Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: BMI Organbank, Body Vision Medical.
While U.S. President Donald Trump’s country-by-country reciprocal and newly negotiated tariffs go into effect today, a separate, global biopharma sector tariff of, possibly, 200% continues to loom over the sector. For many stakeholders, a biopharma sector tariff of even 25%, as first proposed by Trump, would be a disaster in the making, especially when combined with the pressures of Medicare price negotiations and the president’s escalation of most-favored-nation pricing.
Good news bracketed July for Teleflex Inc. as it completed the acquisition of the vascular intervention business of Berlin-based Biotronik SE & Co. for €760 million (US$879 million) on July 1 and released stronger-than-expected second quarter results on the closing day of the month. Both bode well for the company as it proceeds through a thorough restructuring announced in February.
Negotiations for the sixth U.S. FDA device user fee agreement (MDUFA VI) are officially underway, and the Aug. 4 meeting highlighted some of the differences between the agency’s and industry’s expectations.
The FDA announced July 17 that Dexcom Inc. recalled a series of continuous glucose monitor receivers for a failure of speakers to issue an alert for out-of-specification blood glucose measures. This is a clear demonstration of the principle that greater device functionality often creates new types of risk.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Cardioprecision, Corcym, Evident, Inflammatix, Pramana, Quanterix, Transmedics.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alivedx, Roche.
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