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Alphatec Holdings Inc.

https://atecspine.com/

Latest From Alphatec Holdings Inc.

Novel Brain Penetrant For Treating X-ALD Among Raft Of New EU Filings

Investigational products from Minoryx and a host of other companies targeting a range of diseases are now under review by the European Medicines Agency for potential EU approval.

Europe Approvals

Rising Tide Lifts Many Ships In Wake Of Eisai/Biogen’s Lecanemab Readout

Eisai and Biogen had double-digit stock price gains based on the positive Phase III readout for lecanemab. The good news also lifted competitors Lilly and Roche as well as earlier-stage Alzheimer’s drug developers.

Clinical Trials Neurology

The Real World Is Not Enough: Comparability Is Common Obstacle For RWE In US FDA Decisions

Unsuccessful attempts to use real-world evidence for approvals highlight the need to demonstrate relationship between real-world data and clinical trial patients. The Pink Sheet examines what went wrong for Bluebird/Bristol’s Abecma, Ultragenyx’s Dojolvi, and Karyopharm’s Xpovio.

Real-World Evidence Review Pathway

COVID-19, Oncology Dominate Korea’s Fast-Track Approval Program

The number of approvals under a South Korean fast-track scheme launched around two years ago has increased, led more recently by COVID-19 vaccines and treatments, as well as anticancer drugs. Meanwhile, a new breakthrough therapy program similar to that in the US has been introduced to prioritize and speed up regulatory reviews of innovative medicines.

South Korea Approvals
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Company Information

  • Industry
  • Medical Devices
    • Implantable Devices
    • Surgical Equipment & Devices
  • Other Names / Subsidiaries
    • Alphatec Spine, Inc.
    • Atec Spine
    • SafeOp Surgical
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