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RSS FeedPosted by Michael Wonder on 15 Nov 2021
Competing with, and learning from, China in the global pharmaceutical innovation race
15 November 2021 - President Joe Biden has promoted investment in technology based industries, including the life sciences, as a strategic ...
Posted by Michael Wonder on 15 Nov 2021
Celltrion’s monoclonal antibody treatment regdanvimab, approved by the European Commission for the treatment of COVID-19
14 November 2021 - The European Commission granted marketing authorisation for Celltrion’s regdanvimab following positive opinion by the EMA's CHMP last ...
Posted by Michael Wonder on 15 Nov 2021
New FDA chief will face COVID woes and calls for drug approval reform
12 November 2021 - After long delay, US President Joe Biden picks Robert Califf to once again head the US FDA. ...
Posted by Michael Wonder on 15 Nov 2021
Califf has lots of unfinished FDA business
15 November 2021 - Robert Califf, whom President Biden picked to lead the US. FDA, does not have much to show ...
Posted by Michael Wonder on 15 Nov 2021
Rhythm Pharmaceuticals announces FDA acceptance for filing and priority review of supplemental new drug application for Imcivree (setmelanotide) for patients with Bardet-Biedl syndrome and Alström syndrome
15 November 2021 - FDA sets PDUFA goal date of 16 March 2022. ...
Posted by Michael Wonder on 15 Nov 2021
Horizon Therapeutics receives CHMP positive opinion for Uplinza (inebilizumab) as a monotherapy for the treatment of adult patients with neuromyelitis optica spectrum disorder
12 November 2021 - CHMP recommendation based on positive results from N-MOmentum, the largest clinical trial ever conducted in NMOSD to ...
Posted by Michael Wonder on 15 Nov 2021
Ozempic 2 mg recommended for approval for the treatment of type 2 diabetes by the European Medicines Agency
12 November 2021 - Novo Nordisk today announced that the EMA's CHMP has adopted a positive opinion recommending a label ...
Posted by Michael Wonder on 15 Nov 2021
Wegovy recommended for approval for the treatment of obesity by the European regulatory authorities
11 November 2021 - Novo Nordisk today announced that the European Medicines Agency’s CHMP has adopted a positive opinion, recommending ...
Posted by Michael Wonder on 13 Nov 2021
Health Canada authorises the use of the Moderna Spikevax COVID-19 vaccine as a booster shot
12 November 2021 - Health Canada has authorised the use of the Moderna Spikevax COVID-19 vaccine as a booster shot. ...
Posted by Michael Wonder on 13 Nov 2021
FDA approves treatment for rare blood disease
12 November 2021 - Treatment is first FDA approved option patients can take regardless of previous therapies. ...
Posted by Michael Wonder on 13 Nov 2021
Biden nominates Califf as FDA chief
12 November 2021 - President Joe Biden on Friday nominated former Commissioner Robert Califf to lead the FDA, in a ...
Posted by Michael Wonder on 13 Nov 2021
Vertex receives CHMP positive opinion for Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor in children with cystic fibrosis ages 6 through 11
12 November 2021 - If approved, more than 1,500 children would be eligible for a medicine that can treat the ...
Posted by Michael Wonder on 13 Nov 2021
Highlights from CHMP 8-11 November 2021 meeting
12 November 2021 - EMA’s CHMP recommended eleven medicines for approval at its November 2021 meeting. ...
Posted by Michael Wonder on 13 Nov 2021
Strengthening the FDA’s enforcement of ClinicalTrials.gov reporting requirements
12 November 2021 - On 28 April 2021, the US FDA announced that it “issued its first Notice of Non-compliance to ...
Posted by Michael Wonder on 12 Nov 2021
First in class medicine recommended for treatment of rare blood vessel inflammation
12 November 2021 - EMA has recommended granting a marketing authorisation in the European Union for Tavneos (avacopan), a first in ...