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RSS FeedPosted by Michael Wonder on 31 Jul 2020
Global regulatory workshop on COVID-19 real-world evidence and observational studies
31 July 2020 - Vaccines surveillance and vigilance, collaboration on pregnancy studies and building international patient cohorts were the main ...
Posted by Michael Wonder on 31 Jul 2020
Global regulatory workshop on COVID-19 therapeutics #2: agreement on acceptable outcomes for clinical trials
31 July 2020 - International regulators have published a report today on the acceptability of various primary outcomes in the ...
Posted by Michael Wonder on 30 Jul 2020
Imago BioSciences granted access by European Medicines Agency to PRIME scheme for IMG-7289 (bomedemstat) in myelofibrosis
30 July 2020 - Access granted on positive primary analysis of the ongoing Phase 2 trial to evaluate the safety and ...
Posted by Michael Wonder on 30 Jul 2020
Marinus Pharmaceuticals receives rare paediatric disease designation from FDA for ganaxolone for the treatment of CDKL5 deficiency disorder
30 July 2020 - Marinus Pharmaceuticals announced today that the U.S. FDA has granted rare paediatric disease designation for the ...
Posted by Michael Wonder on 30 Jul 2020
Takeda announces U.S. FDA breakthrough therapy designation granted for pevonedistat for the treatment of patients with higher-risk myelodysplastic syndromes
30 July 2020 - Designation based on Phase 2 data and reinforces significant treatment need for higher-risk myelodysplastic syndrome. ...
Posted by Michael Wonder on 30 Jul 2020
FDA approves Genentech’s Tecentriq plus Cotellic and Zelboraf for people with advanced melanoma
30 July 2020 - Genentech today announced that the U.S. FDA approved Tecentriq (atezolizumab) plus Cotellic (cobimetinib) and Zelboraf (vemurafenib) ...
Posted by Michael Wonder on 30 Jul 2020
Merck announces two US regulatory milestones for Keytruda (pembrolizumab) in triple-negative breast cancer
30 July 2020 - FDA grants priority review to supplemental biologics license application for Keytruda plus chemotherapy for the treatment of ...
Posted by Michael Wonder on 30 Jul 2020
Eton Pharmaceuticals submits new drug application to the FDA for zonisamide oral suspension (ET-104)
30 July 2020 - Application is Eton’s sixth drug application under FDA review. ...
Posted by Michael Wonder on 30 Jul 2020
Pathological complete response in neo-adjuvant treatment of high-risk early-stage breast cancer: use as an endpoint to support accelerated approval
29 July 2020 - This guidance is intended to assist sponsors in designing trials to support marketing approval of medicines and ...
Posted by Michael Wonder on 30 Jul 2020
Henlius and Accord Healthcare receive EMA approval for Zercepac, trastuzumab biosimilar
29 July 2020 - The European Commission has approved Shanghai Henlius Biotech and Accord Healthcare's Zercepac, a biosimilar trastuzumab, for ...
Posted by Michael Wonder on 30 Jul 2020
Health Canada Approves Brivlera (brivaracetam) to treat partial-onset seizures in paediatric epilepsy patients
29 July 2020 - Health Canada's approval of Brivlera provides paediatric epilepsy patients with a treatment option which can be initiated ...
Posted by Michael Wonder on 30 Jul 2020
FDA nears decision authorising COVID-19 treatment with convalescent plasma
29 July 2020 - Antibody-rich blood plasma would be one of the first coronavirus treatments to receive approval, which could pave ...
Posted by Michael Wonder on 29 Jul 2020
FDA grants breakthrough therapy designation to Merck’s novel HIF-2α inhibitor MK-6482 for treatment of certain patients with von Hippel-Lindau disease-associated renal cell carcinoma
29 July 2020 - Reinforces important progress in Merck’s oncology pipeline to advance novel therapeutic candidates. ...
Posted by Michael Wonder on 29 Jul 2020
Ridgeback Biotherapeutics announces priority review of biologics license application for ansuvimab Ebola treatment
29 July 2020 - Ridgeback Biotherapeutics today announced the U.S. FDA has accepted the biologics license application and granted priority ...
Posted by Michael Wonder on 29 Jul 2020
Novartis receives Piqray approval in Europe – the first and only targeted medicine for HR+/HER2- advanced breast cancer with a PIK3CA mutation
29 July 2020 - Approval based on SOLAR-1 Phase III trial showing Piqray plus fulvestrant nearly doubled median PFS (11.0 vs. ...