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RSS FeedPosted by Michael Wonder on 26 May 2022
Roche’s Polivy combination approved by European Commission for people with previously untreated diffuse large B-cell lymphoma
25 May 2022 - Approval is based on pivotal data from the Phase 3 POLARIX study, where Polivy plus R-CHP significantly ...
Posted by Michael Wonder on 23 May 2022
'EMA's refusal to authorise Herceptin biosimilar unfair'
23 May 2022 - Prestige BioPharma's recent failure to get European approval for its Herceptin biosimilar could have resulted from ...
Posted by Michael Wonder on 23 May 2022
CHMP recommends European Commission approval of upadacitinib (Rinvoq) for the treatment of adults with moderate to severe ulcerative colitis
23 May 2022 - CHMP positive opinion is based on results from three Phase 3 studies: two for induction and one ...
Posted by Michael Wonder on 23 May 2022
Vaxzevria approved in the EU as third dose booster against COVID-19
23 May 2022 - Approval follows CHMP recommendation for use in patients previously vaccinated with Vaxzevria or an EU approved ...
Posted by Michael Wonder on 21 May 2022
PTC Therapeutics receives positive CHMP opinion for Upstaza for the treatment of AADC deficiency
20 May 2022 - First ever gene therapy directly administered into the brain. ...
Posted by Michael Wonder on 21 May 2022
CHMP recommends approval of Xenpozyme (olipudase alfa), the first and only treatment for ASMD
20 May 2022 - Recommendation based on positive results from two clinical trials in which Xenpozyme provided improvement across multiple non-CNS ...
Posted by Michael Wonder on 21 May 2022
Karyopharm and Menarini Group receive positive CHMP opinion for Nexpovio (selinexor) for the treatment of patients with refractory multiple myeloma
20 May 2022 - European Commission decision anticipated within approximately 60 days. ...
Posted by Michael Wonder on 20 May 2022
Novartis Cosentyx (secukinumab) receives positive CHMP opinion for expanded use in childhood arthritic conditions
20 May 2022 - Positive opinion could expand the role of Cosentyx (secukinumab) in reducing flare risk in paediatric enthesitis-related arthritis ...
Posted by Michael Wonder on 20 May 2022
CHMP recommends approval of Lilly and Incyte's Olumiant (baricitinib) as the first and only centrally authorised treatment for adults with severe alopecia areata
20 May 2022 - Eli Lilly and Incyte announced today that the EMA's CHMP has issued a positive opinion for ...
Posted by Michael Wonder on 20 May 2022
Highlights from the 16-19 May 2022 CHMP meeting
20 May 2022 - The EMA’s human medicines committee (CHMP) recommended nine medicines for approval at its May 2022 meeting. ...
Posted by Michael Wonder on 05 May 2022
Novartis receives European Commission approval for Jakavi to be the first post-steroid treatment for acute and chronic graft versus host disease
5 May 2022 - Jakavi is the first JAK1/2 inhibitor available for patients in Europe who previously had no approved therapies ...
Posted by Michael Wonder on 04 May 2022
Novartis Kymriah receives EC approval as first CAR-T cell therapy for adults with relapsed or refractory follicular lymphoma
4 May 2022 - Approval for relapsed or refractory follicular lymphoma is the third indication for Kymriah in the EU ...
Posted by Michael Wonder on 04 May 2022
European Commission approves Cabometyx as a second-line treatment for people living with radioactive iodine-refractory differentiated thyroid cancer
3 May 2022 - Approval based on data from the COSMIC-311 Phase 3 trial, in which Cabometyx (cabozantinib) demonstrated a 78% ...
Posted by Michael Wonder on 03 May 2022
VBI Vaccines announces European Commission marketing authorisation for PreHevbri, a 3 antigen adult hepatitis B vaccine
2 May 2022 - Regulatory review in the United Kingdom is on-going as part of the European Commission Decision Reliance ...
Posted by Michael Wonder on 02 May 2022
Myovant Sciences announces European Commission approval for Orgovyx (relugolix) for the treatment of advanced hormone sensitive prostate cancer
29 April 2022 - Myovant expects to secure European commercialisation partner ahead of anticipated launches. ...