BioCentury | May 21, 2019
Politics & Policy

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

...a warning about the risk of stress fractures to the label of osteoporosis drug Fosamax alendronate...
BioCentury | Jan 11, 2019
Politics, Policy & Law

Supreme Court may reset FDA-State power balance

...a “developing safety signal” related to a possible association between the company’s osteoporosis drug Fosamax alendronate...
...adverse event data to FDA, and in September 2008 applied to add language to the Fosamax...
...request with regard to Warnings and Precautions. As reports of unusual fractures among patients receiving Fosamax...
BioCentury | Jan 7, 2019
Politics & Policy

Supreme Court hears Merck label preemption case

...justices regarding its position that FDA’s rejection of a proposed warning about the company’s Fosamax alendronate...
...FDA approve a scientifically inaccurate warning. Merck requested in 2008 that FDA add language to Fosamax's...
...arguments, but she will participate in the ruling, according to Supreme Court spokesperson. Steve Usdin Bonalon, Fosamax, alendronate Merck...
BioCentury | Jul 20, 2018
Clinical News

Amgen, UCB again seeking FDA nod for osteoporosis mAb

...Amgen Shares" ). The resubmission adds data from ARCH, which compared Evenity plus alendronate vs. alendronate...
BioCentury | Jul 13, 2018
Company News

Amgen, UCB again seeking FDA nod for osteoporosis mAb

...Amgen Shares" ). The resubmission adds data from ARCH, which compared Evenity plus alendronate vs. alendronate...
BioCentury | Jul 21, 2017
Clinical News

Amgen/UCB osteoporosis therapy gets CRL

...to include data from the Phase III ARCH study, which compared Evenity plus alendronate vs. alendronate...
BioCentury | Jul 17, 2017
Company News

Amgen/UCB osteoporosis therapy gets CRL

...to include data from the Phase III ARCH study, which compared Evenity plus alendronate vs. alendronate...
BioCentury | May 26, 2017
Clinical News

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

...of reducing the incidence of new vertebral fractures and clinical fractures at 24 months vs. alendronate...
...ARCH, Evenity also met the secondary endpoint by reducing the incidence of non-vertebral fractures vs. alendronate...
...once-monthly 210 mg subcutaneous Evenity for 12 months followed by alendronate for 12 months or alendronate...
BioCentury | May 22, 2017
Clinical News

CV signal in osteoporosis trial sinks UCB, Amgen shares

...treatment with Evenity for 12 months followed by alendronate for 12 months vs. treatment with alendronate...
BioCentury | Mar 7, 2016
Product Development

Getting hip in osteoporosis

...He said he thinks data from the ongoing Phase III ARCH trial comparing romosozumab to alendronate...
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