by Stephen Levin
Change is an inevitable part of business and it is often true that companies that resist change generally come to...
Edwards: Transcatheter Valve Leader Proves You Can Go Home Again
After exploring a number of new product markets to drive growth in the decade since its spin-off from Baxter, Edwards has found its sweet spot in its own backyard: heart valves. Through an aggressive early acquisition, the company has emerged as the leader in what looks to be the next major device product market: - transcatheter valves. But in building a transcatheter valve business, Edwards must maintain its surgical customers while also selling to new physician customers: interventionalist cardiologists - a clinical specialty with a history of competing with surgery.
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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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In Partnership with Cerba Research
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.
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While the adoption of most favored nation drug pricing in the US stands to affect Japanese biopharma firms now heavily reliant on this market, it might also present an opportunity for pricing and policy reforms at home.
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Ovid Therapeutics' president and COO Meg Alexander is leading the company’s strategic pivot toward innovative neurological treatments, potentially creating a new class of medicines for rare neurological disorders.
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Thijs Spoor's bet on lead-212 is paying off as Perspective Therapeutics advances three clinical programs with promising early efficacy signals and a comprehensive manufacturing strategy.