AC Immune wins FDA fast track for Alzheimer’s vaccine candidate
AC Immune’s phosphorylated Tau (pTau)-targeting vaccine has secured a fast track designation from the US Food and Drug Administration (FDA)…
25 Jul 2024
Ipsen outlines $461m for ex-US rights to Day One’s glioma therapy
Ipsen is looking to expand its paediatric medication portfolio and has signed a licensing agreement potentially worth $461m with Day One Biopharmaceuticals for its paediatric glioma therapy Ojemda (tovorafenib). Ipsen…
25 Jul 2024
Sandoz launches ustekinumab biosimilar in Europe
Sandoz has announced the European launch of Pyzchiva, a ustekinumab biosimilar approved for the treatment of several autoimmune conditions including psoriasis and Crohn’s disease. Pyzchiva is a biosimilar of Johnson…
25 Jul 2024
ConSynance wins FDA designation for Prader-Willi syndrome therapy
The US Food and Drug Administration (FDA) has granted ConSynance Therapeutics a rare paediatric disease designation for its oral therapy for the treatment of Prader-Willi syndrome. As per the designation,…
25 Jul 2024
FDA agrees wider use of BioMarin’s BRINEURA for CLN2
The US Food and Drug Administration (FDA) has expanded its approval of BioMarin Pharmaceutical's supplemental biologics licence application (sBLA) for enzyme replacement therapy, BRINEURA (cerliponase alfa), to include children aged…
25 Jul 2024
NICE recommends Boehringer’s tenecteplase for NHS stroke care
The UK National Institute for Health and Care Excellence (NICE) has issued final guidance endorsing Boehringer Ingelheim’s tenecteplase, marketed as Metalyse, as a treatment option for adult patients suffering from…
25 Jul 2024
Dren Bio and Novartis link on bispecific antibodies for cancer
Dren Bio has partnered strategically with Novartis subsidiary Novartis Pharma to discover and develop therapeutic bispecific antibodies to treat cancer. The partnership will leverage Dren Bio's targeted myeloid engager and…