Blog
RSS FeedPosted by Michael Wonder on 04 Feb 2020
Seqirus announces U.S. FDA approval of its first-ever adjuvanted, cell-based pandemic influenza A (H5N1) vaccine
3 February 2020 - Seqirus, a global leader in influenza prevention and pandemic response, today announced that the U.S. FDA ...
Posted by Michael Wonder on 04 Feb 2020
Resverlogix receives US FDA breakthrough therapy designation for apabetalone
3 February 2020 - Resverlogix is pleased to announce the U.S. FDA has granted breakthrough therapy designation for apabetalone in combination ...
Posted by Michael Wonder on 04 Feb 2020
Anavex Life Sciences announces fast track designation granted by U.S. FDA for Anavex 2-73 (blarcamesine) clinical development program for the treatment of Rett syndrome
3 February 2020 - Anavex Life Sciences today announced that the U.S. FDA has granted fast track designation for Anavex 2-73 ...
Posted by Michael Wonder on 03 Feb 2020
FDA and FTC announce new efforts to further deter anti-competitive business practices, support competitive market for biological products to help Americans
3 February 2020 - The U.S. Food and Drug Administration and the Federal Trade Commission today signed a joint statement regarding ...
Posted by Michael Wonder on 03 Feb 2020
GSK announces EMA accepted marketing authorisation application for belantamab mafodotin for the treatment of relapsed or refractory multiple myeloma
3 February 2020 - Belantamab mafodotin accepted for accelerated assessment by the EMA’s CHMP. ...
Posted by Michael Wonder on 03 Feb 2020
Pfizer receives positive CHMP opinion for oncology biosimilar, Ruxience (rituximab)
31 January 2020 - Pfizer today announced that the CHMP of the EMA has adopted a positive opinion, recommending marketing ...
Posted by Michael Wonder on 03 Feb 2020
Esperion announces positive CHMP opinion for the marketing authorisation application for bempedoic acid for the treatment of hypercholesterolaemia and mixed dyslipidaemia
31 January 2020 - Positive CHMP opinion is based on the completed pivotal Phase 3 LDL-cholesterol lowering program. ...
Posted by Michael Wonder on 03 Feb 2020
Emergent BioSolutions receives positive CHMP opinion for Vaxchora; anticipates near-term approval by European Medicines Agency
31 January 2020 - Emergent BioSolutions today announced that the CHMP of the EMA adopted a positive opinion for the approval ...
Posted by Michael Wonder on 03 Feb 2020
Bayer receives positive CHMP opinion for darolutamide as a new treatment for men with non-metastatic castration-resistant prostate cancer
31 January 2020 - CHMP opinion is based on Phase III ARAMIS trial data evaluating the efficacy and safety of darolutamide ...
Posted by Michael Wonder on 03 Feb 2020
Alnylam receives positive CHMP opinion for Givlaari (givosiran) for the treatment of acute hepatic porphyria in adults and adolescents
31 January 2020 - Positive opinion is based on data from the pivotal ENVISION Phase 3 study. ...
Posted by Michael Wonder on 03 Feb 2020
AbbVie receives positive CHMP opinion for Venclyxto as a chemotherapy-free combination regimen for patients with previously untreated chronic lymphocytic leukaemia
31 January 2020 - If approved by the European Commission, Venclyxto plus obinutuzumab would be the first chemotherapy-free, combination regimen given ...
Posted by Michael Wonder on 03 Feb 2020
Arrevus Receives FDA qualified infectious disease product designation for the treatment of cystic fibrosis pulmonary exacerbations
28 January 2020 - Arrevus today announced the U.S. FDA has granted qualified infectious disease product designation for ARV-1801 (sodium ...
Posted by Michael Wonder on 02 Feb 2020
Bayer application for nifurtimox to treat paediatric patients with Chagas disease submitted for approval in US
30 January 2020 - Submission based on results of CHICO (CHagas disease In Children treated with NifurtimOx) phase III clinical study ...
Posted by Michael Wonder on 02 Feb 2020
EMA validates Seattle Genetics’ marketing authorisation application for tucatinib for patients with locally advanced or metastatic HER2-positive breast cancer
31 January 2020 - Application Supported by Results of Pivotal HER2CLIMB Trial. ...
Posted by Michael Wonder on 01 Feb 2020
FDA approves first drug for treatment of peanut allergy for children
31 January 2020 - Today the U.S. Food and Drug Administration approved Palforzia [peanut (arachis hypogaea) allergen powder-dnfp] to mitigate allergic ...