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 25 Feb 2022
Assessment of public opinion on transparency at the US Food and Drug Administration
18 February 2022 - Historically, the US FDA has considered much of the oversight of clinical trials, interactions with companies, and ...
Posted by Michael Wonder on 25 Feb 2022
New medicine for rare type of eye cancer
25 February 2022 - EMA has recommended granting a marketing authorisation in the European Union (EU) for Kimmtrak (tebentafusp), a monotherapy ...
Posted by Michael Wonder on 25 Feb 2022
NICE draft guidance recommends tucatinib for advanced breast cancer
25 February 2022 - Taken as two 150 mg tablets twice daily together with anti-cancer medicines trastuzumab and capecitabine, tucatinib ...
Posted by Michael Wonder on 25 Feb 2022
PBAC recommendation for molnupiravir (Lagevrio)
25 February 2022 - The PBAC undertook an expedited consideration of a sponsor submission (MSD) to add molnupiravir (Lagevrio) to the ...
Posted by Michael Wonder on 25 Feb 2022
Updating the Bayh-Dole Act; march-in rights and transparency
24 February 2022 - The Patent and Trademark Law Amendments Act (Bayh-Dole Act [35 USC §200-212]) was enacted in 1980 and ...
Posted by Michael Wonder on 25 Feb 2022
Protalix BioTherapeutics and Chiesi Global Rare Diseases announce the submission of a marketing authorisation application to the European Medicines Agency for PRX-102 for the treatment of Fabry disease
24 February 2022 - Protalix BioTherapeutics and Chiesi Global Rare Diseases today announced the submission of a marketing authorisation application via ...
Posted by Michael Wonder on 25 Feb 2022
Noninvasix receives FDA breakthrough device designation for non-invasive monitoring technology for sepsis
23 February 2022 - LIVOx is first monitoring device to non-invasively monitor sepsis by detecting a key indicator of septic ...
Posted by Michael Wonder on 25 Feb 2022
TGA provisionally approves AstraZeneca's combination therapy (tixagevimab and cilgavimab, Evusheld) - for pre-exposure prevention (prophylaxis) of COVID-19
25 February 2022 - On 24 February 2022, the TGA granted provisional approval to AstraZeneca for its tixagevimab and cilgavimab ...
Posted by Michael Wonder on 25 Feb 2022
MAP offers new online pathway for accessing cancer treatments
25 February 2022 - Medicines Australia and Rare Cancers Australia yesterday provided pharmaceutical industry stakeholders a preview of a new ...
Posted by Michael Wonder on 24 Feb 2022
Cystic fibrosis community disappointed with PTAC recommendations
23 February 2022 - New Zealand’s cystic fibrosis community received disappointing news today with a recommendation to PHARMAC that reduces ...
Posted by Michael Wonder on 24 Feb 2022
Viz.ai receives FDA 510(k) clearance for Viz Aneurysm
24 February 2022 - Viz.ai today announced it has received U.S. FDA 510(k) clearance for Viz Aneurysm. ...
Posted by Michael Wonder on 24 Feb 2022
United Therapeutics Corporation reports fourth quarter and full year 2021 financial results
24 February 2022 - Major amendment to Tyvaso DPI new drug application pushes FDA decision date to May 2022. ...
Posted by Michael Wonder on 24 Feb 2022
AbbVie announces provincial reimbursement for Venclexta (venetoclax) with obinutuzumab for patients with previously untreated chronic lymphocytic leukaemia in Alberta, Saskatchewan, British Columbia and Manitoba
24 February 2022 - AbbVie announced today that Alberta, Saskatchewan, British Columbia, and Manitoba now reimburse Venclexta (venetoclax) in combination ...
Posted by Michael Wonder on 24 Feb 2022
Valeo Pharma obtains public reimbursement for Enerzair Breezhaler and Atectura Breezhaler in Ontario, Manitoba and New Brunswick
24 February 2022 - Private insurance coverage across Canada exceeds 90%. ...
Posted by Michael Wonder on 24 Feb 2022
Insulin cost cap splits Democrats seeking broad drug price curbs
24 February 2022 - ‘Partial solution’ seen problematic as elections loom. ...