Blog
RSS FeedPosted by Michael Wonder on 26 Nov 2021
Health Canada issues Notice of Compliance for Trodelvy, a new treatment option for an aggressive type of metastatic breast cancer
25 November 2021 - Trodelvy significantly reduced the risk of death by 49% compared with single agent chemotherapy in the ...
Posted by Michael Wonder on 26 Nov 2021
Health Canada approves Wegovy for the treatment of adults with obesity
25 November 2021 - Novo Nordisk announced today that Health Canada has approved Wegovy (semaglutide injection), the first-and-only prescription weight-loss medication ...
Posted by Michael Wonder on 25 Nov 2021
Comirnaty COVID-19 vaccine: EMA recommends approval for children aged 5 to 11
25 November 2021 - EMA’s CHMP has recommended granting an extension of indication for the COVID-19 vaccine Comirnaty to include use ...
Posted by Michael Wonder on 25 Nov 2021
Bristol Myers Squibb receives European Commission approval of Zeposia (ozanimod) for use in adults with moderately to severely active ulcerative colitis
23 November 2021 - Zeposia approval is based on the Phase 3 True North trial, which demonstrated clinically meaningful improvements ...
Posted by Michael Wonder on 25 Nov 2021
COVID-19 vaccine weekly safety report (25 November 2021)
25 November 2021 - To 21 November 2021, the TGA has received 341 reports which have been assessed as likely to ...
Posted by Michael Wonder on 25 Nov 2021
A divisive ruling on devices — Genus Medical Technologies v. FDA
24 November 2021 - The FDA has long taken the legal position that regulated devices could also be categorised as drugs. ...
Posted by Michael Wonder on 24 Nov 2021
Trodelvy (sacituzumab govitecan) granted European Commission marketing authorisation for treatment of metastatic triple negative breast cancer in second line
23 November 2021 - Marketing authorisation based on Phase 3 ASCENT study showing Trodelvy significantly improved overall survival versus physician’s choice ...
Posted by Michael Wonder on 24 Nov 2021
A vision for use of real world evidence in EU medicines regulation
24 November 2021 - Enabling the use of real world evidence and establishing its value for regulatory decision-making on the development, ...
Posted by Michael Wonder on 24 Nov 2021
The FDA's dysfunction is a public health crisis of its own
22 November 2021 - Earlier this month, President Biden tapped Dr. Robert Califf to lead the FDA. ...
Posted by Michael Wonder on 24 Nov 2021
COVID-19 vaccine indemnity
24 November 2021 - The Australian Government is reducing the claim threshold of the no fault COVID-19 Vaccine Claims Scheme to ...
Posted by Michael Wonder on 24 Nov 2021
Review of real world evidence and patient reported outcomes
24 November 2021 - The TGA recently commissioned a review into its usage of real world evidence and patient reported ...
Posted by Michael Wonder on 24 Nov 2021
Califf, Biden’s pick to lead FDA, has millions invested in pharma and tech companies
23 November 2021 - Robert Califf, President Biden’s choice to lead the FDA, earned $2.7 million as an executive at ...
Posted by Michael Wonder on 24 Nov 2021
FDA nomination slips after Biden admin fails to send papers to Congress
23 November 2021 - The delay means that Califf is now unlikely to get a confirmation hearing until mid-December at the ...
Posted by Michael Wonder on 24 Nov 2021
Swiss regulator approves Pfizer/BioNTech booster for 16 and up
23 November 2021 - Swissmedic has approved the extension of COVID-19 boosters for the Pfizer/BioNTech vaccine to all people aged 16 ...
Posted by Michael Wonder on 24 Nov 2021
Health Canada approves Keytruda (pembrolizumab) in combination with chemotherapy for the treatment of locally recurrent unresectable or metastatic triple negative breast cancer whose tumours express PD-L1 (CPS ≥10)
23 November 2021 - Conditional approval based on data from Phase 3 KEYNOTE-355 trial; introduces first breast cancer indication for ...