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 Sep 2021
MHRA statement on booster doses of Pfizer and AstraZeneca COVID-19 vaccines
9 September 2021 - The regulatory changes made by the MHRA today give further options for the deployment programme. ...
Posted by Michael Wonder on 11 Sep 2021
Representativeness of participants eligible to be enrolled in clinical trials of aducanumab for Alzheimer disease compared with Medicare beneficiaries with Alzheimer disease and mild cognitive impairment
9 September 2021 - In June 2021, the US FDA granted accelerated approval for aducanumab to treat patients with mild cognitive ...
Posted by Michael Wonder on 11 Sep 2021
Estimated savings from international reference pricing for prescription drugs
10 September 2021 - High prescription drug prices have important implications for health care spending, patient financial burden, and adherence. ...
Posted by Michael Wonder on 10 Sep 2021
MHRA approves Amgen’s Lumykras under Project Orbis
10 September 2021 - Amgen has announced that is first-in-class KRAS G12C inhibitor Lumykras (sotorasib) has been received a conditional ...
Posted by Michael Wonder on 10 Sep 2021
ICER publishes evidence report on treatments for myasthenia gravis
10 September 2021 - While eculizumab and efgartigimod each provide important health benefits, both would need to be priced more than ...
Posted by Michael Wonder on 10 Sep 2021
UK approval for Pfizer’s JAK inhibitor Cibinqo
10 September 2021 - The UK MHRA has approved a marketing authorisation for Pfizer’s oral Janus kinase 1 inhibitor Cibinqo ...
Posted by Michael Wonder on 10 Sep 2021
PBAC Public Summary Documents (first time decisions not to recommend, deferrals and other matters) – May 2021 meeting
10 September 2021 - The Public Summary Documents (first time decisions not to recommend, deferrals and other matters) from the May ...
Posted by Michael Wonder on 10 Sep 2021
Regulatory and clinical consequences of negative confirmatory trials of accelerated approval cancer drugs: retrospective observational study
9 September 2021 - The researchers set out to investigate the regulatory handling of cancer drugs that were granted accelerated approval ...
Posted by Michael Wonder on 10 Sep 2021
Decibel Therapeutics receives orphan drug and rare paediatric disease designations for DB-OTO for the treatment of otoferlin related congenital hearing loss
9 September 2021 - Decibel Therapeutics today announced that the U.S. FDA has granted both orphan drug designation and rare paediatric ...
Posted by Michael Wonder on 10 Sep 2021
FDA grants breakthrough device designation to the NovoTTF-200T system for advanced liver cancer
9 September 2021 - Novocure today announced the United States FDA has granted breakthrough designation to the NovoTTF-200T System, a Tumour ...
Posted by Michael Wonder on 10 Sep 2021
VOR33 granted U.S. FDA fast track designation for AML
9 September 2021 - Vor Biopharma today announced that the U.S. FDA has granted fast track designation to VOR33, the ...
Posted by Michael Wonder on 09 Sep 2021
Senate considers pegging Medicare drug prices to deeply discounted Veterans Affairs rates
9 September 2021 - Senate lawmakers are actively considering pegging the prices Medicare pays for drugs to those drug makers ...
Posted by Michael Wonder on 09 Sep 2021
Biden Administration unveils plan to cut prescription drug prices
9 September 2021 - The Department of Health and Human Services plan supports legislation to empower the government to negotiate Medicare ...
Posted by Michael Wonder on 09 Sep 2021
Insurance benefits for Pfizer’s heart drug Vyndamax uncertain
9 September 2021 - Pfizer’s Vyndamax (tafamidis), a treatment for transthyretin amyloid cardiomyopathy, got in the European Society of Cardiology’s ...
Posted by Michael Wonder on 09 Sep 2021
Professor Gillian Leng to retire from NICE
9 September 2021 - Professor Leng has spent more than 20 years working at NICE. ...