Global Briefs: AstraZeneca, Sanofi, Incyte, Ipsen, Teva & More
A roundup of news from the large and mid-sized bio/pharmaceutical companies featuring AstraZeneca, Sanofi, Incyte, Ispen, Teva, Boehringer Ingelheim, and Tanabe Pharma. Highlights below.
For the latest news roundup on small and Emerging Pharma companies, see Biotech Briefs.
Manufacturing News
* Tanabe Pharma To Sell Mfg Unit, Select Drugs to Towa Pharma
* FDA Cites Sanofi’s Ireland Facility for Documentation, Data Issues
M&A News
* Incyte Completes Acquisition of Vega Therapeutics in $2-Bn Deal
* Ispen To Acquire Kartos Therapeutics in $1.75-Bn Deal
* Ispen To Acquire Rare-Disease Company Meme Therapeutics in $900-M Deal
Partnering News
* AstraZeneca, Sino Biopharma in $2-Bn Respiratory Drug Pact
* Teva, Polpharma Biologics Form Biosimilars Pact
* BI, Prime Therapeutics Partner for Cancer Vaccines
Manufacturing News
Tanabe Pharma To Sell Mfg Unit, Select Drugs to Towa Pharma
Tanabe Pharma Corporation, an Osaka, Japan-based bio/pharmaceutical company, has entered a stock-transfer agreement with Towa Pharmaceutical, an Osaka, Japan-based bio/pharmaceutical company, to transfer manufacturing assets and select products to Towa Pharmaceutical.
Under this agreement, Tanabe Pharma’s consolidated subsidiary, Tanabe Pharma Factory, will be transferred to Towa Pharmaceutical. Once the transfer procedures are completed, Tanabe Pharma Factory—which includes manufacturing plants in Onoda and Yoshitomi, Japan—will become a wholly owned subsidiary of Towa Pharmaceutical.
Tanabe Pharma has also decided to transfer domestic manufacturing and marketing approvals, manufacturing and marketing rights to Towa Pharmaceutical for 17 products and 35 specifications. Starting in April 2027, it will proceed with the transfer to Towa Pharmaceutical in stages. Until the transfer of these products is completed, Tanabe Pharma will collaborate with Towa Pharmaceutical to provide information on these products, promote their proper use, and ensure their stable supplies.
Source: Tanabe Pharma
FDA Cites Sanofi’s Ireland Facility for Documentation, Data Issues
The US Food and Drug Administration (FDA) has issued a Warning Letter to Sanofi over cGMP violations for quality issues at Sanofi’s manufacturing facility in Waterford, Ireland, relating to two biological products: Thymoglobulin (anti-thymocyte globulin [rabbit]) and Altuviiio (antihemophilic factor [recombinant]). Thymoglobulin is a polyclonal antibody medication used to prevent and treat acute organ rejection in transplant patients. Altuviiio is a once-weekly Factor VIII replacement therapy used to treat adults and children with hemophilia A. FDA’s Center for Biologics Evaluation and Research (CBER) issued the Warning Letter. The facility is a former facility of Genzyme, which Sanofi acquired in 2011.
The issuance of the Warning Letter follows inspections of the facility between January 12 and January 20, 2026. The company was previously issued a Form 483 and provided responses in February and April 2026. An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations. The issues cited by FDA involved documentation of testing results and what the agency said was “a pattern in which the quality unit failed to exercise proper oversight, including oversight of data-integrity practices.”
FDA acknowledged that the company provided responses to demonstrate that it had implemented corrective actions to address each individual observation in the Form 483, but said that the company “failed to address the underlying failure of the quality unit to ensure compliance with cGMP requirements” and that the company’s response ‘lacked a comprehensive plan that addresses the root cause of the quality unit’s failure to fulfill its cGMP oversight responsibilities.” FDA is requesting further information on the company’s quality unit and is requesting that the company describe the systemic corrective actions it will take.
Source: US Food and Drug Administration
M&A News
Incyte Completes Acquisition of Vega Therapeutics in $2-Bn Deal
Incyte has completed its acquisition of Vega Therapeutics, a South San Francisco, California-based bio/pharmaceutical company developing antibody therapies for rare blood disorders, in a deal worth up to $2 billion ($1.25 billion upfront and $750 million in milestone payments). Vega Therapeutics is a subsidiary of Star Therapeutics, a South San Francisco-based bio/pharmaceutical company developing antibodies for hematologic and immunologic diseases.
Vega Therapeutics’ lead candidate is VGA039 is in Phase III development for treating von Willebrand disease, an inherited bleeding disorder.
Under the agreement, Star Therapeutics received $1.25 billion upfront, with up to $750 million in additional payments upon achievement of sales milestones, for total potential consideration of up to $2.0 billion.
Source: Incyte
Ispen To Acquire Kartos Therapeutics in $1.75-Bn Deal
Ipsen has agreed to acquire Kartos Therapeutics, a Redwood City, California-based bio/pharmaceutical, in a deal worth up to $1.75 billion ($450 million upfront and $1.3 billion in milestone payments).
The acquisition adds navtemadlin, an investigational MDM2 inhibitor designed to restore the natural tumor-suppressing function of p53, a critical tumor-suppressor in myelofibrosis, a rare blood cancer.
Under the agreement and merger plan, Ipsen, through a fully-owned subsidiary, will pay $450 million upfront at closing. Kartos Therapeutics shareholders are also eligible to receive additional milestone payments of up to $1.3 billion, including for regulatory approval and sales-based milestones.
The transaction is expected to close by the end of the third quarter of 2026, subject to fulfilment of customary closing conditions, including the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.
Source: Ipsen
Ispen To Acquire Rare-Disease Company Meme Therapeutics in $1-Bn Deal
Ipsen has agreed to acquire Memo Therapeutics, a Zurich, Switzerland-based bio/pharmaceutical company, in a deal worth up to $1 billion ($229 million upfront and $801 million in milestone payments).
Memo Therapeutics’ key asset is potravitug, a Phase II clinical-stage antibody against the BK polyomavirus. BK polyomavirus-associated nephropathy is a clinical complication in renal transplanted patients that can lead to graft loss and transplant failure. Potravitug is a monoclonal antibody directed against the BK virus VP1 capsid protein. It acts by blocking viral attachment and cellular entry, thereby preventing infection of host cells and subsequent viral replication.
Potravitug was granted fast-track designation from the US Food and Drug Administration in May 2023 and orphan drug designation in the European Union in December 2025.
Under the agreement, shareholders of Memo Therapeutics AG will receive a EUR 200 million ($229 million) payment on a cash-free and debt-free basis at closing of the transaction, and deferred payments contingent upon the achievement of specified development, regulatory approval, and sales-based milestones, for a total potential consideration in excess of EUR 700 million ($801 million). As a condition precedent to closing the transaction, Memo Therapeutics AG’s assets and employees not related to potravitug, will be transferred to a newly incorporated company, Memorises Bio, retained by Memo Therapeutics AG’s shareholders.
The transaction is expected to close during the third quarter of 2026, subject to fulfilment of customary closing conditions.
Source: Ipsen
Partnering News
AstraZeneca, Sino Biopharma in $2.1-Bn Respiratory Drug Pact
AstraZeneca and Sino Biopharmaceutical, a Hong Kong-based bio/pharmaceutical company, have entered into an exclusive license agreement for the development, manufacturing, and commercialization of Sino Biopharmaceutical’s PDE3/4 inhibitor, TQC3721, a respiratory drug, in a deal worth up to $2.1 billion ($200 million upfront and $1.9 billion in milestone payments).
Under the agreement, Sino Biopharmaceutical, will grant AstraZeneca an exclusive license to develop, manufacture, and commercialize TQC3721 outside China. AstraZeneca also gains exclusive global rights for certain future development programs. Sino Biopharmaceutical is eligible to receive an upfront payment of $200 million, with additional development, regulatory, and sales milestones, totaling up to $1.9 billion, as well as tiered royalties ranging up to double-digit percentages based on the annual net sales of TQC3721 products. The agreement is subject to customary closing conditions, including regulatory clearances.
Source: Sino Biopharma
Teva, Polpharma Biologics Form Biosimilars Pact
Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries, and Polpharma Biologics, have formed a global licensing agreement granting Teva exclusive rights to commercialize both formulations of Polpharma Biologics’ proposed biosimilar to Roche’s Ocrevus (ocrelizumab) a drug for treating multiple sclerosis, upon regulatory approval of the biosimilar. Ocrevus had 2025 sales of CHF $7.0 billion ($8.7 billion).
Under the agreement, Polpharma Biologics retains full responsibility for the development and manufacturing of the biosimilar candidate. Teva will be responsible for regulatory submissions and, upon approval, commercialization of the intravenous and subcutaneous formulations in the US Europe, Brazil, Canada, Australia, New Zealand, Israel, and Turkey.
Source: Teva Pharmaceutical
BI, Prime Therapeutics Partner for Cancer Vaccines
Boehringer Ingelheim and Prime Vector Technologies, a clinical-stage bio/pharmaceutical company developng viral vector-based vaccines, have entered into an agreement for the assignment of certain patents and the exclusive licensing of Prime Vector Technologies’ Orf virus platform for the development of cancer vaccines.
Under the agreement, Prime Vector Technologie is eligible to receive an upfront payment, development, regulatory, and commercial milestone payments as well as royalties on future product sales. Financial terms were not disclosed.
Source: Prime Vector Technologies
