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.
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.
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.
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.
In today's Pharmaceutical Executive Daily, FDA approves Otsuka's Simtriyo as the first NDSRI treatment for ADHD, argenx agrees to acquire Forte Biosciences for approximately $2.2 billion, and an AbbVie neuroscience researcher discusses the shift from symptom management to disease modification in Parkinson's research.
In today's Pharmaceutical Executive Daily, an FDA advisory panel narrowly votes to recommend easing restrictions on four unapproved peptides, a supply chain expert discusses how China's export controls are exposing vulnerabilities in the U.S. pharmaceutical supply chain, and a pharmacy benefits executive lays out a business case for more targeted employer-based GLP-1 coverage.
In today's Pharmaceutical Executive Daily, Eli Lilly's Retatrutide delivers up to 22.6% weight loss in two new Phase III trials, a clinical trial expert discusses why the U.S. is losing trial volume to Australia and China, and a pharmacy benefits executive weighs in on why short-term cost thinking is complicating GLP-1 coverage decisions.
In today's Pharmaceutical Executive Daily, Novo Nordisk sues Eli Lilly over GLP-1 advertising it calls misleading, President Trump announces a phased tariff plan for imported generic drugs, and a new commentary argues pharma's AI investment is missing the areas of drug discovery where it matters most.
In today's Pharmaceutical Executive Daily, FDA grants emergency use authorization for Seegene's multiplex PCR assay, a Pfizer medical lead makes the case for continued antiviral use among Covid-19 high-risk patients, and Nuvation Bio's CEO discusses the company's oncology pipeline and philosophy of developing better drugs rather than more of them.
In today's Pharmaceutical Executive Daily, Invivyd's chief scientific officer discusses a platform designed to predict future viral variants ahead of time, Bristol Myers Squibb expands its AI compute infrastructure with Nvidia to build what it calls the most powerful AI factory in life sciences, and FDA clears Consano Bio's IND for a non-opioid biologic targeting chronic sciatica.
Nuvation CEO David Hung discusses his leadership style, success stories for building camaraderie, and his inspiration for joining the pharma and biotech industry.
In today's Pharmaceutical Executive Daily, FDA converts Fabhalta's accelerated approval to full approval for IgA nephropathy, a Pharmaceutical Executive commentary argues AI-driven patient support still can't replace human connection, and Jasper Therapeutics closes its acquisition of Kira Pharmaceuticals in a deal combining a three-asset immunology pipeline.
In today's Pharmaceutical Executive Daily, FDA approves Merck's Lipfendra as the first oral PCSK9 inhibitor for high cholesterol, Eli Lilly agrees to acquire AtaiBeckley for up to $3.8 billion, and a Pharmaceutical Executive podcast explores how better questions, not just more data, define strong biopharma leadership.
In today's Pharmaceutical Executive Daily, Steer Bio discusses its regenerative cell therapy platform for cancer-related lymphedema, FDA approves Celcuity's Revtorpyk as the first pan-PI3K and mTORC1/2 inhibitor for advanced breast cancer, and Insilico Medicine enters a strategic alliance with Bora Pharmaceuticals worth up to $2.5 billion.
In today's Pharmaceutical Executive Daily, AstraZeneca acquires global rights to Dizal Pharmaceutical's lung cancer drug Zegfrovy in a deal worth up to $1.5 billion, FDA approves a subcutaneous formulation of Leqembi for early Alzheimer's disease, and a pharmacy executive weighs in on the education gap facing patients starting GLP-1 therapies.
In today's Pharmaceutical Executive Daily, a new industry analysis warns that direct-to-patient pharma platforms are scaling faster than the safety infrastructure needed to support them, FDA issues a complete response letter to Elevar Therapeutics over manufacturing deficiencies in its liver cancer combination therapy, and Insilico Medicine deepens its partnership with China Medical System Holdings in a new AI-powered drug discovery collaboration worth up to $177 million.
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.
