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 Mar 2022
Medicines Australia welcomes reform efforts to speed up clinical trials
4 March 2022 - Australian patients will have improved access to clinical trials due to reforms to be introduced by ...
Posted by Michael Wonder on 03 Mar 2022
Criticism of study planning: patient-reported endpoints are often collected far too briefly
3 March 2022 - A striking example: abemaciclib in advanced breast cancer. Shortened data on quality of life, symptoms and side ...
Posted by Michael Wonder on 03 Mar 2022
ICER to develop a California state unsupported price increase report funded by the California Health Care Foundation
3 March 2022 - Expanded funding supports the development of two annual “Unsupported Price Increase” reports specific to drugs identified through ...
Posted by Michael Wonder on 03 Mar 2022
TG Therapeutics announces extension of U.S. FDA BLA/sNDA PDUFA date for ublituximab plus Ukoniq to treat patients with CLL and SLL
3 March 2022 - FDA sets updated PDUFA goal date of June 25, 2022. ...
Posted by Michael Wonder on 03 Mar 2022
PhRMA Statement on the State of the Union Address
1 March 2022 - The Pharmaceutical Research and Manufacturers of America (PhRMA) President and CEO Stephen J. Ubl released the ...
Posted by Michael Wonder on 03 Mar 2022
PRIME enables earlier availability of life-changing medicines
3 March 2022 - EMA’s PRIority Medicines (PRIME) scheme has had a positive impact on the authorisation of new medicines that ...
Posted by Michael Wonder on 03 Mar 2022
Over 500 people a year can access a new life extending lung cancer treatment after NICE recommends its use within the Cancer Drugs Fund
3 March 2022 - An innovative life-extending drug for treating mutation-positive locally advanced or metastatic non-small-cell lung cancer in adults ...
Posted by Michael Wonder on 03 Mar 2022
Digital Therapeutics should be regulated with gold standard evidence
28 February 2022 - There is enormous growth in the digital health sector, illustrated by huge capital investment, and a massive ...
Posted by Michael Wonder on 03 Mar 2022
If Medicare Part D redesign ever happens, it could lead to lower prescription drug prices
2 March 2022 - On 1 March, during the State of the Union address, President Biden continued to push for some ...
Posted by Michael Wonder on 03 Mar 2022
AltPep receives FDA breakthrough device designation for SOBA-AD, a simple blood test for the detection of Alzheimer’s disease
1 March 2022 - AltPep Corporation today announced the U.S. FDA granted the company breakthrough device designation for its SOBA-AD diagnostic ...
Posted by Michael Wonder on 03 Mar 2022
Harpoon Therapeutics receives FDA fast track designation for HPN217
2 March 2022 - Harpoon Therapeutics today announced that the U.S. FDA has granted fast track designation to HPN217, a BCMA ...
Posted by Michael Wonder on 03 Mar 2022
COVID-19 vaccine weekly safety report (3 March 2022)
3 March 2022 - This is the 52nd issue of the COVID-19 vaccine safety report. ...
Posted by Michael Wonder on 03 Mar 2022
Amneal enters U.S. biosimilars market with approval of Releuko (filgrastim-ayow)
1 March 2022 - First of three Amneal biosimilars expected for U.S. approval and launch in 2022. ...
Posted by Michael Wonder on 03 Mar 2022
FDA accepts Alvotech’s BLA supporting interchangeability for ATV02, a high concentration, citrate-free biosimilar candidate for Humira
28 February 2022 - Alvotech is the only known company to have both developed a high-concentration biosimilar to Humira and ...
Posted by Michael Wonder on 03 Mar 2022
FDA approves Kaléo’s naloxone auto-injector 10 mg for the treatment of known or potential exposure to ultra-potent weaponised opioids
2 March 2022 - Product received fast-track designation for military personnel facing the potential threat of exposure to synthetic opioids ...