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RSS FeedPosted by Michael Wonder on 26 Sep 2020
European Commission grants marketing authorisation for Jyseleca (filgotinib) for the treatment of adults with moderate to severe active rheumatoid arthritis
25 September 2020 - Jyseleca demonstrated durable efficacy combined with a consistent safety profile in rheumatoid arthritis through 52 weeks in ...
Posted by Michael Wonder on 25 Sep 2020
CRISPR Therapeutics and Vertex Pharmaceuticals announce Priority Medicines (PRIME) designation granted by the EMA to CTX001 for the treatment of sickle cell disease
24 September 2020 - CRISPR Therapeutics and Vertex Pharmaceuticals today announced the EMA has granted Priority Medicines (PRIME) designation to ...
Posted by Michael Wonder on 24 Sep 2020
bluebird bio’s LentiGlobin for sickle cell disease gene therapy (bb1111) granted priority medicines (PRIME) designation by European Medicines Agency
23 September 2020 - EMA’s PRIME program designed to optimise development and expedite evaluation of innovative medicines for patients with high ...
Posted by Michael Wonder on 24 Sep 2020
Guideline on registry-based studies - launch of public consultation
24 September 2020 - EMA has published its draft Guideline on registry-based studies for a three-month public consultation today. ...
Posted by Michael Wonder on 23 Sep 2020
How incidents with medicines are managed in the EU – a ten year analysis
23 September 2020 - The EU medicines network is supported by a robust regulatory framework with defined processes and clear ...
Posted by Michael Wonder on 23 Sep 2020
Eisai receives positive opinion from EMA's CHMP on use of anti-epileptic agent Fycompa in paediatric patients
23 September 2020 - Eisai announced that it has received a positive opinion from the EMA’s CHMP on the license extension ...
Posted by Michael Wonder on 23 Sep 2020
UCB achieves important regulatory milestone for bimekizumab
22 September 2020 - The U.S. FDA and EMA have accepted marketing application submissions for bimekizumab for the treatment of adults ...
Posted by Michael Wonder on 22 Sep 2020
CHMP recommends approval of MenQuadfi for active immunisation of individuals from the age of 12 months and older against invasive meningococcal ACWY disease
22 September 2020 - Positive opinion based on a large, international clinical program demonstrating a good safety profile and a high ...
Posted by Michael Wonder on 22 Sep 2020
CHMP recommends approval of Supemtek (quadrivalent recombinant influenza vaccine) for the prevention of influenza in adults aged 18 years and older
22 September 2020 - Positive opinion based on clinical data demonstrating safety and efficacy of Supemtek for adults aged 18 and ...
Posted by Michael Wonder on 22 Sep 2020
CHMP grants positive opinion for expanded use of Otsuka’s Deltyba (delamanid) in children and adolescents weighing at least 30 kg treated for pulmonary multi-drug resistant tuberculosis
21 September 2020 - This label extension of Deltyba (delamanid) represents a new treatment option for children and adolescents with pulmonary ...
Posted by Michael Wonder on 21 Sep 2020
Lynparza recommended for approval in the EU by CHMP for BRCA mutated metastatic castration-resistant prostate cancer
21 September 2020 - Only PARP inhibitor to improve overall survival versus new hormonal agent treatments in advanced prostate cancer. ...
Posted by Michael Wonder on 21 Sep 2020
Lynparza recommended for approval in EU by CHMP as first-line maintenance treatment with bevacizumab for HRD positive advanced ovarian cancer
21 September 2020 - Patients treated with Lynparza and bevacizumab lived without disease progression for a median of 37.2 months vs. ...
Posted by Michael Wonder on 21 Sep 2020
Bristol Myers Squibb receives positive CHMP opinion recommending approval of Opdivo (nivolumab) plus Yervoy (ipilimumab) combined with two cycles of chemotherapy as first-line treatment of metastatic non-small cell lung cancer
18 September 2020 - Application based on results from the Phase 3 CheckMate -9LA trial, which showed significantly improved overall survival ...
Posted by Michael Wonder on 20 Sep 2020
Sanofi and GSK will provide up to 300 million doses of COVID-19 vaccine to the European Union
18 September 2020 - Agreement signed today supports scale-up of manufacturing capabilities in several European countries. ...
Posted by Michael Wonder on 20 Sep 2020
Roche receives positive CHMP opinion for Tecentriq in combination with Avastin for the treatment of people with the most common form of liver cancer
18 September 2020 - Recommendation is based on the results of the IMbrave150 study, in which the Tecentriq combination improved overall ...