Blog
RSS FeedPosted 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
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 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 ...
Posted by Michael Wonder on 11 Nov 2021
COVID-19: EMA recommends authorisation of two monoclonal antibody medicines
11 November 2021 - EMA’s CHMP has recommended authorising Ronapreve (casirivimab/imdevimab) and Regkirona (regdanvimab) for COVID-19. ...
Posted by Michael Wonder on 08 Nov 2021
SMC - November 2021 decisions
8 November 2021 - The Scottish Medicines Consortium which advises on newly licensed medicines for use by NHSScotland has published ...
Posted by Michael Wonder on 28 Oct 2021
EMA nod for excessive daytime sleepiness med Ozawade
28 October 2021 - The EMA has approved Bioprojet’s Ozawade (pitolisant) for the treatment of excessive daytime sleepiness associated with ...
Posted by Michael Wonder on 25 Oct 2021
Spikevax: EMA recommendation on booster
25 October 2021 - The EMA’s CHMP has concluded that a booster dose of the COVID-19 vaccine Spikevax (from Moderna) ...
Posted by Michael Wonder on 25 Oct 2021
European Commission approves Merck’s Keytruda (pembrolizumab) plus chemotherapy as treatment for certain patients with locally recurrent unresectable or metastatic triple negative breast cancer
22 October 2021 - Keytruda is now approved in combination with chemotherapy as first-line treatment for patients with locally recurrent unresectable ...
Posted by Michael Wonder on 17 Oct 2021
Pfizer’s abrocitinib receives positive CHMP opinion for the treatment of adults with moderate to severe atopic dermatitis
15 October 2021 - CHMP also recommends Xeljanz (tofacitinib) approval for the treatment of adults with active ankylosing spondylitis ...
Posted by Michael Wonder on 16 Oct 2021
Merck receives positive CHMP opinion for Vaxneuvance (pneumococcal 15 valent conjugate vaccine) in individuals 18 years of age and older
15 October 2021 - Merck today announced that the EMA’s CHMP has recommended the approval of Vaxneuvance (Pneumococcal 15 valent ...
Posted by Michael Wonder on 16 Oct 2021
Bristol Myers Squibb receives positive CHMP opinion for Zeposia (ozanimod) as a treatment for adult patients with moderately to severely active ulcerative colitis
15 October 2021 - CHMP recommendation based on positive results from the Phase 3 True North trial, in which Zeposia demonstrated ...
Posted by Michael Wonder on 16 Oct 2021
AbbVie receives CHMP positive opinion for risankizumab (Skyrizi) for the treatment of adults with active psoriatic arthritis in the European Union
15 October 2021 - CHMP positive opinion is based on data from two Phase 3 studies, KEEPsAKE-1 and KEEPsAKE-2. ...
Posted by Michael Wonder on 06 Oct 2021
Moderna announces European Medicines Agency authorises third dose of COVID-19 vaccine for immunocompromised individuals aged 12 years and older
5 October 2021 - Moderna today announced that the EMA has authorised a third dose of the Moderna COVID-19 vaccine (Spikevax) ...
Posted by Michael Wonder on 20 Sep 2021
EU panel rejects Pfizer’s tanezumab for osteoarthritis pain
19 September 2021 - Any lingering hope that Pfizer’s may finally get a regulatory approval for its nerve growth factor ...
Posted by Michael Wonder on 19 Sep 2021
Highlights from the CHMP 13-16 September 2021 meeting
17 September 2021 - The EMA’s human medicines committee (CHMP) recommended nine medicines for approval at its September 2021 meeting. ...