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Eli Lilly & Co.

www.lilly.com

Latest From Eli Lilly & Co.

Pediatric Exclusivity For ‘Deemed’ Biologics Needs Clarity, Industry Tells US FDA

Draft guidance says unexpired pediatric exclusivity would continue to apply to a deemed 351(a) BLA on March 23, 2020, but industry says differences in how pediatric exclusivity operates under the statutory frameworks governing drugs and biologics could result in the loss of some marketing protection.

Biosimilars Biologics

Insulin Maker Lilly Seeks US FDA Assurances On ‘Authorized Biologics’

Sponsor of an NDA-approved protein product subject to March 2020 ‘transition provisions’ should be able to seek biosimilar licensure of that same product without surrendering its ‘deemed’ 351(a) approval, company says, also requesting that FDA clarify parameters for ‘branded biosimilars.’

Biologics Biosimilars

Mortality Signal For Pfizer's Xeljanz In Rheumatoid Arthritis Puts A Damper On JAK Class

Analyst speculates that risk of pulmonary embolism for a higher unapproved dose of Xeljanz in arthritis could trigger a label change for the same regimen in the drug's ulcerative colitis indication.

FDA Immune Disorders

Tanezumab Dances Through Back Pain Studies With “Acceptable” Safety Answers

In its latest TANGO trial for chronic lower back pain, Eli Lilly and Pfizer’s tanezumab has shown efficacy at 10 mg, but its 5 mg dose missed the statistically significant mark. Vitally, analysts are encouraged by safety data.

Clinical Trials Research & Development
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