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 Nov 2025
EMA publishes agenda for 10-13 November 2025 CHMP meeting
10 November 2025 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 10 Nov 2025
Avenzo Therapeutics granted fast track designation for AVZO-1418, a potential best in class EGFR/HER3 bispecific antibody drug conjugate, for the treatment of patients with EGFR mutated TKI pretreated NSCLC
10 November 2025 - Avenzo Therapeutics today announced the US FDA granted fast track designation to AVZO-1418 (DB-1418), a potential ...
Posted by Michael Wonder on 10 Nov 2025
ICER releases draft scope on vaccines for Covid-19
10 November 2025 - Report will be subject of New England CEPAC meeting in June 2026; draft scoping document open ...
Posted by Michael Wonder on 09 Nov 2025
Mark Cuban Cost Plus Drug Company expands access with addition of Starjemza (ustekinumab-hmny) to give patients more power over prescription costs
6 November 2025 - New biosimilar added to portfolio reinforces the company's commitment to transparency and access ...
Posted by Michael Wonder on 09 Nov 2025
Rhythm Pharmaceuticals announces public reimbursement for Imcivree (setmelanotide) in Canada in five provinces and under the Federal Non-Insured Health Benefits Program
5 November 2025 - Rhythm Pharmaceuticals today announced that it has entered into Product Listing Agreements in the provinces of Ontario, ...
Posted by Michael Wonder on 09 Nov 2025
New cheaper medicine for chronic liver disease
9 November 2025 - Australians living with chronic liver disease will soon have access to a new cheaper medicine on ...
Posted by Michael Wonder on 08 Nov 2025
FDA awards second batch of national priority vouchers
6 November 2025 - The US FDA today announced six additional awardees under the Commissioner’s National Priority Voucher pilot program. ...
Posted by Michael Wonder on 08 Nov 2025
Novo Nordisk announces agreement with the US Administration to bring GLP-1s to more Americans at a lower cost
6 November 2025 - Today it was announced that Novo Nordisk has agreed with the US Administration to lower drug prices ...
Posted by Michael Wonder on 08 Nov 2025
PHARMAC consults on changes to simplify biologic medicine funding criteria
6 November 2025 - PHARMAC is proposing changes to the Special Authority and Hospital Indication Restrictions criteria for four biologic ...
Posted by Michael Wonder on 08 Nov 2025
Vera Therapeutics submits biologics license application to US FDA through accelerated approval program for atacicept for the treatment of adults with IgA nephropathy
7 November 2025 - Vera Therapeutics today announced it has submitted a biologics license application to the US FDA through ...
Posted by Michael Wonder on 08 Nov 2025
Boehringer awarded FDA Commissioner's National Priority Voucher for Hernexeos in HER2 lung cancer
7 November 2025 - The US FDA has awarded a Commissioner's National Priority Voucher for Hernexeos (zongertinib tablets), currently under investigation ...
Posted by Michael Wonder on 07 Nov 2025
Rhythm Pharmaceuticals announces FDA extension of review period for Imcivree (setmelanotide) for patients with acquired hypothalamic obesity
7 November 2025 - Rhythm Pharmaceuticals today announced that the US FDA has extended by three months the review period for ...
Posted by Michael Wonder on 07 Nov 2025
Mark Cuban is trying to shake up biosimilar pricing with a version of J&J’s best selling Stelara drug
6 November 2025 - By selling at a low price, Cuban hopes to convince health plans, employers to embrace his ...
Posted by Michael Wonder on 07 Nov 2025
The FDA is a mess, but don’t blame it for everything
6 November 2025 - Biohaven and Uniqure fault agency volatility for setbacks. The reality may be more complicated. ...
Posted by Michael Wonder on 07 Nov 2025
CMS announces new drug payment model to strengthen Medicaid and better serve vulnerable Americans
6 November 2025 - The CMS is tackling high drug prices and protecting the American taxpayers through a landmark Innovation Center ...