Blog
RSS FeedPosted by Michael Wonder on 30 Dec 2016
Assessment of overall survival, quality of life, and safety benefits associated with new cancer medicines
29 December 2016 - What are the overall survival, quality of life, and safety benefits of recently licensed cancer medicines? ...
Posted by Michael Wonder on 30 Dec 2016
The head of the FDA defends the importance of drug effectiveness
29 December 2016 - First things first: FDA Robert Califf says that he has not had any contact with the ...
Posted by Michael Wonder on 30 Dec 2016
Coverage denial for therapy unconscionable
29 December 2016 - In regard to your 23 December Editorial “The FDA Empire Strikes Back”. ...
Posted by Michael Wonder on 30 Dec 2016
Cempra receives complete response letter from FDA for solithromycin NDAs
29 December 2016 - Cempra Pharmaceuticals today announced that the company has received a complete response letter from the U.S. ...
Posted by Michael Wonder on 28 Dec 2016
Shire announces FDA approval of Adynovate [anti-haemophilic factor (recombinant), PEGylated] for use in children and surgical settings
27 December 2016 - New FDA-approved indications for Adynovate provides more haemophilia A patients access to proven prophylaxis with a ...
Posted by Michael Wonder on 27 Dec 2016
Negative control outcomes: a tool to detect bias in randomised trials
27 December 2016 - Investigators have several design, measurement, and analytic tools to detect and reduce bias in epidemiological studies. One ...
Posted by Michael Wonder on 26 Dec 2016
Charting a new drug review pathway
25 December 2016 - Why the regulators at the FDA must think surgeons. ...
Posted by Michael Wonder on 25 Dec 2016
The FDA's Christmas breakthrough
23 December 2016 - The FDA has always had a tendency to announce big news late on Fridays. ...
Posted by Michael Wonder on 23 Dec 2016
Portola Pharmaceuticals announces FDA accepts new drug application for priority review and EMA validates marketing authorisation application for oral, factor Xa inhibitor anticoagulant betrixaban
23 December 2016 - Portola Pharmaceuticals today announced that the U.S. FDA accepted Portola's new drug application granting priority review ...
Posted by Michael Wonder on 23 Dec 2016
Donald Trump’s pick for Health Secretary traded medical stocks while in house
22 December 2016 - Rep. Tom Price has sponsored and advocated legislation that could affect the companies’ share prices. ...
Posted by Michael Wonder on 23 Dec 2016
FDA approves first drug for spinal muscular atrophy
23 December 2016 - The U.S. FDA today approved Spinraza (nusinersen), the first drug approved to treat children and adults with ...
Posted by Michael Wonder on 22 Dec 2016
FDA officials call for including adolescents in adult oncology trials
20 December 2016 - A team of officials at the US FDA are calling for a "culture shift" by drug ...
Posted by Michael Wonder on 21 Dec 2016
FDA accepts supplemental new drug application for Pfizer’s Ibrance (palbociclib) in HR+, HER2- metastatic breast cancer
21 December 2016 - sNDA includes data from Phase 3 PALOMA-2 trial to support conversion from accelerated approval to regular ...
Posted by Michael Wonder on 21 Dec 2016
Janssen submits two applications to FDA seeking approval of Simponi Aria (golimumab) for the treatment of active psoriatic arthritis and active ankylosing spondylitis
20 December 2016 - Janssen Biotech announced today the submission of two supplemental biologics license applications to the U.S. FDA seeking ...
Posted by Michael Wonder on 21 Dec 2016
Tesaro announces priority review designation for niraparib NDA
20 December 2016 - Niraparib new drug application accepted for review by FDA with a PDUFA goal date of 30 ...