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RSS FeedPosted by Michael Wonder on 29 Mar 2020
IntelGenx receives complete response letter from FDA for Rizaport NDA
27 March 2020 - IntelGenx today announced that it has received a complete response letter from the U.S. FDA regarding ...
Posted by Michael Wonder on 27 Mar 2020
IntraBio fast track designation for GM2 gangliosidosis
26 March 2020 - IntraBio is pleased to share that the US FDA has granted fast track designation to its ...
Posted by Michael Wonder on 26 Mar 2020
Jazz Pharmaceuticals announces FDA acceptance of new drug application for JZP-258 for cataplexy and excessive daytime sleepiness associated with narcolepsy
25 March 2020 - Jazz Pharmaceuticals today announced that the U.S. FDA accepted for filing with priority review the company's new ...
Posted by Michael Wonder on 26 Mar 2020
Gilead declines 'rare disease' status for experimental coronavirus drug
25 March 2020 - In a surprising turnabout, drugmaker Gilead Sciences asked the FDA on Wednesday to rescind orphan status ...
Posted by Michael Wonder on 26 Mar 2020
Orphan Technologies receives rare paediatric disease designation from FDA for OT-58 to treat cystathionine B-synthase deficiency homocystinuria
26 March 2020 - Orphan Technologies today announced that OT-58 for the treatment of cystathionine beta synthase deficiency homocystinuria has ...
Posted by Michael Wonder on 26 Mar 2020
Crowdsourcing to fight COVID-19
26 March 2020 - “We are trying to fly the plane while we are building it.” ...
Posted by Michael Wonder on 26 Mar 2020
FDA continues to support transparency and collaboration in drug approval process as the clinical data summary pilot concludes
26 March 2020 - As our society becomes more global, it has become increasingly clear that the U.S. FDA needs to ...
Posted by Michael Wonder on 26 Mar 2020
U.S. FDA approves Bristol Myers Squibb’s Zeposia (ozanimod), a new oral treatment for relapsing forms of multiple sclerosis
26 March 2020 - In clinical trials, Zeposia demonstrated efficacy on a key clinical marker of disease activity – annualised relapse ...
Posted by Michael Wonder on 26 Mar 2020
Novartis and life sciences companies commit expertise and assets to the fight against COVID-19 pandemic alongside Bill & Melinda Gates Foundation
26 March 2020 - Collaboration to address product development and scale up challenges posed by current pandemic. ...
Posted by Michael Wonder on 26 Mar 2020
Preserving clinical trial integrity during the coronavirus pandemic
25 March 2020 - Randomised clinical trials provide the highest-quality evidence for identifying therapies to help people attain longer and healthier ...
Posted by Michael Wonder on 25 Mar 2020
FDA announces funding opportunity to explore the use of real-world data to generate real-world evidence in regulatory decision making
25 March 2020 - The U.S. Food and Drug Administration is announcing a funding opportunity for projects to support the ...
Posted by Michael Wonder on 25 Mar 2020
Coronavirus drugs, vaccine are many months away, health experts say
24 March 2020 - Public- and private-sector medical officials cautioned that further study is needed to assess possible treatments pushed by ...
Posted by Michael Wonder on 25 Mar 2020
COVID-19 and angiotensin-converting enzyme inhibitors and angiotensin receptor blockers: what is the evidence?
24 March 2020 - Coronavirus disease 2019 is a current pandemic infection caused by a positive-sense RNA virus named the severe ...
Posted by Michael Wonder on 25 Mar 2020
Treating COVID-19—off-label drug use, compassionate use, and randomised clinical trials during pandemics
24 March 2020 - In the 2014 Ebola outbreak, close to 30 000 individuals developed Ebola viral disease, and numerous therapies were ...
Posted by Michael Wonder on 24 Mar 2020
Prevail Therapeutics receives U.S. FDA fast track designation for PR006 to slow the progression of frontotemporal dementia with a GRN mutation
24 March 2020 - Prevail Therapeutics today announced that the U.S. FDA has granted fast track designation for the Company’s ...