BC Extra | May 21, 2019
Politics & Policy

SCOTUS decision a boon to biopharmas in failure-to-warn cases

A U.S. Supreme Court decision that remands Merck v. Albrecht back to the Court of Appeals for the Third Circuit for a judge to make a final ruling will help drug companies avoid unpredictable jury...
BioCentury | Jan 11, 2019
Politics, Policy & Law

Supreme Court may reset FDA-State power balance

Following oral arguments in Merck v. Albrecht on Jan. 7, the Supreme Court is pondering a decision that could reset the balance of power over drug label warnings between FDA and state courts. The outcome...
BC Extra | Jan 7, 2019
Politics & Policy

Supreme Court hears Merck label preemption case

Merck & Co. Inc. (NYSE:MRK) received support during oral arguments Monday from at least four Supreme Court justices regarding its position that FDA’s rejection of a proposed warning about the company’s Fosamax alendronate precludes failure-to-warn...
BC Week In Review | Jul 20, 2018
Clinical News

Amgen, UCB again seeking FDA nod for osteoporosis mAb

A year after receiving a complete response letter for Evenity romosozumab, Amgen Inc. (NASDAQ:AMGN) and UCB S.A. (Euronext:UCB) have resubmitted a BLA to FDA for the mAb to treat osteoporosis. During Evenity's initial FDA review...
BC Extra | Jul 13, 2018
Company News

Amgen, UCB again seeking FDA nod for osteoporosis mAb

A year after receiving a complete response letter for Evenity romosozumab, Amgen Inc. (NASDAQ:AMGN) and UCB S.A. (Euronext:UCB) have resubmitted a BLA to FDA for the mAb to treat osteoporosis. During Evenity's initial FDA review...
BC Week In Review | Jul 21, 2017
Clinical News

Amgen/UCB osteoporosis therapy gets CRL

Amgen Inc. (NASDAQ:AMGN) and UCB S.A. (Euronext:UCB) said FDA issued a complete response letter for Evenity romosozumab (CDP7851, AMG 785) to treat osteoporosis in postmenopausal women. Amgen said in May that it no longer expected...
BC Extra | Jul 17, 2017
Company News

Amgen/UCB osteoporosis therapy gets CRL

Amgen Inc. (NASDAQ:AMGN) and UCB S.A. (Euronext:UCB) said FDA issued a complete response letter for Evenity romosozumab to treat osteoporosis in postmenopausal women. Amgen said in May that it no longer expected FDA to approve...
BC Week In Review | May 26, 2017
Clinical News

Amgen, UCB report CV safety signal in Phase III of osteoporosis candidate Evenity

Amgen Inc. (NASDAQ:AMGN) and UCB S.A. (Euronext:UCB) no longer expect FDA to approve Evenity romosozumab (AMG 785, CDP7851) this year after data from the Phase III ARCH trial in 4,093 postmenopausal women with osteoporosis at...
BC Extra | May 22, 2017
Clinical News

CV signal in osteoporosis trial sinks UCB, Amgen shares

Amgen Inc. (NASDAQ:AMGN) and UCB S.A. (Euronext:UCB) no longer expect FDA to approve Evenity romosozumab this year after new data from the Phase III ARCH trial revealed a previously unseen cardiovascular safety signal in postmenopausal...
BioCentury | Mar 7, 2016
Product Development

Getting hip in osteoporosis

Investors were quick to conclude that Amgen Inc. and UCB Group's romosozumab may be at a disadvantage in the osteoporosis market after the partners reported a miss on non-vertebral fracture rates, and an apparently lower...
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