Blog
RSS FeedPosted by Michael Wonder on 09 Dec 2023
Medicines lobby says the PBS has not kept up with advances — or approvals — in medicines
8 December 2023 - Little Jack Roche was five weeks old when diagnosed with cystic fibrosis. The medication that could help ...
Posted by Michael Wonder on 08 Dec 2023
EnGeneIC granted FDA fast track designation for novel armed nanocell drug conjugate pancreatic cancer therapeutic
7 December 2023 - EnGeneIC has achieved a significant milestone with the granting of FDA fast track designation for its ...
Posted by Michael Wonder on 08 Dec 2023
US sets policy to seize patents of Government funded drugs if price deemed too high
8 December 2023 - The Biden Administration on Thursday announced it is setting new policy that will allow it to ...
Posted by Michael Wonder on 08 Dec 2023
CVS’s new drug payment plan won’t lower patients’ prices, experts warn
5 December 2023 - CVS Health is promising to simplify how its pharmacies get paid for drugs. But that doesn’t ...
Posted by Michael Wonder on 08 Dec 2023
FDA approves expanded use of Cresemba (isavuconazonium sulphate) in children with invasive Aspergillosis and invasive Mucormycosis
8 December 2023 - Approval based on results of two paediatric studies in children aged 1 to 17. ...
Posted by Michael Wonder on 08 Dec 2023
Phathom Pharmaceuticals announces FDA acceptance for filing of Voquenza (vonoprazan) tablets new drug application for the treatment of heartburn associated with non-erosive GERD
6 December 2023 - July 19, 2024 PDUFA target action date assigned by the FDA. ...
Posted by Michael Wonder on 08 Dec 2023
European Commission approves Pfizer’s Elrexfio for relapsed and refractory multiple myeloma
8 December 2023 - Conditional marketing authorisation is based on clinically meaningful response rates, duration of response, and safety from the ...
Posted by Michael Wonder on 08 Dec 2023
FDA Approves Bio-Thera Solutions' Avzivi (bevacizumab-tnjn), a biosimilar referencing Avastin
7 December 2023 - Avzivi is the second biosimilar researched, developed, and manufactured by a Chinese pharmaceutical company to receive FDA ...
Posted by Michael Wonder on 08 Dec 2023
Alpha Cognition announces FDA acceptance of new drug application for ALPHA-1062 for mild to moderate Alzheimer’s disease
7 December 2023 - Alpha Cognition is pleased to announce that the US FDA has completed its filing review and has ...
Posted by Michael Wonder on 08 Dec 2023
Health Canada approves FYB201/Ranopto (ranibizumab), a biosimilar to Lucentis
7 December 2023 - Formycon, Polpharma Biologics, Bioeq and Teva Canada jointly announce that Health Canada has granted the Notice ...
Posted by Michael Wonder on 08 Dec 2023
Lilly announces Health Canada's authorisation of Verzenio (abemaciclib) label expansion
7 December 2023 - Verzenio's label expanded to include the full study population investigated in the Verzenio Phase 3 monarchE trial. ...
Posted by Michael Wonder on 07 Dec 2023
Ipsen confirms US FDA grants priority review for new drug application for elafibranor for the treatment of rare cholestatic liver disease, PBC
7 December 2023 - New drug application granted priority review with PDUFA date set for 10 June 2024. ...
Posted by Michael Wonder on 07 Dec 2023
‘Learning each other’s language’: FDA, patent office seek to work together to lower drug prices
7 December 2023 - In 1997, Celgene obtained a key patent for what would become a blockbuster blood cancer treatment, ...
Posted by Michael Wonder on 07 Dec 2023
Biden Administration could seize patents for high priced drugs
7 December 2023 - The Biden administration proposed a rule Thursday that could let the Government seize patents for medicines developed ...
Posted by Michael Wonder on 07 Dec 2023
Evolving our approach to COVID-19 vaccines and treatments
6 December 2023 - As New Zealand’s response to the COVID-19 pandemic has evolved, so has ours. ...