Blog
RSS FeedPosted by Michael Wonder on 26 Oct 2021
Lilly pipeline success strengthens future growth potential
27 October 2021 - Lilly announces today its U.S. submission of tirzepatide in type 2 diabetes using a priority review ...
Posted by Michael Wonder on 26 Oct 2021
Generating high quality evidence from registry based studies
26 October 2021 - EMA has published guidance to provide key methods and good regulatory practices to pharmaceutical organisations on ...
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
Merck and Ridgeback announce initiation of a rolling review by the European Medicines Agency for molnupiravir, an investigational oral anti-viral medicine, for the treatment of COVID-19 in adults
25 October 2021 - If granted marketing authorisation by the European Commission, molnupiravir could be the first oral anti-viral medicine for ...
Posted by Michael Wonder on 25 Oct 2021
COVID-19: EMA starts rolling review of molnupiravir
25 October 2021 - EMA’s CHMP has started a rolling review of the oral antiviral medicine molnupiravir (MK 4482; Lagevrio), ...
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 24 Oct 2021
EU decision on Russia's Sputnik V shot 'impossible' this year
21 October 2021 - The EU drug regulator is unlikely to decide whether to approve Russia's Sputnik V coronavirus vaccine until ...
Posted by Michael Wonder on 18 Oct 2021
EMA grants PRIME designation for JR-141 for the treatment of mucopolysaccharidosis type II (Hunter syndrome)
18 October 2021 - JCR Pharmaceuticals announced today that the EMA has granted PRIME designation for the investigational drug JR-141 (pabinafusp ...
Posted by Michael Wonder on 18 Oct 2021
EMA starts evaluating use of COVID-19 vaccine Comirnaty in children aged 5 to 11
18 October 2021 - EMA has started evaluating an application to extend the use of BioNTech/Pfizer’s COVID-19 vaccine, Comirnaty, to ...
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 17 Oct 2021
Merck and Eisai receive positive EU CHMP opinions for Keytruda (pembrolizumab) plus Lenvima (lenvatinib) in two different types of cancer
15 October 2021 - Merck and Eisai today announced that the CHMP of the EMA has adopted positive opinions recommending ...
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
Janssen receives Positive CHMP opinion for Rybrevant (amivantamab) for the treatment of patients with advanced non-small cell lung cancer with EGFR exon 20 insertion mutations after failure of platinum-based therapy
15 October 2021 - If approved by the European Commission, amivantamab will be the first treatment in the European Union specifically ...
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. ...