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 16 Oct 2022
Battle over pregnancy drug highlights risks of FDA expediting drugs to market
16 October 2022 - The year's long effort to yank the drug's approval offers a case study of the agency's accelerated ...
Posted by Michael Wonder on 16 Oct 2022
Mirum Pharmaceuticals announces positive CHMP opinion for Livmarli (maralixibat) oral solution for cholestatic pruritus in patients with Alagille syndrome two months of age and older
14 October 2022 - CHMP opinion based on pivotal ICONIC study with more than five years of data demonstrating durable and ...
Posted by Michael Wonder on 15 Oct 2022
Impending relief for Medicare beneficiaries - the Inflation Reduction Act
15 October 2022 - For many Medicare beneficiaries, the Inflation Reduction Act will reduce out of pocket spending for retail prescription ...
Posted by Michael Wonder on 15 Oct 2022
Highlights from the 10-13 October 2022 CHMP meeting
14 October 2022 - The EMA’s CHMP recommended 10 medicines for approval at its October 2022 meeting. ...
Posted by Michael Wonder on 15 Oct 2022
CHMP recommends approval of Atara Biotherapeutics’ Ebvallo (tabelecleucel) for the treatment of Epstein-Barr virus positive post transplant lymphoproliferative disease
14 October 2022 - Ebvallo on track to be the first ever allogeneic T-cell therapy approved. ...
Posted by Michael Wonder on 15 Oct 2022
Gottlieb, McClellan push for FDA regulatory reforms
14 October 2022 - The decision by law makers to drop regulatory reforms of dietary supplements, cosmetics and diagnostic tests from ...
Posted by Michael Wonder on 15 Oct 2022
CHMP recommends conditional marketing authorisation for spesolimab as first in class treatment option for generalised pustular psoriasis flares
14 October 2022 - CHMP positive opinion is based on evidence from the EFFISAYIL® 1 trial, the largest clinical trial in ...
Posted by Michael Wonder on 15 Oct 2022
Biden pushes HHS to do more on drug pricing
14 October 2022 - President Joe Biden plans to sign an executive order asking HHS to explore new ways to ...
Posted by Michael Wonder on 15 Oct 2022
BeiGene receives positive CHMP opinion for Brukinsa (zanubrutinib) for the treatment of adults with CLL
14 October 2022 - If approved, Brukinsa would be the only BTK inhibitor for chronic lymphocytic leukaemia in the European Union to ...
Posted by Michael Wonder on 15 Oct 2022
Takeda receives positive CHMP opinion recommending approval of Dengue vaccine candidate in EU and Dengue endemic countries
14 October 2022 - TAK-003 recommended for the prevention of Dengue disease caused by any Dengue virus serotype in individuals four ...
Posted by Michael Wonder on 14 Oct 2022
Novartis receives positive CHMP opinion for Pluvicto for patients with progressive, PSMA positive metastatic castration-resistant prostate cancer
14 October 2022 - Phase 3 VISION trial showed Pluvicto plus best standard of care significantly improved survival for patients with ...
Posted by Michael Wonder on 14 Oct 2022
Libtayo (cemiplimab) receives positive CHMP opinion recommending approval to treat advanced cervical cancer
14 October 2022 - Recommendation based on a Phase 3 Libtayo trial that was first and only to demonstrate significantly ...
Posted by Michael Wonder on 14 Oct 2022
Outcomes from the September 2022 PBAC intracycle meeting
14 October 2022 - The recommendations made by the PBAC in September 2022 relating to the listing of medicines on ...
Posted by Michael Wonder on 14 Oct 2022
Health Canada approves Illuccix for prostate cancer imaging
13 October 2022 - Telix Pharmaceuticals announces that Health Canada has approved Illuccix [kit for the preparation of gallium (Ga 68) ...
Posted by Michael Wonder on 14 Oct 2022
Decision to list a range of medical devices supplied by Biotronik
12 October 2022 - PHARMAC is pleased to announce the approval of a listing agreement with Biotronik for the supply ...