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RSS FeedPosted by Michael Wonder on 21 Sep 2021
Lilly announces procurement agreement with European Commission to supply bamlanivimab and etesevimab together for the treatment of confirmed COVID-19
21 September 2021 - Joint Procurement Agreement enables European countries to purchase bamlanivimab and etesevimab directly from Lilly, in varying ...
Posted by Michael Wonder on 21 Sep 2021
EU-HTA regulation: methodical preparations for implementation start with IQWiG and G-BA
21 September 2021 - The institute and the G-BA are part of a consortium that is developing the methodological basis ...
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. ...
Posted by Michael Wonder on 19 Sep 2021
GSK receives CHMP positive opinions recommending approval of Nucala (mepolizumab) in three additional eosinophil driven diseases
17 September 2021 - If approved in Europe, mepolizumab would be the only treatment indicated for use in four eosinophil-driven diseases. ...
Posted by Michael Wonder on 19 Sep 2021
Merck receives positive EU CHMP opinion for Keytruda (pembrolizumab) in combination with chemotherapy for certain patients with locally recurrent unresectable or metastatic triple negative breast cancer whose tumours express PD-L1 (CPS ≥10)
17 September 2021 - Recommendation based on data from Phase 3 KEYNOTE-355 trial. ...
Posted by Michael Wonder on 19 Sep 2021
BeiGene receives positive CHMP opinion for Brukinsa (zanubrutinib) for the treatment of adults with Waldenström’s macroglobulinaemia
17 September 2021 - The CHMP recommendation is based on results from the Phase 3 ASPEN trial, in which BRUKINSA ...
Posted by Michael Wonder on 18 Sep 2021
Roche receives positive CHMP opinion for Gavreto (pralsetinib) for the treatment of adults with RET fusion positive advanced non-small-cell lung cancer
17 September 2021 - If approved, Gavreto will be the first and only targeted treatment approved by the EMA that ...
Posted by Michael Wonder on 18 Sep 2021
Alvotech welcomes positive CHMP opinion for AVT02, a proposed biosimilar to Humira
17 September 2021 - Alvotech today welcomed the positive opinion of the EMA's CHMP recommending the approval of Alvotech‘s high-concentration AVT02 ...
Posted by Michael Wonder on 16 Sep 2021
AbbVie submits regulatory applications to FDA and EMA for upadacitinib (Rinvoq) for the treatment of adults with moderately to severely active ulcerative colitis
16 September 2021 - AbbVie today announced that it has submitted applications seeking approval for upadacitinib (15 mg and 30 mg ...
Posted by Michael Wonder on 15 Sep 2021
FDA, EMA launch complex generic, hybrid product advice pilot
15 September 2021 - The US FDA and the EMA on Wednesday launched a new pilot aimed at giving parallel ...
Posted by Michael Wonder on 14 Sep 2021
EMA study reveals need for RWE framework, submission structure
14 September 2021 - The EMA has identified a need for more consistency in how real world evidence is submitted. ...
Posted by Michael Wonder on 14 Sep 2021
Alnylam submits marketing authorisation application to the European Medicines Agency for investigational vutrisiran for the treatment of hereditary ATTR amyloidosis with polyneuropathy
13 September 2021 - If approved, vutrisiran will provide a new, subcutaneously administered, once quarterly treatment option for patients with hATTR ...
Posted by Michael Wonder on 14 Sep 2021
Mirum Pharmaceuticals submits European marketing authorisation application for maralixibat in Alagille syndrome supported by new positive results from natural history study comparison
13 September 2021 - Natural history analysis shows significant improvement in event-free survival and transplant-free survival. ...
Posted by Michael Wonder on 13 Sep 2021
EMA publishes agenda for 13-16 September CHMP meeting
13 September 2021 - The EMA has published a draft agenda for this week's CHMP meeting. ...