Blog
RSS FeedPosted by Michael Wonder on 31 Aug 2025
FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease
29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...
Posted by Michael Wonder on 07 Nov 2021
The prescription drug price negotiation plan in the Biden BBB Bill is not what it’s claimed to be
6 November 2021 - Earlier this week, the New York Times reported, with the headline, “Democrats Add Drug Cost Curbs ...
Posted by Michael Wonder on 07 Nov 2021
AstraZeneca pulls request for Swiss approval of COVID shot
5 November 2021 - AstraZeneca says it is withdrawing its application for approval of its COVID-19 vaccine in Switzerland because the ...
Posted by Michael Wonder on 06 Nov 2021
Novavax files COVID-19 vaccine for emergency use listing with World Health Organization
4 November 2021 - All modules required for regulatory review of Novavax vaccine, including CMC data, are now complete for ...
Posted by Michael Wonder on 06 Nov 2021
Pharmaceutical Benefits Scheme continued dispensing arrangements
5 November 2021 - The Australian Government has extended the Continued Dispensing emergency arrangements until 30 June 2022, when they ...
Posted by Michael Wonder on 06 Nov 2021
Novavax files COVID-19 vaccine for provisional approval in New Zealand
3 November 2021 - Submission to New Zealand's Medsafe marks the first protein-based COVID-19 vaccine submitted for authorisation to regulatory authorities ...
Posted by Michael Wonder on 06 Nov 2021
PHARMAC to fund baricitinib to treat moderate to severe cases of COVID-19
5 November 2021 - PHARMAC has purchased another new medicine, baricitinib, to treat moderate to severe cases of COVID-19, with 500 ...
Posted by Michael Wonder on 06 Nov 2021
Tris Pharma announces FDA approval of Dyanavel XR (amphetamine) once daily extended release oral tablets, CII, for ADHD
5 November 2021 - In a clinical study in adults, Dyanavel XR tablets demonstrated bioequivalence to Dynavel XR (amphetamine) extended-release oral ...
Posted by Michael Wonder on 06 Nov 2021
NICE recommend dapagliflozin for people with chronic kidney disease
5 November 2021 - In draft guidance published today NICE has recommended dapagliflozin as an option for treating certain people ...
Posted by Michael Wonder on 05 Nov 2021
FDA awards breakthrough device designation to the ReWalk ReBoot Soft Exo-Suit
4 November 2021 - Soft exoskeleton device for stroke survivors will be for use at home and in the community ...
Posted by Michael Wonder on 05 Nov 2021
AstraZeneca Canada files for Health Canada authorisation of AZD7442 for prevention of COVID-19
3 November 2021 - AstraZeneca Canada has initiated a rolling review new drug submission with Health Canada for authorization of ...
Posted by Michael Wonder on 05 Nov 2021
Drug Utilisation Sub-Committee outcome statement
5 November 2021 - The Outcome Statement from the October 2021 Drug Utilisation SubCommittee meeting is now available. ...
Posted by Michael Wonder on 04 Nov 2021
Opiant receives FDA fast track designation for OPNT003, nasal nalmefene, for treatment of opioid overdose
4 November 2021 - Fast track designation further underscores the potential for OPNT003 to represent a major advance in the treatment ...
Posted by Michael Wonder on 04 Nov 2021
Libtayo (cemiplimab) approved in Canada for the first-line treatment of adult patients with non-small-cell lung cancer expressing PD-L1 in ≥ 50% of tumour cells with no EGFR, ALK or ROS1 aberrations
29 October 2021 - The approval is based on data from the randomised, open-label, multi-center study 16241. ...
Posted by Michael Wonder on 04 Nov 2021
TGA approves Illuccix for prostate cancer imaging
2 November 2021 - Telix is delighted to announce that the TGA has approved Illuccix (kit for the preparation of ...
Posted by Michael Wonder on 04 Nov 2021
UK approval for MSD/Ridgeback’s COVID-19 anti-viral medicine
4 November 2021 - The UK MHRA has authorised MSD and Ridgeback Therapeutics’ COVID-19 anti-viral medicine molnupiravir. ...