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Former Daiichi Sankyo transparency leader brings more than 30 years of experience across pharmaceutical research, clinical development, and global clinical trial disclosure

The decision to promote Michael Davis and Karim Mikhail from acting to permanent division heads comes as the FDA awaits the potential confirmation of Heidi Overton, President Donald Trump’s nominee for commissioner.

When signing a biotech licensing deal in China, experts say that pharma’s patent attorneys need to understand the geopolitical risk of the BIOSECURE Act.

BMS is barreling toward a clinical trial readout that an H.C. Wainwright analyst believes could contribute to the return of mergers between mega-cap drugmakers.

Leading cognitive-disorders specialist, Dr. William Shankle, will discuss vascular cognitive impairment, vascular dementia and the proposed clinical trial of VesCell™ (ACP-01) today at 12:00 EST, at https://us06web.zoom.us/webinar/register/WN_nJ8ViLkRSeiU_NXMYJ-jbw

Protect Clinical Assets. Preserve Enterprise Value. ClinPro Trials™ today announced the availability of its Independent Executive Compliance Intelligence™ service for investors seeking objective visibility into clinical trial compliance, inspection readiness and regulatory exposure across their clinical investment portfolios. As The Compliance CRO™, ClinPro Trials provides independent executive assessments designed to help protect clinical assets and preserve enterprise value. Every investor expects scientific risk. Few expect compliance failure. Fewer expect to discover it after years of investment and hundreds of millions of dollars—during a pre-approval inspection. A pre-approval inspection often reveals compliance deficiencies that could have been identified much earlier. Not because the science failed. But because compliance drifted during trial execution. Every milestone appeared to have been achieved. Every executive update suggested progress. But one critical question remained unanswered: Do we truly understand the compliance risk, inspection readiness and regulatory exposure of the clinical asset we are funding? ClinPro Trials™ was established to answer that question.

September has been a rough month already for Novo Nordisk, which canned two more late-stage trials of its embattled IL-6 inhibitor, and Novartis, which took Phase 3 hits in both cardiovascular and muscular dystrophy indications; Ultragenyx’s big bet in Angelman syndrome failed to yield benefit in Phase 3 but Ionis’ Pharmaceuticals nabbed the first targeted approval for Alexander disease; and on the business side, biopharma investment is back in a big way.

Inspection access is not “an administrative footnote,” leaders of key FDA divisions wrote in an editorial on Wednesday vowing to expand oversight of foreign clinical trial sites.