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RSS FeedPosted by Michael Wonder on 17 Jul 2019
Trump to order drive for improved flu vaccine
16 July 2019 - President Donald Trump is readying an executive order that would direct HHS to overhaul the development ...
Posted by Michael Wonder on 17 Jul 2019
U.S. FDA accepts Allergan's new drug application for bimatoprost sustained release in patients with open-angle glaucoma or ocular hypertension
17 July 2019 - Filing included data from the Phase 3 ARTEMIS studies, which demonstrated that the majority of patients remained ...
Posted by Michael Wonder on 17 Jul 2019
FDA approves Merck’s Recarbrio (imipenem, cilastatin, and relebactam) for the treatment of adults with complicated urinary tract and complicated intra-abdominal bacterial infections where limited or no alternative treatment options are available
17 July 2019 - Merck today announced that the U.S. FDA has approved Recarbrio (imipenem, cilastatin, and relebactam) for injection, 1.25 ...
Posted by Michael Wonder on 17 Jul 2019
LogicBio Therapeutics receives rare paediatric disease designation for LB-001 for the treatment of methylmalonic acidaemia
16 July 2019 - LogicBio Therapeutics today announced the U.S. FDA has granted rare paediatric disease designation to LB-001, a ...
Posted by Michael Wonder on 16 Jul 2019
How pharma, under attack from all sides, keeps winning in Washington
16 July 2019 - It does not seem to matter how angrily President Trump tweets, how pointedly House Speaker Nancy ...
Posted by Michael Wonder on 16 Jul 2019
Why isn’t insulin a complex generic? PA representative asks the FDA
16 July 2019 - Republican Mike Kelly (R-PA) sent a letter Tuesday to US FDA Acting Commissioner Ned Sharpless questioning ...
Posted by Michael Wonder on 16 Jul 2019
Seattle Genetics and Astellas announce submission of biologics license application to FDA for enfortumab vedotin for patients with locally advanced or metastatic urothelial cancer
16 July 2019 - Submission based on pivotal Phase 2 trial results recently presented at Annual Meeting of American Society of ...
Posted by Michael Wonder on 16 Jul 2019
Dicerna receives breakthrough therapy designation for DCR-PHXC for treatment of primary hyperoxaluria type 1
15 July 2019 - FDA recognises primary hyperoxaluria Types 2 and 3 as meeting criteria for a serious or life-threatening disease ...
Posted by Michael Wonder on 16 Jul 2019
Gilead and Novartis seek to expand what FDA considers as real-world data and real-world evidence
15 July 2019 - Just over two months ago, the US FDA released draft guidance explaining to drugmakers what constitutes ...
Posted by Michael Wonder on 16 Jul 2019
FDA accepts file and accelerates review of Novartis sickle cell disease medicine crizanlizumab
16 July 2019 - FDA grants crizanlizumab Priority Review based on Phase II data showing prevention of vaso-occlusive crises in patients ...
Posted by Michael Wonder on 15 Jul 2019
FDA approves Bayer's Gadavist (gadobutrol) injection as the first and only contrast agent for use in cardiac magnetic resonance imaging in adult patients with known or suspected coronary artery disease
15 July 2019 - Coronary artery disease is an important public health issue-- a disease that affects 16.5 million Americans. ...
Posted by Michael Wonder on 15 Jul 2019
The FDA disagrees with its own expert panels how often?
15 July 2019 - As the FDA grapples with rising pressure to approve new medicines more quickly, a new analysis ...
Posted by Michael Wonder on 15 Jul 2019
Teva announces FDA approval of AirDuo Digihaler (fluticasone propionate 113 mcg and salmeterol 14 mcg) inhalation powder
15 July 2019 - The first digital maintenance asthma inhaler therapy with integrated sensors joins Teva’s digital rescue inhaler therapy to ...
Posted by Michael Wonder on 15 Jul 2019
Update on US regulatory decision for Farxiga in type 1 diabetes
15 July 2019 - AstraZeneca today announced that the US FDA has issued a complete response letter regarding the supplemental ...
Posted by Michael Wonder on 15 Jul 2019
Report on the current status of the use of real‐world data and real‐world evidence in drug development and regulation
10 July 2019 - Radically expanding use of real‐world data and real‐world evidence holds the potential to substantially impact drug development, ...