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Amgen Inc.

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Latest From Amgen Inc.

Sanofi's Oral Type 1 Diabetes Drug Approval May Hinge On Ketoacidosis Management

US FDA also questions composite efficacy endpoint used in one of the phase III trials as sotagliflozin reaches advisory committee in attempt to become first approved oral type 1 diabetes treatment. Sanofi says that type 1 diabetes patients already manage DKA risk because it is inherent to their condition and patients did not seem bothered by the instructions to handle DKA.
Metabolic Disorders Advisory Committees

Scrip Asks...What Does 2019 Hold For Biopharma? Part 3: Pricing, Reimbursement And Market Access

How much therapies should cost and how they should be reimbursed are questions that are expected to dominate in 2019, according to industry experts and participants surveyed by Scrip on their expectations for the coming year. This is the focus for the final installment of our three-part Scrip Asks series.

Pricing Debate Pricing Strategies

Amgen's Evenity Faces CV Safety Gauntlet At US FDA Advisory Cmte.

Narrower indication and a boxed warning for Amgen's osteoporosis drug romosozumab might be sufficient to permit approval.  
Advisory Committees Drug Safety

House Oversight Drug Pricing Hearings Will Begin With Expert, Patient Witnesses

Manufacturers will avoid direct interrogation in first round, but Oversight Committee also seeking information from sponsors on reasons behind price increases. In US Senate, Susan Collins writes to HHS Secretary Alex Azar urging the department to move ahead with rebate reform.

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