avacopan

all catalysts(0)

nothing on the calendar yet

News(10)

• Amgen asset from $27.8B Horizon buy scores in Phase 3 Sjögren's study
  Amgen is awaiting another Phase 3 readout for the investigational Sjögren's disease therapy, set for later this year. William Blair anticipates that at least two trials will be needed to support an…
  biospace · 15d ago
• UK regulator halts sales of Tavneos; UniQure seeks approval for Huntington's gene therapy
  Plus, news about Regeneron, Novocure, Jazz's Ziihera, BioMarin, Ascendis, AstraZeneca, Hutchmed and TScan Therapeutics. Another road bump for Tavneos: The Medicines and Healthcare products Regulato…
  endpoints · 1mo ago
• Tavneos no longer available for new patients in UK as Amgen awaits FDA hearing
  CSL Vifor holds the marketing authorization for Tavneos in the U.K., where the drug is marketed as Avacopan Vifor. It continues to be sold on the U.S. market by Amgen despite concerns raised by the…
  biospace · 1mo ago
• CSL calls Tavneos withdrawal in Europe a 'significant headwind' for sales
  Tavneos’ withdrawal from the European market is creating challenges for CSL Vifor. CSL Limited, Vifor’s Australian parent company, said Vifor’s revenue is expected to fall by roughly a quarter in f…
  endpoints · 1mo ago
• STAT+: Akeso and Summit’s lung cancer drug shows worsening tumor-progression benefit
  Europe pulls Tavneos over trial integrity concerns, pricing concerns over AstraZeneca's hypertension drug, and more biotech news from The Readout
  stat · 1mo ago
• Pressure piles on Amgen after EU pulls Tavneos, flags 'serious breaches' in pivotal study
  Sponsors of the pivotal study behind Amgen’s rare disease drug Tavneos saw unblinded findings for the drug and re-adjudicated data from nine patients to make the drug seem effective, according to E…
  biospace · 1mo ago
• 'Incorrect and misleading' data prompted decision to pull Tavneos in Europe
  European regulators on Thursday explained last week's decision to pull Amgen's rare disease drug Tavneos from the market there, detailing their skepticism about the data. In new documents posted Th…
  endpoints · 1mo ago
• Amgen hit with cybersecurity breach, patient data affected
  The hack is unlikely to affect Amgen’s financial reporting and other operations, nor does the pharma expect its ability to meet patient needs will be compromised.
  biospace · 2mo ago
• Capricor and Replimune prep for FDA adcomms, Q2 earnings roll on, Sarepta’s new leader, more
  The FDA published briefing documents ahead of advisory committee meetings for therapies from Capricor Therapeutics and Replimune indicate an uphill battle for the biotechs; GSK and AstraZeneca outl…
  biospace · 2mo ago
• STAT+: Pharmalittle: We’re reading about a U.S. peptide panel’s votes, Amgen scuffling with the FDA, and more
  An FDA panel recommended that compounding pharmacies be allowed to make two more peptides, a step toward RFK Jr.'s goal to make them more available
  stat · 2mo ago