Blog
RSS FeedPosted 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
TGA approves new medicine for basal cell carcinoma
29 July 2020 - Cemiplimab (Libtayo) has been provisionally registered by the TGA. ...
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
Nabriva receives European approval for Xenleta (lefamulin) for treatment of community-acquired pneumonia
28 July 2020 - Xenleta represents the first new antibiotic class approved for patients with CAP in Europe in nearly 20 ...
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
Health Canada grants marketing authorisation with conditions for Gilead's Veklury (remdesivir) for the treatment of coronavirus disease 2019 (COVID-19)
28 July 2020 - Veklury is the first approved treatment option for COVID-19 in Canada. ...
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
Janssen receives CHMP positive opinion for expanded use of Imbruvica (ibrutinib) in combination with rituximab for previously untreated patients with chronic lymphocytic leukaemia
24 July 2020 - Positive opinion is supported by Phase 3 E1912 study evaluating ibrutinib-rituximab combination versus chemo-immunotherapy in first-line treatment ...
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 ...
Posted by Michael Wonder on 28 Jul 2020
Foresee Pharmaceuticals announces submission of NDA for FDA approval of LMIS 50 mg
27 July 2020 - Foresee Pharmaceuticals announced today that it has submitted to the U.S. FDA a new drug application ...