LONDON – The U.K. life sciences sector has stepped into “a new reality” following publication of the government’s negotiating mandate on the future trading relationship with the EU. “Plan A is no longer on the table,” said Steve Bates, chief executive of the Bioindustry Association, who has spent three long years lobbying for a favorable deal for the industry. Read More
The Senate passed by a vote of 96-1 the spending bill for the outbreak of the new coronavirus (COVID-19), which will be on President Donald Trump’s desk by week’s end. The bill provides $7.8 billion in new funds to tackle the outbreak and another $490 million in existing funds for telehealth, all with the aim of speeding the response to the pathogen. Read More
The first wave of biosimilars began lapping at U.S. shores five years ago when the FDA approved Sandoz Inc.’s Zarxio on March 6, 2015, giving it a label identical to that of its reference biologic, Amgen Inc.’s Neupogen (filgrastim). But the tsunami of biosimilars, and the multibillion dollars of savings they were expected to bring, has yet to wash ashore. Read More
Orionis Biosciences Inc. has begun a four-year collaboration with Novartis AG to discover and design small-molecule therapeutics such as protein degraders that target several therapeutic areas, including cancer. The agreement’s terms include research funding a convertible note investment, royalties and potential clinical milestones. Read More
PERTH, Australia – The FDA granted Melbourne-based Neuren Pharmaceuticals Ltd. and San Diego, California-based Acadia Pharmaceuticals Inc. a rare pediatric disease designation for trofinetide for treatment of Rett syndrome, a rare neurodevelopmental congenital central nervous system disorder. Read More
Keros Therapeutics Inc. CEO Jasbir Seehra told BioWorld that he plans to use at his new company lessons learned as co-founder of Acceleron Pharma Inc., where work with receptors in the TGF-beta superfamily “taught me the potential of the biology and those molecules, but also the limitations” with regard to safety that need to be surmounted. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Actinium, Arch, Auris, Debiopharm, Dynacure, Psioxus. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Allogene, Cellectis, City of Hope, Eleusis, Melinta, Scynexis, Servier. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Allergan, Cardiol, Outlook, TG, Urovant, Zydus. Read More
