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 01 Mar 2022
Triple negative breast cancer: survival benefit with sacituzumab govitecan
1 March 2022 - Those affected survive a median of twelve months compared to seven in the control group. Overall, ...
Posted by Michael Wonder on 01 Mar 2022
Regulation on EMA’s extended mandate becomes applicable
1 March 2022 - The regulation reinforcing EMA’s role in crisis preparedness and management of medicinal products and medical devices becomes ...
Posted by Michael Wonder on 01 Mar 2022
EMA accepts marketing authorisation application for daprodustat
1 March 2022 - Submission for the treatment of anaemia of chronic kidney disease based on the ASCEND Phase III clinical ...
Posted by Michael Wonder on 01 Mar 2022
Gilead receives complete response letter from U.S. FDA for investigational lenacapavir due to vial compatability issues
1 March 2022 - Complete response letter cites issues related to compatibility of vials and lenacapavir solution. ...
Posted by Michael Wonder on 01 Mar 2022
ABPI response to England Rare Diseases Action Plan
28 February 2022 - England's Rare Disease Action plan is published today with details of how to improve diagnosis, care and ...
Posted by Michael Wonder on 01 Mar 2022
CHMP recommends Idorsia’s dual acting treatment Quviviq for insomnia patients
28 February 2022 - Quviviq can be used on a long-term basis, addressing a key limitation of existing therapies ...
Posted by Michael Wonder on 01 Mar 2022
Carvykti (ciltacabtagene autoleucel), BCMA directed CAR-T therapy, receives U.S. FDA approval for the treatment of adult patients with relapsed or refractory multiple myeloma
28 February 2022 - Approval is primarily based on the pivotal Phase 1b/2 CARTITUDE-1 study, which demonstrated an overall response rate ...
Posted by Michael Wonder on 01 Mar 2022
CTI BioPharma announces FDA accelerated approval of Vonjo (pacritinib) for the treatment of adult patients with myelofibrosis and thrombocytopenia
28 February 2022 - New drug application approved under priority review. ...
Posted by Michael Wonder on 01 Mar 2022
U.S. Food and Drug Administration accepts for priority review Bristol Myers Squibb’s application for Opdivo (nivolumab) plus chemotherapy as neo-adjuvant treatment for resectable non-small cell lung cancer
28 February 2022 - Application based on CheckMate-816, the first Phase 3 trial with an immunotherapy-based combination to demonstrate improved event-free ...
Posted by Michael Wonder on 01 Mar 2022
Lexicon voluntarily withdraws sotagliflozin new drug application and plans prompt resubmission targeted early Q2 2022
28 February 2022 - Resubmission to Correct Recently-Identified Technical Issue. ...
Posted by Michael Wonder on 01 Mar 2022
New PBS listings from 1 March 2022
1 March 2022 - Australians will have access to four new medicines through the Pharmaceutical Benefits Scheme from March 1 to ...
Posted by Michael Wonder on 01 Mar 2022
Kiwis call on Government to increase PHARMAC funding to help fund Spinraza treatment
1 March 2022 - A group of Kiwis are calling on the Government to increase PHARMAC funding to provide better ...
Posted by Michael Wonder on 01 Mar 2022
Glucophage is the first oral diabetes treatment approved in Europe for use during pregnancy
28 February 2022 - The approval was granted on the basis of Merck’s own safety cohort study CLUE and a large ...
Posted by Michael Wonder on 01 Mar 2022
AbbVie provides update regarding Skyrizi (risankizumab-rzaa) for the treatment of moderate to severe Crohn's disease in the U.S.
28 February 2022 - AbbVie today announced that the U.S. FDA has extended its review period for Skyrizi (risankizumab-rzaa) for ...
Posted by Michael Wonder on 28 Feb 2022
Flu vaccine price increase
1 March 2022 - PHARMAC has confirmed that the purchase price of the annual influenza vaccine will increase by $2 ...