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Pharma watch: Delayed vaccine decisions, insulin price lawsuit, drug cap win
Updates on US pharmaceutical policy, compliance, and regulation.
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Indian pharma faces challenge from Trump tariffs and US regulators
The US is the third largest importer of drugs made in India. But President Trump’s tariffs plan could derail bilateral trade ties.
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GRIP Extra: SEC Commissioner cautions against rapid deregulation, Greenpeace held liable for $650m
Other news includes the SEC ceasing its defenses of its climate disclosure rule, Fidelity launching its own stablecoin, and UBS limiting its size to skirt capital requirements.
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Celito Tech’s Ravi Monangi and Ethan Grammer on compliant growth in life science
We explored how small and mid-sized pharmaceutical and biotech companies can avoid costly early compliance mistakes and minimize risk as they scale.
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Regulatory uncertainty brings risk and opportunity to pharma in 2025, says Jeff Lemay
CCO Jeff Lemay reflects on his time at Jazz Pharmaceuticals and asseses the road ahead for compliance and legal teams in the pharma sector.
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FDA updates guide on comms about unapproved use of approved medical products
Final guidance clarifies FDA approach and addresses issues the industry raised regarding a draft version.
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SEC dings Becton Dickinson $175m for misrepresenting product risks
The company failed to properly inform investors about regulatory challenges it was experiencing with the FDA.
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SEC charges Kiromic BioPharma for failing to disclose FDA holds
Two former executives were fined, but the company itself will not receive a civil penalty due to its self-reporting.