Global Briefs: Lilly, GSK, Regeneron & More
A roundup of news from Eli Lilly and Company, GSK/Empirico, Regeneron, Nvidia, Lupin and Novavax. Highlights below.
Mfg News
* Regeneron Gets FDA Complete Response Letter for Mfg Issues for HD Eylea
M&A News
* Lilly To Acquire Gene-Therapy Company Adverum Biotechnologies
Partnering News
* GSK, Empirico, in $745-M Deal for Oligio Drug Candidate
* Lilly, Nvidia Partner To Create AI-Based Supercomputer for Drug Discovery & Development
General
* Lupin Opens New Corporate Offices in NJ
* Novavax Advancing Site Consolidation
Mfg News
Regeneron Gets FDA Complete Response Letter for Mfg Issues for HD Eylea
The US Food and Drug Administration has issued a Complete Response Letter (CRL) to Regeneron Pharmaceuticals, a Tarrytown, New York-based bio/pharmaceutical company, over manufacturing issues for the company’s pre-filled syringe supplemental biologics license application (sBLA) of HD Eylea (aflibercept), a high-dose concentration of Eylea, a drug used to treat neovascular (wet) age-related macular degeneration, diabetic macular edema, and diabetic retinopathy.
The sole approvability issue cited in the CRL relates to unresolved inspection findings at Catalent, the contract manufacturer of Eylea HD. In October 2025, Regeneron was notified by Catalent Indiana that it had received an official action indicated (OAI) letter from the FDA citing unresolved issues related to a July 2025 FDA general site inspection (not specific to Eylea HD).
Regeneron is planning to submit an application by January 2026 to include a new pre-filled syringe manufacturer in the Eylea HD BLA. There is also an sBLA under review by the FDA for Eylea HD every-four-week dosing and for the treatment of macular edema following retinal vein occlusion, which has a target action date in late November 2025. In addition, the company has submitted an application to include an additional vial filler, with an FDA decision regarding this new vial filler expected by late December 2025.
Source: Regeneron
M&A News
Lilly To Acquire Gene-Therapy Company Adverum Biotechnologies
Eli Lilly and Company has agreed to acquire Adverum Biotechnologies, a clinical-stage gene-therapy company.
Adverum’s lead product candidate is ixoberogene soroparvovec (ixo-vec), an intravitreal gene therapy in Phase III development to treat vision loss associated with wet age-related macular degeneration (wAMD). Ixo-vec is designed as a single one-time treatment to deliver continuous and stable intraocular aflibercept levels. The program has been granted Fast-Track and Regenerative Medicine Advanced Therapy (RMAT) designations by the US Food and Drug Administration, as well as Prime Designation by the European Medicines Agency and the Innovation Passport from the UK’s Medicines and Healthcare Products Regulatory Agency for the treatment of wAMD.
Under the agreement, Lilly will commence a tender offer to acquire all of the outstanding shares of Adverum common stock for a per share price of (1) $3.56 per share in cash payable at closing plus (2) one non-transferrable contingent value right (CVR) that entitles the holder to receive up to an additional $8.91 per CVR in cash upon the achievement of two milestones described below, for total potential per share consideration of up to $12.47. The CVR provides payments if and when the following milestones are achieved:
- Up to $1.78 per CVR in cash payable upon US approval of ixo-vec prior to the seventh anniversary of closing.
- Up to $7.13 per CVR in cash payable upon the first achievement of annual worldwide net sales of ixo-vec by Lilly, its affiliates or licensees exceeding $1.0 billion dollars prior to the tenth anniversary of closing.
The transaction is expected to close in the fourth quarter of 2025, subject to satisfaction of the closing conditions.
Source: Adverum Biotechnologies
Partnering News
GSK, Empirico, in $745-M Deal for Oligio Drug Candidate
GSK and Empirico, a clinical-stage bio/pharmaceutical company, have entered into a worldwide exclusive license agreement for Empirico’s EMP-012, a siRNA medicine, a type of oligonucleotide, in a deal worth up to $745 million ($85 million upfront and $660 million in milestone payments).
EMP-012 is currently in a Phase I trial for the treatment of chronic obstructive pulmonary disease (COPD), with the potential for expansion into other inflammatory respiratory diseases.
The agreement grants GSK full worldwide development and commercial rights to EMP-012. Empirico will continue to lead the clinical development of EMP-012 through the completion of the ongoing Phase I clinical trial, following which GSK will assume responsibility for worldwide development, regulatory filings, and commercialization.
GSK will pay an $85-million upfront payment and up to $660 million in success-based development, regulatory and commercial milestones, as well as tiered royalties on net sales worldwide.
Source: Empirico
Lilly, Nvidia Partner To Create AI-Based Supercomputer for Drug Disocovery & Development
Eli Lilly and Company has announced it is building a supercomputer for drug-discovery and development., in collaboration with Nvidia, a large high-tech company developing graphics processing units (GPUs), systems on chips, and application programming interfaces (APIs) for data science, high-performance/accelerated computing and artificial intelligence (AI). The supercomputer will power an “AI factory,” a specialized computing infrastructure that manages the entire AI lifecycle from data ingestion and training to fine-tuning and high-volume inference.
The supercomputer will be the world’s first Nvidia DGX SuperPOD with DGX B300 systems, according to information from Lilly. It will be powered by more than 1,000 B300 GPUs on a unified networking fabric, which means communication across GPUs, storage and related systems runs on one high-speed network.
The new supercomputer and AI factory is designed to enable rapid learning and iteration. Scientists will be able to train AI models on millions of experiments to test potential medicines, thereby expanding the scope and sophistication of drug-discovery efforts. A number of these proprietary AI models will be available on Lilly TuneLab, a collaborative federated AI/machine-learning drug-discovery platform created to expand access to advanced discovery tools across the biopharma ecosystem.
Beyond discovery, Lilly plans to use the supercomputer to shorten development cycles. New scientific AI agents can support researchers in reasoning, planning and collaborating across digital and physical environments. With advanced medical imaging, scientists would benefit from a clearer view of how diseases progress and can develop new biomarkers for more personalized care. Manufacturing processes can benefit from digital twins together with Nvidia’s robotic technologies to improve production efficiency and reduce downtime.
Source: Eli Lilly and Company
General
Lupin Opens New Corporate Offices in NJ
Lupin, a Mumbai, India-based bio/pharmaceutical company, has opened new corporate offices in Bridgewater, New Jersey. The new location expands Lupin’s presence in New Jersey, which already includes manufacturing and research facilities in Somerset and follows an October 2025 announcement from Lupin that it would build a $250-million manufacturing facility in Florida.
The approximately 18,000-square foot office in Bridgewater will accommodate various corporate functions, including commercial, HR, finance, legal, marketing, business development, and R&D. Lupin first entered New Jersey in 2016, acquiring a manufacturing facility in Somerset.
Source: Lupin
Novavax Advancing Site Consolidation
Novavax, a Gaithersburg, Maryland-based vaccines company, has signed definitive agreements related to one of its Maryland-based locations and surrounding property as part of a planned site consolidation of its operations in Maryland.. The site consolidation includes agreements that will result in $60 million in payments to Novavax and is expected to result in future cost savings of $230 million over 11 years related to both lease expense and facility operating costs.
Assignment of the lease for this facility and sale of certain related assets are expected to close in January of 2026 and result in $40 million in payments to Novavax. Sale of property adjacent to the company’s headquarters building is expected to close in the fourth quarter of 2025 and result in a $20-million payment to Novavax. The company’s headquarters will continue to remain in Gaithersburg, Maryland.
Source: Novavax
