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Uncertainty Abounds With SEC Climate Reporting Rule Tied Up In Courts

 
• By Lauren Nardella

Despite questions surrounding the SEC rule, including disputes being litigated in the US Eighth Circuit, companies must prepare to meet the new climate disclosure requirements in addition to related mandates in California and abroad. Experts emphasize opportunities beyond compliance.

(Shutterstock)

Companies that ready themselves to comply with the US Securities and Exchange Commission’s climate disclosure rule – in limbo since shortly after it was issued in March – can stave off future headaches and get a leg up on the competition, experts suggest.

Under the SEC’s long-awaited Final Rule on Mandatory Climate Disclosures, companies are required to disclose to the financial community greenhouse gas emissions and climate change risks and

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Inclusive By Design: UK Invites Sponsors To Submit Trial Diversity Plans

 
• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.

Disparities — Including Financials Shortcomings — Remain In Women’s Health, Execs Say

 
• By Brian Bossetta

FemTech leaders discussed some of the barriers that remain in unlocking the full potential of the women’s health market during SiS New York last week. They also offered solutions.

FDA Scrubs ‘Gender’ From Final Guidance On Sex-Specific Data But Encourages More Women In Clinical Trials

 
• By Brian Bossetta

The US FDA has published its final document to guide sponsors on using sex-specific data in designing clinical trials of medical devices. However, the guidance removes all references to gender that appeared in January’s draft guidance, released before the Trump administration took office.

Drop Email Pronouns And Return To Work, Administration Orders FDA Staffers

 
• By Brian Bossetta

Chaos continues at the FDA’s device center as reinstated staffers begin daily commutes to comply with the administration’s return to office policy. Staffers can no longer publicly share their pronouns per Trump’s “Defending Women” executive order.

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23andMe Purchase Will Let Regeneron Scale Drug Development

 
• By Alaric DeArment

The consumer genomics firm will operate as a subsidiary, while Regeneron plans to leverage its database for drug discovery and trial design efforts.

Disparities — Including Financials Shortcomings — Remain In Women’s Health, Execs Say

 
• By Brian Bossetta

FemTech leaders discussed some of the barriers that remain in unlocking the full potential of the women’s health market during SiS New York last week. They also offered solutions.

Mirvie Launches Predictive Blood Test For Preeclampsia

 
• By Marion Webb

Mirvie launched Encompass, a blood test to help identify women over age 35 who are at moderate risk for preeclampsia, and will conduct additional studies to support reimbursements from payers.