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Latest From VIASYS Healthcare, Inc.

Efficacy Overstatements In Evofem’s Phexxi Brochure, Otsuka’s Rexulti TV Ad Draw Untitled Letters

US FDA releases two letters on the same day citing two different kinds of advisements for two different kinds of products, but both with a classic problem: overstatement of efficacy. And while sending multiple letters at once can be seen as bid to draw attention to its enforcement action, the move also underscores just how few letters the agency has been sending lately.

Ad Complaints Enforcement

Advertising Untitled Letter For Exeltis Slynd Social Media Spot Renews Attention To Online Risk Disclosure

Oral contraceptive’s ad did not contain any risk information and was not submitted to US FDA beforehand, so the letter seems an easy call. But with two citations released in as many weeks, is the agency signaling an uptick in enforcement?

Advertising, Marketing & Sales Regulation

Finance Watch: 2021 Nearing Record Funding Levels For Regenerative Medicine

ARM counts $14.1bn in fundraising in the first half of 2021, up 35% from mid-year 2020. Also, Chinese mRNA players Abogen raises a $700m series C venture capital round, Pfizer prices a $1bn sustainability bond and while IPOs slow in the US, China and South Korea see new first-time offerings.

Financing Innovation

Forrest Bird, Inventor Of Mechanical Ventilators, Dies At 94

Forrest Bird, inventor of mechanical ventilators and a respirator known as the “BabyBird” for pediatric uses, and founder of Bird Medical Technologies Inc., passed away Aug. 2 at age 94. His initial respirators and ventilators were bought out and improved upon over the last 40 years by a series of device firms.

Medical Device Business Strategies
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