The majority of FDA’s Endocrinologic and Metabolic Drugs Advisory Committee agrees the potential advantages of Novo Nordisk’s long-acting basal insulin justify approval before a cardiovascular risk signal seen in a meta-analysis is fully explored in a dedicated outcomes study.
Novo Nordisk AS’ long-acting basal insulin degludec should be approved despite the presence of a potentially concerning cardiovascular safety signal, an FDA advisory committee said Nov. 8.
The Endocrinologic and Metabolic Drugs Advisory Committee voted 8-4 that efficacy and safety data support marketing of Tresiba (insulin degludec)...
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The new CDER director focused on plans to improve morale during an Aug. 8 townhall, but staff comments indicate that may be a challenge.
Eli Lilly's CEO argued that pricing reforms aimed at existing drugs would be “hard to sustain or justify,” while other companies suggested a growing interest in direct-to-consumer sales programs.
New CDER Director George Tidmarsh promised to keep politics out of drug approvals, but suggested during a meeting with staff that he could not insulate the drug center from political pressures coming from those above him.
Companies in Europe cannot delay business decision making much longer to wait for more certainty on major US policy shifts on tariffs and pricing.
HHS' culling of mRNA vaccine projects under BARDA will heavily impact pandemic preparedness. Tiba Biotech was even “caught off guard” by its inclusion, because its project was neither a vaccine nor mRNA-based.
The program would allow early interactions with FDA staff to speed construction and approval of pharmaceutical manufacturing facilities in the US, but will staff be available?
Quantitative estimates of the safety risks with opioid pain medication, including the risk of addiction and misuse, must be added to labeling.
