There’s been a change of plans. Following a preliminary review of briefing materials for a type C meeting, the FDA told Reata Pharmaceuticals Inc. that a pre-NDA meeting is instead the next best step in the development of omaveloxolone (RT-408) for treating Friedreich’s ataxia (FA).
Building on a deal first struck in 2019, artificial intelligence (AI) specialist Exscientia Ltd. has agreed to take responsibility for a multitarget drug discovery collaboration with Bristol Myers Squibb Co. that could be worth more than $1.2 billion in all. The expanded collaboration, first established with BMS-acquired Celgene Corp., includes $50 million in up-front funding, up to $125 million in near to mid-term potential milestones, plus additional clinical, regulatory and commercial payments. It remains focused on small-molecule drug candidates in areas including oncology and immunology.
Although more than a third of U.S. citizens are fully vaccinated from COVID-19 and society moves closer to normalcy in many parts of the world, the SARS-CoV-2 virus continues to dramatically impact biopharma dealmaking with nonprofit entities, as well as grant awards.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beigene, Bioxcel, Genetx, Iovance, Myovant, Polypid, Reata, Ultragenyx.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acceleron, Apeiron, Astrazeneca, Biomarin, CNS, Cytokinetics, Galapagos, Idera, Immunocore, Pfizer, Silence, Veru.
Amid the trend of investors partnering with Western biotech companies to set up China-focused joint ventures, San Diego-based Kinnate Biopharma Inc. has joined Orbimed Asia Partners, Orbimed Private Investments and Foresite Capital to establish a JV in Shanghai to move its preclinical kinase inhibitor candidates forward in greater China.
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