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RSS FeedPosted by Michael Wonder on 10 Jul 2019
U.S. appeals court signals sympathy to bid to strike down Obamacare
9 July 2019 - A federal appeals court panel appeared sympathetic on Tuesday to Republican efforts to overturn Obamacare, expressing skepticism ...
Posted by Michael Wonder on 10 Jul 2019
Novartis launches Adamis allergy shots in U.S. pharmacies amid EpiPen shortage
9 July 2019 - A unit of Novartis said on Tuesday it would make partner Adamis Pharmaceuticals Corp’s emergency allergy ...
Posted by Michael Wonder on 10 Jul 2019
FDA approves Katerzia, the first and only amlodipine oral suspension for paediatric patients 6 years of age and older
10 July 2019 - Azurity Pharmaceuticals announced today that the U.S. FDA has approved Katerzia (amlodipine) 1 mg/mL oral suspension, ...
Posted by Michael Wonder on 10 Jul 2019
FDA to review isatuximab as a potential treatment for relapsed/refractory multiple myeloma
10 July 2019 - The U.S. FDA has accepted for review the biologics license application for isatuximab for the treatment ...
Posted by Michael Wonder on 10 Jul 2019
Cellectar receives FDA fast track designation for CLR 131 in diffuse large B-cell lymphoma
9 July 2019 - Cellectar Biosciences today announced the U.S. FDA has granted fast track designation for CLR 131 in relapsed ...
Posted by Michael Wonder on 09 Jul 2019
ViiV Healthcare announces start of first-ever study to identify and evaluate approaches to implementing its once-monthly injectable HIV treatment in clinical practice
9 July 2019 - The long-acting injectable regimen has been granted priority review status by the FDA, with a target approval ...
Posted by Michael Wonder on 09 Jul 2019
FDA accepts Merck’s supplemental biologics license applications for Keytruda (pembrolizumab) six-week dosing schedule for melanoma and multiple other indications
9 July 2019 - Merck today announced that the U.S. FDA has accepted for review six supplemental biologics license applications to ...
Posted by Michael Wonder on 09 Jul 2019
FDA leverages private sector technology-based tools in its embrace of real world evidence
9 July 2019 - Following decades of near total reliance on randomised clinical trial data, the U.S. FDA (with a ...
Posted by Michael Wonder on 09 Jul 2019
The fragility of phase 3 trials supporting FDA approved anti-cancer medicines: a retrospective analysis
8 July 2019 - The fragility index of trial results—ie, the minimum number of changes from non-events to events resulting in ...
Posted by Michael Wonder on 09 Jul 2019
FDA to speed review of generic versions of opioid overdose antidote
8 July 2019 - The US FDA on Monday said it would prioritise and expedite the review of generic versions ...
Posted by Michael Wonder on 09 Jul 2019
Trump rule requiring drug prices in TV ads blocked
8 July 2019 - Federal judge sides with companies, saying regulation would violate free speech. ...
Posted by Michael Wonder on 08 Jul 2019
ADMA Biologics receives FDA approval for license transfers for Bivigam and Nabi-HB
8 July 2019 - All aspects of the Biotest Therapy Business Unit acquisition are successfully completed. ...
Posted by Michael Wonder on 08 Jul 2019
Prevail Therapeutics receives U.S. FDA fast track designation for PR001 for the treatment of Parkinson’s disease patients with a GBA1 mutation
8 July 2019 - Company plans to initiate Phase 1/2 clinical trial in the second half of 2019. ...
Posted by Michael Wonder on 08 Jul 2019
Plan on more pharma mega-mergers
6 July 2019 - With a drought in new blockbuster drugs, generating growth has become a challenge. ...
Posted by Michael Wonder on 07 Jul 2019
Fast-track drug approval, designed for emergencies, is now routine
5 July 2019 - Three-quarters of new drugs get an expedited regulatory review, thrusting families and doctors into a new world ...