ESG and climate disclosure
Healthcare and life sciences companies face a tightening grid of ESG and climate disclosure obligations, with the U.S. Securities and Exchange Commission's climate disclosure rule, the European Securities and Markets Authority's ESRS reporting standards, and California's SB 253 all creating overlapping compliance timelines for publicly traded and large private entities in the sector. Pharma and medtech firms are the ones currently mapping Scope 3 emissions through supply chains that include contract manufacturers, clinical research organizations, and distributors. That mapping work is due before many firms expected.
Watch
- SEC climate disclosure rule: litigation-driven implementation pause, watch for final effective dates
- California SB 253 first reporting deadline applies to entities with over $1 billion in revenue
- ESRS E1 climate standard: EU-listed subsidiaries of U.S. health systems face 2025 reporting triggers
- FDA has not yet aligned product lifecycle guidance with supply-chain emissions disclosures
Recent material activity in Healthcare & Life Sciences
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FDA issues Complete Response Letter for novel GLP-1 receptor agonist oral formulation
The FDA issued a CRL for a once-daily oral GLP-1 receptor agonist citing manufacturing consistency concerns at the primary production facility. The agency requested additional CMC data and a pre-approval inspection befor…
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