Nicholas Jacobus

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.

Novartis shareholders share deepened trust issues around the company's dealmaking strategy.

Artisan Partners' David Samra calls for a board shake-up at Novartis after costly deal failures, Kura Oncology spins out Caspian Therapeutics to pursue menin inhibition for diabetes, and Ira Studin examines how payers are redefining unmet need for orphan products.

Artisan Partners' David Samra is publicly calling for Novartis to overhaul its board and compensation structure following back-to-back trial failures.

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.

Aptar Pharma and Aceso Therapeutics have partnered to advance ACT-101, an antisense oligonucleotide targeting the underlying mechanisms of cystic fibrosis.

Moonwalk Biosciences has closed a $70 million Series B to advance its adipose-targeted RNAi platform toward first-in-human studies.

Sebastian Arana, head of process solutions at MilliporeSigma, discusses the operational tradeoffs facilities face as they move toward multi-modality production and the persistent cost and scale-up challenges shaping cell and gene therapy, mRNA, and ADC manufacturing.

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.

FDA has approved Ionis Pharmaceuticals' Zanvastro (zilganersen) as the first disease-modifying treatment for Alexander disease.

Nate Hill, co-founder & CEO, Strive Pharmacy, breaks down looming questions around the completed FDA PCAC hearing on 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.

Ultragenyx shares plunge more than 40% after apazunersen fails to meet both endpoints in a Phase III trial for Angelman syndrome.

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.

Nate Hill, co-founder & CEO, Strive, notes the key milestone to watch for during the remaining step in FDA's formal Category one announcement for peptides.

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.

Novartis suspends eight autoimmune trials of its CAR-T therapy Rap-cel after three cases of fatal outcomes, while Bristol Myers Squibb voluntarily pauses enrollment in its Zola-cel autoimmune studies over transient inflammatory events.

Alteogen grants Novartis options to develop subcutaneous formulations using its ALT-B4 hyaluronidase platform, NewBiologix and Synastra partner to develop a stable producer cell line, and RedHill acquires global commercialization rights to Ferring's Rebyota and Clenpiq.

Nate Hill, co-founder & CEO, Strive, explains how Strive is managing peptide uncertainty by pre-sourcing API, running stability and testing, and working with legal counsel to calibrate risk.

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.

Simcere Zaiming has licensed its first-in-class tri-specific CD79a/CD19/CD3 T-cell engager Sim0660 to Roche for up to $1.53 billion, including a $75 million upfront payment.

GSK is advancing its mRNA seasonal influenza vaccine candidate FLUm3HA.b-3NA into a Phase III efficacy trial starting in September.

Nate Hill, co-founder & CEO of Strive Pharmacy, argues that a Category one designation for peptides would give physicians a trusted, regulated channel they currently lack.

The Trump administration adds nine midsize pharmaceutical companies, including Teva, UCB, Astellas, and BeOne Medicines to its Most-Favored-Nation drug pricing program.

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.

Eli Lilly has agreed to acquire Merida Biosciences for up to $2.875 billion to gain a precision autoantibody degradation platform led by MER511.

BioNTech and Genentech elect to end their Phase II trial of autogene Cevumeran after DSMB identified a numerical overall survival imbalance and recommended to terminate.

Nate Hill, co-founder & CEO of Strive Pharmacy, warns that restricting peptides without establishing a clear regulated pathway would push demand deeper into the gray market.

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.

FDA approved Priovant's Lisraya (brepocitinib) as the first targeted therapy for dermatomyositis, Gilead's Bixlenvo as the first once-daily single tablet regimen for virologically suppressed HIV patients, and expanded Mounjaro's label to include cardiovascular risk reduction in high-risk type 2 diabetes patients.