
GOP struggles to revamp ailing Obamacare repeal bill
10 July 2017 - A key disagreement within the caucus centers on a conservative proposal from Mike Lee and Ted Cruz ...
Posted by Michael Wonder on 11 Jul 2017
Institute for Clinical and Economic Review posts draft scoping document on voretigene neparvovec, first gene therapy submitted for FDA approval
10 July 2017 - Report expected to review clinical effectiveness, value of the therapy; Scoping Document will be open to ...
Posted by Michael Wonder on 11 Jul 2017
What to watch for as Novartis heads to the FDA with a novel cancer therapy
10 July 2017 - The FDA has weighed in on Novartis’ pioneering personalized cancer therapy, which looks almost certain to ...
Posted by Michael Wonder on 11 Jul 2017
FDA speeding generic drug approvals: not just lip service
10 July 2017 - May and June 2017 have seen the most generic drug approvals since the US FDA began ...
Posted by Michael Wonder on 10 Jul 2017
Considering the side effects of drug makers’ money back guarantees
10 July 2017 - More than a decade ago, Italy tried a novel approach to help bring down drug costs: ...
Posted by Michael Wonder on 10 Jul 2017
CSL to fight patent infringement claim from US based Bioverativ
10 July 2017 - Australian vaccines and blood products developer CSL says it will vigorously fight a patent infringement claim ...
Posted by Michael Wonder on 10 Jul 2017
Value based pricing and state reform of prescription drug costs
10 July 2017 - Faced with increasing prescription drug costs and congressional gridlock, some states have enacted meaningful reforms. ...
Posted by Michael Wonder on 10 Jul 2017
Fewer issuers apply to participate in Health Insurance Exchanges for 2018
10 July 2017 - Less choice for consumers as issuer health plan applications drop 38 percent from last year. ...
Posted by Michael Wonder on 10 Jul 2017
GOP senators suggest bill to repeal health care law ‘dead’
10 July 2017 - The initial GOP bill to repeal and replace the US’s health law is probably “dead” and ...
Posted by Michael Wonder on 10 Jul 2017
U.S. FDA accepts for priority review Bristol-Myers Squibb’s application for Sprycel (dasatinib) in children with Philadelphia chromosome positive chronic phase chronic myeloid leukaemia
10 July 2017 - Application is based on results from Phase 2 CA180-226 study. ...