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 27 Jan 2023
Risankizumab for the treatment of patients with previously treated moderate to severe active Crohn's disease
27 January 2023 - The Department of Health and Social Care has asked NICE to produce guidance on using risankizumab in ...
Posted by Michael Wonder on 27 Jan 2023
MSAC publishes agenda for April 2023 PASC meeting
27 January 2023 - The MSAC Secretariat has published a list of applications scheduled to be considered by the PICO Advisory ...
Posted by Michael Wonder on 27 Jan 2023
Marketing authorisation application for lecanemab as treatment for early Alzheimer's disease accepted by EMA
27 January 2023 - Eisai and Biogen announced today that the EMA has accepted a marketing authorisation application for lecanemab, an ...
Posted by Michael Wonder on 26 Jan 2023
Syros receives fast track designation from the FDA for tamibarotene for the treatment of higher-risk myelodysplastic syndrome
26 January 2023 - Currently evaluating tamibarotene in combination with azacitidine pivotal SELECT-MDS-1 Phase 3 clinical trial in newly diagnosed higher-risk myelodysplastic ...
Posted by Michael Wonder on 26 Jan 2023
FDA approves pembrolizumab as adjuvant treatment for non-small-cell lung cancer
26 January 2023 - Today, the FDA approved pembrolizumab (Keytruda, Merck) for adjuvant treatment following resection and platinum-based chemotherapy for ...
Posted by Michael Wonder on 26 Jan 2023
Big pharma groups rejoin battle with governments on drug prices
24 January 2023 - Tight budgets and US reforms are ending a truce between the industry and health authorities. ...
Posted by Michael Wonder on 26 Jan 2023
New atopic dermatitis drugs for young patients to get expanded coverage
26 January 2023 - As the Government moves toward expanding insurance coverage for atopic dermatitis from adult to children and ...
Posted by Michael Wonder on 26 Jan 2023
Update on US FDA emergency use authorisation of Evusheld
26 January 2023 - The US FDA has stated that AstraZeneca’s Evusheld (tixagevimab and cilgavimab) is not currently authorised for ...
Posted by Michael Wonder on 26 Jan 2023
Draft methods (version 7.0): IQWiG is extending the comment period
26 January 2023 - The new deadline is 28 February 2023. ...
Posted by Michael Wonder on 26 Jan 2023
DiscGenics announces FDA regenerative medicine advanced therapy designation granted to IDCT for degenerative disc disease
26 January 2023 - DiscGenics today announced the US FDA granted regenerative medicine advanced therapy designation to injectable disc cell ...
Posted by Michael Wonder on 26 Jan 2023
Patent reform and lower drug prices should be bipartisan priorities
25 January 2023 - As the 118th Congress convenes this month in Washington D.C., many pundits and advocates have little ...
Posted by Michael Wonder on 26 Jan 2023
Evolus receives regulatory approval for Nuceiva in Australia
23 January 2023 - Australia among the largest countries in the world for aesthetic neurotoxins. ...
Posted by Michael Wonder on 26 Jan 2023
More than 400 people set to benefit after NICE approves ground-breaking CAR-T therapy to treat aggressive form of blood cancer
26 January 2023 - Hundreds of people with an aggressive form of lymphoma are set to benefit from the first ...
Posted by Michael Wonder on 26 Jan 2023
Enhertu approved in the EU as the first HER2 directed therapy for patients with HER2 low metastatic breast cancer
26 January 2023 - Approval based on DESTINY-Breast04 results where AstraZeneca and Daiichi Sankyo’s Enhertu reduced the risk of disease ...
Posted by Michael Wonder on 26 Jan 2023
A “method of use” to prevent generic and biosimilar market entry
25 January 2023 - A critical pathway that generics and biosimilars manufacturers have used to circumvent patent thickets has been “skinny ...