Blog
RSS FeedPosted by Michael Wonder on 04 Feb 2025
CHMP recommends subcutaneous Rybrevant (amivantamab) for the treatment of patients with advanced EGFR mutated non-small cell lung cancer
3 February 2025 - Data from the Phase 3 PALOMA-3 study showed non-inferiority to intravenous administration meeting both co-primary pharmacokinetic endpoints, ...
Posted by Michael Wonder on 04 Feb 2025
Fondazione Telethon submits EU marketing authorisation application for etuvetidigene autotemcel gene therapy for the treatment of Wiskott-Aldrich syndrome
3 February 2025 - Fondazione Telethon announced that it has submitted the marketing authorisation application for the gene therapy - etuvetidigene ...
Posted by Michael Wonder on 04 Feb 2025
Comparison of clinical evidence submitted to the FDA and EMA for cell and gene therapies
3 February 2025 - Harmonisation in regulatory submissions across agencies may support timelier access to innovative treatments, including cell and gene ...
Posted by Michael Wonder on 03 Feb 2025
Imfinzi recommended for approval in the EU by CHMP as first and only immunotherapy for limited-stage small cell lung cancer
3 February 2025 - Recommendation based on ADRIATIC Phase 3 trial results which showed a 27% reduction in the risk ...
Posted by Michael Wonder on 31 Jan 2025
Datopotamab deruxtecan recommended for approval in the EU by CHMP for patients with previously treated metastatic HR positive, HER2 negative breast cancer
31 January 2025 - Recommendation based on TROPION-Breast01 results showing Daiichi Sankyo and AstraZeneca’s datopotamab deruxtecan reduced risk of disease ...
Posted by Michael Wonder on 31 Jan 2025
Bristol Myers Squibb receives positive CHMP opinion for Opdivo (nivolumab) plus Yervoy (ipilimumab) as a first-line treatment option for adult patients with unresectable or advanced hepatocellular carcinoma
31 January 2025 - Recommendation based on results of Phase 3 CheckMate-9DW clinical trial demonstrating statistically significant and clinically meaningful ...
Posted by Michael Wonder on 31 Jan 2025
Bristol Myers Squibb receives positive CHMP opinion for CAR T cell therapy Breyanzi for relapsed or refractory follicular lymphoma
31 January 2025 - Recommendation based on the Phase 2 TRANSCEND FL study in which 97.1% of patients responded to Breyanzi, ...
Posted by Michael Wonder on 31 Jan 2025
Highlights from the 27-30 January 2025 CHMP meeting
31 January 2025 - Eight new medicines recommended for approval; one positive opinion for a medicine intended for use outside the ...
Posted by Michael Wonder on 31 Jan 2025
Rystiggo (rozanolixizumab) for generalised myasthenia gravis receives EU approval for two new administration methods
31 January 2025 - Rystiggo can now be self-administered, or administered by a caregiver, with an infusion pump or manual push ...
Posted by Michael Wonder on 29 Jan 2025
EMA publishes agenda for 27-30 January 2025 CHMP meeting
27 January 2025 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 29 Jan 2025
Depemokimab accepted for review by the EMA for use in asthma with type 2 inflammation and CRSwNP
28 January 2025 - If approved, depemokimab will be the first ultra long-acting biologic with 6 month dosing. ...
Posted by Michael Wonder on 28 Jan 2025
GSK’s Shingrix new pre-filled syringe presentation accepted for review by EMA
27 January 2025 - If approved, the new presentation will offer a convenient administration option to healthcare professionals. ...
Posted by Michael Wonder on 28 Jan 2025
ImmunityBio announces EMA acceptance of marketing authorisation application for Anktiva for the treatment of patients with BCG unresponsive non-muscle invasive bladder cancer carcinoma in situ
27 January 2025 - Submission is based on the on-going QUILT 3.032 study in which 100 patients with Bacillus Calmette-Guérin (BCG)-unresponsive ...
Posted by Michael Wonder on 25 Jan 2025
X4 Pharmaceuticals announces EMA validation of marketing authorisation application for mavorixafor - licenced to Norgine for commercialisation in Europe
24 January 2025 - Following the licensing agreement with X4 Pharmaceuticals, Norgine is pleased to see the announcement from X4 ...
Posted by Michael Wonder on 23 Jan 2025
FDA and EMA accept applications for higher dose regimen of nusinersen in spinal muscular atrophy
23 January 2025 - Applications are based on data from the DEVOTE study, which demonstrate the potential for the investigational higher ...