Go to any gathering of medical device start-up CEOs and their investors, and beneath a veneer of passionate intensity about individual technology lie concern, anxiety, and in some cases, real pessimism. Central to the debate: is the device innovation model broken? Six years ago, one of the most celebrated device entrepreneurs, Tom Fogarty, MD, working with officials at El Camino Hospital in Mountain View, CA, an independent community hospital located in the heart of the San Francisco device community, launched the Fogarty Institute for Innovation, an initiative designed to help the earliest-stage companies ramp up technology development quickly and efficiently in an effort to minimize, if not eliminate the external challenges. To date, the Institute has started or nurtured five companies.
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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.
