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 11 Aug 2021
Update on US regulatory review of roxadustat in anaemia of chronic kidney disease
11 August 2021 - The US FDA has issued a complete response letter regarding the new drug application for roxadustat ...
Posted by Michael Wonder on 11 Aug 2021
Pressure builds for full FDA approval of vaccines
11 August 2021 - Pressure is building for the FDA to fully approve the COVID-19 vaccine, a step that could ...
Posted by Michael Wonder on 11 Aug 2021
TGA head John Skerritt says NSW death toll would be much higher without AstraZeneca vaccine
11 August 2021 - The head of the national medical regulator says NSW would be recording “dozens” of covid deaths a ...
Posted by Michael Wonder on 11 Aug 2021
Medicare expansion and a lower eligibility age are included in Democrats’ $3.5 trillion budget plan
9 August 2021 - There’s no guarantee that these proposals will make it through the full legislative process. ...
Posted by Michael Wonder on 11 Aug 2021
PhRMA’s misleading description of Medicare drug price legislation
10 August 2021 - “They want to repeal a protection in Medicare that protects access to my medicines. They call ...
Posted by Michael Wonder on 11 Aug 2021
TGA grants provisional determination to MSD's anti-viral COVID-19 treatment molnupiravir
10 August 2021 - On 9 August 2021 the Therapeutic Goods Administration granted provisional determination to MSD in relation to ...
Posted by Michael Wonder on 10 Aug 2021
What are the obligations of pharmaceutical companies in a global health emergency?
5 August 2021 - During a global health emergency, everyone is morally required to help to combat the disease. ...
Posted by Michael Wonder on 10 Aug 2021
Pear Therapeutics announces formulary availability for its three FDA authorised prescription digital therapeutics at OptumRx
10 August 2021 - OptumRx to make Pear’s three commercial prescription digital therapeutics accessible to patients with Optum formulary access. ...
Posted by Michael Wonder on 10 Aug 2021
Dermavant announces FDA acceptance for filing of new drug application for tapinarof cream for the treatment of adults with plaque psoriasis
10 August 2021 - FDA PDUFA action expected in Q2 2022. ...
Posted by Michael Wonder on 10 Aug 2021
Implementing outcomes based managed entry agreements for rare disease treatments: nusinersen and tisagenlecleucel
10 August 2021 - Enthusiasm for the use of outcomes based managed entry agreements to manage uncertainties apparent at the time ...
Posted by Michael Wonder on 10 Aug 2021
FDA accepts application for Merck’s Keytruda (pembrolizumab) as single agent for certain patients with MSI-H/dMMR advanced endometrial carcinoma
10 August 2021 - Merck today announced that the U.S. FDA has accepted for review a new supplemental biologics license application ...
Posted by Michael Wonder on 10 Aug 2021
Characterisation of the pharmaceutical risk sharing arrangement process in Catalonia
10 August 2021 - Pharmaceutical risk sharing arrangements have emerged as a reasonable tool to promote sustainable access to innovative medicines ...
Posted by Michael Wonder on 10 Aug 2021
GW Pharmaceuticals receives approval for Epidyolex (cannabidiol) from the MHRA for the treatment of seizures associated with tuberous sclerosis complex
10 August 2021 - It is estimated that between 3,700 and 11,000 people in the UK live with tuberous sclerosis complex. ...
Posted by Michael Wonder on 10 Aug 2021
FDA grants priority review to Merck’s supplemental biologics license application for Keytruda (pembrolizumab) as adjuvant therapy in certain patients with renal cell carcinoma following surgery
10 August 2021 - Application based on KEYNOTE-564, a Phase 3 trial that evaluated adjuvant immunotherapy in renal cell carcinoma. ...
Posted by Michael Wonder on 10 Aug 2021
Companion diagnostics are growing rapidly worldwide. What about in Korea?
10 August 2021 - The global companion diagnostics market is expanding fast, but Korea has yet to develop related technologies, ...