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In today's Pharmaceutical Executive Daily, FDA's advisory committee votes in favor of Replimune's RP1 efficacy data in advanced melanoma, three clinical-stage biopharmaceutical companies file for IPOs spanning cardiovascular, immune, and metabolic disease, and a new analysis examines why two-thirds of pharmaceutical product launches fail to meet expectations.

FDA's advisory committee voted 10 to 3 that efficacy data from the Ignyte study is evaluable and clinically meaningful.

Braveheart Bio, Attovia, and Vogenx have all announced Initial public offerings, focusing on a cardiovascular drug, an immune-disease biologics platform, and a metabolic disease program.

John Stanford, executive director at Incubate, explains the COINS Act debate: should Treasury restrict US biotech investment in China, and what happens to American leadership if it does.

In today's Pharmaceutical Executive Daily, Johnson & Johnson, Processa Pharmaceuticals, and Relation strike new deals spanning cell therapy, BTK inhibition, and AI-driven target discovery, Inizio Engage launches Connected Insights to turn medical information interactions into strategic intelligence, and a commentary argues pharma companies need to manage direct-to-patient sales as a core commercial channel rather than a side program.

Inizio Engage is expanding its Global Medical Information platform with Connected Insights to convert the more than one million scientific interactions its teams handle annually into actionable intelligence.

Johnson & Johnson moves to acquire Sail Biomedicines, Processa acquires Vidya Therapeutics, and Relation partners with GSK on AI-driven target discovery collaboration.

Two-thirds of pharmaceutical product launches fail to meet first-year commercial expectations, and the gap between launch strategy and field execution is almost always why, according to this examination of how to identify, diagnose, and correct launch drift before it becomes irreversible.

Incubate’s executive director John Stanford defines the three buckets of the US-China pharma challenge: API manufacturing, clinical trial competitiveness, and the complex ethics of licensing Chinese innovation.

An FDA advisory panel voted to recommend six of seven unapproved peptides for compounding access, raising concerns about its newly appointed members.

FDA has approved Viatris' Gwyn Lo as a once-weekly low-dose estrogen contraceptive patch, offering women with a BMI below 30 a non-invasive hormonal contraception option.

Replimune shares fell nearly 32% after FDA staff reviewers raised concerns that its lead melanoma therapy RP1 lacks clear evidence of systemic efficacy.

The shift from looking at lots of possibilities to focusing on specific ones in a drug discovery pipeline is why traditional pipelines don’t work well.