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
Lilly to supply 388,000 doses of etesevimab to U.S. Government for treatment of COVID-19
15 September 2021 - Additional doses of etesevimab will be paired with existing bamlanivimab purchased by the U.S. Government ...
Posted by Michael Wonder on 15 Sep 2021
FDA advances data, IT modernisation efforts with new Office of Digital Transformation
15 September 2021 - FDA prioritises effective and efficient use of data by reorganising IT, data and cybersecurity functions to ...
Posted by Michael Wonder on 15 Sep 2021
Drug prices measure blocked in House Committee as Democrats splinter
15 September 2021 - Provision of $3.5 trillion budget package would allow Medicare to negotiate over the cost of prescriptions. ...
Posted by Michael Wonder on 15 Sep 2021
Venetoclax in acute myeloid leukaemia: indication of a considerable added benefit
15 September 2021 - Third new area of application/those affected still live a good year on average - and thus ...
Posted by Michael Wonder on 15 Sep 2021
U.S. FDA grants Brukinsa (zanubrutinib) accelerated approval in relapsed or refractory marginal zone lymphoma
15 September 2021 - This marks the third FDA approval for Brukinsa and first approval in marginal zone lymphoma. ...
Posted by Michael Wonder on 15 Sep 2021
NICE backs Opdivo for head and neck cancer
15 September 2021 - NICE has recommended Bristol Myers Squibb’s (BMS) immunotherapy Opdivo (nivolumab) for routine use on the NHS ...
Posted by Michael Wonder on 15 Sep 2021
Aduhelm backlash threatens to reverse progress in FDA’s reviews of rare and ultra-rare disease drugs
14 September 2021 - The FDA’s approval of Aduhelm to treat Alzheimer’s disease has unleashed criticism about the decision and ...
Posted by Michael Wonder on 15 Sep 2021
ObsEva announces submission of new drug application to U.S. FDA for linzagolix for the treatment of uterine fibroids
15 September 2021 - NDA submission includes positive data from Phase 3 PRIMROSE trials up to 52 weeks on treatment 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 ...