European Regulator Calls for Amgen’s Tavneos to Have Authorization Revoked
European regulators are recommending the revocation of marketing authorization for Amgen's rare-disease drug Tavneos following new data.
📍 Where it landed
European regulators recommended revoking the marketing authorization for Amgen's Tavneos after the EMA found study data unreliable. This decision followed findings of new data and allegations of data manipulation.
Epilogue added 42d ago, after coverage quieted.
The reporting (8)
- Latest CHMP decisions led by recommendation to revoke approval of Tavneos FirstWord Pharma · 45d ago
- CSL Faces EU Withdrawal Of Tavneos After EMA Finds Study Data Unreliable Citeline News & Insights · 45d ago
- Inside FDA’s Effort to Pull an Amgen Drug Over Alleged Data Manipulation Bloomberg · 45d ago
- New Data Lead to Decision to Revoke Autoimmune Disease Drug Medscape · 45d ago
- Europe's CHMP reverses endorsement of Tavneos as Amgen FDA hearing looms Fierce Pharma · 45d ago
- EU regulators recommend revoking the marketing authorization for Amgen’s Tavneos Endpoints News · 45d ago
- EU regulator backs revoking Amgen's right to sell rare-disease drug Reuters · 45d ago
- European Regulator Calls for Amgen’s Tavneos to Have Authorization Revoked WSJ · 45d ago broke it first
What happened
The Committee for Medicinal Products for Human Use (CHMP) has reversed its endorsement of Tavneos, a drug used for an autoimmune disease. European regulators are now recommending that the marketing authorization for the Amgen-developed treatment be revoked.
Coverage from Reuters, the Wall Street Journal, Endpoints News, and Fierce Pharma emphasizes the shift in the regulator's position. Medscape reports that the decision to revoke the drug's status was driven by new data.
Attention now turns to an upcoming FDA hearing regarding the drug, as noted in coverage from Fierce Pharma.
Synthesized by Newsylist from the headlines below under a strict no-invention contract. ✓ fact-checked: all claims supported by sources Updated 45d ago.
Questions people are asking
What drug is facing authorization revocation?
The drug is Tavneos, developed by Amgen.
Why is the authorization being revoked?
According to Medscape, the decision was prompted by new data.
Which regulatory body issued the recommendation?
The recommendation was made by the CHMP (Committee for Medicinal Products for Human Use).
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