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 15 Apr 2022
Valneva COVID-19 vaccine approved by MHRA
14 April 2022 - The COVID-19 vaccine developed by Valneva has today been given regulatory approval by the MHRA. ...
Posted by Michael Wonder on 15 Apr 2022
TG Therapeutics announces voluntary withdrawal of the BLA/sNDA for U2 to treat patients with CLL and SLL
15 April 2022 - TG Therapeutics today announced that the Company has voluntarily withdrawn the pending biologics license application/supplemental new drug ...
Posted by Michael Wonder on 15 Apr 2022
Evusheld receives Health Canada approval for pre-exposure prophylaxis (prevention) of COVID-19 in immune-compromised individuals
14 April 2022 - Evusheld is the first long-acting antibody combination to receive Health Canada authorisation for the prevention of ...
Posted by Michael Wonder on 14 Apr 2022
Merck announces US FDA has granted breakthrough therapy designation for V116, the Company’s investigational 21 valent Pneumococcal conjugate vaccine, for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults
14 April 2022 - V116 designed to target serotypes that account for 85% of all invasive pneumococcal disease in individuals aged ...
Posted by Michael Wonder on 14 Apr 2022
Over 700 people a year could benefit from a new potentially life-extending lung cancer drug which targets a specific genetic mutation
14 April 2022 - An innovative and potentially life-extending drug for treating people with a specific gene mutation of advanced ...
Posted by Michael Wonder on 14 Apr 2022
ICER publishes 2022 research protocol for assessing unsupported price increases on prescription drugs
14 April 2022 - Final assessment to be published on 6 December 2022. ...
Posted by Michael Wonder on 14 Apr 2022
U.S. FDA extends review of biologics license application for Regen-Cov (casivirimab and imdemivab) for treatment and prophylaxis of COVID-19
14 April 2022 - Regeneron continues to progress its next generation antibodies, and has initiated a first in human trial. ...
Posted by Michael Wonder on 14 Apr 2022
Alpelisib for patients with advanced hormone receptor positive, HER2 negative, PIK3CA mutated breast cancer
7 April 2022 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...
Posted by Michael Wonder on 14 Apr 2022
COVID-19 vaccine weekly safety report (14 April 2022)
14 April 2022 - To 10 April 2022, the TGA has received 528 reports which have been assessed as likely to ...
Posted by Michael Wonder on 14 Apr 2022
Public summary documents – December 2021 PBAC meeting (first time decisions not to recommend, deferrals and other matters)
14 April 2022 - The Public Summary Documents (first time decisions not to recommend, deferrals and other matters) from the December ...
Posted by Michael Wonder on 13 Apr 2022
Europe’s new HTA system spurs more debate, concern
12 April 2022 - Fresh round of discussions around health technology assessment. ...
Posted by Michael Wonder on 13 Apr 2022
Irish cancer patients wait four months longer for access to new drugs than rest of Europe
11 April 2022 - Cancer patients in Ireland are waiting on average four months longer than people with the disease ...
Posted by Michael Wonder on 13 Apr 2022
Amneal achieves second U.S. biosimilars approval with Alymsys (bevacizumab-maly)
13 April 2022 - Marks the second of three biosimilars Amneal expects to receive U.S. approval for in 2022. ...
Posted by Michael Wonder on 13 Apr 2022
Insulin isn't affordable for many Americans. That may be a human rights abuse, report says.
13 April 2022 - The cost of insulin has sparked Congressional hearings and calls for change from diabetics and patient advocates. ...
Posted by Michael Wonder on 13 Apr 2022
Paxlovid ‘inaccessible’ to many patients in Canada. Here’s why that needs to change.
13 April 2022 - A pill to treat COVID-19 appears to be the country’s best hope, outside of vaccines and ...