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RSS FeedPosted by Michael Wonder on 09 Aug 2017
Valeant Pharmaceuticals receives complete response letter from the FDA for latanoprostene bunod ophthalmic solution, 0.024% NDA
7 August 2017 - Valeant Pharmaceuticals today announced it has received a complete response letter from the U.S. FDA regarding ...
Posted by Michael Wonder on 09 Aug 2017
Institute for Clinical and Economic Review posts draft scoping document on CAR-T therapies for public comment
9 August 2017 - Report expected to review axicabtagene ciloleucel and tisagenlecleucel-t, first CAR-T therapies submitted for FDA. ...
Posted by Michael Wonder on 08 Aug 2017
FDA approves Medicines360's sNDA for Liletta (levonorgestrel-releasing intrauterine system) 52 mg to prevent pregnancy for up to four years
7 August 2017 - Approval offers women additional flexibility for pregnancy prevention. ...
Posted by Michael Wonder on 07 Aug 2017
AbbVie wages HCV drug price war on Gilead
7 August 2017 - Pharma already leads the business world in unpredictability, with billions in sales potentially riding on a few ...
Posted by Michael Wonder on 07 Aug 2017
Drugs cleared through the FDA’s expedited review offer greater gains than drugs approved by conventional process
7 August 2017 - Chambers et al. investigated whether drugs approved by the FDA through expedited review have offered larger ...
Posted by Michael Wonder on 07 Aug 2017
Teva announces FDA approval of Qvar RediHaler (beclomethasone dipropionate HFA) inhalation aerosol
7 August 2017 - Maintenance treatment option designed to eliminate the need for hand-breath co-ordination during inhalation. ...
Posted by Michael Wonder on 07 Aug 2017
Take the generic, patients are told. Until they are not.
6 August 2017 - It’s standard advice for consumers: if you are prescribed a medicine, always ask if there is ...
Posted by Michael Wonder on 06 Aug 2017
FDA’S generic drug labelling rule delayed again
4 August 2017 - The FDA won’t be issuing a controversial final rule on label changes concerning generic drug safety ...
Posted by Michael Wonder on 04 Aug 2017
Dynavax provides U.S. regulatory update on Heplisav following FDA Advisory Committee meeting
3 August 2017 - Dynavax Technologies Corporation today announced that the U.S. FDA has requested more detailed information about the company's ...
Posted by Michael Wonder on 04 Aug 2017
Portola Pharmaceuticals announces resubmission of biologics license application for AndexXa (andexanet alfa)
3 August 2017 - Portola Pharmaceuticals today announced that on August 3, 2017 it resubmitted its Biologics License Application (BLA) ...
Posted by Michael Wonder on 04 Aug 2017
FDA grants Genentech’s Alecensa priority review for initial treatment of people with ALK positive lung cancer
4 August 2017 - Genentech announced today that the U.S. FDA has accepted the company’s supplemental new drug application and granted ...
Posted by Michael Wonder on 04 Aug 2017
Senate passes F.D.A. funding and ‘right to try’ drug bills
3 August 2017 - The Senate on Thursday gave final approval to legislation to finance the Food and Drug Administration, ...
Posted by Michael Wonder on 03 Aug 2017
Pharma's quieter price war continues
4 August 2017 - Pharmacy benefit managers are still squeezing drugmakers for discounts. ...
Posted by Michael Wonder on 03 Aug 2017
Addressing antimicrobial resistance and stewardship: the Priority Antimicrobial Value and Entry (PAVE) award
3 August 2017 - Antimicrobial-resistant infections affect more than 2 million people annually in the United States alone, accounting for an ...
Posted by Michael Wonder on 03 Aug 2017
FDA approves Mavyret for Hepatitis C
3 August 2017 - The U.S. FDA today approved Mavyret (glecaprevir and pibrentasvir) to treat adults with chronic hepatitis C virus ...