Global Briefs: Novo Nordisk, Sanofi, Lilly, Amgen, BI & More
A roundup of news from the large and mid-sized bio/pharmaceutical companies featuring Amgen, Bayer, Boehringer Ingelheim, Eli Lilly and Company, Johnson & Johnson, Novo Nordisk, Sanofi, Takeda, Alnylam, Argenx, Arthrosi Therapeutics, Basilea Pharmaceutica, Cradle, Dark Blue Therapeutics, Disco Pharmaceuticals, Dynavax, Earendil Labs, Halozyme Therapeutics, Insilico Medicine, Nimbus Therapeutics, Prokaryotics, Rectify, Servier, Sobi, Variant Bio and Ventyx Biosciences.
For the latest news roundup on small and Emerging Pharma companies, see Biotech Briefs
Mfg News
* Alnylam To Invest $250 M To Expand siRNA Mfg Facility
* Novo Nordisk Receives Warning Letter from FDA for Indiana Site
M&A News
* Sanofi to Acquire Dynavax for $2.2 Bn
* Lilly To Acquire Ventyx Biosciences for $1.2 Bn
* Amgen Acquires Dark Blue Therapeutics in $840-M Deal
* Shionogi To Acquire Tanabe Pharma’s Newly Formed Company for ALS Drug
* Sobi To Acquire Arthrosi Therapeutics in $1.5-Bn Deal
Partnering News
* Sanofi, Earendil Labs in $2.6-Bn AI-Enabled Bispecific Antibody Drug Pact
* Lilly, Nimbus in $1.3-Bn Pact for Oral Obesity Drug
* Amgen, Disco Pharmaceuticals in $618-M Cancer Drug Pact
* BI in Kidney Disease Drug Pacts with Variant Bio, Rectify
* Takeda, Halozyme Therapeutics in Drug Mfg Pact
* Bayer, Cradle Partner for AI-Enabled Protein Engineering
* Servier, Insilico Medicine in $888-M Oncology Drug Pact
* Basilea Pharmaceutica, Prokaryotics in Antifungal Drug Pact
Pipeline & Product News
* Novo Nordisk Gains FDA OK for Oral Version of Obesity Drug Wegovy
* FDA Issues Complete Response Letter for Sanofi’s MS Drug
* FDA Awards J&J National Priority Voucher to J&J’s Multiple Myeloma Drug
Appointments
* argenx Appoints new CEO
Mfg News
Alnylam To Invest $250 M To Expand siRNA Mfg Facility
Alnylam Pharmaceuticals, an Alnylam, UK-based bio/pharmaceutical company, has announced a $250-million expansion of its siRNA manufacturing facility in Norton, Massachusetts.
The company is preparing to invest $250 million to expand the facility to become a fully dedicated siRNA enzymatic-ligation manufacturing facility. The expansion of Alnylam’s 200,000-square-foot facility will increase its capabilities to locally produce both clinical and commercial supply of siRNA oligonucleotide drug substances.
As part of the expansion, Alnylam also announced that its enzymatic ligation manufacturing platform, siRELIS, has been accepted into the US Food and Drug Administration’s (FDA) Emerging Technology Program. This acceptance follows successful demonstration of Alnylam’s enzymatic ligation platform through production of pilot-scale batches of zilebesiran, which is being studied to reduce the risk of major adverse cardiovascular events in patients with hypertension, and nucresiran, which is in development for the treatment of transthyretin-mediated amyloidosis
Source: Alnylam Pharmaceuticals
Novo Nordisk Receives Warning Letter from FDA for Indiana Site
The US Food and Drug Administration (FDA) has issued a Warning Letter to Novo Nordisk, following an inspection of the company’s manufacturing facility for finished pharmaceuticals in Bloomington, Indiana, for quality issues at the facility.
The Indiana facility is one of three facilities acquired by Novo Nordisk as part of a $16.5-billion acquisition of the CDMO Catalent by Novo Nordisk’s parent company, Novo Holdings in December 2024. Novo Nordisk later acquired the Bloomington facility, along with two other former Catalent fill-finish facilities in Anagni, Italy, and Brussels, Belgium.
The company was cited for failure to conduct adequate investigations into drug-product failures and discrepancies. FDA cited that the company’s investigations frequently lacked data supporting the assigned root cause(s), were not adequately expanded to include all potentially affected drug products, were not formally or adequately documented in the company’s deviation system, and/or did not assess the effectiveness of corrective actions taken. This included more than than 20 deviations related to extrinsic “mammalian hair” contamination in or around the stopper region of vials, including in direct contact with the drug product. The company was also cited for failure to initiate timely and thorough investigations into unexplained batch terminations.
In response to Warning Letter, the FDA requested the company provide a comprehensive independent assessment of its overall system for investigating complaints, deviations, discrepancies, out-of-specification results, and failures and t0 a detailed action plan to remediate this system.
Source: US Food and Drug Administration
M&A News
Sanofi to Acquire Dynavax for $2.2 Bn
Sanofi has agreed to acquire Dynavax Technologies, a vaccines company, for $2.2 billion.
Dynavax’s adult hepatitis B vaccine, Heplisav-B, is marketed in the US and is differentiated by its two-dose regimen over one month, which enables high levels of seroprotection faster than other hepatitis B vaccines, which are given in three doses over six months, according to the company. The acquisition also includes Dynavax’s shingles vaccine candidate (Z-1018), which is currently in Phase I/II clinical development and additional vaccine pipeline projects.
Under the agreement, Sanofi will commence a cash tender offer to acquire all outstanding shares of Dynavax for $15.50 per share in cash, reflecting a total equity value of approximately $2.2 billion.
The transaction has been unanimously approved by the Dynavax Board of Directors. The consummation of the tender offer is subject to customary closing conditions, including the tender of a number of shares of Dynavax common stock that represent at least a majority of the outstanding shares of Dynavax common stock, the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, certain foreign regulatory filings and clearances, and other customary conditions.
Source: Sanofi
Lilly To Acquire Ventyx Biosciences for $1.2 Bn
Eli Lilly and Company has agreed to acquire Ventyx Biosciences, a San Diego, California-based clinical-stage bio/pharmaceutical company, for $1.2 billion.
Ventyx is developing a pipeline of small-molecule therapeutics, including NLRP3 inhibitors, designed to treat inflammation across a broad range of disease states, including cardiometabolic disorders, neurodegenerative diseases, and inflammatory disorders. The company’s clinical-stage programs target key immune pathways with the goal of offering improved efficacy and safety compared to existing treatments.
Under the terms of the agreement, Lilly will acquire all of the outstanding shares of Ventyx for $14.00 per share of common stock in an all-cash transaction (equal to an aggregate equity value of approximately $1.2 billion). The transaction is not subject to any financing condition and is expected to close in the first half of 2026, subject to approval by Ventyx stockholders and satisfaction of other customary closing conditions, including regulatory approvals.
Source: Eli Lilly and Company
Amgen Acquires Dark Blue Therapeutics in $840-M Deal
Amgen has acquired Dark Blue Therapeutics, an Oxford, UK-based bio/pharmaceutical company developing small-molecule-targeted protein degraders for oncology, in a deal worth up to $840 million. The acquisition adds to Amgen’s portfolio an investigational small-molecules that target and degrades two proteins (MLLT1/3) that drive specific types of acute myeloid leukemia, a fast-growing blood cancer.
Source: Amgen
Shionogi To Acquire Tanabe Pharma’s Newly Formed Company for ALS Drug
Shionogi & Co has agreed to acquire a company that Tanabe Pharma Corporation will create to hold the rights to Radicava Ors (edaravone), an oral form of a drug for treating amyotrophic lateral Sclerosis (ALS), commoly referred to as Lou Gehrig’s disease drug, a progressive neuromuscular disorder, and IV Radicava, an intravenous formulation of the drug.
Tanabe Pharma plans to form this new entity, and Shionogi intends to purchase 100% of its shares. As part of the transaction, a new business company established by Tanabe for Radicava in the US will become a wholly owned subsidiary of Shionogi.
Source: Shionogi
Sobi To Acquire Arthrosi Therapeutics in $1.5-Bn Deal
Sobi, a Stockholm, Sweden-based bio/pharmaceutical company focused on rare diseases, has agreed to acquire Arthrosi Therapeutics, a San Diego, California-based bio/pharmaceutical company, in a deal worth up to $1.5 billion ($950 million upfront and $550 million in milestone payments).
The acquisition strengthens Sobi’s gout franchise by adding pozdeutinurad (AR882), an investigational, once-daily oral URAT1 inhibitor currently being evaluated in two global Phase III clinical studies for the potential management of progressive and tophaceous gout. Results are expected to read out in 2026.
Under the agreement, Sobi will pay $950 million upfront in cash to acquire Arthrosi, together with up to $550 million in cash in clinical, regulatory and sales milestones. The transaction is subject to the satisfaction of customary closing conditions and is expected to close in the first half of 2026.
Source: Arthrosi Therapeutics
Partnering News
Sanofi, Earendil Labs in $2.6-Bn AI-Enabled Bispecific Antibody Drug Pact
Sanofi and Earendil Labs, an AI-focused biotechnology company, have entered a strategic collaboration to apply Earendil’s discovery platform to multiple autoimmune and inflammatory disease programs, in a deal worth up to $2.6 billion ($160 million upfront and $2.4 billion in milestone payments). Sanofi will lead the development and worldwide commercialization of bispecific antibody drug candidates arising from the collaboration.
As part of the agreement, Earendil Labs will receive up to $160 million in upfront and near-term payments tied to early program achievements. The total potential value of the collaboration, including upfront, development, and commercial milestones, is up to $2.56 billion. Earendil Labs will also receive tiered royalties on net product sales up to low double-digit percent.
This transaction is subject to customary closing conditions.
Source: Earendil Labs
Lilly, Nimbus in $1.3-Bn Pact for Oral Obesity Drug
Eli Lilly and Company has entered an agreement with Nimbus Therapeutics, an AI-focused drug discovery company, to develop an oral treatment for obesity and other metabolic diseases, in a deal worth up to $1.3 billion ($55 million upfront and $1.3 billion in milestone payments).
This new collaboration follows the previous collaboration between Nimbus and Lilly targeting adenosine monophosphate-activated protein kinase (AMKP), an enzyme that plays a role in cellular energy homeostasis, in cardiometabolic diseases. The companies will apply Nimbus’ computational chemistry and structure-based drug design approach to an early-stage, small-molecule discovery program for obesity.
Under the agreement, Nimbus is eligible to receive upfront and near-term milestone payments totaling $55 million, with eligibility to receive up to approximately $1.3 billion in total including development, commercial, and sales milestone payments, as well as tiered royalties on global net sales.
Source: Nimbus Therapeutics
Amgen, Disco Pharmaceuticals in $618-M Cancer Drug Pact
Amgen and Disco Pharmaceuticals, a drug-discovery company, have entered an agreement to advance therapeutic candidates addressing a target that was mapped on the surface of a cancer cell by Disco’s proprietary platform, in a deal worth up to $618 million.
Disco’s platform combines cell-surface proteomics with advanced protein community mapping to identify target pairs and surface-bound protein communities. These discoveries are used to guide the development of highly specific, surfaceome-directed therapies such as bispecific antibody-drug conjugates and T-cell The company’s internal pipeline is currently focused on programs in small cell lung cancer and microsatellite-stable colorectal cancer ,
Under the agreement, Disco will be eligible to receive up to $618 million total potential deal value plus royalties. Amgen will receive exclusive global rights to develop and commercialize the resulting programs directed against the target.
Source: Disco Pharmaceuticals
BI in Kidney Disease Drug Pacts with Variant Bio, Rectify
Boehringer Ingelheim (BI) has entered into pacts with Variant Bio, an AI drug discovery company, and Rectify Pharmaceuticals, a Cambridge, Massachusetts-based bio/pharmaceutical company, for the development of kidney disease drugs.
The partnership with Variant will focus on the discovery and validation of targets for cardiorenal and kidney disease by using Variant Bio’s AI-powered Inference platform, which integrates proprietary genomic, deep phenotyping, and multi-omic data from studies with global populations. Under the agreement, Variant Bio will receive an upfront payment and is eligible for potential license and milestone payments totaling over $120 million.
The collaboration with Rectify leverages Rectify’s positive functional modulators platform to develop oral, small molecules that enhance ABCC6 protein function and reduce calcification, which is a key disease driver of cardiorenal dysfunction in chronic kidney diseases. Under the agreement, Rectify will receive an upfront payment and has the potential to earn up to $448 million through preclinical, clinical, regulatory, and commercial milestones, in addition to tiered royalties on future product sales.
Source: Variant Bio & Rectify Pharmaceuticals
Takeda, Halozyme Therapeutics in Drug Mfg Pact
Takeda has entered an agreement with Halozyme Therapeutics, a San Diego, California-based bio/pharmaceutical company, granting Takeda exclusive access to Halozyme’s Enhanze drug-delivery technology for use with Takeda’s Entyvio (vedolizumab), a drug for treating moderately to severely active ulcerative colitis and Crohn’s disease.
Under the agreement, Takeda will provide Halozyme with an upfront payment, as well as potential future development and commercial milestone payments. Halozyme will also be eligible to receive royalties on sales of products containing vedolizumab in combination with Enhanze.
Source: Takeda
Bayer, Cradle Partner for AI-Enabled Protein Engineering
Bayer and Cradle, an AI-focused drug-engineering company, have entered a three-year strategic collaboration to use Cradle’s scientific AI software platform for protein engineering.
As part of the collaboration, Bayer will integrate the generative AI platform into existing R&D workflows to enhance lead generation and optimization across its therapeutic antibody pipeline. Under the agreement, Cradle will provide Bayer’s antibody scientists with full access to its scientific AI software platform supporting a lab-in-the-loop approach, streamlined design-test-learn cycles, and coordinated execution across laboratory and external partners. Bayer and Cradle will also jointly work on a machine learning research project aimed at extending these capabilities even further.
Source: Bayer
Servier, Insilico Medicine in $888-M Oncology Drug Pact
Servier, a French bio/pharmaceutical company, and Insilico Medicine, a Hong Kong-based bio/pharmaceutical companies with a proprietary AI-enabled drug-discovery platform for oncology, have entered a multi-year research and development (R&D) collaboration focused on identifying and developing therapeutics for challenging targets in the oncology space, in a deal worth up to $888 million ($32 million upfront and $856 million in milestone payments).
Insilico has established an oncology pipeline that targets multiple cancer indications, leveraging both moderately and well-established mechanisms. Among its most promising assets are the pan-TEAD inhibitor, ISM6331, and the MAT2A inhibitor, ISM3412, which are both undergoing global Phase I clinical trials. Additionally, four other oncology programs have been fully or partially out-licensed to partners, with Phase I clinical trials in progress.
Under the agreement, Insilico will be eligible to receive up to $32 million in upfront and near-term R&D payments and will lead the AI-driven discovery and development of potential drug candidates that meet predefined criteria while Servier will share the R&D expenses and lead clinical validation and commercialization processes.
Source: Insilico Medicine
Basilea Pharmaceutica, Prokaryotics in Antifungal Drug Pact
Basilea Pharmaceutica, an Allschwil, Switzerland-based commercial-stage bio/pharmaceutical company, has entered an agreement with Prokaryotics, a privately held US-based bio/pharmaceutical company, to jointly develop a broad-spectrum antifungal for the treatment of severe invasive infections.
The collaboration is focused on a program of antifungal molecules, addressing invasive infections caused by strains of Candida, Aspergillus, and rare molds. The joint efforts aim to deliver a clinical candidate, which will then be further progressed through clinical development by Basilea.
Under the agreement, Basilea will make an undisclosed upfront payment, along with near-term milestone payments to Prokaryotics. After selection of a clinical candidate, Basilea would be responsible for the clinical development and global commercialization under an exclusive global license. Under such license, Prokaryotics would be eligible to receive up to $48.5 million in development, regulatory, and commercial milestone payments, as well as tiered low single-digit royalties on global net sales.
Source: Basilea Pharmiceutica
Pipeline & Products News
Novo Nordisk Gains FDA OK for Oral Version of Obesity Drug Wegovy
Novo Nordisk has announced that the US Food and Drug Administration (FDA) has approved an oral form of its obesity medicine, Wegovy pill (once-daily oral semaglutide 25 mg) to reduce excess body weight and maintain weight reduction long term and to reduce the risk of major adverse cardiovascular events.
The Wegovy pill is the first oral glucagon-like peptide-1 (GLP-1) receptor agonist therapy approved for weight management, according to the company.
The FDA approval of the Wegovy pill was announced on December 22, 2025, and Novo Nordisk subsequently announced that the pill was launched in the US this week (January 5, 2026). The pill is used with a reduced calorie diet and increased physical activity for adults with obesity, or with overweight who also have weight-related medical problems.
Source: Novo Nordisk (approval) & Novo Nordisk (launch)
FDA Issues Complete Response Letter for Sanofi’s MS Drug
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for Sanofi’s new drug application for tolebrutinib for treating non-relapsing secondary progressive multiple sclerosis (nrSPMS) in adult patients.
On December 15, 2025, Sanofi provided an update on the ongoing review of the drug and reported: (1) FDA was expecting the review to go beyond the previously communicated revised US target action date of December 28, 2025; (2) further guidance from FDA was expected by the end of the first quarter of 2026; and (3) in response to an FDA request, Sanofi had submitted an expanded access protocol for tolebrutinib in nrSPMS.
The announcement was based on the company’s latest discussions with the FDA, which took place just before the update was provided. FDA’s CRL to Sanofi was issued in late December 2025.
Tolebrutinib was provisionally approved in the United Arab Emirates in July 2025 for the treatment of non-relapsing secondary progressive multiple sclerosis and to slow disability accumulation independent of relapse activity in adults. It is currently under regulatory review in the Europe Union and other jurisdictions worldwide.
Source: Sanofi
FDA Awards J&J National Priority Voucher to J&J’s Multiple Myeloma Drug
The US Food and Drug Administration (FDA) has awarded a Commissioner’s National Priority Voucher (CNPV) to Johnson & Johnson’s teclistamab in combination with daratumumab for treating relapsed/refractory multiple myeloma.
FDA launched a pilot CNPV program last June (June 2025) with the goal of reducing the agency’s drug review times to 1 to 2 months for certain novel drugs. The voucher applies to drugs participating in a novel drug FDA priority program and that meet certain criteria, including consideration for being manufactured in the US, meeting unmet medical need, and having US-based drug development. Thus far (as of December 15, 2025), 16 drugs have been accepted in the pilot program. Voucher recipients receive enhanced communications with review staff throughout the development process, and review decisions are targeted for completion within 1-2 months following submission of an application.
Source: US Food and Drug Administration
Appointments
argenx Names New CEO
argenx, a bio/pharmaceutical company focused on autoimmune diseases, has announced that Karen Massey, current Chief Operating Officer, will transition to the roles of Chief Executive Officer and Executive Director, and Tim Van Hauwermeiren, current Chief Executive Officer, will transition to non-Executive Director and Chairman of the Board of Directors.
Van Hauwermeiren will succeed Peter Verhaeghe, who is retiring from the Board of Directors after dedicated service to the company since 2008. These changes are subject to shareholder approval at the company’s Annual General Meeting on May 6, 2026.
Massey joined argenx as Chief Operating Officer in March 2023. He has over 20 years of experience in the biopharma industry, including in commercial leadership, product development, corporate strategy and innovation roles.
Prior to joining argenx, Massey was with Roche’s Genentech for over nine years, where she most recently served as Senior Vice President of Product Development and Global Clinical Operations. She previously held various commercial leadership roles across marketing and business operations, including as Vice President of the company’s multiple sclerosis and neuromyelitis optica business.
She started her bio/pharmaceutical career in marketing at Pfizer and returned there, after two years as a management consultant at Bain & Company, to take on leadership positions in corporate strategy, sales, and as a commercial lead in Latin America.
Source: argenx
