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RSS FeedPosted by Michael Wonder on 27 Jul 2020
Checkmate Pharmaceuticals granted FDA fast track designation for CMP-001 combined with PD-1 blockade in the treatment of certain types of metastatic or unresectable melanoma
27 July 2020 - Checkmate Pharmaceuticals today announced that the U.S. FDA granted fast track designation to its product candidate, ...
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
Breztri Aerosphere approved in the US for the maintenance treatment of COPD
24 July 2020 - Approval based on Phase III ETHOS trial which showed a statistically significant reduction in the rate of ...
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
FDA approves first cell-based gene therapy for adult patients with relapsed or refractory mantle cell lymphoma
24 July 2020 - Today, the U.S. Food and Drug Administration approved Tecartus (brexucabtagene autoleucel), a cell-based gene therapy for treatment ...
Posted by Michael Wonder on 24 Jul 2020
Sarepta Therapeutics receives fast track designation for SRP-9001 micro-dystrophin gene therapy for the treatment of Duchenne muscular dystrophy
24 July 2020 - Sarepta Therapeutics today announced that the U.S. FDA has granted fast track designation to SRP-9001 (AAVrh74.MHCK7.micro-dystrophin). ...
Posted by Michael Wonder on 24 Jul 2020
FDA grants fast track designation for Hanmi LAPS triple agonist
22 July 2020 - Hanmi Pharmaceutical announced on July 16th that its LAPS Triple Agonist (HM15211), an innovative new drug for ...
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. ...