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Brian Bossetta

Senior Writer, US Policy & Regulation

New York, NY

After moving to New York from his hometown of New Orleans, Brian worked on the East End of Long Island covering news, politics and the military. He has since covered the diamond and jewelry industries and most recently pharmacy and health care. His experience also includes freelance reporting and photography contributed to the New York Times.

Brian holds a BA in history from Loyola University of New Orleans, is a die-hard Saints fan, and loves running, classical music and jazz. He lives with his wife, Caroline, in New York’s magnificent Hudson Valley.

Latest From Brian Bossetta

Facility Inspection Leads To FDA Warning For iRhythm

The US FDA issued a warning letter to iRhythm Technologies related to its Zio cardiac monitor system after an August 2022 inspection of the firm’s California facility. Wells Fargo predicts little impact on the company.

FDA Regulation

News We’re Watching: Medtronic To Buy EOFLow, Neuralink Cleared For Human Trials, NICE Backs Genetic Tests

This week, Medtronic said it would pay $738m for insulin patch firm EOFlow; Neuralink got an FDA OK for first-in-human trials; and UK agency NICE backed genetic tests for stroke patients and digital therapeutics for mental health conditions.

Regulation Commercial

White House Takes Steps To Advance ‘Responsible’ AI That ‘Upholds Democratic Values’

The White House Office of Science and Technology Policy has released an updated national strategic framework outlining priorities and goals for federal investment in AI. Industry executive Peter Shen weighs in on the plan.

FDA Policy

Integra LifeSciences Recalls Products From Boston Facility, Takes Financial Hit

After consulting with the US FDA, Integra Life Sciences initiated a recall of products produced in its Boston Facility. The company expects losses of $22m.

FDA Regulation

No More Carb Counting: FDA Clears Next Generation Insulin Pump

The US FDA granted 510(k) clearance to Beta Bionics iLet ACE Pump and dosing decision software for treating type 1 diabetes with less diet monitoring.

FDA Regulation

News We’re Watching: Premom Data Privacy Settlement, Labcorp Owes $372m For Patent Violations, Elixir Stent Trial Success

This week, the DC Attorney General announced a settlement with ovulation-tracking app Premom; a novel scoliosis treatment won FDA approval; research showed Fractyl Health’s Rejuva delivery system can deliver gene therapy directly to the pancreas; and BearCare recalled a thermometer over burn risks.

Commercial Regulation
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