Topline results: Tezepelumab improves dysphagia frequency, severity in EoE

AstraZeneca settled a $34M case with Texas over alleged improper patient support services for 17 drugs. EyePoint Pharmaceuticals settled a $4.66M case over alleged kickbacks for its eye medication DEXYCU. The FDA's PCAC recommended six peptides for inclusion on the 503A bulks list, contradicting FDA staff recommendations.

The FTC filed an amicus brief in a case involving Amgen's acquisition of patent applications for Enbrel, alleging antitrust violations. The FTC argues that such acquisitions can extend monopoly power and block competition, despite Amgen's claim of immunity under the Noerr-Pennington doctrine. The case could impact biologic drug markets and pharma M&A strategies. Amgen has appealed the district court's decision to deny its motion to dismiss.

CSL Vifor may withdraw Tavneos from the U.K. market after regulators questioned its efficacy study. Amgen, which acquired Tavneos' developer, disagrees. Tavneos sales were $150M in Q2, up 36% YoY. The FDA is also reviewing Tavneos in the U.S. Amgen's U.S. commercial rights are unaffected in the U.K. decision.

AstraZeneca (AZN) and HUTCHMED reported positive phase III SANOVO study results for Tagrisso (osimertinib) plus Orpathys (savolitinib) in treatment-naïve EGFR-mutated NSCLC with MET overexpression. The combination showed statistically significant improvement in progression-free survival (PFS) versus Tagrisso alone. AZN shares have fallen 11.7% year to date, underperforming the industry.

The U.K. has suspended new prescriptions for Tavneos (Avacopan Vifor) due to data integrity concerns, according to the MHRA. Amgen, which owns Tavneos in the U.S., disagrees, citing real-world studies supporting the drug's effectiveness. The MHRA will revoke the drug's authorization by March 1, 2027. Similar actions have been taken by the FDA and EMA.

AstraZeneca (AZN) and Ionis Pharmaceuticals (IONS) discontinued a phase 3 trial for Wainua, a combination therapy for ATTR-CM. Analysts debate whether Alnylam Pharmaceuticals (ALNY) can succeed with its RNA silencing drugs in this area. ALNY's drugs are being considered for use with standard TTR stabilizers, targeting the disease through different pathways. The outcome may impact the ATTR-CM market and RNA therapeutics sector.