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Pfizer Inc.

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Latest From Pfizer Inc.

Novartis Adds To NASH Pipeline By Licensing Pliant’s Integrin Inhibitor

Deal for preclinical asset adds an anti-fibrotic mechanism to Novartis’ NASH program. Pliant produced preclinical data showing strong anti-fibrotic effect.

Deals Research and Development Strategies

Clinical Data Fraud Involving CROs Attracting US Justice Department Attention

Submission of manipulated clinical data to support product approval is a ‘major concern’ for the DoJ, consumer protection branch director Gusav Eyler says, adding that some of the problems relate to outsourcing of trials. Also, DoJ and HHS OIG are using data analytics to identify outliers in prescribing and reimbursement claims.

Enforcement Advertising, Marketing & Sales

US FDA's Temple On Real-World Evidence: 'I Find The Whole Thing Very Frustrating'

CDER deputy director for clinical science reiterates his long-held skepticism about whether real-world evidence can be used to demonstrate efficacy claims.

Drug Approval Standards Real-World Evidence

Bayer's Aleve 'Proven Better' Than Tylenol Claims Fail In J&J Challenge At NAD

Bayer appeals to National Advertising Review Board over NAD’s finding the firm didn't support claims its Aleve OTC provides superior pain-relief to J&J’s Tylenol. It says NAD misunderstands scientific data and it will argue pain studies it submitted were methodologically sound and pain-relief statements were not overly broad.
OTC Drugs Ad Complaints
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