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RSS FeedPosted by Michael Wonder on 05 May 2020
Gilead's drug pricing in the crosshairs again in wake of OK to use remdesivir against COVID-19
4 May 2020 - Gilead plans to spend $1 billion on its COVID-19 drug remdesivir. Now some members of Congress ...
Posted by Michael Wonder on 04 May 2020
Randomised clinical trials and COVID-19: managing expectations
4 May 2020 - Despite the millions of cases and hundreds of thousands of deaths that have occurred in this devastating ...
Posted by Michael Wonder on 04 May 2020
U.S. law makers question Jaguar Health on price hike of drug that may help treat COVID-19 patients
4 May 2020 - The chair of a House of Representatives committee and a fellow Democratic committee member on Monday ...
Posted by Michael Wonder on 04 May 2020
How remdesivir, new hope for COVID-19 patients, was resurrected
4 May 2020 - The drug failed as a treatment for hepatitis and Ebola. With federal funding, scientists trained it on ...
Posted by Michael Wonder on 04 May 2020
Two potential therapies for COVID-19 have some effect
4 May 2020 - Hope rears its head, but more information is needed. ...
Posted by Michael Wonder on 04 May 2020
FDA approves Fensolvi (leuprolide acetate) for injectable suspension for paediatric patients with central precocious puberty
4 May 2020 - Fensolvi is the only six-month, subcutaneously administered leuprolide acetate approved for the treatment of paediatric patients two ...
Posted by Michael Wonder on 04 May 2020
NDA filing for potential new ADHD treatment, KP415, accepted by FDA
4 May 2020 - Corium, GPC’s portfolio company, to lead all commercialisation activities for KP415. ...
Posted by Michael Wonder on 04 May 2020
Gilead’s investigational anti-viral remdesivir receives U.S. FDA emergency use authorisation for the treatment of COVID-19
1 May 2020 - Authorisation enables broader use of remdesivir to treat hospitalised patients with severe COVID-19 disease in the United ...
Posted by Michael Wonder on 04 May 2020
Banner Life Sciences announces final FDA approval of Bafiertam for multiple sclerosis
30 April 2020 - Bafiertam (monomethyl fumarate), the bioequivalent alternative to Biogen’s Tecfidera (dimethyl fumarate), is a new oral treatment option ...
Posted by Michael Wonder on 02 May 2020
Genmab announces U.S. FDA approval of subcutaneous formulation of daratumumab, Darzalex Faspro (daratumumab and hyaluronidase-fihj), for the treatment of patients with multiple myeloma
1 May 2020 - Approval based on data from Phase III COLUMBA and Phase II PLEIADES studies. ...
Posted by Michael Wonder on 01 May 2020
COVID-19 update: FDA issues Emergency Use Authorisation for potential COVID-19 treatment
1 May 2020 - Today, the U.S. FDA issued an emergency use authorization for the investigational antiviral drug remdesivir for the ...
Posted by Michael Wonder on 01 May 2020
U.S. FDA accepts for priority review Bristol Myers Squibb’s application for CC-486 for maintenance treatment of adult patients in remission with acute myeloid leukaemia
1 May 2020 - Application based on results from the Phase 3 QUAZAR-AML-001 study. ...
Posted by Michael Wonder on 30 Apr 2020
FDA moving at ‘lightning speed’ on Gilead drug, Commissioner says
30 April 2020 - Several different pathways available for review, Hahn says. ...
Posted by Michael Wonder on 30 Apr 2020
Google searches for unproven COVID-19 cures spike by 1000 per cent after Trump, Musk endorsements
30 April 2020 - They’re unproven cures for COVID-19, but that hasn’t stopped a massive spike in attempts to buy these ...
Posted by Michael Wonder on 29 Apr 2020
FDA in ‘ongoing’ talks with Gilead to make remdesivir available to coronavirus patients ‘as quickly as possible’
29 April 2020 - The FDA has been in “sustained and ongoing” discussions with Gilead Sciences to make antiviral drug ...