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RSS FeedPosted 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 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
Statement from President Joe Biden on FDA approval of gene therapies to treat sickle cell disease
8 December 2023 - As we’ve seen throughout our history, when the US Government invests in innovation, we can achieve breakthroughs ...
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 first gene therapies to treat patients with sickle cell disease
8 December 2023 - Today, the US FDA approved two milestone treatments, Casgevy and Lyfgenia, representing the first cell-based gene therapies ...
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
Adaptimmune completes submission of rolling biologics license application to US FDA for afami-cel for the treatment of advanced synovial sarcoma
6 December 2023 - First BLA for an engineered T-cell therapy for solid tumours submitted to US 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
Updates to the HTA Policy and Methods Review Reference Committee (8 December 2023)
8 December 2023 - The agenda for the HTA Review Reference Committee meeting (meeting 29) held on 1 December 2023 is ...