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RSS FeedPosted by Michael Wonder on 06 Oct 2021
Complete response letter received from FDA
6 October 2021 - Requirement to address approvability issues identified by FDA ahead of NDA resubmission ...
Posted by Michael Wonder on 06 Oct 2021
Moderna announces European Medicines Agency authorises third dose of COVID-19 vaccine for immunocompromised individuals aged 12 years and older
5 October 2021 - Moderna today announced that the EMA has authorised a third dose of the Moderna COVID-19 vaccine (Spikevax) ...
Posted by Michael Wonder on 06 Oct 2021
EMA to consider rolling review for Merck's molnupiravir in coming days
5 October 2021 - The EMA will consider in the coming days whether to launch a rolling review of Merck's ...
Posted by Michael Wonder on 06 Oct 2021
Johnson & Johnson announces submission of emergency use authorisation amendment to the U.S. FDA to support booster of its single shot COVID-19 vaccine
5 October 2021 - Submission includes data showing a booster increased protection to 94% against moderate to severe/critical COVID-19 in the ...
Posted by Michael Wonder on 06 Oct 2021
Australian Government buys 300,000 doses of Merck COVID-19 treatment drug molnupiravir that has not yet been approved
5 October 2021 - While Australia is still trying to reach its COVID-19 vaccination targets, treatment options for the virus ...
Posted by Michael Wonder on 06 Oct 2021
Australia secures additional supplies of sotrovimab
4 October 2021 - The Australian Government has increased supplies of the promising COVID-19 treatment sotrovimab with over 15,000 additional doses ...
Posted by Michael Wonder on 06 Oct 2021
Amber Implants VCFix spinal system receives US FDA breakthrough designation
5 October 2021 - Set to vastly improve treatment of vertebral fractures. ...
Posted by Michael Wonder on 06 Oct 2021
US FDA grants fast track designation for JR-171 for the treatment of mucopolysaccaridosis type I
5 October 2021 - JCR Pharmaceuticals announced today that the US FDA has granted fast track designation for the investigational drug ...
Posted by Michael Wonder on 05 Oct 2021
AZD7442 request for emergency use authorisation for COVID-19 prophylaxis filed in US
5 October 2021 - Filing includes data from PROVENT Phase 3 trial showing 77% reduction in risk of developing symptomatic COVID-19 ...
Posted by Michael Wonder on 05 Oct 2021
The Product Monograph for Protopic has been updated
4 October 2021 - LEO Pharma Inc. today announced that Health Canada has approved an update to the Product Monograph of ...
Posted by Michael Wonder on 05 Oct 2021
TGA grants provisional determination to Pfizer's COVID-19 treatment PF-07321332 and ritonavir
5 October 2021 - On 1 October 2021, the TGA granted provisional determination to Pfizer in relation to a new ...
Posted by Michael Wonder on 05 Oct 2021
Heron Therapeutics announces filing of a supplemental new drug application for significant expansion of Zynrelef indication statement based on successful outcome of FDA type C meeting
4 October 2021 - FDA agreed to the immediate filing of supplemental new drug application to significantly expand the Zynrelef indication ...
Posted by Michael Wonder on 05 Oct 2021
Comirnaty and Spikevax: EMA recommendations on extra doses and boosters
4 October 2021 - EMA’s CHMP has concluded that an extra dose of the COVID-19 vaccines Comirnaty (BioNTech/Pfizer) and Spikevax ...
Posted by Michael Wonder on 05 Oct 2021
FDA’s naming rule for biosimilars has undermined Congress and health care
4 October 2021 - I recently tried to order white blood cell growth factor (pegfilgrastim) biosimilar for one of my ...
Posted by Michael Wonder on 05 Oct 2021
Turning Point Therapeutics granted breakthrough therapy designation for repotrectinib treatment in patients with NTRK positive, TKI pretreated advanced solid tumours
4 October 2021 - Turning Point Therapeutics today announced the U.S. FDA granted a seventh regulatory designation to lead drug ...