Blog
RSS FeedPosted by Michael Wonder on 04 Feb 2025
Comanche Biopharma awarded Innovation passport designation by the UK Innovative Licensing and Access Pathway Steering Group for CBP-4888, an investigational siRNA drug candidate for the treatment of sFlt1-mediated preterm pre-eclampsia
30 January 2025 - A novel investigational drug candidate, CBP-4888 leverages the precise targeting ability of siRNAs to downregulate sFlt1 ...
Posted by Michael Wonder on 04 Feb 2025
Comparison of clinical evidence submitted to the FDA and EMA for cell and gene therapies
3 February 2025 - Harmonisation in regulatory submissions across agencies may support timelier access to innovative treatments, including cell and gene ...
Posted by Michael Wonder on 01 Feb 2025
Refined interpretation of the Mutual Recognition Agreement between Canada and Switzerland
31 January 2025 - Swissmedic and Health Canada agreed to expand their approach regarding the implementation of the current mutual ...
Posted by Michael Wonder on 30 Jan 2025
Drugmakers show restraint on price increases in new Trump era
28 January 2025 - Companies raised prices a median 4%, though some medicines will cost thousands of dollars more. ...
Posted by Michael Wonder on 30 Jan 2025
CMS statement on lowering the cost of prescription drugs
29 January 2025 - Lowering the cost of prescription drugs for Americans is a top priority of President Trump and his ...
Posted by Michael Wonder on 28 Jan 2025
Vanda Pharmaceuticals accepts FDA opportunity for a hearing on new drug application for tradipitant in gastroparesis
27 January 2025 - Highlights faulty FDA review. ...
Posted by Michael Wonder on 23 Jan 2025
EU-HTA: maintaining the achievements of AMNOG
20 January 2025 - IQWiG welcomes the fact that the adjustments to the AMNOG procedure planned for the integration with European ...
Posted by Michael Wonder on 21 Jan 2025
Drug shortage crisis demands intervention, AMA warns, as patients struggle to secure medicines
20 January 2025 - There are more than 400 medicine shortages, and the country’s leading medical group blames it on ‘ad ...
Posted by Michael Wonder on 21 Jan 2025
Albertan with rare blood cancer calls on Health Canada to approve life-saving drug
20 January 2025 - An Alberta woman living with a rare form of blood cancer is calling on Health Canada ...
Posted by Michael Wonder on 20 Jan 2025
BIO statement on new list of medicines targeted for Government price setting
17 January 2025 - The Biotechnology Innovation Organization (BIO) today released the following statement after the Biden administration released a ...
Posted by Michael Wonder on 19 Jan 2025
Human medicines in 2024
16 January 2025 - In 2024, EMA recommended 114 medicines for marketing authorisation. ...
Posted by Michael Wonder on 19 Jan 2025
Long wait for cancer drug approvals causing 'great anguish' among patients, doctors
18 January 2025 - Potentially life-saving treatments delayed by bureaucracy, doctors say. ...
Posted by Michael Wonder on 19 Jan 2025
Ozempic among the next drugs up for Medicare price negotiations
17 January 2025 - List of drugs account for $41 billion in annual Medicare spending, Biden administration says. ...
Posted by Michael Wonder on 17 Jan 2025
HHS announces 15 additional drugs selected for Medicare drug price negotiations in continued effort to lower prescription drug costs for seniors
17 January 2025 - Medicare has selected 15 more drugs to negotiate directly with participating drug companies. Building on the ...
Posted by Michael Wonder on 12 Jan 2025
Vanda's letter to FDA Commissioner highlights faulty gastroparesis NDA review
8 January 2025 - Vanda Pharmaceuticals letter to FDA Commissioner highlights faulty gastroparesis NDA review. ...