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 19 Jul 2021
Endologix receives FDA breakthrough device designation for ChEVAS system
19 July 2021 - Investigational EVAS system designed for patients with complex abdominal aortic aneurysm. ...
Posted by Michael Wonder on 19 Jul 2021
Aquestive Therapeutics announces FDA acceptance of new drug application resubmission for Libervant (diazepam) buccal film
19 July 2021 - Prescription Drug User Fee Act target goal date set for 23 December 2021. ...
Posted by Michael Wonder on 19 Jul 2021
G1 Therapeutics receives fast track designation from U.S. Food and Drug Administration for Cosela (trilaciclib) in combination with chemotherapy for the treatment of locally advanced or metastatic triple negative breast cancer
19 July 2021 - G1 Therapeutics today announced that the U.S. FDA has granted fast track designation to Cosela (trilaciclib) ...
Posted by Michael Wonder on 19 Jul 2021
BlueRock Therapeutics receives FDA fast track designation for DA01 in the treatment of advanced Parkinson’s disease
19 July 2021 - BlueRock Therapeutics announced that the U.S. FDA has granted fast track designation for DA01 for advanced Parkinson’s ...
Posted by Michael Wonder on 19 Jul 2021
Making sense of the FDA’s ‘indefensible’ decision to approve Aduhelm
19 July 2021 - There are three sides to every story that defies logic: the defenders’ side, the critics’ side and ...
Posted by Michael Wonder on 19 Jul 2021
EMA starts evaluating the use of Kineret in adult COVID-19 patients at increased risk of severe respiratory failure
19 July 2021 - EMA has started evaluating an application to extend the use of Kineret (anakinra) to include treatment ...
Posted by Michael Wonder on 19 Jul 2021
Lilly and Incyte provide update on supplemental new drug application for baricitinib for the treatment of moderate to severe atopic dermatitis
16 July 2021 - Eli Lilly and Incyte announced today that the U.S. FDA will not meet the Prescription Drug User ...
Posted by Michael Wonder on 19 Jul 2021
PHARMAC ensuring supply of prednisolone to treat children with respiratory conditions
19 July 2021 - PHARMAC is working hard to ensure on-going supply of an important medicine used to treat respiratory conditions ...
Posted by Michael Wonder on 19 Jul 2021
AbbVie provides update regarding Rinvoq (upadacitinib) for the treatment of moderate to severe atopic dermatitis in the U.S.
16 July 2021 - AbbVie today announced the U.S. FDA did not meet the Prescription Drug User Fee Act action ...
Posted by Michael Wonder on 19 Jul 2021
Decision to fund rasagiline
16 July 2021 - PHARMAC is pleased to announce the decision to fund rasagiline (Azilect) a new treatment for people ...
Posted by Michael Wonder on 19 Jul 2021
Imfinzi approved in China for the treatment of extensive-stage small cell lung cancer
19 July 2021 - Only PD-1/PD-L1 immunotherapy to demonstrate both a significant survival benefit and improved response rate in combination ...
Posted by Michael Wonder on 19 Jul 2021
Decision to widen access to rituximab for people with B-cell acute lymphoblastic leukaemia/lymphoma
9 July 2021 - PHARMAC is widening access to rituximab (Riximyo) to include treatment of people with newly diagnosed B-cell ...
Posted by Michael Wonder on 18 Jul 2021
UnitedHealth seeks more clarity on Biogen's $56,000 Alzheimer's drug coverage
16 July 2021 - UnitedHealth Group said it needed more time to determine its coverage policy for Biogen's recently approved $56,000 ...
Posted by Michael Wonder on 18 Jul 2021
Pfizer agrees to pay $345 million to resolve EpiPen pricing lawsuit
17 July 2021 - Pfizer has agreed to pay $345 million to resolve claims by consumers who say they overpaid ...
Posted by Michael Wonder on 18 Jul 2021
How to integrate evidence from patient preference studies into health technology assessment: a critical review and recommendations
15 July 2021 - Health technology assessment agencies vary in their use of quantitative patient preference data and the extent to ...