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 15 Sep 2021
Regeneron announces new U.S. Government agreement to purchase additional doses of REGEN-COV (casirivimab and imdemivab) antibody cocktail
14 September 2021 - New agreement for 1.4 million doses of REGEN-COV, brings total purchased by the U.S. government to nearly ...
Posted by Michael Wonder on 15 Sep 2021
Final report on the Australian Government response to the recommendations of the Senate Community Affairs References Committee Report
15 September 2021 - The Government acknowledges the efforts and actions detailed in this progress report to implement the Senate ...
Posted by Michael Wonder on 15 Sep 2021
PDUFA goal date extension for Nefecon NDA in the U.S.
14 September 2021 - Calliditas Therapeutics today announced that the U.S. FDA has extended the PDUFA goal date for its ...
Posted by Michael Wonder on 15 Sep 2021
Health Canada approves Lumakras (sotorasib), the first and only targeted treatment for patients with KRAS G12C mutated locally advanced or metastatic non--small cell lung cancer
14 September 2021 - Once daily dosing option now available to address KRAS G12C, a driver of tumour growth found ...
Posted by Michael Wonder on 15 Sep 2021
Medicines Australia and AusBiotech say COVID-19 vaccine patent waiver will not speed up global vaccination
15 September 2021 - Medicines Australia and AusBiotech, the peak bodies representing the Australian innovative pharmaceutical and biotechnology sectors, urge ...
Posted by Michael Wonder on 14 Sep 2021
Drug prices and value of oncology drugs in Italy
13 September 2021 - The main objective of this study was to evaluate the potential role of efficacy data and other ...
Posted by Michael Wonder on 14 Sep 2021
Trodelvy approved by the TGA
14 September 2021 - Sacituzumab govitecan is a new treatment option for adult patients with unresectable locally advanced or metastatic triple negative ...
Posted by Michael Wonder on 14 Sep 2021
EMA study reveals need for RWE framework, submission structure
14 September 2021 - The EMA has identified a need for more consistency in how real world evidence is submitted. ...
Posted by Michael Wonder on 14 Sep 2021
Moderate House Democrats threaten drug pricing bill in House panel
14 September 2021 - Three moderate House Democrats announced that they would vote against their party's legislation to lower drug ...
Posted by Michael Wonder on 14 Sep 2021
ISA Pharmaceuticals receives fast track designation for lead product ISA101b
14 September 2021 - Fast track designation for the treatment of recurrent and metastatic HPV16 positive oropharyngeal cancer to improve ...
Posted by Michael Wonder on 14 Sep 2021
Axsome Therapeutics announces FDA acceptance of new drug application for AXS-07 for the acute treatment of migraine
14 September 2021 - Axsome Therapeutics today announced that the U.S. FDA has accepted for filing the Company’s new drug application ...
Posted by Michael Wonder on 14 Sep 2021
New therapy to treat advanced small cell lung cancer approved for Australian patients
14 September 2021 - Zepzelca approval granted under a provisional regulatory pathway. ...
Posted by Michael Wonder on 14 Sep 2021
Nyxoah announces U.S. FDA breakthrough device designation granted for the Genio system for obstructive sleep apnea and complete concentric collapse
14 September 2021 - Nyxoah today announced that the U.S. FDA has granted the Genio bilateral hypoglossal nerve stimulation system breakthrough ...
Posted by Michael Wonder on 14 Sep 2021
MTAA supports call for future of private health summit
13 September 2021 - The Medical Technology Association of Australia (MTAA) today supported calls from AMA President, Dr Omar Khorshid, ...
Posted by Michael Wonder on 14 Sep 2021
Biden drug pricing plan seeks to balance access and innovation
13 September 2021 - On Thursday 9 September, Health and Human Services Secretary Xavier Becerra publicly released the Biden Administration’s ...