Sometimes just getting FDA approval isn't enough. AccessClosure got FDA clearance of its PMA vascular closure device, only to delay the product's launch in order to develop an improved version. The company forestalled one-and-a-half years of revenue to address physicians' concerns and introduce an improved product. This was particularly wise in the field of vascular access closure devices, where previous devices have disappointed. The decision appears to be paying off as the company is seeing rapid adoption even though its product is priced at a premium.
By Stephen Levin
Of the nine companies that the company and product development organization Incept has launched in its 11 year history,
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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.
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.
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.
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.
