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 24 Jan 2023
Reform Medicare to sustain system
25 January 2023 - Australia’s hybrid public/private healthcare system, including the principle of universal coverage through Medicare, has served the nation ...
Posted by Michael Wonder on 24 Jan 2023
Sequential, multiple assignment, randomised trial designs
24 January 2023 - An adaptive intervention is a set of diagnostic, preventive, therapeutic, or engagement strategies that are used in ...
Posted by Michael Wonder on 24 Jan 2023
Fabre-Kramer Pharmaceuticals announces FDA acceptance of NDA resubmission as complete response and assignment of PDUFA regulatory action date
24 January 2023 - Submission of Exxua (gepirone hydrochloride), a novel targeted single serotonin receptor agonist for treatment of major ...
Posted by Michael Wonder on 24 Jan 2023
Verrica Pharmaceuticals announces resubmission of new drug application for VP-102 for the treatment of molluscum contagiosum
24 January 2023 - Potential first FDA approved therapy for treatment of molluscum contagiosum. ...
Posted by Michael Wonder on 24 Jan 2023
Private insurance can contribute to a healthier system
24 January 2023 - Given what many describe as a crisis in primary care, it’s well past time to revisit the ...
Posted by Michael Wonder on 23 Jan 2023
Conditional power: how likely is trial success?
23 January 2023 - Because of the costs and potential risks to participants, clinical trials should be initiated or continued only ...
Posted by Michael Wonder on 23 Jan 2023
Despite court ruling, FDA will continue with its approach to approving orphan drug exclusivity
23 January 2023 - In an unexpected move, the FDA will continue to apply exclusive marketing rights for so called ...
Posted by Michael Wonder on 23 Jan 2023
Calls to allow private health insurance to cover fee gaps
24 January 2023 - Health funds are pushing to be able to cover doctors’ gap fees as part of national ...
Posted by Michael Wonder on 23 Jan 2023
Pharma’s strategy to exploit a depression era antitrust law would raise drug costs for consumers
23 January 2023 - The prescription drug market is bewildering to many, and its complexity can make rational discussions about the ...
Posted by Michael Wonder on 23 Jan 2023
EMA publishes agenda for 23-26 January 2023 CHMP meeting
23 January 2023 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 23 Jan 2023
ICER publishes final evidence report on fezolinetant for vasomotor symptoms associated with menopause
23 January 2023 - Independent appraisal committee voted that evidence is not yet adequate to demonstrate a net health benefit ...
Posted by Michael Wonder on 23 Jan 2023
Cadrenal Therapeutics granted FDA fast track designation for tecarfarin for prevention of systemic thromboembolism of cardiac origin in patients with end stage renal disease and atrial fibrillation
23 January 2023 - Cadrenal Therapeutics announced today that the US FDA has granted a fast track designation to tecarfarin ...
Posted by Michael Wonder on 23 Jan 2023
TheracosBio announces FDA approval of Brenzavvy (bexagliflozin) for the treatment of adults with type 2 diabetes
23 January 2023 - Once daily, oral SGLT2 inhibitor shown to reduce blood sugar and improve glycemic control as an adjunct ...
Posted by Michael Wonder on 23 Jan 2023
Blueprint Medicines announces FDA acceptance of supplemental new drug application for Ayvakit (avapritinib) for the treatment of indolent systemic mastocytosis
23 January 2023 - FDA grants priority review and sets PDUFA action date of 22 May 2023. ...
Posted by Michael Wonder on 23 Jan 2023
The EMA validated regulatory application for arpraziquantel, a potential treatment for schistosomiasis in pre-school aged children
23 January 2023 - Arpraziquantel is the first investigational drug in regulatory phase amongst the different projects supported by the Global ...