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State-level access pathways won't cannibalize clinical trials for patients. Instead they could solve biotech's in-human data catch-22, and restore patient trust along the way.

In today's Pharmaceutical Executive Daily, Roche and Nurix Therapeutics announce a global collaboration, a pharma M&A roundup covers three deals announced today, and Pharmaceutical Executive contributors examine how an emerging wave of biologics is signaling a new treatment era in alopecia areata beyond the established JAK inhibitor class.

Incyte, Galmed Pharmaceuticals, and Johnson & Johnson each announced acquisitions this week, with deals spanning a $2 billion bet on a Phase III bleeding disorder antibody, a GI medtech pivot, and a $1 billion move into KRAS-targeting degrader conjugates as dealmaking across therapeutic categories continues.

Roche has struck an exclusive collaboration with Nurix Therapeutics to co-develop BTK degrader bexobrutideg, paying over $700 million upfront in a deal that could top $3 billion in total.

Driven by rising prevalence and awareness of aesthetic appeal and self-image, the Alopecia Areata market is poised for steady growth.

In today's Pharmaceutical Executive Daily, the Supreme Court unanimously rules in favor of Hikma Pharmaceuticals in its patent dispute with Amarin over Vascepa, Pfizer licenses Chai Discovery's generative AI platform, and C.K. Wang argues that high-quality real-world data represents the most promising path forward for closing persistent gaps in ovarian cancer care.

The Supreme Court ruled unanimously in favor of Hikma Pharmaceuticals, finding its generic Vascepa did not infringe Amarin's patents under the skinny-label pathway, a decision that strengthens legal protections for generic manufacturers.

Chai Discovery has licensed its generative AI drug discovery platform to Pfizer, giving the company early access to its next-generation Chai-3 model and a custom model trained on Pfizer's own data.

Amidst this backdrop of challenges, one area of promise for closing gaps and advancing ovarian cancer care is the growing availability of high-quality, research-ready, real-world data.

Alnylam Pharmaceuticals has partnered with Inceptive to apply generative AI to siRNA design, pairing Inceptive's biology-trained models with Alnylam's two decades of proprietary RNAi data to accelerate candidate discovery.

Model N Senior Vice President Jesse Mendelsohn explores the hidden costs and realities of PBM-driven drug pricing and the growing challenges manufacturers face in ensuring contract compliance, formulary access and reimbursement accuracy.

Robertson discusses the trends shaping the future of oncology commercialization.

In today's Pharmaceutical Executive Daily, Cam Olig of Prescryptive Health touches on the results of a new market access survey, Eli Lilly and Ascidian Therapeutics announce a global research collaboration worth up to $1.9 billion to develop RNA exon editors for inherited kidney diseases, and the FDA issues new draft guidance to reduce the submission burden for gene therapy developers.

Eli Lilly moves to deny 340B discounts to hospitals refusing to submit claims data under its documentation policy, escalating a months-long standoff with the American Hospital Association and prompting calls for federal intervention.

FDA's CBER details a framework for sponsors to apply existing CMC, nonclinical, and clinical data to genome-editing-based product development and regulatory filings.

Ascidian Therapeutics has entered a global research and licensing deal with Eli Lilly to develop RNA exon-editing therapies for monogenic kidney diseases, a class of genetic conditions with an unmet need for treatment.

Prescryptive Health’s chief commercial officer discusses the results of a market access survey that asked industry executives about DTC models, affordability, and patient access.

In today's Pharmaceutical Executive Daily, FDA has accepted a new drug application for giredestrant under priority review, FDA also issues a complete response letter for Cingulate's CTx-1301, and Dan Troy, former FDA Chief Counsel, explains the roadblocks and hurdles facing the FDA's efforts to bring stricter oversight to direct-to-consumer prescription drug advertising.

FDA has accepted Roche's NDA for giredestrant under Priority Review, moving the investigational oral SERD closer to potential approval .

FDA has issued a Complete Response Letter to Cingulate’s ADHD candidate CTx-1301 over manufacturing-related deficiencies, delaying approval of the once-daily therapy while leaving its clinical safety and efficacy profile unchallenged.

Between 2026 and 2030, billions of dollars in revenue will be at risk due to expiring patents and periods of exclusivity.

The former lead counsel discusses FDA’s efforts to bring about strict oversight on DTC drug ads and the difficulties the agency faces in doing so.

In today's Pharmaceutical Executive Daily, the FDA approves Shionogi's Xocova, a pharma M&A roundup covers Servier's acquisition of Edgewise Therapeutics' muscular dystrophy, Eli Lilly's licensing of Hanmi's long-acting GLP-2 therapy, and the merger of Rallybio and Avenzo Therapeutics, finally Sean Werner examines why breakthrough cell and gene therapies continue to fail at the regulatory finish line.

FDA approves Shionogi’s Xocova as First Oral Post-Exposure Covid-19 Prevention Therapy, marking a major milestone for Covid-19 prevention treatments.

A trio of deals from Eli Lilly, Servier, and Avenzo highlights continued industry investment in rare diseases and oncology, spanning gastrointestinal disorders, muscular dystrophy, and next-generation cancer therapeutics.

As FDA complete response letters continue to impact nearly half of cell and gene therapy submissions, manufacturing strategy and process design are emerging as the industry’s most persistent regulatory vulnerabilities.

With recent leadership shakeups, many are wondering how FDA will change its approach to regulating DTC pharma advertisements.

In today’s Pharmaceutical Executive Daily, Harpreet Singh discusses the evolving regulatory landscape for biopharma, the World Health Organization identifies three priority treatment candidates for the Bundibugyo strain of Ebola virus disease, and this week’s pharma roundup highlights new findings on Mounjaro and long COVID-related immune system changes.