Blog
RSS FeedPosted by Michael Wonder on 24 May 2021
Gilead withdraws submission for Jyseleca
24 May 2021 - Decision should not come as a major surprise given FDA rejection last year. ...
Posted by Michael Wonder on 24 May 2021
Positive CHMP opinion for Ryeqo (relugolix combination tablet)
21 May 2021 - Gedeon Richter announces that the CHMP of the EMA has adopted a positive opinion recommending approval of ...
Posted by Michael Wonder on 24 May 2021
Bristol Myers Squibb receives positive CHMP opinion recommending Opdivo (nivolumab) plus Yervoy (ipilimumab) for treatment of mismatch repair deficient or microsatellite instability–high metastatic colorectal cancer after prior chemotherapy
21 May 2021 - Application based on positive results from the Phase 2 CheckMate-142 trial demonstrating a durable clinical benefit in ...
Posted by Michael Wonder on 24 May 2021
ATAGI/THANZ statement provides further guidance for the AstraZeneca vaccine and narrows contra-indication
23 May 2021 - The Australian Technical Advisory Group on Immunisation and the Thrombosis and Haemostasis Society of Australia and New ...
Posted by Michael Wonder on 23 May 2021
EU regulator backs extending approval for remdesivir for another year
21 May 2021 - The EMA on Friday recommended extending conditional marketing approval by a year for Gilead Sciences’ COVID-19 ...
Posted by Michael Wonder on 23 May 2021
Prescription medicines: applications under evaluation (May 2021 update)
21 May 2021 - The TGA has updated its list of applications for new medicines or new uses for existing ...
Posted by Michael Wonder on 23 May 2021
Positive CHMP opinion for Bayer’s new symptomatic chronic heart failure treatment vericiguat
21 May 2021 - Vericiguat is being considered for adult patients with reduced ejection fraction who are stabilised after a recent ...
Posted by Michael Wonder on 23 May 2021
First gene therapy to treat children with rare inherited neurological disease
21 May 2021 - The EMA has recommended granting a marketing authorisation in the European Union for the gene therapy ...
Posted by Michael Wonder on 23 May 2021
New treatment for obesity caused by rare genetic disorders
21 May 2021 - EMA has recommended granting a marketing authorisation in the European Union for Imcivree (setmelanotide) to support weight ...
Posted by Michael Wonder on 23 May 2021
Pfizer and BioNTech to supply the European Union with up to 1.8 billion additional doses of Comirnaty
20 May 2021 - New agreement to supply 900 million doses to the European Commission, with option to request up to ...
Posted by Michael Wonder on 22 May 2021
US biotech Novavax could make COVID vaccine onshore in Australia
20 May 2021 - American biotechnology company Novavax has outlined plans to make doses of its coronavirus vaccine in Australia ...
Posted by Michael Wonder on 21 May 2021
EMA issues advice on use of sotrovimab (VIR-7831) for treating COVID-19
21 May 2021 - EMA’s CHMP has completed its review on the use of the monoclonal antibody sotrovimab (also known as ...
Posted by Michael Wonder on 21 May 2021
Vaxzevria: further advice on blood clots and low blood platelets
21 May 2021 - EMA has provided additional advice on blood clots or low blood platelets occurring after vaccination with Vaxzevria ...
Posted by Michael Wonder on 21 May 2021
FDA grants accelerated approval to amivantamab-vmjw for metastatic non-small cell lung cancer
21 May 2021 - Today, the FDA granted accelerated approval to amivantamab-vmjw (Rybrevant, Janssen), a bispecific antibody directed against epidermal ...
Posted by Michael Wonder on 21 May 2021
U.S. FDA grants priority review of maribavir for the treatment of post-transplant recipients with cytomegalovirus infection in those resistant and/or refractory to prior anti-CMV treatment
21 May 2021 - New drug application based on Phase 3 trial of maribavir which met its primary outcome of superiority ...