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 Dec 2022
ETF concludes that bivalent original/Omicron BA.4-5 mRNA vaccines may be used for primary vaccination
6 December 2022 - EMA’s Emergency Task Force considers that adapted mRNA bivalent vaccines targeting the original strain and Omicron ...
Posted by Michael Wonder on 07 Dec 2022
Ocuphire Pharma announces submission of new drug application to FDA for Nyxol eye drops for reversal of mydriasis
6 December 2022 - NDA supported by positive Phase 3 data demonstrating rapid reversal of dilated eyes and favourable safety profile ...
Posted by Michael Wonder on 07 Dec 2022
Differences in evidentiary requirements between European Medicines Agency and European health technology assessment of oncology drugs—can alignment be enhanced?
5 December 2022 - National health technology assessments across Europe show differences in evidentiary requirements from assessments by the EMA, affecting ...
Posted by Michael Wonder on 07 Dec 2022
Sage Therapeutics and Biogen complete rolling submission of new drug application for zuranolone in the treatment of major depressive disorder and post-partum depression
6 December 2022 - Zuranolone is being evaluated as a short course, rapid-acting, oral medication for major depressive disorder (MDD) and ...
Posted by Michael Wonder on 07 Dec 2022
An innovation surcharge to fund the repurposing of generic drugs
10 November 2022 - The use of generic drugs continues to increase, generating substantial savings for purchasers and improving affordable access ...
Posted by Michael Wonder on 06 Dec 2022
SQZ Biotechnologies receives FDA fast track designation for its eAPC therapeutic candidate for treatment of HPV16 positive tumours
6 December 2022 - Stable disease observed in two out of four evaluable patients in eAPC Phase 1/2 trial including a ...
Posted by Michael Wonder on 06 Dec 2022
Vistagen receives FDA fast track designation for development of PH10 to treat major depressive disorder
6 December 2022 - Vistagen today announced the US FDA has granted fast track designation for the development of PH10, ...
Posted by Michael Wonder on 06 Dec 2022
Germany's use of reference pricing for biologics: lessons for the US
5 December 2022 - A redesign of consumer cost sharing in the US is important to accelerate the adoption of biosimilars ...
Posted by Michael Wonder on 06 Dec 2022
PHARMAC and a very curious case of media management
6 December 2022 - PHARMAC’s funding of Trikafta is a huge win for people with cystic fibrosis. But the media management ...
Posted by Michael Wonder on 06 Dec 2022
Data sharing and the growth of medical knowledge
5 December 2022 - In medical research, data sharing facilitates discovery and innovation, transparency, and reproducibility, and, ultimately, trust in ...
Posted by Michael Wonder on 06 Dec 2022
Istesso announces FDA fast track and orphan drug designation for MBS2320
5 December 2022 - Istesso today announces that the US FDA has granted fast track designation for Istesso’s investigational metabolic ...
Posted by Michael Wonder on 06 Dec 2022
IDEAYA Biosciences receives fast track designation for darovasertib combination therapy with crizotinib for the treatment of metastatic uveal melanoma
5 December 2022 - Fast track designation granted by US FDA for evaluation of darovasertib in combination with crizotinib in adult ...
Posted by Michael Wonder on 06 Dec 2022
Ionis announces European Medicines Agency accepts marketing authorisation application of tofersen to treat rare, genetic form of ALS
5 December 2022 - EMA acceptance follows FDA's acceptance of tofersen new drug application earlier this year. ...
Posted by Michael Wonder on 06 Dec 2022
Swissmedic approves Quviviq (daridorexant) – a first in class treatment for chronic insomnia disorder to improve both nighttime symptoms and daytime functioning
5 December 2022 - Quviviq, Switzerland's first approved dual orexin receptor antagonist, offers a new targeted mechanism of action that decreases ...
Posted by Michael Wonder on 06 Dec 2022
Molnupiravir ‘effective Covid-19 anti-viral’: acting CMO Michael Kidd
6 December 2022 - Acting chief medical officer Michael Kidd has contradicted the nation’s top advisers on Covid-19 treatments on ...