Here are the latest stories being discussed in biopharma today:

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Bristol Myers’ CAR-T Therapy Breyanzi Adds New Approval in Mantle Cell Lymphoma

Bristol Myers Squibb’s CAR-T therapy Breyanzi has notched its third approval in recent months, targeting relapsed or refractory mantle cell lymphoma in adults. Based on findings from the Phase 3 TRANSCEND NHL 001 trial, the FDA’s decision underscores Breyanzi’s efficacy, with 85.3% of patients responding to treatment and 67.6% achieving a complete response. Bristol Myers emphasizes ongoing investments to scale manufacturing in anticipation of heightened demand, reflecting Breyanzi’s financial contributions of $107 million in Q1 2024 and $364 million in 2023.

FDA to Begin Restructuring Its Inspection Office in October

The FDA’s planned restructuring of its inspection operations has been approved, set to begin October 1. The Office of Regulatory Affairs will now be called the Office of Inspections and Investigations (OII), emphasizing its crucial role. This overhaul aims to bolster facility inspections, investigations, and import operations. Additional adjustments include realigning resources and laboratory safety foundations, as indicated in an HHS draft document.

UK Delays Decision on Grail’s Cancer Test, Impacting Divestiture Plans

The UK’s National Health Service has decided to wait until 2026 before rolling out Grail’s cancer test to a million individuals, delaying divestiture plans for parent company Illumina. The NHS cited promising but not decisive data from the first year of a three-year study. This postponement impacts Illumina’s strategy to spin off or sell Grail, following antitrust regulators’ intervention in the $8 billion deal originally proposed.

Doctors Who Endorse Drugs on Social Media Often Compensated, JAMA Study Finds

A new JAMA study reveals that physicians endorsing drugs on social media frequently receive compensation from the pharmaceutical industry. The study examined cases where endorsements were financially motivated, rather than unsolicited positive opinions. This disclosure highlights the need for transparency around such promotional activities to maintain ethical standards.

Novo Nordisk Initiates Legal Actions Against Compounded Semaglutide Marketers

Novo Nordisk has escalated its legal efforts against entities marketing compounded versions of its weight loss and diabetes drugs. The pharmaceutical giant filed nine lawsuits against medical spas, pharmacies, and clinics across multiple states. Instances like compounded semaglutide from Midtown Express, which contained no semaglutide, prompted Novo’s actions to safeguard patient trust in FDA-approved medications.

Lab Group Sues FDA Over New Regulation of Laboratory-Developed Tests

The American Clinical Laboratory Association (ACLA) has filed a lawsuit against the FDA, challenging the new rule regulating laboratory-developed tests (LDTs). The ACLA argues that Congress, not the FDA, should have enacted regulatory changes. This pivotal lawsuit is the first major challenge following the FDA’s publication of the final rule incorporating LDTs under its regulatory framework, diverging from the CLIA rules administered by CMS.

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