Sanofi Set To Jump Zika Vaccine Scientific and Regulatory Hurdles
In an interview, Sanofi's global head of research Nicholas Jackson discusses firm's 'jumpstart' and where FDA and WHO should step in.
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Zika Vaccine Trials Could Test Multiple Candidates Vs. Common Control Group
FDA and NIH officials propose three strategies for clinical trials, saying it will be challenging to identify the most promising candidates; Sanofi and Walter Reed researchers note challenges in vaccine development, including manufacturing scale up.
False Claims Act Liability: Defendant’s Belief Claims Were False Matters, Supreme Court Finds
In unanimous decision, court backs whistleblowers’ fraud theory that SuperValu and Safeway defrauded Medicare and Medicaid by reporting higher retail prices than their discounted prices. BIO, AdvaMed and MIWG submitted amicus brief in support of the retail pharmacies.
DOJ Enforcement: Talking With US FDA Is Not Enough To Get Credit For Self-Disclosure
Remediation of a problem with FDA is one factor the DOJ considers in assessing whether a company gets credit for self-disclosure of misconduct prior to a criminal investigation, but it wants companies to come directly to the department to divulge wrongdoing.