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Antares Pharma Inc.

Latest From Antares Pharma Inc.

Keeping Track: A Burst of CRLs and BTDs, A Busy Week Of Submissions And Another Approval For Soliris

The latest drug development news and highlights from our US FDA Performance Tracker.
Drug Review Regulation

Oral Testosterone Battle Looms As Lipocine's Tlando Joins Clarus' Jatenzo In US FDA Review Queue

Lipocine resubmits Tlando NDA with new study data supporting twice-daily fixed dosing regimen for the oral testosterone replacement candidate; FDA action expected by Feb. 8.

Complete Response Letters Gynecology & Urology

Policy Prescriptions: Kite's CAR-T; Price And Value Scrutiny; Biosimilars; Manufacturing Missteps

Kite's CAR-T application seems to be sailing ahead without US FDA AdComm review; large employers in the US look into value-based contracting while European regulators band together on joint price negotiations; Teva is back at FDA with its EpiPen application. Policy Prescriptions rounds up recent regulatory news and trends reported by sister publication the Pink Sheet.

Reimbursement Advisory Committees

Keeping Track: Zelboraf Takes Breakthrough Path For Rare Blood Disease; Teva Resubmits Generic EpiPen

The latest drug development news and highlights from our US FDA Performance Tracker.

Approvals Regulation
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Company Information

  • Industry
  • Medical Devices
  • Pharmaceuticals
    • Drug Delivery
      • Controlled Release
      • Topical Delivery
      • Transdermal
  • Therapeutic Areas
  • Gynecological, Urological
  • Metabolic Disorders
  • Alias(es)
  • Medi-Ject Corp.
  • Ownership
  • Public
  • Headquarters
  • Worldwide
    • North America
      • USA
  • Parent & Subsidiaries
  • Antares Pharma Inc.
  • Senior Management
  • Robert Apple, Pres. & CEO
    Fred M Powell, SVP, CFO
    Jonathan S Jaffe, MD, VP, Clin. Dev.
    Greg DeFilippis, VP, Bus. Dev. & Alliances
    Peter Sadowski, PhD, SVP, Tech and IP
    John J Howarth, VP, Corp Affairs
    Patrick Madsen, SVP, Ops
    Keith Muckenhirn, Principal Financial/Principal Accounting Officer
    Steven Knapp, SVP, Reg Affairs & QA
    Edward Kessig, VP, Sales
    Henry R Wolfe, PhD, SVP, Product Dev
  • Contact Info
  • Antares Pharma Inc.
    Phone: (609) 359-3020
    100 Princeton S.
    Ste. 300
    Ewing, NJ 08628