Blog
RSS FeedPosted by Michael Wonder on 29 Jul 2020
BioMed Valley Discoveries’ ulixertinib (BVD-523), a first-in-class ERK inhibitor cancer therapy, receives fast track designation and launches Phase II trial in collaboration with Cmed and Strata Oncology
28 July 2020 - BioMed Valley Discoveries announces the receipt of fast track designation from the US FDA for investigation of ...
Posted by Michael Wonder on 28 Jul 2020
Janssen receives CHMP positive opinion for expanded use of Imbruvica (ibrutinib) in combination with rituximab for previously untreated patients with chronic lymphocytic leukaemia
24 July 2020 - Positive opinion is supported by Phase 3 E1912 study evaluating ibrutinib-rituximab combination versus chemo-immunotherapy in first-line treatment ...
Posted by Michael Wonder on 28 Jul 2020
European Commission grants marketing authorisation for world’s first subcutaneous formulation of infliximab, Remsima SC, for an additional five indications including for use in inflammatory bowel disease and ankylosing spondylitis
27July 2020 - The EU marketing authorisation is based on pivotal data comparing the pharmacokinetics, efficacy and safety of the intravenous ...
Posted by Michael Wonder on 27 Jul 2020
EU talks with Pfizer, Sanofi, J&J on COVID vaccines hit snags
28 July 2020 - European efforts to secure potential COVID-19 vaccines from Pfizer, Sanofi and Johnson & Johnson are mired in ...
Posted by Michael Wonder on 27 Jul 2020
Insmed receives positive CHMP opinion for Arikayce liposomal 590 mg nebuliser dispersion for the treatment of NTM lung infections caused by MAC in non-CF patients with limited treatment options
24 July 2020 - If approved, Arikayce will be first and only therapy in the European Union for this difficult to ...
Posted by Michael Wonder on 27 Jul 2020
Gilead and Galapagos announce positive European CHMP opinion for Jyseleca (filgotinib) for the treatment of adults with moderate to severe rheumatoid arthritis
24 June 2020 - Clinical development program of filgotinib demonstrated durable efficacy balanced with a consistent safety profile in rheumatoid ...
Posted by Michael Wonder on 27 Jul 2020
Sobi will file for a re-examination of emapalumab in Europe following negative opinion by CHMP
24 July 2020 - Swedish Orphan Biovitrum today announced that the Committee for Medicinal Products for Human use (CHMP) has adopted ...
Posted by Michael Wonder on 27 Jul 2020
Calquence recommended for approval in the EU by CHMP for chronic lymphocytic leukaemia
27 July 2020 - Recommendation based on two Phase III trials demonstrating superior progression-free survival across multiple settings while maintaining ...
Posted by Michael Wonder on 27 Jul 2020
Imfinzi recommended for approval in the EU by CHMP for extensive-stage small cell lung cancer
27 July 2020 - Only PD-1/PD-L1 immunotherapy to demonstrate a significant survival benefit and improved response rate in combination with a ...
Posted by Michael Wonder on 27 Jul 2020
Kyowa Kirin receives positive CHMP opinion for the expanded use of Crysvita (burosumab) to include older adolescents and adults for the treatment of X-linked hypophosphataemia
24 July 2020 - X-linked hypophosphataemia is a rare, life-long genetic disease that causes abnormalities in the bones, muscles and joints. ...
Posted by Michael Wonder on 27 Jul 2020
EMA starts review of dexamethasone for treating adults with COVID-19 requiring respiratory support
24 July 2020 - EMA is reviewing results from the RECOVERY study arm that involved the use of dexamethasone in the ...
Posted by Michael Wonder on 26 Jul 2020
GSK receives positive CHMP opinion recommending approval of belantamab mafodotin for the treatment of relapsed and refractory multiple myeloma
24 July 2020 - GlaxoSmithKline today announced the CHMP of the EMA adopted a positive opinion recommending the approval of belantamab ...
Posted by Michael Wonder on 25 Jul 2020
Novartis Adakveo receives positive CHMP opinion for the prevention of recurrent vaso-occlusive crises in patients with sickle cell disease
24 July 2020 - If approved, Adakveo would be the first targeted sickle cell disease therapy available for use in ...
Posted by Michael Wonder on 24 Jul 2020
Adaptimmune granted access to PRIority MEdicines (PRIME) regulatory support by the European Medicines Agency for ADP-A2M4 for the treatment of synovial sarcoma
23 July 2020 - Adaptimmune Therapeutics today announced that the EMA has granted access to the PRIME initiative to the ...
Posted by Michael Wonder on 24 Jul 2020
BioMarin submits marketing authorisation application to European Medicines Agency for vosoritide to treat children with achondroplasia
23 July 2020 - If approved, vosoritide would be the first medicine to treat Achondroplasia in EU. ...