Orphalan SA is laying the ground for a 2023 U.S. launch of Cuvrior for the treatment of Wilson’s disease, following FDA approval of the copper chelating drug. Cuvrior (trientine tetrahydrochloride) is a new salt of trientine that was designed to have superior properties to Syprine (trientine hydrochloride) from Bausch Health Companies Inc. and Cufence from Univar Solutions BV, which are approved as second-line treatments for the rare inherited copper transport disorder, in the U.S. and EU respectively.
China’s Amoy Diagnostics Co. Ltd. (Amoydx) signed a development and commercialization agreement under which Amoy will develop multiple companion diagnostics for Astrazeneca plc across China, the E.U. and Japan.
Astrazeneca plc led the handful of firms rolling out COVID-19-related news, as the company said detailed results from the Provent phase III pre-exposure prophylaxis (prevention) trial with Evusheld (tixagevimab and cilgavimab), were published in the New England Journal of Medicine, the “culmination of about 19 months of pretty intensive work,” said Mark Esser, vice president of microbial sciences.
Harbour Biomed Therapeutics Ltd. has out-licensed a preclinical bispecific antibody, HBM-7022, to Astrazeneca plc in a global licensing deal worth up to $350 million.
Harbour Biomed Therapeutics Ltd. has out-licensed a preclinical bispecific antibody, HBM-7022, to Astrazeneca plc in a global licensing deal worth up to $350 million.
Astrazeneca plc and Ionis Pharmaceuticals Inc. have unveiled some eye-catching figures from their cholesterol drug, AZD-8233, in a phase IIb trial, taking aim at the PCSK9 inhibitor market where Novartis AG, Sanofi SA/Regeneron Inc. and Amgen Inc. are vying for supremacy.
Janssen Pharmaceutical Cos, Inc.’s CAR T-cell therapy, Carvykti (ciltacabtagene autoleucel), looks set for approval in Europe after endorsement by regulators for advanced multiple myeloma. At its monthly meeting, the EMA’s Committee for Medicinal Products for Human Use recommended Carvykti for adults with relapsed and refractory disease who have received at least three prior therapies and whose cancer has worsened since their last treatment.
Janssen Pharmaceutical Cos, Inc.’s CAR T-cell therapy, Carvykti (ciltacabtagene autoleucel), looks set for approval in Europe after endorsement by regulators for advanced multiple myeloma. At its monthly meeting, the EMA’s Committee for Medicinal Products for Human Use recommended Carvykti for adults with relapsed and refractory disease who have received at least three prior therapies and whose cancer has worsened since their last treatment.
Astrazeneca plc is selling its disease management platform Amaze to U.K. digital therapeutics company Huma Therapeutics Ltd. through a new collaboration agreement. The companies said they will work together to launch Software as a Medical Device (SaMD) companion apps for several therapeutic areas and accelerate adoption of decentralized clinical trials (DCTs). The partnership marks Astrazeneca’s first major deal in the digital health space.
As it settles a patent dispute with Japan’s Chugai Pharmaceutical Co. for $775 million, the U.K.’s Astrazeneca plc is looking to bring intellectual property in-house by snapping up a new generation of talented scientists.