Blog
RSS FeedPosted by Michael Wonder on 03 Apr 2025
Real-world evidence to support health technology assessment and payer decision making: is it now or never?
31 March 2025 - The aim of this policy article is twofold: (i) to provide a summary and update of recent ...
Posted by Michael Wonder on 03 Apr 2025
Novartis receives FDA accelerated approval for Vanrafia (atrasentan), the first and only selective endothelin A receptor antagonist for proteinuria reduction in primary IgA nephropathy
3 April 2025 - Phase 3 data showed Vanrafia achieved proteinuria reduction of 36.1% (P<0.0001) vs. placebo with improvements seen at ...
Posted by Michael Wonder on 03 Apr 2025
Averoa receives positive opinion from the EMA for Xoancyl, an oral therapy for chronic kidney disease
2 April 2025 - Final European Commission decision expected by June 2025; UK regulatory submission foreseen via MHRA’s international recognition procedure. ...
Posted by Michael Wonder on 03 Apr 2025
GSK Korea's long-acting HIV injection therapy gains insurance benefit
1 April 2025 - GSK Korea said its long-acting injectable HIV-1 combination treatment, Vocabria (cabotegravir 600 mg) and Rekambys (rilpivirine ...
Posted by Michael Wonder on 02 Apr 2025
Denali Therapeutics announces initiation of BLA filing for accelerated approval of tividenofusp alfa for the treatment of Hunter syndrome
2 April 2025 - Rolling submission of BLA initiated for tividenofusp alfa; preparations ongoing for potential US commercial launch in late ...
Posted by Michael Wonder on 02 Apr 2025
Biogen’s investigational tau-targeting therapy BIIB080 receives FDA fast track designation for the treatment of Alzheimer’s disease
2 April 2025 - Biogen today announced that the US FDA has granted fast track designation to BIIB080, an investigational ...
Posted by Michael Wonder on 02 Apr 2025
Sydnexis announces positive CHMP opinion in Europe for SYD-101 for slowing the progression of paediatric myopia
1 April 2025 - Santen is Sydnexis’ licensing partner to commercialise SYD-101 within the EMEA region upon issuance of a ...
Posted by Michael Wonder on 02 Apr 2025
Rystiggo now approved for adults with generalised myasthenia gravis in Canada
2 April 2025 - The approval is supported by the pivotal Phase 3 MycarinG study in gMG, which demonstrated that treatment ...
Posted by Michael Wonder on 02 Apr 2025
Sanofi launches new cholesterol lowering injection in Korea with health insurance coverage
1 April 2025 - Sanofi Korea announced the launch of Praluent Pen 300 mg (alirocumab) today following its inclusion in ...
Posted by Michael Wonder on 02 Apr 2025
Agenda for the July 2025 PBAC meeting
2 April 2025 - The agenda for the July 2025 PBAC meeting is now available. ...
Posted by Michael Wonder on 02 Apr 2025
Apellis announces FDA acceptance and priority review of the supplemental new drug application for Empaveli (pegcetacoplan) for C3G and primary IC-MPGN
1 April 2025 - PDUFA target action date is 28 July 2025. ...
Posted by Michael Wonder on 02 Apr 2025
Doctors push for weight loss drugs to be added to the PBS
1 April 2025 - The cost of prescriptions for weight loss drugs is being brought into question, with doctors pushing ...
Posted by Michael Wonder on 01 Apr 2025
GRIN Therapeutics receives PRIME designation from EMA for radiprodil in the treatment of GRIN related neurodevelopmental disorder
1 April 2025 - GRIN Therapeutics today announced that the EMA has granted Priority Medicine (PRIME) designation to radiprodil, the company's ...
Posted by Michael Wonder on 01 Apr 2025
Highlights from the 24-27 March 2025 CHMP meeting
28 March 2025 - The EMA’s CHMP recommended five medicines for approval at its March 2025 meeting. ...
Posted by Michael Wonder on 01 Apr 2025
Pembrolizumab in combination with carboplatin and paclitaxel for the treatment of patients with advanced or recurrent endometrial cancer
24 March 2025 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...