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 ...

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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 ...

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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. ...

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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. ...

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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. ...

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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 ...

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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 ...

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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 ...

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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 ...

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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. ...

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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 ...

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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. ...

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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. ...

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EMA evaluating data on booster dose of COVID-19 vaccine Comirnaty

6 September 2021 - EMA has started evaluating an application for the use of a booster dose of Comirnaty to be ...

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Moderna announces submission of data to European Medicines Agency for its COVID-19 vaccine booster

3 September 2021 - mRNA-1273 at 50 µg dose level induced robust antibody responses of more than 40 times against ...

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