FDA approves Ultragenyx's Fayuvi as the first treatment for Sanfilippo syndrome type A, Lisata Therapeutics acquires Marea Therapeutics as mAbxience partners with Sandoz on a hemophilia A biosimilar, and Joe Cunningham argues that executive drug-pricing deals alone won't fix costs.
FDA approves Kerendia as the first new treatment for kidney disease in type 1 diabetes in decades, Novo, Roche, and Aethlon Medical strike major deals and mergers with Orbis Medicines, Dualitas Therapeutics, and North Immunology, and Thani Jambulingam of Saint Joseph's University examines the fight to control the GLP-1 patient journey.
Novo teams up with Anthropic on AI-driven drug discovery, Sling Therapeutics and Circle Pharma close major financing rounds, and IQVIA's Phil Ford makes the case for reimagining medical content as a loop rather than a pipeline.
GSK is acquiring a trispecific T-cell engager from Chimagen Biosciences and Sanofi expanding its manufacturing partnership with Cheplapharm, Stewart Gandolf discusses why pharma marketing now has to write for both people and AI, and Dr. Elena Christofides explains why cortisol dysregulation may be the hidden reason some diabetes patients fail to respond to incretin therapies.
Cellectis pivots from CAR-T to in vivo gene editing, Novo Nordisk rebrands as "Novo" to sharpen its competitive edge in obesity and diabetes care, and Wendy Short Bartie of Bristol Myers Squibb makes the case for reputation as a strategic currency.
Novartis investors intensify pressure on the company's M&A strategy after a string of trial failures, Michelle Carnahan argues health care needs an orchestration layer rather than more point solutions, and Nacho Quinones and Aisling O'Loughlin make the case for synthetic advisory boards in biopharma decision-making.
Model N's Jesse Mendelsohn examines the growing stakes surrounding the 340B Drug Pricing Program — and how claims data, rebate models and simmering legal challenges are influencing manufacturer response and strategy today.
Aptar Pharma and Aceso Therapeutics team up to advance an inhaled cystic fibrosis therapy, Moonwalk Biosciences raises a $70 million Series B for its fat-targeted obesity platform, and Sebastian Arana of MilliporeSigma talks through the real cost of manufacturing flexibility.
Ionis wins FDA approval for Zanvastro, the first disease-modifying treatment for Alexander disease, Pharmaceutical Executive’s weekly biotech roundup gathers analyst reaction to the week's biggest stories, and Nate Hill of Strive Pharmacy talks through the regulatory uncertainty around compounded peptides.
Ultragenyx shares plunge after apazunersen fails its Phase III trial in Angelman syndrome, Mark Cziraky of Carelon Research talks through the mechanics of analyzing linked real-world data sets, and Melanie Whittington joins The Ron Lanton Report to argue biopharma policy needs to stay tethered to patients, not abstractions.
Melanie Whittington, managing director and head of the Leerink Center for Pharmacoeconomics, joins Ron Lanton to argue that biopharmaceutical policy only makes sense when traced back to its purpose.
Novartis and Bristol Myers Squibb pause autoimmune CAR-T trials over safety concerns, a dealmaking roundup covers Alteogen's licensing deal with Novartis, NewBiologix's gene therapy partnership with Synastra, and RedHill's acquisition of Rebyota and Clenpiq from Ferring, and Lexi Cogswell and Tom Rotolo make the case for real-world insights in obesity medical strategy.
The Trump administration adds nine drugmakers to its Most Favored Nation pricing program, GSK advances its dual-antigen mRNA flu vaccine into Phase III, and Simcere Zaiming licenses its tri-specific antibody Sim0660 to Roche for up to $1.53 billion.
Eli Lilly agrees to acquire Merida Biosciences for up to $2.875 billion, BioNTech halts a Phase II trial of its cancer immunotherapy Cevumeran, and Parth Khanna argues that more competitive data doesn't mean better intelligence in pharma.
FDA approves three new therapies spanning autoimmune disease, HIV, and cardiovascular risk, DualityBio and Teva strike major biopharma deals, and Israel Ortiz makes the case for preventive maintenance in manufacturing.
Osivax and GC Biopharma team up on a next-generation flu vaccine, K2 Therapeutics' Ying Huang talks through why so few drugs make it to market, and the Trump administration opens a new round of Medicaid drug pricing deals.
A new Eli Lilly study links Zepbound to lower healthcare costs in older adults with obesity, Biohaven and Haisco strike major licensing deals with SK Biopharmaceuticals and Sentivera, and Raviv Pryluk makes the case for rethinking clinical trial sample sizing.
FDA approves Imaavy as the first treatment for warm autoimmune hemolytic anemia, McKesson agrees to acquire Precision Medicine Group as Lundbeck partners with Eversana on AI-driven commercialization, and Adam Bartley examines how integrated GMP operating models are reshaping outsourced manufacturing.
Hanmi Pharm licenses its obesity drug candidate HM17321 to Genentech, James LaValle weighs in after FDA advisors back most nominated peptides for the compounding bulks list, and Ivo Carre examines how tau- and microglia-targeted therapies are reshaping the Alzheimer's pipeline beyond amyloid.
A partnership roundup covers deals from IntraGel Therapeutics/UroGen Pharma and Lupin/Tenpoint Therapeutics, FDA approves Regeneron's Pasatru for fibrodysplasia ossificans progressiva, and RELEX's Rohit Tripathi discusses reshoring pharma manufacturing.
LEO Pharma, BioMarin, OmniAb, and Chugai post a busy week of pharma dealmaking, RELEX's Rohit Tripathi weighs in on who ultimately pays for tariff-driven input costs, and Spherix Global Insights' Sybil Mead unpacks IRA-driven formulary pressure spreading across payer portfolios.
Henlius and Sandoz ink a biosimilars collaboration, ADVI's Tyler Seville makes the case for 340B reform, and RELEX's Rohit Tripathi weighs in on what real pharma reshoring requires.
Pharmaceutical Executive releases its 2026 Top 50 company rankings, FDA grants Bristol Myers Squibb's Zenbexus accelerated approval for multiple myeloma, and PwC's Glenn Hunzinger talks the shifting economics of pharma dealmaking.
A funding roundup covers new IPO and Series A raises across Silence Therapeutics, AbCellera, Beyang Therapeutics, and Remepy, Tyler Seville of ADVI examines the policy concerns building around the 340B Drug Pricing Program, and Pharmaceutical Executive names its 2026 Emerging Pharma Leaders.
In today's Pharmaceutical Executive Daily, a new report finds U.S. rare disease biotech investment rebounding after FDA's Priority Review Voucher program renewal, President Trump signs an executive order narrowing the recommended childhood vaccine schedule, and BeOne Medicines and Revolution Medicines announce a multi-part oncology collaboration.
In today's Pharmaceutical Executive Daily, Jazz Pharmaceuticals agrees to acquire Actio Biosciences, Novo Nordisk, Innate Pharma, and Innovent Biologics strike a trio of new partnerships, and a Veeva executive discusses how agentic AI is surfacing HCP insights that traditional field reporting has historically missed.
In today's Pharmaceutical Executive Daily, Amazon Pharmacy launches a GLP-1 delivery service for eligible Medicare patients, Tarsus Pharmaceuticals agrees to acquire Alkeus Pharmaceuticals for $450 million to advance a Stargardt disease therapy, and FDA grants accelerated approval to Replimune's Tudriqev in combination with nivolumab for advanced melanoma.
In today's Pharmaceutical Executive Daily, an antitrust attorney weighs the legal risks of a hypothetical AstraZeneca-Bristol Myers Squibb merger, Eli Lilly beats Wall Street estimates on soaring Mounjaro and Zepbound sales and raises its full-year guidance, and the FDA approves Moderna's first mRNA-based flu vaccine for adults 50 and older.
In today's Pharmaceutical Executive Daily, a senior source denies reports of merger talks between AstraZeneca and Bristol Myers Squibb, CSPC Pharmaceutical and AstraZeneca form a joint venture for biologics manufacturing in China, and a feature examines how U.S. Patent and Trademark Office policy changes are slowing patent challenges for generic and biosimilar drugmakers.
In today's Pharmaceutical Executive Daily, Pathos AI signs licensing deals with Alphamab Oncology and AstraZeneca while Curium agrees to acquire Lantheus for up to $8 billion, Sandoz agrees to a $450 million settlement with 43 U.S. states over generic drug antitrust claims, and a new analysis argues real-time data analytics are essential to managing the growing data burden in clinical trials.
