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RSS FeedPosted by Michael Wonder on 29 Mar 2022
Novo Nordisk receives FDA approval of higher-dose Ozempic 2 mg providing increased glycemic control for adults with type 2 diabetes
28 March 2022 - Ozempic demonstrated 2.1% blood sugar reduction and also weight loss in adults with type 2 diabetes ...
Posted by Michael Wonder on 29 Mar 2022
Santhera and ReveraGen start rolling NDA submission to the FDA for vamorolone for the treatment of Duchenne muscular dystrophy
29 March 2022 - Santhera Pharmaceuticals and ReveraGen BioPharma announce the initiation of a rolling new drug application submission to the ...
Posted by Michael Wonder on 29 Mar 2022
Consequences of US FDA approval decisions in high-income countries
29 March 2022 - Akhade and colleagues highlight the global consequences of approving cancer medicines on the basis of uncertain evidence ...
Posted by Michael Wonder on 29 Mar 2022
European Medicines Agency commences review of novel gene therapy candidate etranacogene dezaparvovec for people with haemophilia B
29 March 2022 - Marketing authorisation application for etranacogene dezaparvovec will be reviewed under accelerated assessment and has the potential to ...
Posted by Michael Wonder on 29 Mar 2022
Seqirus receives Health Canada approval for expanded age indication of its cell-based quadrivalent influenza vaccine for people as young as six months
28 March 2022 - Seqirus announced today that it has received Health Canada approval of Flucelvax Quad (influenza vaccine), its cell-based ...
Posted by Michael Wonder on 28 Mar 2022
Dupixent (dupilumab injection) now approved in Canada for the treatment of severe asthma in children aged six to 11 years with type 2 inflammation
28 March 2022 - This is the sixth indication for Dupixent in Canada, its second in asthma, and its second in ...
Posted by Michael Wonder on 28 Mar 2022
U.S. FDA approves Fintempla (fenfluramine) oral solution for treatment of seizures associated with Lennox-Gastaut syndrome
28 March 2022 - Approval based on data where fenfluramine demonstrated efficacy in the most difficult to treat seizure types, including ...
Posted by Michael Wonder on 28 Mar 2022
Blueprint Medicines' Ayvakyt (avapritinib) receives European Commission approval for the treatment of adults with advanced systemic mastocytosis
25 March 2022 - Initial commercial launch is planned for Germany immediately following the European Commission approval. ...
Posted by Michael Wonder on 28 Mar 2022
Health Canada grants marketing authorisation for Kalydeco (ivacaftor) for patients with cystic fibrosis between the ages of 4 months and 18 years with the R117H mutation in the CFTR gene
25 March 2022 - CNW/ - Vertex Pharmaceuticals Canada today announced that Health Canada has granted marketing authorisation for the ...
Posted by Michael Wonder on 28 Mar 2022
Evusheld long-acting antibody combination approved in the EU for pre-exposure prophylaxis of COVID-19 in a broad population
28 March 2022 - Evusheld retains neutralising activity against the Omicron BA.2 subvariant, now the dominant strain in Europe ...
Posted by Michael Wonder on 28 Mar 2022
ATAGI update following weekly COVID-19 meeting (23 March 2022)
28 March 2022 - ATAGI have provided recommendations on a winter booster dose of COVID-19 vaccine to increase vaccine protection ...
Posted by Michael Wonder on 28 Mar 2022
2022 seasonal influenza vaccines
25 March 2022 - The Australian Influenza Vaccine Committee has reviewed data related to epidemiology, antigenic and genetic characteristics of recent ...
Posted by Michael Wonder on 25 Mar 2022
Bristol Myers Squibb announces new Prescription Drug User Fee Act goal date for Reblozyl (luspatercept-aamt) supplemental biologics license application
25 March 2022 - Bristol Myers Squibb today announced that the U.S. FDA has extended the review of the supplemental ...
Posted by Michael Wonder on 25 Mar 2022
Highlights from the CHMP 21-24 March 2022 meeting
25 March 2022 - The EMA’s CHMP recommended five medicines for approval at its March 2022 meeting. ...
Posted by Michael Wonder on 25 Mar 2022
Merck receives positive EU CHMP opinion for Keytruda (pembrolizumab) for patients with microsatellite instability-high or mismatch repair deficient tumours in five different types of cancer
25 March 2022 - Recommendation supports use of Keytruda for certain patients with unresectable or metastatic MSI-H/dMMR colorectal, gastric, small ...