Blog
RSS FeedPosted by Michael Wonder on 10 Dec 2018
The rise of use of medical devices force FDA to change the rules
9 December 2018 - A disruptive market of $410 billion until 2023, changes dramatically with the entrance of small and medium ...
Posted by Michael Wonder on 10 Dec 2018
Investigation of generic ‘cartel’ expands to 300 drugs
9 December 2018 - Executives at more than a dozen generic drug companies had a form of shorthand to describe ...
Posted by Michael Wonder on 09 Dec 2018
Medical device price differentials in the U.S. and Europe – rethinking price regulation?
7 December 2018 - Recently, there has been a robust discussion of an October Trump administration proposal that Medicare pay for ...
Posted by Michael Wonder on 08 Dec 2018
Patent abuse is driving up drug prices. Just look at Lantus.
7 December 2018 - A rare point of consensus following the midterm elections is that Americans are adamant about lowering ...
Posted by Michael Wonder on 07 Dec 2018
FDA approves Genentech’s Tecentriq in combination with Avastin and chemotherapy for the initial treatment of people with a specific type of metastatic lung cancer
6 December 2018 - Approval based on survival benefit of Tecentriq, in combination with Avastin, paclitaxel and carboplatin (chemotherapy), in people ...
Posted by Michael Wonder on 06 Dec 2018
FDA breaks NME approval record in 2018
6 December 2018 - FDA has approved 55 new molecular entities so far in 2018, surpassing in mid October the ...
Posted by Michael Wonder on 06 Dec 2018
Federal officials call out FDA over lapses in rare-disease drug approval
5 December 2018 - The 1983 Orphan Drug Act motivated pharmaceutical companies to develop drugs for people who lacked treatments ...
Posted by Michael Wonder on 06 Dec 2018
Statement from FDA Commissioner on FDA’s new strategic framework to advance use of real-world evidence to support development of drugs and biologics
6 December 2018 - The health care system is integrating more effective ways to leverage electronic tools to gather and use ...
Posted by Michael Wonder on 06 Dec 2018
Statement from FDA Commissioner on the FDA’s new effort for developing and class labelling of in vitro companion diagnostics for classes of oncology therapeutic products
6 December 2018 - One challenge we face right now, when it comes to developing diagnostics that can help target ...
Posted by Michael Wonder on 06 Dec 2018
FDA publishes post CRL guidance for generic companies
4 December 2018 - The US FDA has published final guidance for the generics industry on post-complete response letter meetings. ...
Posted by Michael Wonder on 05 Dec 2018
Generic drug prices ‘strongly predictive’ of shortages, study finds
4 December 2018 - How a generic drug is priced may be the difference between whether it experiences a shortage ...
Posted by Michael Wonder on 05 Dec 2018
FDA grants priority review to Genentech’s Tecentriq in combination with chemotherapy for the initial treatment of extensive-stage small cell lung cancer
4 December 2018 - Genentech today announced that the U.S. FDA has accepted the company’s supplemental biologics license application and granted ...
Posted by Michael Wonder on 05 Dec 2018
FDA grants fast track designation for AMG 420
3 December 2018 - Amgen today announced the first clinical results from studies evaluating investigational novel bi-specific T cell engager (BiTE) ...
Posted by Michael Wonder on 04 Dec 2018
The Biosimilars Forum joins calls for FDA action on biosimilar communications
3 December 2018 - The Biosimilars Forum is lending its support to Pfizer’s August 2018 citizen petition to the FDA ...
Posted by Michael Wonder on 04 Dec 2018
Shield Therapeutics announces the new drug application for Feraccru has been accepted for filing and review by the FDA
3 December 2018 - Shield Therapeutics today announces that the US FDA has accepted for review the new drug application ...