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Ionis Pharmaceuticals, Inc.

http://www.ionispharma.com

Latest From Ionis Pharmaceuticals, Inc.

Ipsen’s Onivyde SCLC Dreams Die With Phase III Failure, Focus Shifts To Pancreatic

The French firm’s Onivyde has missed the mark in an advanced small-cell lung cancer Phase III trial, prompting the firm to tout the drug’s prospects in a large pancreatic cancer indication instead.

Clinical Trials Cancer

Chinese Biotechs Partner Up 18.2-Targeting ADCs Amid Intense Domestic Competition

Following rapid R&D growth in the area, China now has roughly 40 drug candidates targeting Claudin 18.2 across various modalities including monoclonal antibodies, antibody-drug conjugates and bispecific antibodies, with a number of contenders now striking international licensing-out deals in a bid to get ahead of rivals.

China Deals

Here We Go Again: US FDA Weighing Accelerated Approval For Biogen’s ALS Drug Tofersen

Company seeks accelerated approval based on changes in neurofilament as a surrogate for efficacy; with controversy over FDA’s Aduhelm approval in Alzheimer’s still raging, agency is again faced with deciding whether biomarker data in a neurodegenerative disease with high unmet need are sufficient to justify approval in the face of a failed clinical endpoint study.

Drug Approval Standards Drug Review

Biogen ALS Drug Granted FDA Priority Review, Triggering Aduhelm Déjà Vu

FDA accepted the NDA for tofersen based on a surrogate biomarker after a Phase III trial failure, echoing some elements of the Aduhelm experience, though in this instance the target patient population is ultra-niche.

Neurology Clinical Trials
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Company Information

  • Industry
  • Biotechnology
  • Pharmaceuticals
  • Pharmaceuticals
    • Drug Delivery
  • Biotechnology
    • Antisense, Oligonucleotides
    • Drug Discovery Tools
    • Large Molecule
  • Other Names / Subsidiaries
    • Akcea Therapeutics, Inc.
    • Regulus Therapeutics, Inc.
    • Symphony GenIsis, Inc.
    • Isis Pharmaceuticals, Inc.
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