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RSS FeedPosted by Michael Wonder on 15 Mar 2023
EMA-FDA parallel scientific advice program has ‘limited’ uptake
14 March 2023 - A review of the last five years of the parallel scientific advice program between the FDA ...
Posted by Michael Wonder on 08 Mar 2023
Genethon given PRIME status by EMA for gene therapy to treat Crigler-Najjar syndrome, a rare liver disease
7 March 2023 - Genethon today announced that the EMA has granted PRIME (Priority Medicines) status to the gene therapy, ...
Posted by Michael Wonder on 08 Mar 2023
In Amsterdam, EU drugs regulator doesn’t want brothel moving in next door
7 March 2023 - Sex and drugs don’t mix, argues the EMA. ...
Posted by Michael Wonder on 06 Mar 2023
Bristol Myers Squibb receives European Commission approval of Reblozyl (luspatercept) for anaemia in adult patients with non-transfusion-dependent beta thalassaemia
3 March 2023 - Third authorised indication in Europe for Reblozyl, a first in class treatment for patients with diseases ...
Posted by Michael Wonder on 05 Mar 2023
Replacing RCTs with real world data for regulatory decision-making: a self-fulfilling prophecy?
2 March 2023 - Real world data are advocated as an alternative approach to randomised clinical trials for closing knowledge gaps ...
Posted by Michael Wonder on 03 Mar 2023
Nubeqa (darolutamide) receives EU approval for additional indication in prostate cancer
1 March 2023 - Approval is based on Phase 3 ARASENS trial data. ...
Posted by Michael Wonder on 28 Feb 2023
US FDA accepts Bristol Myers Squibb’s supplemental biologics license application and EMA validates application for Opdivo (nivolumab) as an adjuvant treatment for patients with completely resected stage IIB or IIC melanoma
28 February 2023 - The applications are based on results from the Phase 3 CheckMate-76K trial, in which Opdivo demonstrated a ...
Posted by Michael Wonder on 27 Feb 2023
EMA pilots scientific advice for certain high risk medical devices
27 February 2023 - The EMA has launched a pilot to give scientific advice on the intended clinical development strategy ...
Posted by Michael Wonder on 27 Feb 2023
Incyte announces positive CHMP opinion for ruxolitinib cream (Opzelura) for the treatment of non-segmental vitiligo in adults and adolescents
24 February 2023 - The positive CHMP opinion is based on Phase 3 data showing treatment with ruxolitinib cream resulted in ...
Posted by Michael Wonder on 27 Feb 2023
AbbVie receives positive CHMP opinion for upadacitinib (Rinvoq) for the treatment of adults with moderate to severe Crohn's disease
27 February 2023 - The positive CHMP opinion for upadacitinib is based on results from two induction studies and one maintenance ...
Posted by Michael Wonder on 26 Feb 2023
Servier receives a positive CHMP opinion for Tibsovo in IDH1 mutated acute myeloid leukaemia and cholangiocarcinoma patients
24 February 2023 - The positive CHMP opinion is based on clinical data from the AGILE (in AML) and ClarIDHy (in ...
Posted by Michael Wonder on 24 Feb 2023
Highlights from the 20-23 February 2023 CHMP meeting
24 February 2023 - Eight new medicines recommended for approval ...
Posted by Michael Wonder on 24 Feb 2023
Merck and Ridgeback provide update on EU marketing authorisation application for Lagevrio (molnupiravir)
24 February 2023 - Merck and Ridgeback Biotherapeutics today announced that the CHMP of the EMA has recommended the refusal ...
Posted by Michael Wonder on 24 Feb 2023
Libtayo (cemiplimab) in combination with chemotherapy receives positive CHMP opinion for the treatment of advanced PD-L1 positive non-small cell lung cancer
24 February 2023 - Recommendation based on a Phase 3 trial demonstrating superior survival outcomes for Libtayo plus chemotherapy compared to ...
Posted by Michael Wonder on 24 Feb 2023
Chiesi Global Rare Diseases and Protalix BioTherapeutics receive positive CHMP opinion for pegunigalsidase alfa for treatment of Fabry disease
24 February 2023 - European Commission decision anticipated in beginning of May 2023. ...