In today's Pharmaceutical Executive Daily, FDA quietly pauses its real-time public release of complete response letters, FDA approves Sanofi's Sarclisa Escena as the first anticancer treatment in the U.S. to be administered via an on-body injector, and AstraZeneca shares fall nearly 10 percent after its Phase III Cardio-TTRansform trial of Wainua in transthyretin-mediated amyloid cardiomyopathy fails to meet its primary endpoint.
In today's Pharmaceutical Executive Daily, FDA approves Ennumo, a pharma roundup covers Chemomab Therapeutics' merger with AI-enabled precision medicine company Scipher Medicine and Teva's global licensing agreement with Polpharma Biologics, and Alina Chesnokova of Cencora examines how the rise of cold chain-dependent specialty therapies is fundamentally changing how pharmaceutical manufacturers think about commercialization strategy and supply chain partnerships.
In today's Pharmaceutical Executive Daily, Novartis files notices to lay off 322 employees at its East Hanover, New Jersey location, Evogene partners with Tel Aviv University's Blavatnik Center for Drug Discovery to accelerate AI-powered small-molecule discovery, and Sanofi's Chief Digital Officer Emmanuel Frenehard on why genuine AI transformation requires concentrated investment—not just automation.
Sanofi Chief Digital Officer Emmanuel Frenehard on scaling AI across a Big Pharma global enterprise and why a strategy of concentrated AI bets — not scattered pilots — can better drive real transformation without losing sight of governance, culture or patients.
In today's Pharmaceutical Executive Daily, Vertex Pharmaceuticals announces a $10 billion acquisition of Crinetics Pharmaceuticals and its approved acromegaly therapy Palsonify, Catalent expands its partnership with Nanoscope Therapeutics to support potential commercialization of an optogenetic gene therapy for retinal degenerative diseases, and Cencora's Alina Chesnokova examines how the rise of specialty therapies is making cold chain logistics a front-line strategic priority.
In today's Pharmaceutical Executive Daily, AlzeCure Pharma announces a collaboration with QuantumCell ApS worth more than $2.2 billion for global rights to its Neurostore platform including Alzheimer's candidate ACD856, the Medicare GLP-1 Bridge launches today, giving eligible Medicare Part D beneficiaries access to Wegovy, Foundayo, and Zepbound for a $50 monthly copay through the end of 2027, and Pharmaceutical Executive speaks with Ryan Last of Troutman Pepper Locke on the limits of targeted pharmaceutical tariffs as a reshoring tool and why thin margins on many generic products complicate the policy's effectiveness.
In today's Pharmaceutical Executive Daily, FDA selects seven companies for its new PreCheck Pilot Program, Kirsten Whipple examines how the concept of healthspan is emerging from academic obscurity into a powerful consumer driver reshaping pharma's role in aging, and Pharmaceutical Executive speaks with Jeff Talbot of Roseman University of Health Sciences on how Las Vegas is positioning itself as an emerging life sciences hub beyond its casino-driven reputation.
In today's Pharmaceutical Executive Daily, a pharma M&A roundup covers Ipsen's up to $1.75 billion acquisition of Kartos Therapeutics and Zymeworks' $929 million acquisition of Theravance Biopharma, Krista Pinto of Eversana argues that fully staffed pharma field teams are still missing revenue targets because the traditional deployment model itself needs to evolve, and EMA's CHMP issues a positive opinion recommending approval of Eli Lilly's Jaypirca for chronic lymphocytic leukemia across all lines of therapy in the European Union.
In today's Pharmaceutical Executive Daily, the FDA approves Gilead's Trodelvy for the first-line treatment of metastatic triple-negative breast cancer — as both a monotherapy and in combination with Keytruda — marking the first new backbone therapy option for this aggressive disease in more than two decades, Novartis announces a $105 million collaborative agreement with Antares Therapeutics to jointly discover and develop first-in-class precision medicines in oncology and other serious diseases, with potential milestones totaling $1.8 billion, and Pharmaceutical Executive speaks with Kyle Smith, president and COO of Aprecia Pharmaceuticals, on the real-world benefits and persistent challenges of operating as a fully domestic manufacturer in an era of tariffs and supply chain pressure.
In today's Pharmaceutical Executive Daily, Eli Lilly and Abbisko Therapeutics announce a new strategic research collaboration in which Abbisko will leverage its early-stage drug discovery platform to advance targets selected by Lilly, building on a prior partnership between the two companies, Pharmaceutical Executive speaks with Kyle Smith, president and COO of Aprecia Pharmaceuticals, on how the company's 3D printing technology enables real-time quality monitoring and rapid iteration to accelerate drug production, and life sciences industry advisor Partha Anbil examines the economics of the 340B Drug Pricing Program — including the forces driving its record $81.4 billion in 2024 purchases, the legal battles over manufacturer restrictions and rebate models, and what it all means strategically for pharmaceutical manufacturers in 2026.
In today's Pharmaceutical Executive Daily, the FDA announces Operation TrialBlazer, a pilot program aimed at cutting early-stage clinical trial timelines by six to 12 months as the US looks to reclaim its footing in global clinical research, market access expert Manasi Salgaonkar explains why Class of Trade classification is becoming one of the hardest — and most consequential — problems in pharmaceutical commercial operations, and Pharmaceutical Executive speaks with Kyle Smith, president and COO of Aprecia Pharmaceuticals, on how DARPA's EQUIP-A-Pharma program is using federal investment to incentivize the reshoring of drug manufacturing to the United States.
In today's Pharmaceutical Executive Daily, AbbVie announces a $10.9 billion agreement to acquire Apogee Therapeutics, adding a suite of clinical-stage immunology assets to its portfolio, Insilico Medicine enters an AI-powered drug discovery collaboration with SK Biopharmaceuticals valued at up to $2.5 billion to advance neuroimmune treatments in the central nervous system, and Pharmaceutical Executive speaks with Kyle Smith, president and COO of Aprecia Pharmaceuticals, on the real-world benefits and persistent challenges of operating as a fully domestic manufacturer in an era of tariffs and supply chain pressure.
In today's Pharmaceutical Executive Daily, an FDA advisory committee votes unanimously in favor of the benefit-risk profile of Moderna's investigational mRNA-1010 seasonal influenza vaccine across both younger and older adult populations, a pharma funding roundup covers Kardigan's upsized $400 million IPO debut on Nasdaq and cAMPfield Therapeutics' $180 million Series A launch, and Pharmaceutical Executive speaks with Brian Hilberdink of Boehringer Ingelheim on redefining what success looks like in obesity care in the GLP-1 era.
In today's Pharmaceutical Executive Daily, Biogen announces its second acquisition of 2026, a deal worth up to $1 billion for private immunology biotech RayThera, FDA approves Utebzi as the first and only oral carbapenem antibiotic for adults with complicated urinary tract infections, and FDA expands the indication for Merck's Capvaxive to include children and adolescents aged 2 through 17 with chronic medical conditions at increased risk for pneumococcal disease.
In today's Pharmaceutical Executive Daily, FDA staff release briefing documents flagging evidence gaps in Moderna's mRNA flu vaccine, a pharma roundup covers Merck's $510 million collaboration with Protillion Biosciences and Jazz Pharmaceuticals' multi-program antibody discovery deal with AbCellera, and Jack McFeely argues that behavioral and engagement insights are the missing ingredient in patient support programs that struggle to sustain long-term persistence.
In today's Pharmaceutical Executive Daily, Elicio Therapeutics shares tumble after its Phase II Amplifgy-7P trial of KRAS-targeting immunotherapy ELI-002 7P misses its primary endpoint in adjuvant pancreatic cancer, FDA approves Skinvive by Juvéderm as the first and only hyaluronic acid injectable indicated to reduce neck lines, and Pharmaceutical Executive speaks with Dr. Edward Littler and Dave Watson, the newly paired executive chairman and CEO of Persica Pharmaceuticals, on how they are driving the company's non-opioid pain program PP353 toward Phase III.
In today's Pharmaceutical Executive Daily, Boehringer Ingelheim's Brian Hilberdink argues that obesity innovation must evolve beyond the scale, a pharma regulatory roundup covers two significant FDA approvals, and Pharmaceutical Executive speaks with Raj Indupuri, CEO of eClinical Solutions, on making the ROI case for smarter clinical trials in an era of exploding trial data complexity.
In today's Pharmaceutical Executive Daily, Kardigan sets terms for a $350 million IPO that would value the cardiovascular biotech at approximately $1.3 billion, Pharmaceutical Executive speaks with Rick Winningham on building the next generation of leaders behind the pipeline, and Jazz Pharmaceuticals reports that the Phase III Lagoon trial of Zepzelca failed to meet its primary endpoint of overall survival in second-line small cell lung cancer.
In today's Pharmaceutical Executive Daily, Bruce Liu examines China's latest policy guidance establishing premium pricing and priority reimbursement access for truly innovative drugs, Parabilis Medicines surges more than 45 percent on its first day of trading on Nasdaq, and Pharmaceutical Executive speaks with Eli Lilly's Sarah O'Keeffe, Group Vice President of Product Research and Development, on how the company's $4.5 billion Medicine Foundry is designed to transform the discovery-to-production handoff and accelerate speed to patient.
In today's Pharmaceutical Executive Daily, Parabilis Medicines prices a record-breaking $670 million IPO, Swedish biotech AlzeCure Pharma enters a collaboration and out-licensing agreement with Eli Lilly for its Alzheimer's candidate, and FDA approves an every-eight-week maintenance dosing regimen for Eli Lilly's Ebglyss.
In this episode, Ron Lanton draws on insights from the JP Morgan Healthcare Conference to explain how healthcare investment is shifting from backing novel ideas to funding organizations that can scale, survive regulatory and reimbursement pressure, and embed technology into the operational infrastructure of care delivery.
In today's Pharmaceutical Executive Daily, a pharma funding roundup covers two RNA-focused biotechs that secured fresh capital, GSK announces a $10.6 billion agreement to acquire Nuvalent in its largest deal in over a decade, , and Pharmaceutical Executive speaks with David Coman, CEO of BGBx, on why the firm's rebranding from BGB reflects a broader shift in how biopharma commercialization now demands integrated consulting, communications, and scientific frameworks.
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.
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.
In today's Pharmaceutical Executive Daily, Eli Lilly escalates its 340B enforcement standoff by notifying covered entities of a five-business-day window to submit required claims data or lose access to 340B pricing, Alnylam Pharmaceuticals and Inceptive Nucleics announce a three-year strategic AI collaboration worth up to $2 billion, and Anne Marie Robertson of Eversana speaks on the trends shaping the future of oncology commercialization following ASCO 2026.
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.
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.
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.
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.
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.
