Global Briefs: Pfizer, Lilly, Biogen & More
A roundup of news from Pfizer, Eli Lilly and Company, Biogen/Eisai, Boehringer Ingelheim, Intas Pharmaceuticals, bluebird bio, and the US Food and Drug Administration.
Manufacturing News
* BI Opens New $33-M ADC R&D Center
* WHO Member States Advance Draft Pandemic Agreement
Mergers & Acquisitions
* Intas Completes Acquisition of Biosimilar from Coherus BioSciences
* bluebird bio Reaffirms Merger Agreement With Investment Firms Carlyle and SK Capital
Drug Approvals & Pipelines
* Biogen, Eisai Get EU OK for Alzheimer’s Drug; Lilly Does Not Get EU Nod for its Alzheimer’s Drug
* Pfizer Discontinues Development of GLP-1 Obesity Drug
Regulatory News
* FDA Announces New Policy on Individuals Serving on FDA Advisory Committees
* FDA Announces Plan to Phase Out Animal Testing Requirement for mAbs, Other Drugs
Manufacturing News
BI Investing $33 M for New ADC R&D Center
NBE Therapeutics, a wholly owned subsidiary of Boehringer Ingelheim (BI), has opened a new antibody drug conjugate (ADC) R&D facility in Basel, Switzerland. NBE Therapeutics, a Swiss biotech company, was founded in 2012 and became part of BI in 2020. The new facility represents an investment of CHF 27 million ($33 million) in ADC R&D over several years. It provides 1,826 square meters of laboratories and office space and will house a team of approximately 50 scientists, in addition to supporting various functions, including human resources, administration, and management.
Source: Boehringer Ingelheim
WHO Member States Advance Draft Pandemic Agreement
Member states of the World Health Organization (WHO) have finalized a draft pandemic agreement for consideration for adoption at the Word Health Assembly, the decision-making body of WHO, in May (May 2025). The proposal aims to strengthen global collaboration on prevention, preparedness and response to future pandemic threats, including through supply chain and manufacturing initiatives.
In December 2021, during the COVID-19 pandemic, WHO member states established the Intergovernmental Negotiating Body (INB) to draft and negotiate a convention, agreement or other international instrument, under the WHO Constitution, to strengthen pandemic prevention, preparedness and response. Following 13 formal rounds of meetings, nine of which were extended, and informal and intersessional negotiations on various aspects of the draft agreement, the INB has finalized a proposal for the WHO Pandemic Agreement. The outcome of the INB’s work will now be presented to the World Health Assembly for its consideration.
Proposals within the text developed by the INB include establishing a pathogen access and benefit sharing system; taking concrete measures on pandemic prevention, including through a One Health approach; building geographically diverse research and development capacities; facilitating the transfer of technology and related knowledge, skills and expertise for the production of pandemic-related health products; mobilizing a skilled, trained and multidisciplinary national and global health emergency workforce; setting up a coordinating financial mechanism; taking concrete measures to strengthen preparedness, readiness and health system functions and resilience; and establishing a global supply chain and logistics network.
Source: World Health Organization
Mergers & Acquisitions
Intas Completes Acquisition of Biosimilar from Coherus BioSciences
Intas Pharmaceuticals, an Ahmedabad, Gujarat, India-based bio/pharmaceutical company and CDMO, has completed its acquisition of the Udenyca (pegfilgrastim-cbqv) business, a biosimilar to Amgen’s Neulasta (pegfilgrastim), from Coherus BioSciences, a Redwood City, California-based bio/pharmaceutical company. The drug is used to treat neutropenia (low white blood cells) as a side effect of cancer treatment.
The companies had announced the deal last December (December 2024). The acquisition was made through Accord BioPharma, the US specialty division of Intas Pharmaceuticals. Under the acquisition announcement made last December (December 2024), Coherus was to receive an upfront cash payment of $483.4 million, subject to closing adjustments for final inventory valuation, plus two net sales milestone payments totaling $75.0 million, and in exchange Intas was to receive identified assets related to the Udenyca franchise, including the Udenyca prefilled syringe, the Udenyca autoinjector, and the Udenyca Onbody and assume identified liabilities.
Source: Intas Pharmaceuticals
bluebird bio Reaffirms Merger Agreement With Investment Firms Carlyle and SK Capital
bluebird bio, a Somerville, Massachusetts-based company specializing in gene therapies, has reaffirmed its acquisition agreement with the investment firms, Carlyle and SK Capital Partners, which the companies had announced in February (February 2024) after reporting that another suitor company, Ayrmid, had not submitted a binding proposal to acquire bluebird and had not obtained necessary financing. The Board of Directors of bluebird bio said it reaffirms its recommendation in support of the transaction with Carlyle and SK Capital and recommends all stockholders tender into the current agreement by May 2, 2025.
In February (February 2025), bluebird had agreed to be acquired by Carlyle and SK Capital and to be taken private for an offer of $3.00 per share in cash and a one-time contingent value right of $6.84 per share payable upon achievement of a net sales milestone, contingent upon certain offer conditions. After commencing the tender offer with Carlyle and SK Capital, bluebird subsequently received an unsolicited non-binding written proposal from Ayrmid to acquire bluebird for an upfront cash payment of $4.50 per share and a one-time contingent value right of $6.84 per share payable upon achievement of a net sales milestone. The Ayrmid proposal was subject to certain conditions and further negotiations between the parties, including confirmatory diligence, and ultimately the offer did not come to fruition.
Source: bluebird bio
Drug Approvals & Pipelines
Biogen, Eisai Get EU OK for Alzheimer’s Drug; Lilly Does Not Get EU Nod for its Alzheimer’s Drug
Biogen and Eisai report that the European Commission has granted marketing authorization to the company’s Leqembi (lecanemab), an amyloid-beta monoclonal antibody for treating adults with mild cognitive impairment and mild dementia due to Alzheimer’s disease. The marketing authorization applies to all 27 member states of the European Union as well as Iceland, Liechtenstein, and Norway.
Eisai serves as the lead for lecanemab’s development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority. In the EU (excluding the Nordic countries), Eisai and Biogen will co-promote the medicine, with Eisai distributing the product as the marketing authorization holder. In the Nordic countries, Eisai and BioArctic will co-promote the medicine, with Eisai distributing the product as the marketing authorization holder. The drug is also approved in the US for treating Alzheimer’s disease.
Separately, Eli Lilly and Company reports that European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued an opinion that does not recommend the company’s donanemab be granted marketing authorization for the treatment of early symptomatic Alzheimer’s disease. Lilly says it will seek re-examination by CHMP. The drug is approved in the US as Kisunla (donanemab-azbt) injection for treating Alzheimer’s disease.
Pfizer Discontinues Development of GLP-1 Obesity Drug
Pfizer reports that it has decided to discontinue development of danuglipron, an oral glucagon-like peptide-1 (GLP-1) receptor agonist, which was being investigated for chronic weight management, due to a report of one case of liver toxicity in a clinical trial.
Pfizer said the dose-optimization studies of once-daily formulations of danuglipron met key pharmacokinetic objectives and confirmed a formulation and dose with the potential to deliver a competitive efficacy and tolerability profile in Phase III testing, based on earlier studies of twice-daily danuglipron. While the overall frequency of liver enzyme elevations across the over 1,400 participant safety database of danuglipron is in-line with approved agents in the class, a single asymptomatic participant in one of the dose-optimization studies experienced potential drug-induced liver injury, which resolved after discontinuation of danuglipron. After a review of the totality of information, including all clinical data generated to date for danuglipron and recent input from regulators, Pfizer said it decided to discontinue development of the molecule.
Regulatory News
FDA Announces New Policy on Individuals Serving on FDA Advisory Committees
US Food and Drug Administration (FDA) Commissioner Martin A. Makary, has announced a policy directive that limits individuals employed at companies regulated by FDA, such as pharmaceutical companies, from serving as official members on FDA advisory committees, where statutorily allowed. As part of this effort, the agency says it will prioritize and elevate the role of patients and caregivers. FDA uses its advisory committees to obtain independent expert advice and recommendations on scientific, technical, and policy decisions.
The policy directive will not preclude employees of regulated companies from attending or presenting their views at FDA advisory committee meetings or serving as representative members of the committee when required by statute. Also, FDA says exceptions can be made in rare circumstances (i.e., when the scientific expertise in an area is only available from an employee of an FDA-regulated company) provided that the official complies with the applicable ethics requirements.
Source: US Food and Drug Administration
FDA Announces Plan to Phase Out Animal Testing Requirement for mAbs, Other Drugs
The US Food and Drug Administration (FDA) has announced a plan to phase out animal testing requirements for monoclonal antibodies and other drugs. FDA says its animal testing requirement will be reduced, refined, or potentially replaced using a range of approaches, including AI-based computational models of toxicity and cell lines and organoid toxicity testing in a laboratory setting (so-called New Approach Methodologies or NAMs data). Implementation of the regimen will begin immediately (as reported on April 10, 2025) for investigational new drug applications, where inclusion of NAMs data is encouraged, and the plan for implementation is outlined in a newly released roadmap. To make determinations of efficacy, the agency will also begin use pre-existing, real-world safety data from other countries, with comparable regulatory standards, where the drug has already been studied in humans.
Source: US Food and Drug Administration
