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Latest From Novo Nordisk A/S
US FDA Biologics Designation As Price Protection: Lilly Charts New Course With Retatrutide
An effort to change the US Food and Drug Administration’s conclusion that its obesity treatment candidate retatrutide is a drug and not a biologic could give the product more time with unrestricted pricing in Medicare, among other benefits.
Lilly Challenges US FDA Classification Of Obesity Drug Retatrutide, Citing Chevron Overturn
Determining what falls within the statutory definition of ‘biological product’ is an interpretative question that courts, rather than the agency, must resolve, Lilly said in a lawsuit repeatedly citing the US Supreme Court’s June decision in Loper Bright.
Terns’ Early Data May Position It Well In GLP-1 Obesity Race
In a multiple-ascending dose Phase I trial, Terns’ oral GLP-1 agonist showed 4.9% placebo-adjusted weight loss at 28 weeks, with no severe gastrointestinal side effects.
Quotable: Words Of Wisdom From Our Recent APAC Coverage
Scrip's APAC team selects notable quotes from recent interviews, conferences and other coverage to highlight the views of senior executives and officials on major topics facing the biopharma sector in the region and more widely.
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Biotechnology
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Large Molecule
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- Carbometrics
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- Novo Holdings A/S
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