Blog
RSS FeedPosted by Michael Wonder on 18 Dec 2021
Tepmetko (tepotinib) receives positive CHMP opinion for patients with advanced NSCLC with METex14 skipping alterations
17 December 2021 - Tepmetko is the first and only oral MET inhibitor to receive CHMP positive opinion in Europe ...
Posted by Michael Wonder on 16 Dec 2021
EMA issues advice on use of Paxlovid (PF-07321332 and ritonavir) for the treatment of COVID-19
16 December 2021 - Rolling review starts in parallel ...
Posted by Michael Wonder on 16 Dec 2021
AVT02, Alvotech’s biosimilar to high concentration formulation of adalimumab (Humira) approved for use in European Union
15 December 2021 - Alvotech received approval for AVT02 (100 mg/mL), the company’s high concentration biosimilar to Humira (adalimumab), from the ...
Posted by Michael Wonder on 16 Dec 2021
COVID-19: EMA recommends authorisation of antibody medicine Xevudy
16 December 2021 - EMA’s CHMP has recommended authorising the monoclonal antibody Xevudy (sotrovimab) for the treatment of COVID-19. ...
Posted by Michael Wonder on 16 Dec 2021
EMA recommends approval for use of Kineret in adults with COVID-19
16 December 2021 - EMA’s CHMP has recommended extending the indication of Kineret (anakinra) to include treatment of COVID-19 in ...
Posted by Michael Wonder on 16 Dec 2021
Apellis and Sobi Announce EU approval of Aspaveli (pegcetacoplan) for treatment of PNH
15 December 2021 - The first targeted C3 therapy approved in the EU. ...
Posted by Michael Wonder on 16 Dec 2021
CSL Behring receives accelerated CHMP assessment for etranacogene dezaparvovec for European patients living with haemophilia B
15 December 2021 - CSL Behring today announced that the CHMP, the chief scientific body of the EMA accepted its ...
Posted by Michael Wonder on 15 Dec 2021
EMA launches the Regulatory Science Research Needs initiative
15 December 2021 - For the first time, EMA has issued a list of regulatory science topics that need further research ...
Posted by Michael Wonder on 15 Dec 2021
COVID-19 Vaccine Janssen: EMA recommendation on booster dose
15 December 2021 - EMA’s CHMP has concluded that a booster dose of COVID-19 Vaccine Janssen may be considered at ...
Posted by Michael Wonder on 15 Dec 2021
Alnylam submits regulatory applications to the U.S. FDA and EMA to support label expansion for Oxlumo for the treatment of advanced primary hyperoxaluria type 1
14 December 2021 - Findings from the ILLUMINATE-C Phase 3 study showed substantial reductions in plasma oxalate in PH1 patients with ...
Posted by Michael Wonder on 14 Dec 2021
EMA reviewing new data on effectiveness of Lagevrio (molnupiravir) for the treatment of COVID-19
14 December 2021 - Following EMA’s interim recommendations to support national authorities who may decide on early use of Lagevrio ...
Posted by Michael Wonder on 13 Dec 2021
EMA publishes agenda for 13-16 CHMP meeting
13 December 2021 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 13 Dec 2021
European Commission approves Pfizer's Cibinqo (abrocitinib) for the treatment of adults with moderate to severe atopic dermatitis
10 December 2021 - Cibinqo is a once daily oral treatment with proven efficacy demonstrated in a large scale clinical ...
Posted by Michael Wonder on 13 Dec 2021
International regulators recommend use of remote inspections as complementary tool beyond pandemic
13 December 2021 - Remote inspections have been useful in maintaining regulatory oversight during the COVID-19 pandemic, but cannot fully replace ...
Posted by Michael Wonder on 13 Dec 2021
Janssen EMEA receives conditional marketing authorisation for Rybrevant (amivantamab), the first treatment approved for patients with advanced non-small-cell lung cancer with EGFR exon 20 insertion mutations
10 December 2021 - Janssen EMEA receives conditional marketing authorisation for Rybrevant (amivantamab), the first treatment approved for patients with advanced ...