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Research targeting botanicals generally, as well as cannabis, as potential APIs is increasing, a factor in CDER’s publication of cannabis trials guidance, the FDA’s Norman Birenbaum says in an interview.
During Q4, biopharmas brought in an aggregate $17.5bn in financing and device company fundraising totaled $1.9bn; while in vitro diagnostic firms and research tools players raised $848m.
Weeks after Coherus BioSciences put pen to paper on a deal to bring in Formycon’s FYB203 proposed biosimilar to Eylea (aflibercept), the candidate has shown positive efficacy and safety data, according to preliminary Phase III trial results.
Roche is looking to challenge AstraZeneca's dominance in PNH with its subcutaneously administered once-a-month treatment but could struggle to rival the company's and Novartis’s oral therapy.
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