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FDA turns focus on biologics in spate of warning letters
The three letters point to an enforcement posture toward manufacturers marketing biologics derived from human placentas and umbilical cords.
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CVS Health resolves $37.76m settlement with DOJ for over-dispensing insulin pens to patients
CVS admitted to dispensing more insulin to patients than needed and receiving ineligible reimbursements.
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Fujifilm blazes a trail through pharma’s ethical quagmire
As advancements in research and drug development become more complex, bioethicists are helping companies find their footing along an increasingly ambiguous path.
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IAPP EU Data Protection Congress 2025: Assessing Europe’s Health Data Space
An animated discussion on the theoretical benefits of the regulation and the gap between legislative dream and market reality.
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PMCPA concludes Gossamer Bio pre-license promotion breach investigation
The UK watchdog found the biopharma company did not comply with two clauses of the AMPI Code related to a seralutinib meeting display.
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CMS quietly rolls out new round of Medicare-negotiated drug prices
The second-cycle negotiated-price drugs include medicines to treat cancer, asthma, and metabolic conditions.
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Australia’s treasurer stops Cosette Pharmaceuticals’ $387.2m takeover bid of Mayne Pharma
The ups and downs of the proposed deal demonstrate the evolving landscape of compliance in the context of geopolitical tensions.
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Report to US lawmakers flags impact of China pharma on US drug supply chain
The report urges Congress to bolster US pharmaceutical supply-chain resilience and reduce dependence on China.