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Pfizer Inc.

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Latest From Pfizer Inc.

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 Post Market Regulation & Studies

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

Genentech Builds Case For Rituxan In Pemphigus With Comparator Study Data

Genentech reports that Rituxan yields better results over 52 weeks in pemphigus patients than off-label use of CellCept. Principia, meanwhile, unveils positive Phase II data for its pemphigus candidate.

Clinical Trials Rare Diseases

Novo Nordisk, Bluebird Targeting ‘Lifelong’ Gene Therapies

Novo Nordisk and bluebird bio will jointly develop genome editing treatments for genetic diseases, beginning with hemophilia.
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