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What Steps US Regulators Are Taking to Promote Domestic InvestmentLatest Content

Why Real-Time Data Analytics Are Vital for the Next Evolution of Clinical Trials

Pharmaceutical Executive Daily: FDA Votes 10 to 3 in Favor of Replimune's Rp1 Efficacy Data

FDA CTGTAC Committee Votes in Favor of Replimune’s RP1 Efficiency Results in Ignyte Study

Funding Roundup: Braveheart, Attovia, Vogenx All Announce IPO’s

What Steps US Regulators Are Taking to Promote Domestic Investment

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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.

In today's Pharmaceutical Executive Daily, a commentary examines why fragmented software tooling causes scientific judgment to get lost across the biologics R&D pipeline, Replimune shares crash nearly 32 percent after FDA reviewers raise concerns about its melanoma therapy, and FDA approves Viatris's Gwyn Lo as a new once-weekly contraceptive patch.

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.

LucyRx’s chief commercial officer explains why the traditional two-bucket approach to GLP-1 coverage, which focuses on diabetes and weight loss, leaves high-risk populations without access.

John Stanford, executive director at Incubate, discusses how China's two decades of biotech investment are paying off.

In this episode, Ron Lanton argues that healthcare's next constraint isn't capital or technology but rather people.

In today's Pharmaceutical Executive Daily, BioMarin and n-Lorem Foundation partner on the first disease-targeted therapy for the recently identified ReNU syndrome, a trio of biotech financings advance rare disease, sleep apnea, and oncology pipelines, and a Wharton professor offers career advice for MBA graduates navigating an AI-reshaped job market.

BioMarin and n-Lorem Foundation have partnered to develop the first ASO therapy targeting ReNU syndrome.




















