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RSS FeedPosted by Michael Wonder on 28 Jun 2021
Success rate for marketing authorisation applications from SMEs doubles between 2016 and 2020
28 June 2021 - EMA has published today a report highlighting the Agency’s support for micro, small and medium sized ...
Posted by Michael Wonder on 28 Jun 2021
UCB receives positive CHMP opinion recommending approval of Bimzelx (bimekizumab) in the EU for the treatment of adults with moderate to severe plaque psoriasis
25 June 2021 - The positive CHMP opinion is supported by data from three Phase 3 trials where bimekizumab demonstrated superior ...
Posted by Michael Wonder on 28 Jun 2021
Incyte and MorphoSys announce positive CHMP opinion for tafasitamab in combination with lenalidomide for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma
25 June 2021 - The positive opinion from the CHMP is based on data from the Phase 2 L-MIND study evaluating ...
Posted by Michael Wonder on 28 Jun 2021
Astellas receives positive CHMP opinion for Evrenzo (roxadustat) for adult patients with symptomatic anaemia of chronic kidney disease
25 June 2021 - Astellas Pharma today announced the CHMP of the EMA has adopted a positive opinion relating to the ...
Posted by Michael Wonder on 28 Jun 2021
Forxiga recommended for approval in the EU by CHMP for the treatment of patients with chronic kidney disease
26 June 2021 - If approved, Forxiga has the potential to change the treatment paradigm for millions of people in ...
Posted by Michael Wonder on 28 Jun 2021
Bristol Myers Squibb receives positive CHMP opinion for Opdivo (nivolumab) as adjuvant treatment for oesophageal or gastro-oesophageal junction cancer patients with residual pathologic disease following chemoradiotherapy
25 June 2021 - Recommendation based on positive results from the Phase 3 CheckMate -577 trial in which Opdivo doubled disease-free ...
Posted by Michael Wonder on 28 Jun 2021
Libtayo (cemiplimab) approved by the European Commission as the first immunotherapy indicated for patients with advanced basal cell carcinoma
25 June 2021 - Approval based on data from the largest trial to date in patients with advanced basal cell carcinoma ...
Posted by Michael Wonder on 28 Jun 2021
Libtayo (cemiplimab) approved by the European Commission for first-line treatment of patients with advanced non-small cell lung cancer with ≥50% PD-L1 expression
25 June 2021 - Approval based on a Phase 3 trial demonstrating Libtayo significantly improved overall survival compared to chemotherapy in ...
Posted by Michael Wonder on 27 Jun 2021
BioMarin receives positive CHMP opinion in Europe for vosoritide for the treatment of children with achondroplasia from age 2 until growth plates close
25 June 2021 - Temporary Authorization for Use (ATU) granted in France to allow access and reimbursement of vosoritide to begin ...
Posted by Michael Wonder on 27 Jun 2021
Samsung Bioepis and Biogen receive positive CHMP opinion for ranibizumab biosimilar, Byooviz
25 June 2021 - Samsung Bioepis and Biogen today announced that the EMA's CHMP has adopted a positive opinion for Byooviz, ...
Posted by Michael Wonder on 27 Jun 2021
Highlights from 21-24 June CHMP meeting
25 June 2021 - EMA’s CHMP recommended eight medicines for approval at its June 2021 meeting. ...
Posted by Michael Wonder on 26 Jun 2021
CHMP recommends approval of Rinvoq (upadacitinib) for the treatment of atopic dermatitis
25 June 2021 - Positive opinion based on three global Phase 3 pivotal clinical trials evaluating the safety and efficacy of ...
Posted by Michael Wonder on 23 Jun 2021
Genmab announces that Janssen has received European marketing authorisations for Darzalex (daratumumab) subcutaneous formulation, including for the treatment of patients with newly diagnosed light-chain amyloidosis
22 June 2021 - Janssen received European approval for Darzalex SC (daratumumab and hyaluronidase-fihj) in combination with bortezomib, cyclophosphamide and dexamethasone ...
Posted by Michael Wonder on 23 Jun 2021
LEO Pharma announces European Commission approval of Adtralza (tralokinumab) as the first and only treatment specifically targeting IL-13 for adults with moderate-to-severe atopic dermatitis
22 June 2021 - The European Commission regulatory approval is primarily supported by data from the ECZTRA 1, 2 and ECZTRA ...
Posted by Michael Wonder on 22 Jun 2021
Koselugo approved in the EU for children with neurofibromatosis type 1 and plexiform neurofibromas
22 June 2021 - First medicine approved in the EU to treat this rare and debilitating genetic condition. ...