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 03 May 2022
HutchMed receives complete response letter from the U.S. FDA for surufatinib for the treatment of advanced neuroendocrine tumours
2 May 2022 - HutchMed announced that the U.S. FDA has issued a complete response letter regarding the new drug application ...
Posted by Michael Wonder on 03 May 2022
CMS’s decision to restrict coverage of Aduhelm very unlikely to impact other accelerated approvals in other classes
2 May 2022 - CMS Administrator, Chiquita Brooks-LaSure, said last week that CMS will continue to reimburse drugs approved by ...
Posted by Michael Wonder on 03 May 2022
VBI Vaccines announces European Commission marketing authorisation for PreHevbri, a 3 antigen adult hepatitis B vaccine
2 May 2022 - Regulatory review in the United Kingdom is on-going as part of the European Commission Decision Reliance ...
Posted by Michael Wonder on 03 May 2022
Limaca Medical receives FDA breakthrough device designation
2 May 2022 - Limaca's precision GI endoscopic biopsy device advances precision medicine. ...
Posted by Michael Wonder on 02 May 2022
Vaxxinity receives FDA fast track designation for UB-311 for treatment of Alzheimer’s disease
2 May 2022 - Vaxxinity today announced that UB-311, an anti-amyloid beta immunotherapeutic vaccine, has been granted fast track designation by ...
Posted by Michael Wonder on 02 May 2022
Prices of Tecentriq, Avastin go down due to broader insurance benefits
2 May 2022 - The Government granted health insurance benefits to the combination therapy of Tecentriq and Avastin to treat ...
Posted by Michael Wonder on 02 May 2022
Most people won’t get a $10-$12 medicine price cut after election
2 May 2022 - The vast majority of Australians will not benefit from the $10-$12.50 price cut to prescription medicines ...
Posted by Michael Wonder on 02 May 2022
HAS clarifies the framework for use of Xevudy
29 April 2022 - After authorising early access to Xevudy (sotrovimab) as a curative treatment for COVID-19 on 6 January, HAS ...
Posted by Michael Wonder on 02 May 2022
TLV submits proposals for increased access to new gene therapies
2 May 2022 - How should society handle new gene therapies for serious diseases, where the effect of the drugs is ...
Posted by Michael Wonder on 02 May 2022
What is the HTA review and why is it important for Australia’s health system?
3 May 2022 - Medicines Australia has released its fourth video in its Federal Election series, explaining the upcoming independent ...
Posted by Michael Wonder on 02 May 2022
Gilead Science’s hepatitis B drug Vemlidy gets expanded insurance benefit
2 May 2022 - Gilead Science Korea said its hepatitis B treatment Vemlidy (tenofovir alafenamide) started receiving expanded health insurance ...
Posted by Michael Wonder on 02 May 2022
SpineX receives FDA breakthrough device designation for SCiP
2 May 2022 - SpineX’s proprietary non-surgical device SCiP offers new hope for children with cerebral palsy. ...
Posted by Michael Wonder on 02 May 2022
Myovant Sciences announces European Commission approval for Orgovyx (relugolix) for the treatment of advanced hormone sensitive prostate cancer
29 April 2022 - Myovant expects to secure European commercialisation partner ahead of anticipated launches. ...
Posted by Michael Wonder on 02 May 2022
Orphalan announces FDA approval of Cuvrior for the treatment of adult patients with stable Wilson’s disease who are de-coppered and tolerant to penicillamine
2 May 2022 - Orphalan announces FDA approval of Cuvrior for the treatment of adult patients with stable Wilson’s disease ...
Posted by Michael Wonder on 02 May 2022
Sage Therapeutics and Biogen initiate rolling submission of new drug application to US FDA for zuranolone for the potential treatment of major depressive disorder
2 May 2022 - The companies expect to complete submission of the new drug application for treatment of major depressive ...