Oral replacements for injectable drugs have long been an industry aspiration. The complex issues riased by the first oral MS drugs, as they try to take over territory pioneered by large molecules, reveal the challenges for companies pursuing other biologic-dominated businesses.
Christopher Morrison
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Mary Jane Hinrichs, Ipsen’s head of early development, talks to In Vivo about getting ahead of the competition by securing deals for candidates before they enter Phase I trials.
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The cell and gene therapy (CGT) clinical trial landscape in general and CAR-T cell clinical trials in particular are a special focus for the FDA, EMA, and other regulatory agencies. The whole industry is thus aware of the recent FDA safety investigation and requirements for labeling CAR therapy products.
During Q2, biopharma merger and acquisition deal value reached $24.6bn and drew in $60.7bn in potential deal value from alliances. Device company M&A values reached $223m, while in vitro diagnostics and research tools players’ M&A activity totaled $802m.
Facing rising costs and tighter regulations, PBMs and insurers are accelerating the shift to value-based drug coverage, demanding stronger proof of therapeutic and economic benefit from pharma.
Akelos is developing a first-in-class, non-addictive HCN1 inhibitor for peripheral neuropathic pain, based on anesthesiology research from Weill Cornell. The compound is designed to avoid the brain and heart, and has shown strong preclinical efficacy and safety with NIH backed development underway.
