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RSS FeedPosted by Michael Wonder on 17 Sep 2021
Pfizer-BioNTech COVID-19 vaccine Comirnaty receives full Health Canada approval for individuals 12 years and older
16 September 2021 - Health Canada Notice of Compliance is based on a comprehensive submission package including six month efficacy ...
Posted by Michael Wonder on 17 Sep 2021
BridgeBio Pharma receives FDA fast track designation for investigational therapy for the treatment of limb-girdle muscular dystrophy type 2i (LGMD2i)
15 September 2021 - If successful, BridgeBio's drug could be the first approved therapy for patients with LGMD2i. ...
Posted by Michael Wonder on 16 Sep 2021
Moderna announces Health Canada approves its COVID-19 vaccine
16 September 2021 - Moderna today announced Health Canada has approved the new drug submission for Spikevax (elasomeran mRNA vaccine), which ...
Posted by Michael Wonder on 16 Sep 2021
ATAGI update following weekly COVID-19 meeting – 15 September 2021
16 September 2021 - An update from the Australian Technical Advisory Group on Immunisation (ATAGI) following their weekly meeting on 15 ...
Posted by Michael Wonder on 16 Sep 2021
Raising the bar for using surrogate outcomes in drug regulation and health technology assessment
16 September 2021 - Surrogate outcomes provide no guarantee of clinical benefit, and Dalia Dawoud and colleagues argue they should ...
Posted by Michael Wonder on 16 Sep 2021
Emergency use authorisation for Lilly's bamlanivimab and etesevimab administered together expanded to include post-exposure prophylaxis for COVID-19
16 September 2021 - Expanded emergency use authorisation includes certain people who have been exposed to someone infected with SARS-CoV-2 ...
Posted by Michael Wonder on 16 Sep 2021
AbbVie submits regulatory applications to FDA and EMA for upadacitinib (Rinvoq) for the treatment of adults with moderately to severely active ulcerative colitis
16 September 2021 - AbbVie today announced that it has submitted applications seeking approval for upadacitinib (15 mg and 30 mg ...
Posted by Michael Wonder on 16 Sep 2021
COVID-19 vaccine weekly safety report (16 September 2021)
16 September 2021 - To 12 September 2021, approximately 22.8 million vaccine doses have been given in Australia – 14 million ...
Posted by Michael Wonder on 16 Sep 2021
Sage Therapeutics receives fast track designation for SAGE-718 for the treatment of Huntington’s disease
15 September 2021 - Sage Therapeutics today announced that the U.S. FDA has granted fast track designation to SAGE-718 for development ...
Posted by Michael Wonder on 16 Sep 2021
Takeda’s Exkivity (mobocertinib) approved by U.S. FDA as the first oral therapy specifically designed for patients with EGFR exon 20 insertion positive NSCLC
15 September 2021 - Next generation sequencing companion diagnostic test approved simultaneously to support identification of patients with EGFR exon 20 ...
Posted by Michael Wonder on 15 Sep 2021
Pulmocide’s lead drug candidate opelconazole (PC945) granted orphan drug, fast track and qualified infectious disease product designations by US FDA
15 September 2021 - Pulmocide today announced that the US FDA has granted orphan drug, fast track and qualified infectious disease ...
Posted by Michael Wonder on 15 Sep 2021
FDA, EMA launch complex generic, hybrid product advice pilot
15 September 2021 - The US FDA and the EMA on Wednesday launched a new pilot aimed at giving parallel ...
Posted by Michael Wonder on 15 Sep 2021
FDA advances data, IT modernisation efforts with new Office of Digital Transformation
15 September 2021 - FDA prioritises effective and efficient use of data by reorganising IT, data and cybersecurity functions to ...
Posted by Michael Wonder on 15 Sep 2021
U.S. FDA grants Brukinsa (zanubrutinib) accelerated approval in relapsed or refractory marginal zone lymphoma
15 September 2021 - This marks the third FDA approval for Brukinsa and first approval in marginal zone lymphoma. ...
Posted by Michael Wonder on 15 Sep 2021
Aduhelm backlash threatens to reverse progress in FDA’s reviews of rare and ultra-rare disease drugs
14 September 2021 - The FDA’s approval of Aduhelm to treat Alzheimer’s disease has unleashed criticism about the decision and ...