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RSS FeedPosted by Michael Wonder on 12 Oct 2017
First FDA approval agnostic of cancer site — when a biomarker defines the indication
11 October 2017 - In May 2017, the FDA approved pembrolizumab, a programmed death 1 inhibitor, for adult and paediatric patients ...
Posted by Michael Wonder on 12 Oct 2017
Janssen submits new drug application to U.S. FDA for apalutamide (ARN-509) to treat men with non-metastatic castration-resistant prostate cancer
11 October 2017 - First Agent Submitted to Address a Critical Need in Earlier Stage Castration-Resistant Prostate Cancer at High-Risk ...
Posted by Michael Wonder on 12 Oct 2017
U.S. FDA accepts for review Astellas’ supplemental new drug application for mirabegron for use in combination with solifenacin succinate 5 mg for the treatment of overactive bladder
12 September 2017 - If approved, the combination therapy could potentially offer a new treatment option for patients whose overactive ...
Posted by Michael Wonder on 11 Oct 2017
An FDA program to approve old drugs causes higher prices and shortages
11 October 2017 - In 2006, the FDA launched a program to require drug makers to win approval of medicines ...
Posted by Michael Wonder on 11 Oct 2017
Here come more gene therapies -- and more pricing debates
11 October 2017 - Tomorrow an advisory committee to the FDA will meet to discuss Luxturna (voretigene neparvovec), a gene ...
Posted by Michael Wonder on 11 Oct 2017
Statement by FDA Commissioner Scott Gottlieb on new steps by FDA to advance patient engagement in the agency’s regulatory work
11 October 2017 - The FDA is hosting a pioneering event today: the first meeting of the Patient Engagement Advisory ...
Posted by Michael Wonder on 11 Oct 2017
FDA grants priority review to Gilotrif for uncommon EGFR mutations in advanced non-small-cell lung cancer
10 October 2017 - Submission is based on a meta-analysis of three LUX-Lung Phase III studies that examined Gilotrif (afatinib) in ...
Posted by Michael Wonder on 11 Oct 2017
U.S. FDA grants fast track designation to Astellas for development of gilteritinib in relapsed or refractory acute myeloid leukaemia
10 October 2017 - Astellas announced today that the U.S. FDA has granted fast track designation for the development of gilteritinib ...
Posted by Michael Wonder on 11 Oct 2017
Ultragenyx and Kyowa Hakko Kirin announce FDA acceptance and priority review designation of burosumab's biologics license application
10 October 2017 - Ultragenyx, Kyowa Hakko Kirin and Kyowa Kirin International today announce that the U.S. FDA has accepted the ...
Posted by Michael Wonder on 11 Oct 2017
Ansun BioPharma announces breakthrough designation for its experimental drug DAS181
10 October 2017 - Today, Ansun BioPharma announced that the Division of Anti-viral Products of the U.S. FDA has granted breakthrough ...
Posted by Michael Wonder on 11 Oct 2017
Food and drug chief Gottlieb skirts health secretary talk, says most effective at FDA
11 October 2017 - U.S. FDA Commissioner Scott Gottlieb, considered a potential successor to recently departed Health and Human Services Secretary ...
Posted by Michael Wonder on 10 Oct 2017
The lifecycle of a rare disease cancer drug
10 October 2017 - One pharma company’s medicine illustrates how firms can benefit from different layers of market-exclusivity protections. ...
Posted by Michael Wonder on 10 Oct 2017
Gatekeeping strategies for avoiding false-positive results in clinical trials with many comparisons
10 October 2017 - Clinical trials characterizing the effects of an experimental therapy rarely have only a single outcome of interest. ...
Posted by Michael Wonder on 10 Oct 2017
Clovis Oncology submits supplemental new drug application for rucaparib as maintenance treatment for patients with platinum-sensitive recurrent ovarian cancer
9 October 2017 - Company plans to file marketing authorisation application in Europe in early 2018 for maintenance treatment indication. ...
Posted by Michael Wonder on 10 Oct 2017
US FDA issues complete response letter for proposed biosimilar pegfilgrastim
10 October 2017 - The U.S. FDA has issued a complete response letter for Mylan´s biologics license application for MYL-1401H, ...