Blog
RSS FeedPosted by Michael Wonder on 23 Aug 2019
FDA focuses on Novartis delay in reporting drug-test data manipulation
22 August 2019 - Regulators zeroing in on the company’s two-month delay in launching a formal inquiry. ...
Posted by Michael Wonder on 22 Aug 2019
AstraZeneca agrees to buy US FDA priority review voucher from Sobi
22 August 2019 - AstraZeneca today announced that it has agreed to buy a US FDA priority review voucher for ...
Posted by Michael Wonder on 22 Aug 2019
Gilead files challenge to government patents for HIV prevention pill
21 August 2019 - Gilead Sciences took the unusual step of mounting a challenge to U.S. government patents on Wednesday, ...
Posted by Michael Wonder on 22 Aug 2019
U.S. FDA grants Xtandi (enzalutamide) application priority review for the treatment of men with metastatic hormone-sensitive prostate cancer
21 August 2019 - Xtandi supplemental new drug application seeks to add an indication for men with prostate cancer that has ...
Posted by Michael Wonder on 21 Aug 2019
BeiGene announces U.S. FDA acceptance and grant of priority review for its new drug application of zanubrutinib in patients with relapsed/refractory Mantle cell lymphoma
21 August 2019 - BeiGene today announced that the U.S. FDA has accepted the company’s new drug application for zanubrutinib for ...
Posted by Michael Wonder on 21 Aug 2019
Appealing court ruling, Trump administration renews fight to require drug prices in TV ads
21 August 2019 - The Trump administration isn’t giving up the fight to require drug makers include their sticker prices ...
Posted by Michael Wonder on 21 Aug 2019
Former FDA Commissioners seek to expand use of RWE in regulatory, payment decisions
21 August 2019 - A new report from the Bipartisan Policy Center makes recommendations to expand the use of real-world ...
Posted by Michael Wonder on 21 Aug 2019
Cerecor receives fast track designation from FDA for CERC-802 for the treatment of mannose-phosphate isomerase deficiency
21 August 2019 - Cerecor announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for ...
Posted by Michael Wonder on 21 Aug 2019
FDA on Novartis data manipulation controversy: ‘we happened to be lucky’
21 August 2019 - Since the FDA blasted Novartis earlier this month over data manipulation, one of the major questions ...
Posted by Michael Wonder on 21 Aug 2019
Cassiopea announces FDA submission of new drug application for clascoterone 1% cream, the first new mechanism of action for acne in nearly 40 years
20 August 2019 - Cassiopea announced today that it has submitted a new drug application to the U.S. FDA seeking ...
Posted by Michael Wonder on 20 Aug 2019
Novartis delayed reveal of bad data for $2.1 million gene therapy. Now patients and pharma suffer.
20 August 2019 - Novartis CEO had a rocky start to his tenure. ...
Posted by Michael Wonder on 20 Aug 2019
Teva launches generic version of EpiPen for young children
20 August 2019 - Teva Pharmaceutical Industries on Tuesday made its generic version of Mylan’s EpiPen for young children available in ...
Posted by Michael Wonder on 20 Aug 2019
Ousted Novartis scientist ‘categorically denies’ wrongdoing in data manipulation scandal
20 August 2019 - The scientist, Brian Kaspar, “is a respected member of the scientific community with an impeccable record,” his ...
Posted by Michael Wonder on 20 Aug 2019
Eiger announces FDA breakthrough therapy designation for peginterferon lambda for treatment of hepatitis delta virus infection
20 August 2019 - Fourth Eiger program granted breakthrough therapy designation. ...
Posted by Michael Wonder on 20 Aug 2019
FDA accepts new drug application for VX-445 (elexacaftor), tezacaftor and ivacaftor combination treatment
20 August 2019 - FDA grants priority review of the application and sets a PDUFA target action date of 19 ...