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RSS FeedPosted by Michael Wonder on 28 Feb 2022
Astellas and Seagen announce CHMP confirms positive opinion for Padcev (enfortumab vedotin) in locally advanced or metastatic urothelial cancer
28 February 2022 - Astellas Pharma and Seagen today announced that the CHMP of the EMA has confirmed its previously ...
Posted by Michael Wonder on 28 Feb 2022
Bristol Myers Squibb receives positive CHMP opinion for Opdivo (nivolumab) plus chemotherapy for first-line treatment of patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%
25 February 2022 - Recommendation based on positive results from the Phase 3 CheckMate -648 trial, in which the combination demonstrated ...
Posted by Michael Wonder on 28 Feb 2022
Bristol Myers Squibb receives positive CHMP opinion recommending approval for Opdivo (nivolumab) plus Yervoy (ipilimumab) for first-line treatment of patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma
25 February 2022 - Recommendation based on results from the Phase 3 CheckMate -648 trial, in which the immunotherapy combination demonstrated ...
Posted by Michael Wonder on 28 Feb 2022
Bristol Myers Squibb receives positive CHMP opinion recommending approval for Opdivo (nivolumab) as adjuvant treatment for patients with radically resected, high-risk muscle-invasive urothelial carcinoma with tumour cell PD-L1 expression ≥1%
25 February 2022 - Recommendation based on results from the Phase 3 CheckMate-274 trial, in which Opdivo significantly reduced patients’ risk ...
Posted by Michael Wonder on 28 Feb 2022
Biohaven and Pfizer receive positive CHMP opinion for migraine treatment
25 February 2022 - Biohaven Pharmaceutical and Pfizer today announced that the CHMP of the EMA adopted a positive opinion for ...
Posted by Michael Wonder on 26 Feb 2022
Highlights from CHMP 21-24 February 2022 meeting
25 February 2022 - EMA’s CHMP recommended thirteen medicines for approval at its February 2022 meeting. ...
Posted by Michael Wonder on 25 Feb 2022
New medicine for rare type of eye cancer
25 February 2022 - EMA has recommended granting a marketing authorisation in the European Union (EU) for Kimmtrak (tebentafusp), a monotherapy ...
Posted by Michael Wonder on 15 Feb 2022
Human medicines: highlights of 2021
15 February 2022 - In 2021, EMA recommended 92 medicines for marketing authorisation. Of these, 53 had a new active substance ...
Posted by Michael Wonder on 31 Jan 2022
CHMP recommends approval of Dupixent (dupilumab) for children aged 6 to 11 years with severe asthma with type 2 inflammation
31 January 2022 - Recommendation based on pivotal trial that showed Dupixent significantly reduced severe asthma attacks and improved lung function ...
Posted by Michael Wonder on 30 Jan 2022
Blueprint Medicines' Ayvakyt (avapritinib) receives positive CHMP opinion for the treatment of adults with advanced systemic mastocytosis
28 January 2022 - Positive opinion based on results from two clinical trials that comprise the largest clinical trial dataset in ...
Posted by Michael Wonder on 30 Jan 2022
CHMP issues positive opinion to expand Jardiance (empagliflozin) indication based on unprecedented benefit in adult heart failure patients with preserved ejection fraction
28 January 2022 - The positive opinion is based on the landmark EMPEROR-Preserved Phase 3 trial, which showed significant outcomes in ...
Posted by Michael Wonder on 28 Jan 2022
Highlights from CHMP 24-27 January 2022 meeting
28 January 2022 - EMA’s CHMP recommended seven medicines for approval at its January 2022 meeting. ...
Posted by Michael Wonder on 24 Jan 2022
EMA publishes agenda for 24-27 Jan CHMP meeting
23 January 2022 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 20 Dec 2021
EMA adopts a positive CHMP opinion for Pfizer’s and OPKO’s somatrogon, a long-acting treatment for paediatric growth hormone deficiency
17 December 2021 - If approved by the European Commission, somatrogon will offer children and adolescents living with growth hormone ...
Posted by Michael Wonder on 20 Dec 2021
Saphnelo recommended for approval in the EU by CHMP for the treatment of patients with systemic lupus erythematosus
20 December 2021 - Saphnelo is a first-in-class type I interferon receptor antibody shown to reduce overall disease activity in ...