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.
David Hung, Nuvation Bio’s CEO, explains the company’s focus on providing patients with better drugs.
Insilico Medicine has deepened its partnership with China Medical System Holdings with a second CNS-focused collaboration in three months, pairing Insilico's PandaOmics-identified mechanism with CMS's clinical and commercial infrastructure in a deal worth up to $177 million in milestones.
FDA issued a complete response letter to Elevar Therapeutics for its rivoceranib and camrelizumab combination in first-line hepatocellular carcinoma, rejecting the application over manufacturing deficiencies rather than clinical concerns.
The pharmaceutical industry has spent the last two years debating whether direct-to-patient pharma business models are real. That debate is over.
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.
FDA has paused public release of complete response letters while reviewing a citizen petition challenging the legal basis of the practice, stalling a transparency initiative the agency launched less than a year ago.
FDA has approved Sarclisa Escena as the first anticancer treatment administered via an on-body injector, offering multiple myeloma patients and providers a subcutaneous alternative to time-intensive IV infusions across all three of isatuximab's existing indications.
AstraZeneca's Wainua failed to meet the primary endpoint of a late-stage trial in transthyretin-mediated amyloid cardiomyopathy, sending shares down nearly 10% in their largest single-day decline since late 2024.
This case could redefine the legal boundary between protecting pharmaceutical patents and allowing lower-cost generic drugs onto the market.
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.
FDA has approved Accord BioPharma's Ennumo as a second pegfilgrastim biosimilar, giving the company what it claims is the world's largest G-CSF biosimilar portfolio from a single manufacture.
Chemomab and Scipher Medicine agreed to merge in an all-stock deal to advance an anti-CCL24 antibody into an AI-guided Phase II rheumatoid arthritis trial, while Teva struck a global licensing deal with Polpharma Biologics for exclusive commercialization rights to a proposed ocrelizumab biosimilar across major markets.
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.
The two companies will work together to advance the development of small molecule discovery at the research center.
Novartis filed paperwork in NJ revealing plans to layoff 322 workers in October of this year.
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.
Catalent will support Nanoscope’s commercialization of Nanoscope’s MCO-010.
The deal will bring Palsonify into Vertex’s pipeline.
As advanced therapies scale, manufacturers are rethinking how they bring products to market and who they rely on to get there.
The acquisition adds Myricx’s NMTi ADC delivery platform to Novartis’ pipeline.
Empower Pharmacy founder and CEO Shaun Noorian argues that declining patient engagement across demographics is a failure of system design not patient behavior.
The Troutman Pepper Locke senior associate discusses strategies for pharma and biotech companies to implement ahead of the July 31st tariff deadlines.
Modern biopharma firms are adapting their R&D investment strategies in response to challenges such as the impending $300 billion patent cliff, the pricing pressures of the Inflation Reduction Act, and shifting regulatory dynamics.
Troutman Pepper Locke senior associate Ryan Last explains when markets will start to significantly react to the upcoming pharma tariffs.
Ryan Last, senior associate at Troutman Pepper Locke explains how existing regulations and potential foreign countermeasures have a significant impact on reshoring efforts.
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.
Novo Nordisk has launched the Medicare GLP-1 Bridge, making Wegovy available to eligible Medicare beneficiaries for $50 a month through the end of 2027, giving millions of older adults with obesity a structured pathway to the FDA-approved weight management drug.
AlzeCure Pharma has licensed its NeuroRestore platform and lead CNS candidate ACD856 to QuantumCell ApS, following positive Phase Ib safety and pharmacokinetic data.
