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RSS FeedPosted by Michael Wonder on 31 Jul 2020
Medicare expands coverage for BRACAnalysis CDx in prostate cancer
31 July 2020 - Myriad Genetics announced today that Medicare has expanded coverage for BRACAnalysis CDx for men with prostate cancer ...
Posted by Michael Wonder on 31 Jul 2020
Weighing the benefits and risks of proliferating observational treatment assessments: observational cacophony, randomised harmony
31 July 2020 - Amid the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic, substantial effort is being directed toward ...
Posted by Michael Wonder on 31 Jul 2020
Sanofi and GSK in advanced discussions with European Union to supply up to 300 million doses of COVID-19 vaccine
31 July 2020 - Both companies are committed to making their COVID-19 vaccine affordable and available globally. ...
Posted by Michael Wonder on 31 Jul 2020
Tagrisso granted breakthrough therapy designation in the US for the adjuvant treatment of patients with Stage IB-IIIA EGFR mutated lung cancer
30 July 2020 - Designation based on unprecedented results from the Phase III ADAURA trial where Tagrisso reduced the risk of ...
Posted by Michael Wonder on 31 Jul 2020
U.S. Food and Drug Administration approves Stelara (ustekinumab) for treatment of paediatric patients with moderate to severe plaque psoriasis
30 July 2020 - Stelara is the first and only biologic to target interleukin (IL)-12 and IL-23 approved for paediatric psoriasis ...
Posted by Michael Wonder on 31 Jul 2020
Sanofi and GSK selected for Operation Warp Speed to supply United States government with 100 million doses of COVID-19 vaccine
31 July 2020 - Promising vaccine candidate selected by U.S. government’s Operation Warp Speed. ...
Posted 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 ...