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 08 Feb 2023
Speeding up access to new medicines in Scotland: abbreviated process
8 February 2023 - A process brought in to streamline decision-making around access to new medicines in NHSScotland during the ...
Posted by Michael Wonder on 08 Feb 2023
Appili Therapeutics announces that FDA accepts the ATI-1501 NDA
8 February 2023 - ATI-1501, liquid oral reformulation of the antibiotic metronidazole, receives PDUFA action date of 23 September 2023. ...
Posted by Michael Wonder on 08 Feb 2023
Santhera concludes agreement with French authorities on Raxone reimbursement and plans to submit a request for an early access program for vamorolone
8 February 2023 - Santhera Pharmaceuticals announces that it has secured a final reimbursement agreement with the French authorities related to ...
Posted by Michael Wonder on 08 Feb 2023
Stakeholders want more clarity on FDA's statistical approach to assessing bioequivalence
7 February 2023 - Commenters on the US FDA draft guidance outlining principles for in vivo or in vitro bioequivalence ...
Posted by Michael Wonder on 08 Feb 2023
Nivolumab in combination with fluoropyrimidine- and platinum-based chemotherapy for patients with untreated unresectable advanced, recurrent, or metastatic oesophageal squamous cell carcinoma
8 February 2023 - Nivolumab, when used in combination with fluoropyrimidine-based and platinum-based combination chemotherapy, is recommended as an option ...
Posted by Michael Wonder on 08 Feb 2023
ATAGI recommendations on use of the Pfizer bivalent (Original/Omicron BA.4/5) COVID-19 vaccine
8 February 2023 - On 20 January 2023, the TGA provisionally approved the Pfizer (Comirnaty) Bivalent Original/Omicron BA.4/5 vaccine for use ...
Posted by Michael Wonder on 08 Feb 2023
Bayer submits aflibercept 8 mg for regulatory approval in two major retinal eye diseases in the EU
6 February 2023 - Filing for aflibercept 8 mg in neovascular (wet) age-related macular degeneration and diabetic macular oedema is based ...
Posted by Michael Wonder on 08 Feb 2023
Fintepla (fenfluramine) oral solution approved in the EU for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome
8 February 2023 - UCB’s Fintepla (fenfluramine) oral solution has been approved in the European Union for the treatment of ...
Posted by Michael Wonder on 08 Feb 2023
ATAGI 2023 booster advice
8 February 2023 - Recommendations from the Australian Technical Advisory Group on Immunisation (ATAGI) regarding COVID-19 boosters in 2023. ...
Posted by Michael Wonder on 07 Feb 2023
Payback and health technology assessment in Italy: a new governance for medical devices?
1 February 2023 - While waiting for a new governance to make the process of selecting and purchasing medical devices more ...
Posted by Michael Wonder on 07 Feb 2023
Miracle’ cystic fibrosis drug kept out of reach in developing countries
7 February 2023 - Vertex Pharmaceuticals is not making its drug, Trikafta, available in poorer countries, where thousands of diagnosed patients ...
Posted by Michael Wonder on 07 Feb 2023
The EU butts heads with big pharma to make medicines cheaper
2 February 2023 - The bloc’s pharma reform aims to get new drugs to patients faster, for less money. But it ...
Posted by Michael Wonder on 07 Feb 2023
The medicine is a miracle, but only if you can afford it
7 February 2023 - A wave of new treatments have cured devastating diseases. When the costs are too much, even for ...
Posted by Michael Wonder on 07 Feb 2023
Valeo Pharma obtains public reimbursement for Onstryv in Quebec
7 February 2023 - Quebec public reimbursement coverage to facilitate and expand medication access for Parkinson’s patients in Quebec. ...
Posted by Michael Wonder on 07 Feb 2023
Rocket Pharmaceuticals receives FDA regenerative medicine advanced therapy designation for RP-A501 gene therapy for Danon disease
7 February 2023 - Rocket Pharmaceuticals today announced that the US FDA has granted regenerative medicine advanced therapy designation to ...