Blog
RSS FeedPosted 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 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
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
Moderna pitches virus vaccine at about $50-$60 per course
29 July 2020 - Price charged to governments would be higher than that agreed for rival jabs from Pfizer and BioNTech. ...
Posted by Michael Wonder on 29 Jul 2020
Moderna’s mysterious coronavirus vaccine delivery system
29 July 2020 - For a decade, Moderna has been working to develop mRNA technology that could turn the body’s cells ...
Posted by Michael Wonder on 29 Jul 2020
Bristol Myers Squibb and bluebird bio announce submission of biologics license application to FDA for idecabtagene vicleucel (Ide-cel, bb2121) for adults with relapsed and refractory multiple myeloma
29 July 2020 - BLA submission based on results from pivotal Phase 2 KarMMa study evaluating ide-cel in heavily pre-treated patient ...