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Alphatec Holdings Inc.

https://atecspine.com/

Latest From Alphatec Holdings Inc.

Mayne And Mithra Obtain Long-Awaited NuvaRing Nod From FDA

Following a trio of complete response letters received since late 2018, Mayne Pharma and partner Mithra Pharmaceuticals have finally obtained US FDA approval for a generic version of Organon’s NuvaRing vaginal hormonal contraceptive ring.

Approvals Generic Drugs

FDA Accepts Kabi’s Actemra Biosimilar – Will It Be First?

Fresenius Kabi has been tipped to strike first in the race to launch a biosimilar to Actemra – a market where competition “is likely to be thin for some time.”

Biosimilars FDA

Kabi Awaits Melrose Park Fate As mAbxience Deal Closes

Fresenius Kabi is pressing on with its ‘Vision 2026’ strategic growth initiatives, with the company wrapping up its acquisition of Insud Pharma’s bio unit mAbxience. However, it remains “to some degree output constrained,” which looks set to continue to impact operations, amid staff shortages.

Biosimilars M & A

Accelerated Assessment Requests Fall Flat At EMA

Very few companies asked the European Medicines Agency to fast track their drug marketing authorization applications in the first half of this year, and those that did were all turned down.

Review Pathway Europe
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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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