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RSS FeedPosted 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 ...
Posted by Michael Wonder on 21 May 2021
TGA evaluating first monoclonal antibody treatment for COVID-19 sotrovimab - GlaxoSmithKline
21 May 2021 - The Therapeutic Goods Administration granted a provisional determination to GlaxoSmithKline in relation to the monoclonal antibody ...
Posted by Michael Wonder on 20 May 2021
Government calls for pitches for mRNA vaccine production facilities
21 May 2021 - Plans to build a new Australian vaccine facility will be launched on Friday in a call ...
Posted by Michael Wonder on 20 May 2021
Omeros announces extension of FDA review period for narsoplimab in HSCT-TMA
20 May 2021 - PDUFA date is 17 October 2021. ...
Posted by Michael Wonder on 20 May 2021
FDA approves nivolumab for resected oesophageal or GEJ cancer
20 May 2021 - Today the FDA approved nivolumab (Opdivo, Bristol-Myers Squibb) for patients with completely resected oesophageal or gastro-oesophageal ...
Posted by Michael Wonder on 20 May 2021
FDA authorises longer time for refrigerator storage of thawed Pfizer-BioNTech COVID-19 vaccine prior to dilution, making vaccine more widely available
19 May 2021 - Based on a review of recent data submitted by Pfizer today, the U.S. FDA is authorising undiluted, ...
Posted by Michael Wonder on 20 May 2021
EMA, MHRA to review Vertex' Kaftrio for children with cystic fibrosis
20 May 2021 - The EMA and the MHRA have validated Vertex' applications to expand the scope of its cystic ...
Posted by Michael Wonder on 20 May 2021
NICE turns down Janssen's Erleada
20 May 2021 - NICE has published draft guidance rejecting Janssen's Erleada (apalutamide) with androgen deprivation therapy for treating prostate ...
Posted by Michael Wonder on 20 May 2021
COVID-19 vaccine weekly safety report
20 May 2021 - Six additional cases of blood clots with low blood platelets have been assessed as thrombosis with thrombocytopenia ...
Posted by Michael Wonder on 20 May 2021
Canada's change to Pfizer vaccine storage temperature has major implications on rollout
19 May 2021 - Health Canada now recommends storing Pfizer vaccine at fridge temperatures for up to 1 month. ...
Posted by Michael Wonder on 19 May 2021
Leading real world data and analytics organisations form industry coalition to advance policies to support regulatory use of real world evidence
19 May 2021 - RWE Alliance Launched by Aetion, Flatiron Health, IQVIA, Syapse, and Tempus. ...