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RSS FeedPosted 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 ...
Posted by Michael Wonder on 29 Jul 2020
Alzheimer's: 'promising' blood test for early stage of disease
29 July 2020 - A blood test could spot Alzheimer's disease at the earliest stage and years before symptoms appear, ...
Posted by Michael Wonder on 29 Jul 2020
FDA approves Roche’s new VENTANA HER2 Dual ISH test as companion diagnostic to identify breast cancer patients eligible for targeted therapy
29 July 2020 - Developed with enhanced technology, this new assay provides high-quality staining with improved turnaround time. ...
Posted by Michael Wonder on 29 Jul 2020
Protara Therapeutics receives rare paediatric disease designation for TARA-002 for the treatment of lymphatic malformations
28 July 2020 - Protara Therapeutics today announced that the U.S. FDA has granted rare paediatric disease designation for TARA-002 for ...
Posted by Michael Wonder on 29 Jul 2020
BioMed Valley Discoveries’ ulixertinib (BVD-523), a first-in-class ERK inhibitor cancer therapy, receives fast track designation and launches Phase II trial in collaboration with Cmed and Strata Oncology
28 July 2020 - BioMed Valley Discoveries announces the receipt of fast track designation from the US FDA for investigation of ...
Posted by Michael Wonder on 28 Jul 2020
HemoShear Therapeutics receives FDA fast track and rare paediatric disease designations for HST5040 to treat methylmalonic acidaemia and propionic acidaemia
28 July 2020 - HemoShear Therapeutics has received fast track and rare paediatric disease designations from the U.S. FDA for ...
Posted by Michael Wonder on 28 Jul 2020
Momenta Pharmaceuticals announces FDA rare paediatric disease designation for nipocalimab in HDFN
28 July 2020 - Momenta Pharmaceuticals today announced that its novel drug candidate, nipocalimab, has received rare paediatric disease designation ...
Posted by Michael Wonder on 28 Jul 2020
Black Diamond Therapeutics granted fast track designation by the FDA for BDTX-189 for the treatment of adult patients with a solid tumour harbouring an allosteric HER2 mutation or an EGFR or HER2 exon 20 insertion mutation
28 July 2020 - Black Diamond Therapeutics today announced that the U.S. FDA granted fast track designation to BDTX-189 for the ...