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RSS FeedPosted by Michael Wonder on 12 Dec 2021
FDA approves NGS based companion diagnostic for EGFR exon20 insertion mutant non-small-cell lung cancer tumour tissue
9 December 2021 - Oncomine Dx Target Test now approved for 12 NSCLC targeted therapies globally. ...
Posted by Michael Wonder on 12 Dec 2021
Australian Technical Advisory Group on Immunisation recommendations on the use of Spikevax (Moderna) as a COVID-19 booster vaccine
12 December 2021 - Spikevax (Moderna), also referred to as the Moderna COVID-19 vaccine, has been provisionally approved for use as ...
Posted by Michael Wonder on 12 Dec 2021
ATAGI statement on the Omicron variant and timing of COVID-19 booster vaccination
12 December 2021 - The COVID-19 vaccines used in Australia are critical in protecting against COVID-19 due to all variants, including ...
Posted by Michael Wonder on 10 Dec 2021
Cytokinetics announces receipt of breakthrough therapy designation from FDA for aficamten
9 December 2021 - FDA granted designation for the treatment of symptomatic obstructive hypertrophic cardiomyopathy Based on results of REDWOOD-HCM. ...
Posted by Michael Wonder on 10 Dec 2021
International regulators stress continued need for COVID-19 therapeutics
11 December 2021 - EMA has endorsed a statement by the International Coalition of Medicines Regulatory Authorities that urges all ...
Posted by Michael Wonder on 10 Dec 2021
VBI Vaccines announces filing of new drug submission for 3 antigen hepatitis B vaccine to Health Canada
9 December 2021 - VBI Vaccines today announced the filing of a new drug submission to Health Canada for the Company’s ...
Posted by Michael Wonder on 10 Dec 2021
Intercept announces withdrawal of EMA marketing authorisation application for obeticholic acid for advanced liver fibrosis due to NASH
9 December 2021 - Intercept Pharmaceuticals today announced that it has formally notified the EMA of its decision to withdraw ...
Posted by Michael Wonder on 09 Dec 2021
FDA issues draft guidance for industry, considerations for the use of real world data and real world evidence to support regulatory decision-making for drugs and biological products
9 December 2021 - The U.S. FDA issued a draft guidance for industry titled Considerations for the Use of Real-World Data ...
Posted by Michael Wonder on 09 Dec 2021
FDA expands eligibility for Pfizer-BioNTech COVID-19 booster dose to 16 and 17 year olds
9 December 2021 - Today, the U.S. FDA amended the emergency use authorisation for the Pfizer-BioNTech COVID-19 Vaccine, authorising the use ...
Posted by Michael Wonder on 09 Dec 2021
Consensus lacking on ‘value’ for new anti-cancer drugs
8 December 2021 - The high price tag of new anticancer drugs has fuelled debate about the value of these treatments, ...
Posted by Michael Wonder on 09 Dec 2021
Heron Therapeutics announces FDA approval of a significant indication expansion for Zynrelef
9 December 2021 - Approval provides a significantly broader indication for Zynrelef, now covering approximately 7 million procedures a year. ...
Posted by Michael Wonder on 09 Dec 2021
Canada's national strategy for drugs for rare diseases needs a holistic approach
8 December 2021 - International report summarises drugs for rare disease best practices and recommendations. ...
Posted by Michael Wonder on 09 Dec 2021
COVID-19 vaccine weekly safety report (9 December 2021)
9 December 2021 - To 5 December 2021, the TGA has received 389 reports which have been assessed as likely to ...
Posted by Michael Wonder on 09 Dec 2021
FDA authorises new long-acting monoclonal antibodies for pre-exposure prevention of COVID-19 in certain individuals
8 December 2021 - Today, the U.S. FDA issued an emergency use authorization for AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab and ...
Posted by Michael Wonder on 08 Dec 2021
FoundationOne CDx receives FDA approval as a companion diagnostic for BRAF inhibitor therapeutics in melanoma
8 December 2021 - Foundation Medicine’s tissue-based test is the first and only comprehensive genomic profiling test to be approved as ...