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RSS FeedPosted by Michael Wonder on 13 May 2020
Gilead’s remdesivir tested with other drugs to fight COVID-19
13 May 2020 - Researchers are looking to find a more potent coronavirus-fighting cocktail. ...
Posted by Michael Wonder on 13 May 2020
COVID-19 exposes drug supply gaps as 'made in Canada' solution proposed
10 May 2020 - For more than a decade, Canada has had a supply shortage of essential medication, an issue ...
Posted by Michael Wonder on 13 May 2020
Arbor Pharmaceuticals announces FDA filing acceptance of new drug application for AR19, an investigational ADHD prescription stimulant treatment specifically designed to resist physical manipulation for non-medical misuse or abuse
13 May 2020 - If approved, AR19 would be the first-ever FDA approved ADHD stimulant medication designed to resist manipulation for ...
Posted by Michael Wonder on 13 May 2020
Vanda Pharmaceuticals announces agreement with FDA on resubmission of the application for Hetlioz for the treatment of patients with Smith-Magenis syndrome
13 May 2020 - Vanda Pharmaceuticals today announced that following the completion of a Type A meeting with the U.S. FDA ...
Posted by Michael Wonder on 13 May 2020
Rhythm Pharmaceuticals announces FDA acceptance of new drug application for setmelanotide for the treatment of POMC and LEPR deficiency obesities
13 May 2020 - FDA grants priority review of application and sets PDUFA goal date of 27 November 2020. ...
Posted by Michael Wonder on 13 May 2020
Bristol Myers Squibb and bluebird bio provide regulatory update on idecabtagene vicleucel (ide-cel, bb2121) for the treatment of patients with multiple myeloma
Bristol Myers Squibb and bluebird bio today announced that the companies received a Refusal to File letter from the U.S. ...
Posted by Michael Wonder on 13 May 2020
Gilead strikes deal to make remdesivir coronavirus treatment in 127 countries
12 May 2020 - Gilead Sciences has struck a licensing agreement with five generic drugmakers to make anti-viral drug remdesivir in ...
Posted by Michael Wonder on 13 May 2020
Seattle Genetics announces the approval of Tukysa (tucatinib) in Switzerland for the treatment of patients with metastatic HER2-positive breast cancer
12 May 2020 - First approval for Tukysa outside of the U.S. ...
Posted by Michael Wonder on 12 May 2020
Investigators propose different measures for biosimilar equivalence
12 May 2020 - Investigators use the HERITAGE trial findings to argue for a more precise way of measuring clinical equivalence ...
Posted by Michael Wonder on 12 May 2020
Doctors face 'nearly an impossible situation' as they ration remdesivir
11 May 2020 - As coronavirus cases surged across the United States earlier this year, doctors faced a harrowing prospect. ...
Posted by Michael Wonder on 12 May 2020
Moderna receives FDA fast track designation for mRNA vaccine (mRNA-1273) against novel voronavirus
12 May 2020 - Finalizing protocol for Phase 3 study of mRNA-1273, expected to begin in early summer of 2020. ...
Posted by Michael Wonder on 12 May 2020
ZolpiMist update
12 May 2020 - SUDA submitted a marketing authorisation application to the TGA for ZolpiMist in April 2019. ...
Posted by Michael Wonder on 12 May 2020
COVID-19 update: FDA takes new actions to accelerate development of novel prevention, treatment options for COVID-19
11 May 2020 - Today, the U.S. FDA took important actions to help accelerate the development of prevention and treatment options ...
Posted by Michael Wonder on 12 May 2020
FDA's drug approval system is more open than Australia's
11 May 2020 - Australia’s secretive drug approval system gives what some believe is an unfair advantage to rival drug companies. ...
Posted by Michael Wonder on 11 May 2020
CRISPR Therapeutics and Vertex Pharmaceuticals announce FDA regenerative medicine advanced therapy designation granted to CTX001 for the treatment of severe hemoglobinopathies
11 May 2020 - CTX001 has received orphan drug designation from the U.S. FDA for transfusion-dependent beta thalassemia and from the ...