Blog
RSS FeedPosted by Michael Wonder on 30 Oct 2021
FDA approves Novartis Scemblix (asciminib) with novel mechanism of action for the treatment of chronic myeloid leukemia
29 October 2021 - Scemblix provides much-needed and long-awaited new option for patients with chronic myeloid leukaemia who suffer with intolerance ...
Posted by Michael Wonder on 29 Oct 2021
Kite's Tecartus (brexucabtagene autoleucel) authorised by Health Canada for the treatment of relapsed or refractory mantle cell lymphoma
28 October 2021 - Tecartus is first CAR T therapy in mantle cell lymphoma and Kite becomes the first company ...
Posted by Michael Wonder on 29 Oct 2021
Incyte announces the validation of the European marketing authorisation application for ruxolitinib cream in vitiligo
28 October 2021 - The marketing authorisation application seeks approval of ruxolitinib cream for the treatment of adolescent and adult patients ...
Posted by Michael Wonder on 29 Oct 2021
Reata Pharmaceuticals submits marketing authorisation application to the EMA for bardoxolone methyl in chronic kidney disease caused by Alport syndrome
28 October 2021 - Reata Pharmaceuticals today announced its submission of a marketing authorisation application for bardoxolone methyl to the ...
Posted by Michael Wonder on 29 Oct 2021
CytoDyn announces FDA accepts revised rolling review timeline for resubmission of its BLA
28 October 2021 - Management expects the non-clinical and CMC sections of the BLA to be resubmitted to FDA in ...
Posted by Michael Wonder on 28 Oct 2021
FDA acknowledges hurdles in utilising real world data
28 October 2021 - FDA is seeking to address the added complexities for incorporating real-world data and real-world evidence into ...
Posted by Michael Wonder on 28 Oct 2021
Spero Therapeutics submits new drug application to U.S. FDA for tebipenem hydrobromide for the treatment of complicated urinary tract infections including pyelonephritis
28 October 2021 - Spero Therapeutics today announced the submission of a new drug application to the U.S. FDA, seeking approval ...
Posted by Michael Wonder on 28 Oct 2021
EMA nod for excessive daytime sleepiness med Ozawade
28 October 2021 - The EMA has approved Bioprojet’s Ozawade (pitolisant) for the treatment of excessive daytime sleepiness associated with ...
Posted by Michael Wonder on 28 Oct 2021
Repurposing of authorised medicines: pilot to support not for profit organisations and academia
28 October 2021 - EMA and the Heads of Medicines Agencies are launching a pilot project to support the repurposing ...
Posted by Michael Wonder on 28 Oct 2021
Booster doses of COVID-19 vaccines recommended for people aged 18 and over
28 October 2021 - The Australian Technical Advisory Group on Immunisation (ATAGI) have recommended a booster dose of COVID-19 vaccine for ...
Posted by Michael Wonder on 28 Oct 2021
Breakthrough Ortek-ECD technology enables dentists to detect cavities often not seen by X-rays
26 October 2021 - Ortek announced today the widespread availability of its ECD device, which provides dental professionals a new diagnostic ...
Posted by Michael Wonder on 28 Oct 2021
Be careful who you sue: CytoDyn knowingly submitted an incomplete drug application to FDA, new documents show
28 October 2021 - CytoDyn and its CEO Nader Pourhassan have known the company’s long delayed HIV drug was in ...
Posted by Michael Wonder on 28 Oct 2021
COVID-19 vaccine weekly safety report (28 October 2021)
28 October 2021 - To 24 October, the TGA has received 235 reports which have been assessed as likely to be ...
Posted by Michael Wonder on 27 Oct 2021
Moderna announces Swissmedic authorises booster dose of Moderna’s COVID-19 vaccine
26 October 2021 - Authorisation granted for particularly vulnerable individuals 12 years of age and older. ...
Posted by Michael Wonder on 27 Oct 2021
FDA collaborates with Health Canada and UK’s MHRA to foster good machine learning practice
27 October 2021 - Today, the U.S. FDA, Health Canada and the United Kingdom’s MHRA jointly issued the “Good Machine Learning ...