Scaling AI in Pharma Requires More Than Algorithms
Pharma companies are racing to embed AI, reporting productivity lifts such as 28% faster target identification and 22% quicker biomarker discovery. However, fewer than half of executives feel their firms are truly ready to scale these technologies. Capgemini’s Sheetal Chawla stresses that speed alone is insufficient; success hinges on clear, patient‑centered outcomes, robust data foundations, and sustained human oversight. By aligning R&D, clinical, commercial, and regulatory teams around measurable goals, the industry can turn AI pilots into a disciplined, value‑driven engine for drug development.
What Does It Take to Scale Cell and Gene Therapies From Discovery to Commercialization
MaxCyte CEO Maher Masoud says scaling cell and gene therapies requires developers to partner with manufacturers that can move seamlessly from R&D to commercial production. Integrated, best‑in‑class platforms eliminate the need for repeated process re‑optimization, enabling consistent, automated manufacturing. Advances...
Pfizer at a Crossroads: Leadership, Strategy, and the Risk of a Narrative Cliff
Pfizer’s post‑COVID era is marked by falling legacy sales, looming patent expirations on drugs such as Eliquis and Prevnar, and a $43 billion Seagen acquisition that has yet to coalesce into a clear growth narrative. While the company boasts a broad...
Pharmaceutical Executive Daily: Eli Lilly Acquires Kelonia Therapeutics
Eli Lilly announced a $7 billion deal to acquire Kelonia Therapeutics, adding genetic‑medicine and novel delivery technologies to its pipeline. In parallel, President Trump issued an executive order to speed FDA reviews of psychedelic therapies, signaling a policy shift toward emerging mental‑health...
Using AI to Advance Validated Real-World Evidence
The HealthVerity event highlighted how AI can turn early‑stage life‑science questions into reproducible real‑world evidence (RWE) within minutes. Speakers from HealthVerity, Chiesi USA, Argenx and Medeloop shared practical methods for building transparent, iterative analyses that support feasibility, patient‑journey, regulatory and...
Inside Pharma's Revenue Engine: The Gross-to-Net Reckoning
Model N’s new podcast, Pricing & Policy with Model N, spotlights its annual state‑of‑revenue survey, revealing escalating gross‑to‑net (GTN) complexity across the pharmaceutical sector. Executives discuss how opaque PBM contracts, Medicaid program exits, and coordination‑of‑benefits failures erode net pricing. The conversation also...
Bringing New Delivery Methods to Treatments: Q&A with Richard Lowenthal
In March 2025 the FDA cleared ARS Pharmaceutical’s neffy, a needle‑free epinephrine nasal spray, marking the first major delivery innovation for the drug in over 35 years. CEO Richard Lowenthal explained that the spray eliminates needle anxiety, simplifies administration, and improves portability,...
The Turning Point for Oral Biologics: Q&A With Morten Graugaard
Orbis Medicines CEO Morten Graugaard says the FDA’s approval of Icotyde validates oral biologics as a viable drug class. He frames the decision as a proof point that macrocycle chemistry can translate biologic efficacy into a pill, but cautions that...
Pharmaceutical Executive Daily: Eli Lilly Releases Updated Safety Data for Foundayo
Eli Lilly has released topline safety results from its Phase III Achieve‑4 trial for Foundayo, addressing FDA‑requested evidence on cardiovascular, liver and gastric safety. The FDA’s post‑approval letter, issued on the day of approval, demanded trial data rather than observational studies. Concurrently,...
ICER and Verdant Research Publish White Paper Examining FDA’s Accelerated Approval Pathway
The Institute for Clinical and Economic Review (ICER) and Verdant Research released a white paper urging reforms to the FDA’s accelerated approval pathway. The report highlights persistent issues such as surrogate‑endpoint uncertainty, delayed confirmatory trials, and opaque decision‑making. It proposes...
Johnson & Johnson’s Experience Navigating The Commissioner’s National Priority Voucher Program
Johnson & Johnson’s hematology division secured FDA approval for a new multiple myeloma regimen—Tecvayli plus Darzalex Faspro—through the FDA Commissioner’s National Priority Voucher pilot. The approval came just 55 days after filing, marking the first blood‑cancer therapy to use the voucher...
Pharma Finance Roundup: Platform Innovation Drives Biotech Investment Across Oncology and Immunology
This week’s biotech financing spotlighted platform‑driven innovation in oncology and immunology. Adcendo closed a $75 million Series C to expand its ADC pipeline, while Beeline Medicines launched with $300 million Series A to develop precision autoimmune therapies. Harbinger Health secured $100 million for its multi‑cancer...
A New Standard for Copay Excellence: Q&A with Brian Laird
Pharmaceutical manufacturers are confronting escalating out‑of‑pocket costs, high‑deductible plans and fragmented payer rules, prompting a shift from static copay reimbursements to strategic, data‑driven solutions. EVERSANA, which already processes over 12 million claims for 1.5 million patients, launched its Intelligent Copay Solution to...
How Are Regulatory Factors Impacting Biosimilars
The FDA issued draft guidance in March that would drop certain pharmacokinetic (PK) studies for biosimilars, aiming to lower development costs. At the same time, the Inflation Reduction Act (IRA) and most‑favored‑nation (MFN) pricing provisions are reshaping how manufacturers price...
Pharmaceutical Executive Daily: AbbVie and Haisco Enter $745 Million Licensing Agreement
AbbVie signed an exclusive licensing deal with China’s Haisco Pharmaceutical to develop, manufacture and sell a suite of novel pain compounds outside mainland China, Hong Kong and Macau. The agreement provides Haisco $30 million upfront and up to $715 million in milestone payments,...
How Serious Is the Biosimilar Void?
The FDA released a draft guidance in March 2026 that would drop certain pharmacokinetic (PK) studies, easing biosimilar development and cutting costs. Samsung Bioepis SVP Thomas Newcomer says a biosimilar void still exists in the U.S., especially for mid‑volume and...
Building Operational Visibility in Clinical Trials: Q&A with Deepak Prakash
Identiv VP Deepak Prakash explains how RFID and Bluetooth‑enabled tracking is reshaping clinical trial operations by delivering continuous, real‑time visibility of assets, samples, and shipments. The technology replaces fragmented, manual data entry with automated condition monitoring, cutting reconciliation costs and...
Implications of Tecvayli Plus Darzalex Faspro Demonstrating 83% Reduction in Disease Progression or Death.
Johnson & Johnson’s Tecvayli (teclistamab) combined with Darzalex Faspro (daratumumab) achieved an 83% reduction in disease progression or death in a Phase III trial for relapsed/refractory multiple myeloma. The study, presented at ASH, reported a hazard ratio of 0.17, higher response rates,...
Pharmaceutical Executive Daily: FDA Issues Second CRL for Replimune's RP1 Melanoma Treatment
The FDA issued a second complete response letter rejecting Replimune’s biologics license application for RP1 combined with nivolumab in advanced melanoma, citing insufficient data to isolate RP1’s contribution. Replimune’s CEO warned of job cuts and a scale‑back of U.S. manufacturing....
Managing Patient Experience and RWE in Clinical Trials: Q&A with Matt Holms, MB
Recent enrollment shortfalls in Pfizer/BioNTech COVID‑19 and Lyme vaccine studies underscore how operational flaws can derail promising drugs. Matt Holms, VP of commercial, patient engagement and recruitment at Citeline, explains that modern trial design must integrate real‑world data, AI‑driven patient...
Pharmaceutical Executive Daily: Shionogi Receives Contract Through BARDA's Project BioShield
Shionogi’s U.S. subsidiary secured a BARDA Project BioShield contract that could total $482 million to develop and manufacture its gram‑negative antibiotic Fetroja, with an initial $119 million funded. The agreement funds a U.S. production facility and expands research against high‑priority biothreat pathogens...
How Does the Complexity of Obesity Impact the Effectiveness of GLP-1s?
The FDA granted accelerated approval for a high‑dose injectable version of Wegovy, while Novo Nordisk introduced a multi‑month subscription model aimed at telehealth prescribers. New data from Phenomix and the Mayo Clinic reveal that many patients lack a clear understanding...
Pharmaceutical Executive Daily: Shah Capital's Plan to Vote Against Novavax Board Nominees
Shah Capital, Novavax's second‑largest shareholder with about 9% ownership, announced it will vote against the re‑election of all board nominees and the company's executive compensation proposals at the upcoming annual meeting. In a letter, the activist fund demanded a 30%...
Q&A: Supply Chain Fallout From Iran War, Tariff Uncertainty
The Iran war has disrupted airspace and closed the Strait of Hormuz, driving up fuel surcharges and forcing pharma shipments onto longer, costlier routes. Simultaneously, the Supreme Court ruled that the president lacks authority to impose blanket tariffs under IEEPA,...
Why Advisory Committees Remain Essential in an Era of Complex Medicines
A senior FDA official recently dismissed advisory committees as costly, slow, and theatrical, prompting renewed debate over their role in drug review. Advisory committees (AdComs) are independent panels that convene when a therapy presents a nuanced benefit‑risk profile, offering real‑time...
Bridging the Precision Gap: Accelerating Clinical Adoption of Companion Diagnostics in Oncology
Companion diagnostics (CDx) are central to precision oncology, yet clinical adoption lags due to lengthy evidence generation, regulatory hurdles, and reimbursement challenges. The article outlines three core bottlenecks—clinical validation, workflow integration, and payer coverage—that can stretch implementation timelines to a...
Medical Supply Chains at Risk Over Escalating Conflicts in Iran: Report
The escalating U.S.-Iran conflict is choking key maritime and air routes, slashing global air‑cargo capacity by 22% and threatening the Strait of Hormuz and, potentially, the Bab al‑Mandeb. These chokepoints are vital for transporting active pharmaceutical ingredients (APIs) and finished...
Pharmaceutical Executive Daily: Wegovy HD Now Available in the U.S.
Novo Nordisk has rolled out Wegovy HD, a 7.2 mg weekly semaglutide injection, across the United States, delivering an average 20.7% weight loss in trials—significantly higher than the 2.4 mg dose. The FDA approved the product in March under its National Priority Review...
Wegovy HD Now Available in the U.S.
Novo Nordisk launched Wegovy HD, a 7.2 mg semaglutide injection, across the United States. Clinical data from the Phase III Step Up trial showed an average 21% weight loss under ideal conditions and 19% in real‑world adherence, with nearly one‑third achieving ≥25% loss....
World Health Day 2026: Quotes that Stand with Science
World Health Day 2026 spotlights the theme “Together for health, Stand with science,” emphasizing evidence‑based decision‑making across public health, policy, and drug discovery. Jeanne Marrazzo warns that declining vaccination rates have reignited measles outbreaks, underscoring a trust gap fueled by misinformation....
How Many GLP-1 Users Must Seek Medical Care for Side Effects?
Recent Phenomix and Mayo Clinic data reveal that 50‑60% of GLP‑1 users experience significant side effects, far higher than earlier estimates. About 10% of patients incur $5,000 in out‑of‑pocket expenses, while many spend roughly $1,000 managing symptoms. The high cost...
New Federal Market Access Restrictions: Optimizing Manufacturer Strategies as PBMs Gain Power
The 2026 Consolidated Appropriations Act forces pharmacy benefit managers (PBMs) to pass 100% of rebates, fees and discounts through to employer‑sponsored health plans, ending spread‑pricing and increasing transparency. To protect revenue, PBMs will lean on more aggressive formulary tiering, expanded...
Pharmaceutical Executive Daily: Neurocrine Biosciences Agrees to Acquire Soleno Therapeutics
Neurocrine Biosciences announced a $2.9 billion cash acquisition of Soleno Therapeutics, paying $53 per share—a 34% premium to Soleno’s closing price and 51% premium to its 30‑day VWAP. The deal brings Vykat XR, the only FDA‑approved therapy for hyperphagia in Prader‑Willi syndrome,...
Bringing the Bayesian Method to Clinical Trials: Q&A with Dr. Stacy Lindborg
The FDA issued a January 2026 draft guidance formally recognizing Bayesian methods for drug and biologic trials, offering sponsors a clear regulatory pathway to incorporate prior data and adaptive designs. Imunon CEO Dr. Stacy Lindborg explains how the guidance could...
Scaling AI's Promise in Healthcare: The Time Is Now
ZS CEO Pratap Khedkar warns pharma must move from isolated AI pilots to scalable, high‑impact use cases such as clinical trials, commercialization, and supply‑chain intelligence. He cites a new ZS‑Healthcare Leadership Council report showing the sector is transitioning toward targeted...
Why ‘Boring’ AI Could Save Healthcare When the Bubble Bursts
The healthcare AI market is facing a sharp correction, with Series B funding dropping 84% from its 2021 peak and 95% of enterprise pilots failing to show ROI. Most failures stem from demo‑centric tools that cannot survive fragmented clinical data environments....
President Trump Imposes 100% Tariffs on Branded Pharmaceuticals
President Trump has announced 100% tariffs on patented pharmaceutical products that lack a Most‑Favored Nation (MFN) agreement with his administration. The tariffs will take effect in 120 days for large firms and 180 days for smaller ones, while imports from...
Pharmaceutical Executive Daily: Leadership Turnover Under Trump Administration
Leadership turnover continues across major federal health agencies under the Trump administration, creating uncertainty around drug‑approval timelines, pricing policies, and public‑health initiatives. Shionogi announced a roughly $2 billion deal to acquire worldwide rights to Radicava, bolstering its neurology portfolio and gaining...
Shionogi Enters $2.5 Billion Agreement to Acquire All Rights to Radicava
Shionogi completed a $2.5 billion acquisition of global rights to Radicava from Tanabe Pharma, adding an approved ALS treatment to its portfolio. The deal transfers all intellectual property, sales rights and the existing commercial team, delivering an estimated $700 million in annual...
The New Antitrust Era: Why CVS-Style Healthcare Integration Is Now the FTC’s Primary Target
The FTC and DOJ are overhauling antitrust review in healthcare, shifting focus from traditional market‑share and price analysis to how vertically integrated systems control patient flow. Updated Hart‑Scott‑Rodino filing rules now demand explanations of ecosystem design, strategic intent, and internal...
Pharmaceutical Executive Daily: Trump Administration Delays Appeal of Federal Ruling Blocking Vaccine Policy Overhaul
The Trump administration has postponed filing an appeal against a federal judge’s injunction on RFK Jr.’s vaccine policy overhaul, citing internal debates over election‑year politics. Meanwhile, Biogen announced a $5.6 billion cash acquisition of Apellis Pharmaceuticals, paying $41 per share—a premium of...
Being Specific About Being General: Vaccines Edition
Emerging platforms are converging on a universal influenza vaccine, aiming to replace strain‑specific shots that require yearly reformulation. Companies such as Versatope are leveraging engineered bacterial outer‑membrane vesicles to deliver precise antigens, while NIH’s FluMos‑v2 expands hemagglutinin coverage to six...
The Ways Pharma Leaders Are Rewiring Their Organizations for Launch Success
Pharma executives face accelerating market pressure, prompting a shift from static launch plans to agile, data‑driven execution. Remco op den Kelder of Inizio Ignite argues that real‑time insights, AI integration, and cross‑functional collaboration are essential for successful product launches over...
Can Damage to a Stressed Cell Be Reversed?
Soley Therapeutics’ co‑founder and CEO Dr. Yerem Yeghiazarians explained the company’s novel strategy of using small‑molecule drugs to reverse cellular stress rather than targeting a specific virus or gene. The platform aims to restore function in stressed cells implicated in non‑oncology...
Pharmaceutical Executive Daily: Eli Lilly Presses U.K. Government to Raise NHS Drug Pricing
Eli Lilly is pressuring the U.K. government to raise NHS drug prices and eliminate the VPAG rebate scheme before it resumes new investment in Britain. The company is also exploring outcome‑based pricing for its anti‑obesity medicines. In parallel, Lilly struck a...
Eli Lilly Seeks Agreement with U.K. Government to Raise Prices for Medicines: Report
Eli Lilly is negotiating with the U.K. government to raise NHS drug prices and overhaul the Voluntary Scheme for Branded Medicines Pricing, Access and Growth (VPAG). The company argues that current rebate rates of 25‑33% of revenues are unsustainable and threaten...
How Does MFN Pricing Work Within TrumpRx?
TrumpRx, launched early 2026, is a direct‑to‑patient portal offering more than 40 drugs with cash‑pay prices, coupons and discounts. The platform aligns with the administration’s most‑favored‑nation (MFN) pricing policy, but the listed prices do not always match the official MFN...
Why Are Cancer Cells Able to Thrive in Conditions That Other Cells Cannot?
Soley Therapeutics, founded by clinician‑scientist Yerem Yeghiazarians and a cancer biologist, built a decade‑long, image‑based platform that treats cells as sophisticated sensors of their micro‑environment. The technology decodes how cells decide to live or die under low‑oxygen, nutrient‑poor conditions—an environment...
Pharmaceutical Executive Daily: Trump Administration Misses Deadline to Nominate Permanent CDC Director
The Trump administration failed to meet the 210‑day deadline to nominate a permanent CDC director, leaving the agency without confirmed leadership for most of the second term. Meanwhile, the FDA granted accelerated approval to Denali Therapeutics’ Avlayah, the first enzyme...
Pharmaceutical Executive Daily: FDA Issues Warning Letter to ImmunityBio
The FDA issued a warning letter to ImmunityBio for misleading promotional claims about its bladder‑cancer drug Anktiva, triggering a roughly 26 percent drop in the company’s shares and giving it 15 days to submit a corrective plan. In parallel, Merck announced a...