avacopan

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News(10)

• 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 · 23h 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 · 1d 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 · 11d 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 · 16d 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 · 18d ago
• Amgen shares new Tavneos analysis in effort to resolve FDA dispute
  Amgen shared a new analysis with the FDA that the company said supports keeping its controversial rare disease drug Tavneos on the market. The submission, made Thursday, includes an independent ree…
  endpoints · 21d ago
• Amgen sheds around 40 staffers amid continuing struggles
  Amgen has laid off around 40 employees as part of “organizational changes” meant to better align operations with the company’s strategic objectives, Fierce has learned.
  fiercebiotech · 21d ago
• Amgen deploys patients to defend troubled Tavneos in FDA hearing request
  Facing pressure around the world to withdraw the rare kidney disease drug Tavneos, Amgen has launched a robust defense with real-world evidence to support the product’s benefit-risk profile.
  biospace · 21d ago
• Jasper finds new purpose in merger with Kira, while offloading Tavneos rival to Mirador
  Jasper Therapeutics is being reborn via a merger with Nasdaq-listed immune-mediated disease biotech Kira Pharmaceuticals.
  fiercebiotech · 29d ago
• Mirador unveils part of pipeline with drug from Kira to rival Tavneos
  Mirador Therapeutics, the secretive immune disease biotech with more than $650 million in VC funding, is finally revealing a piece of its pipeline. The San Diego biotech said Thursday it reached a…
  endpoints · 29d ago