Blog
RSS FeedPosted by Michael Wonder on 01 Jul 2024
Lynparza and Imfinzi combination recommended for approval in the EU by CHMP for patients with mismatch repair proficient advanced or recurrent endometrial cancer
1 July 2024 - Recommendation based on DUO-E Phase 3 results, which showed both regimens demonstrated statistically significant and clinically ...
Posted by Michael Wonder on 30 Jun 2024
Roche’s Vabysmo gets CHMP recommendation for third indication retinal vein occlusion
28 June 2024 - Positive recommendation is based on two Phase 3 studies. In addition to robust retinal drying with Vabysmo, ...
Posted by Michael Wonder on 29 Jun 2024
Highlights from the 24-27 June 2024 CHMP meeting
28 June 2024 - The EMA’s CHMP recommended ten medicines for approval at its June 2024 meeting. ...
Posted by Michael Wonder on 28 Jun 2024
Odronextamab recommended for EU approval by the CHMP to treat relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma
28 June 2024 - Recommendation based on data from the Phase 1 and pivotal Phase 2 trials demonstrating robust and ...
Posted by Michael Wonder on 28 Jun 2024
Pfizer and BioNTech receive positive CHMP opinion for omicron JN.1 adapted COVID-19 Vaccine in the European Union
27 June 2024 - The updated COVID-19 vaccine is tailored to the Omicron JN.1 lineage of SARS-CoV-2 and is recommended for ...
Posted by Michael Wonder on 28 Jun 2024
AbbVie receives positive CHMP opinion for epcoritamab (Tepkinly) for the treatment of adults with relapsed/refractory follicular lymphoma
28 June 2024 - Positive CHMP opinion based on results from the Phase 1/2 EPCORE NHL-1 study. ...
Posted by Michael Wonder on 26 Jun 2024
Tofidence (tocilizumab), a biosimilar referencing RoActemra, approved in the European Union
24 June 2024 - Tofidence complements existing portfolio of immunology biosimilars commercialised by Biogen ...
Posted by Michael Wonder on 25 Jun 2024
Roche’s Ocrevus subcutaneous administration approved by European Commission, as first and only twice-a-year injection for relapsing and primary progressive multiple sclerosis
25 June 2024 - Roche is working closely with national health systems in Europe to ensure people with multiple sclerosis ...
Posted by Michael Wonder on 22 Jun 2024
Takeda receives approval from European Commission for Fruzaqla in previously treated metastatic colorectal cancer
21 June 2024 - Approval based on results from positive, global, Phase 3 FRESCO-2 trial. ...
Posted by Michael Wonder on 20 Jun 2024
Truqap plus Faslodex approved in the EU for patients with advanced oestrogen receptor positive breast cancer
20 June 2024 - Approval based on CAPItello-291 results which showed this combination reduced the risk of disease progression or ...
Posted by Michael Wonder on 19 Jun 2024
European Commission grants Sobi marketing authorisation for Altuvoct for treatment of haemophilia A
19 June 2024 - Sobi today announced the European Commission has granted marketing authorisation for Altuvoct's (efanesoctocog alfa), for the ...
Posted by Michael Wonder on 10 Jun 2024
European Commission approves Roche’s Alecensa as the first and only targeted adjuvant treatment for people with ALK positive early-stage lung cance
10 June 2024 - Alecensa reduced the risk of disease recurrence or death by an unprecedented 76% in people with ALK ...
Posted by Michael Wonder on 04 Jun 2024
CStone announces European Medicine Agency CHMP recommends approval of Cejemly (sugemalimab, anti-PD-L1) as first-line treatment for NSCLC
1 June 2024 - EMA CHMP recommendation is based on the results of a Phase 3 clinical trial (GEMSTONE-302) demonstrating significant ...
Posted by Michael Wonder on 03 Jun 2024
Biogen receives European Commission approval for Qalsody (tofersen), the first therapy to treat a rare, genetic form of ALS
30 May 2024 - Qalsody is Biogen’s third rare disease therapy to be approved in the EU, demonstrating the company’s commitment ...
Posted by Michael Wonder on 03 Jun 2024
Tagrisso with the addition of chemotherapy recommended for approval in the EU by CHMP for patients with EGFR mutated advanced lung cancer
3 June 2024 - Recommendation based on FLAURA2 results which showed Tagrisso plus chemotherapy extended median progression-free survival by nearly ...