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 14 Jul 2021
Prescription medicines: applications under evaluation (July 2021 update)
14 July 2021 - The TGA has updated its list of applications for new medicines/vaccines or new uses for existing medicines/vaccines ...
Posted by Michael Wonder on 14 Jul 2021
FDA grants Alkeus Pharmaceuticals breakthrough therapy designation for ALK-001 (C20-D3-vitamin A) for the treatment of Stargardt disease
14 July 2021 - Only drug to receive breakthrough therapy designation for Stargardt disease. ...
Posted by Michael Wonder on 14 Jul 2021
Kesimpta (ofatumumab) approved for relapsing remitting MS in Scotland
12 July 2021 - The SMC has recommended that Kesimpta can be prescribed for people with relapsing remitting multiple sclerosis who ...
Posted by Michael Wonder on 14 Jul 2021
ASP3772 receives FDA breakthrough therapy designation
12 July 2021 - The U.S. FDA has granted breakthrough therapy designation for ASP3772 for the prevention of pneumonia and invasive ...
Posted by Michael Wonder on 14 Jul 2021
PHARMAC 'cruel' for failing to fund drugs for rare illnesses — advocate
14 July 2021 - New Zealand’s drug-buying agency doesn’t value the lives of all people equally, according to those advocating for ...
Posted by Michael Wonder on 14 Jul 2021
Harvard doctor urges FDA reforms after Biogen Alzheimer nod
13 July 2021 - Curtail biomarker use for clearance, Kesselheim writes in JAMA. ...
Posted by Michael Wonder on 14 Jul 2021
PHARMAC has for decades refused to fund Synagis drug that could save vulnerable babies from RSV
14 July 2021 - Newshub can reveal after two decades of refusing to fund a drug that could halve the ...
Posted by Michael Wonder on 13 Jul 2021
Tecentriq, Kesimpta lead latest SMC decisions
13 July 2021 - The SMC has accepted three new medicines for use by NHS Scotland and rejected one in its ...
Posted by Michael Wonder on 13 Jul 2021
Biden in standoff with Democratic senators over who should lead FDA
13 July 2021 - Nearly six months into a presidency fully engulfed in a battle against a global pandemic, President Joe ...
Posted by Michael Wonder on 13 Jul 2021
European efforts to assess Russia’s Sputnik V vaccine stymied by data gaps
13 July 2021 - The developers of Russia’s Sputnik V coronavirus vaccine have repeatedly failed to provide data that regulators ...
Posted by Michael Wonder on 13 Jul 2021
'A price on your life': Toronto cystic fibrosis patients slam review process while waiting for access to life-saving treatment
13 July 2021 - While Health Canada approved Trikafta for patient use on June 18, 2021, it is still not ...
Posted by Michael Wonder on 13 Jul 2021
Biden wants a drug pricing plan in 45 days. Who’s going to write it?
13 July 2021 - Medicare announced it’s opening a so-called National Coverage Determination for Biogen’s divisive new Alzheimer’s drug, Aduhelm. ...
Posted by Michael Wonder on 13 Jul 2021
Stryker announces the FDA clearance of the first biodegradable subacromial balloon spacer, filling a gap in the shoulder continuum of care
13 July 2021 - The InSpace balloon implant is a breakthrough solution for arthroscopic treatment of massive irreparable rotator cuff tears ...
Posted by Michael Wonder on 13 Jul 2021
ATAGI statement on use of COVID-19 vaccines in an outbreak setting
13 July 2021 - A statement from the Australian Technical Advisory Group on Immunisation (ATAGI) on the use of COVID-19 vaccines ...
Posted by Michael Wonder on 13 Jul 2021
Powerful House Democrats demand documents from Biogen about co-ordination with FDA on new Alzheimer’s drug
12 July 2021 - Two powerful House Democrats on Monday demanded documents from Biogen about the approval process, marketing, and ...