Citeline, a Norstella company

A White House spokesperson provided Medtech Insight with a vague response to multiple reports suggesting Marty Makary’s tenure as US FDA commissioner is coming to an end, while a current reviewer at the agency said Makary’s ouster would be a “disaster.”

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 60 documents have been posted on the tracker since its last update.

Pink Sheet reporter and editors discuss the calls for FDA Commissioner Martin Makary to resign, as well as the many reforms and hiring initiatives he discussed during a busy week of appearances.

Scrip spoke with rare disease head Giacomo Chiesi about buying KalVista and its HAE drug, the abundance of rare diseases opportunities and his hope that more companies enter the space.

“We have no plans to try to price through” a $25m to $30m headwind from costs and inflation, says CEO Richard Dierker. But it grows to $50 million to $150 million, “who knows where it stops, then you have to solve a different problem with different solutions.”

Confidence in the prospects for Germany’s in vitro diagnostics businesses has dipped to its lowest level since the VDGH industry association began surveying market sentiment. The IVDR and lower reimbursement are part of the problem. The industry says it’s time for action.

McKinsey & Co partner Bart Van de Vyver adds insight to dealmaking and growth trends as the firm releases its latest assessment of what’s driving strategic decision-making at the top end of the healthcare products industries.

Forty thousand laptops wiped. Manufacturing shut down. EPS down 8.5%. Yet Stryker walked out of its Q1 earnings call with full-year guidance intact, no identifiable customer losses and a CEO who said the company's brand emerged from the crisis stronger than it went in.