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Drug Safety

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Latest From Drug Safety

How CAR-Ts Are Changing The Lifecycle Paradigm For ATMPs

CAR T-cell therapies have resulted in the industry and regulators exploring unconventional approaches to collecting real-world safety and efficacy data from existing registries. Can this approach also work for other types of cell and gene therapy products in the future? Delegates at a conference in London explored the topic.
Europe Regulation

Uloric U-Turn: Gout Therapy Likely To Stay On Market Despite CV Safety Concern

US FDA would not have approved Takeda’s Uloric but for a post-market safety study commitment. Now that the study is complete and suggests a potential increased risk of mortality, however, FDA doesn’t seem inclined to pull the product.
Drug Safety Post Market Regulation & Studies

FDA’s Sentinel Strategy: Starting Slow Move Toward “Active” Surveillance

US FDA’s strategic plan for Sentinel includes pilot projects to move towards the vision of active surveillance. However, FDA is also making clear that it won’t be a quick or easy transformation. 
Drug Safety Post Market Regulation & Studies

Evenity Likely Headed For Approval With Amgen's Proposed Indication, But Postmarketing Requirements Remain Unclear

US FDA advisory committee splits on whether Amgen's osteoporosis drug romosozumab needs observational study or randomized controlled trial to assess cardiovascular risks. 
Advisory Committees Orthopedics

EU Extends Pilot Of New Drug Safety Reporting System

Testing of the enhanced EU drug safety reporting system, EudraVigilance, is to be extended beyond February in an effort to gain more information on how stakeholders are finding the new requirements.

Drug Safety Regulation

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

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

Can A REMS Mitigate CV Risks? Avandia, Meridia Offer Point, Counterpoint

As US FDA weighs fate of Takeda’s febuxostat, advisory committee members suggest REMS to ensure prescribers have informed benefit/risk conversation with patients, but agency staff highlight design and assessment challenges for such a program.

Advisory Committees Drug Safety

Is There A REMS In Uloric’s Future? US FDA Panelists Say Yes, Agency Says Not Likely

Continued availability of Takeda’s febuxostat should be restricted to second-line use in gout patients who cannot tolerate or fail allopurinol, advisory committee majority says, opposing market withdrawal; but panelists’ suggestion that a Risk Evaluation and Mitigation Strategy be put in place to ensure patients and prescribers discuss cardiovascular risks receives pushback from agency.

Advisory Committees Drug Safety
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