Global Briefs: Shionogi, Teva, Novartis & More
A roundup of news from the large and mid-sized bio/pharmaceutical companies featuring Novo, Merck & Co., Shionogi, Viatris, Teva Pharmaceuticals, Roche and CSL. Highlights below.
For the latest news roundup on small and Emerging Pharma companies, see Biotech Briefs.
Manufacturing News
* FDA Delays Review of Novo’s Hemophilia Drug Candidate Due to Mfg Issues
* Halozyme Wins Injunction Against Merck & Co. for Subcutaneous Form of Keytruda
M&A News
* Shionogi To Acquire Rare-Disease Specialist IntraBio for $2 Bn
* Viatris To Acquire Pacira BioSciences for $1.65 Bn
Partnering News
* Teva, Samsung Bioepis Expand Biosimilars Pact for Six Potential Biosimilar Candidates
* Novartis, China’s Abogen Biosciences in $7.8-Bn RNA-Encoded Drug Pact
* Roche, Alector in $1.3-Bn Pact for Enzyme-Replacement Drug for Parkinson’s Disease
* CSL, Alentis in $1.56-Bn Pact for mAb for Rare Kidney Diseases
Manufacturing News
FDA Delays Review of Novo’s Hemophilia Drug Candidate Due to Mfg Issues
The US Food and Drug Administration (FDA) has informed Novo that the review of its biologics license application (BLA) for denecimig for the treatment of hemophilia A is still ongoing due to ongoing facility remediation activities. FDA has not communicated a new timeline for regulatory action on the BLA.
Novo submitted a BLA for denecimig for the treatment of hemophilia A in adult and pediatric patients to FDA in September 2025, with an anticipated regulatory decision in the third quarter of 2026. Following this submission, FDA performed a pre-license inspection of the manufacturing site and provided feedback. FDA has now informed Novo that the ongoing facility remediation activities are the cause for the extension of the agency’s review.
Novo reports that FDA has not identified any deficiencies related to the clinical efficacy or safety data submitted in the denecimig BLA. Novo says it is actively working with FDA to address the agency’s requests for remediations related to the manufacturing facility.
Novo says the extended FDA review time for the denecimig BLA has no impact on Novo’s financial outlook for 2026. Pending a regulatory decision, Novo says it aims to launch denecimig in the US in the first half of 2027.
Denecimig is a late-stage asset and part of the company’s growth strategy to position itself in therapeutics segments outside its leading diabetes and obesity franchise. Outside of obesity and diabetes, Novo is looking to build its position in three main therapeutic areas: blood and endocrine disorders, liver disease, and cardiovascular disease. The company has multiple late-stage assets in its blood and endocrine disorder franchise and has a goal of increasing its blood and endocrine disorder business by 50% by 2030 from a 2026 base. Its lead product in this franchise is denecimig, an investigational, bispecific antibody Factor VIIIa (FVIIIa) mimetic, designed as a routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults, adolescents, and children with hemophilia A (congenital FVIIIa deficiency), with or without inhibitors. Novo says denecimig is the first FVIIIa mimetic to offer once-monthly, once-every-two-weeks and once-weekly prophylaxis in a single-use pre-filled pen.
Source: Novo
Halozyme Wins Injunction Against Merck & Co. for Subcutaneous Form of Keytruda
Halozyme Therapeutics, a San Diego-based drug-delivery company specializing in subcutaneous drug delivery, reports that the specialized Dutch patent court of the Hague has found Merck & Co. to be infringing one of Halozyme’s patents relating to rapid, high-volume subcutaneous drug delivery (European Patent No. 2,797,622 [i.e., EP622]) of a subcutaneous form of Merck & Co.’s blockbuster immuno-oncology drug, Keytruda (pembrolizumab). Merck had received FDA approval of Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph), the subcutaneous form of the drug, in September 2025 as part of a biosimilars defense strategy for Keytruda. Keytruda is administered by infusion, and Keytruda Qlex is the brand name in the US for the subcutaneous version of the drug. It is marketed as Keytruda SC in Europe and was approved by European regulatory authorities in November 2025.
The Dutch proceedings are part of Halozyme’s global enforcement of its MDASE patents, which are patented enzyme technologies developed by Halozyme designed to break down hyaluronan locally in the extracellular matrix to allow large-volume or rapid subcutaneous (under-the-skin) drug injections.
Halozyme says that the Court has ordered Merck & Co.’s central European market authorization holder and worldwide packaging and distribution hub, MSD BV, to refrain from manufacturing, offering, placing on the market, using, importing, or stocking Keytruda SC in Belgium, Denmark, France, Ireland, Italy, Sweden, Switzerland, and the Netherlands. The injunction also prohibits MSD to facilitate infringement by its affiliates, including by allowing the use of its European marketing authorization. The company further reported that the Court also rejected Merck’s arguments that the EP622 patent is invalid.
Halozyme previously sued Merck in Germany and was granted a preliminary injunction on December 4, 2025, stopping Merck’s launch of Keytruda SC in Germany. Halozyme has also sued Merck for patent infringement in the US in a federal district court in New Jersey. In that case, Halozyme alleges the subcutaneous formulation of Keytruda, which is being marketed in the US as Qlex, infringes 15 patents that Halozyme filed beginning in 2011 to protect its MDASE technology. The patents at issue arise from Halozyme’s research into nearly 7,000 modifications to human hyaluronidases, according to the company. Among their uses, these hyaluronidases served as a basis for a mechanism for rapid SC administration of therapeutic drugs.
Source: Halozyme
M&A News
Shionogi To Acquire Rare-Disease Specialist IntraBio for $2 Bn
Shionogi has agreed to acquire IntraBio, an Austin, Texas-based bio/pharmaceutical company developing and commercializing therapies for rare neurodegenerative diseases and genetic neurological diseases, for $2.0 billion.
IntraBio’s lead commercial product is Aqneursa (levacetylleucine) for treating certain rare neurodegenerative diseases. It was approved by the US Food and Drug Administration (FDA) in September 2024 for neurological manifestations of Niemann-Pick disease Type C, a rare, inherited lysosomal storage disorder, in adults and pediatric patients and by the European Medicines Agency (EMA) in January 2026. It also was approved by FDA for the treatment of ataxia, a neurological condition characterized by the loss of full control of body movements, balance, and coordination, in adults and pediatric patients diagnosed with ataxia-telangiectasia (A-T), a rare, progressive, autosomal recessive genetic disorder that damages the nervous system, immune system, and other body organs. It is currently under review by EMA for adult and pediatric patients diagnosed with A-T.
Through this transaction, Shionogi would acquire global rights, including intellectual property and commercialization rights, for Aqneursa.
The acquisition would strengthen Shionogi’s position in rare diseases. In April (April 2026), the company acquired the global rights to Radicava/Radicut (edaravone), a treatment for amyotrophic lateral sclerosis (ALS), a progressive neurodegenerative disease, commonly known as Lou Gehrig’s disease, from Tanabe Pharma for $2.5 billion.
Under the agreement, Shionogi will acquire all outstanding shares of IntraBio for an upfront consideration of $2.0 billion payable to IntraBio shareholders. The proposed transaction is subject to the expiration of all applicable waiting periods under competition laws in each relevant country, and to the satisfaction of conditions precedent to the execution of the proposed transaction, including the acquisition of approvals and clearances from relevant regulatory authorities.
Source: Shionogi
Viatris To Acquire Pacira BioSciences for $1.65 Bn
Viatris has agreed to acquire Pacira BioSciences, a Brisbane, California-based bio/pharmaceutical company developing non-opioid pain therapies, for $1.65 billion.
Pacira has two commercial products: Exparel (bupivacaine liposome injectable suspension) and Zilretta (triamcinolone acetonide extended-release injectable suspension). The company generated approximately $746 million in total revenue during the last 12 months ended June 30, 2026. Viatris plans to apply its intellectual property expertise and expertise in extending product lifecycles to expand the products’ reach across select markets within its global infrastructure.
Under the agreement, Viatris will commence a tender offer to acquire all the outstanding shares of Pacira’s common stock for $36.50 per share in cash. Following completion of the tender offer, Viatris will acquire all remaining shares of Pacira’s common stock not tendered in the tender offer through a second-step merger for the same consideration.
The transaction, which was unanimously approved by the Boards of Directors of both companies, is subject to customary closing conditions, including the tender of a majority of the outstanding shares of Pacira’s common stock and expiration of the applicable regulatory waiting period. Pacira’s Board of Directors unanimously recommends that Pacira’s stockholders tender their shares in the tender offer. The transaction is expected to close by the end of 2026. Upon completion of the transaction, Pacira will become a wholly owned subsidiary of Viatris
Source: Viatris
Partnering
Teva, Samsung Bioepis Expand Biosimilars Pact for Six Potential Biosimilar Candidates
Teva Pharmaceutical Industries and Samsung Bioepis, a biosimilars company, have entered into a global license, development, and commercialization agreement for up to six potential biosimilar candidates, with two confirmed investigational biosimilar candidates, SB41, a biosimilar candidate referencing AstraZeneca’s Fasenra (benralizumab), and SB44, a biosimilar candidate referencing Novartis’ Ilaris (canakinumab), with an option for four additional biosimilar assets.
Under the agreement, Samsung Bioepis will be responsible for the development, regulatory registration, and manufacture of the biosimilars, and Teva will be responsible for commercialization in global markets, including the US, Europe, and Canada. The companies have agreed to an option for expanding the partnership to other territories.
The companies are already partnered in biosimilars with two commercial products: Epysqli (eculizumab-aagh) in the US and Opuviz (aflibercept) in Canada.
Source: Samsung Bioepis and Teva Pharmaceutical
Novartis, China’s Abogen Biosciences in $7.8-Bn RNA-Encoded Drug Pact
Novartis has entered into a licensing and option agreement with Abogen Biosciences, a Suzhou, China clinical-stage bio/pharmaceutical companies, to advance RNA-encoded therapeutics, in a deal worth up to $7.8 billion ($575 million upfront and $7.2 billion in potential milestone payments). The agreement includes an exclusive worldwide license to Abogen’s lead asset, ABO2203, as well as options to exclusively license other potential programs using Abogen’s proprietary RNA platform.
ABO2203 is an mRNA-encoded CD19xCD3 T-cell engager for treating certain autoimmune diseases. It is designed to reset B cells by using mRNA to direct the endogenous production of T-cell engagers in vivo. This approach offers a differentiated mechanism for B-cell depletion, potentially providing advantages over traditional recombinant T-cell engagers.
Under the agreement, Abogen will receive an upfront payment of $575 million and, if all options on all programs are exercised, Abogen is eligible to receive up to approximately $7.2 billion in potential milestone payments, subject to the achievement of agreed development, regulatory, and commercial milestones. In addition, Abogen may be eligible to receive potential royalties on future product sales. The transaction is subject to customary closing conditions, including required regulatory clearances.
Source: Abogen Biosciences
Roche, Alector in $1.3-Bn Pact for Enzyme-Replacement Drug for Parkinson’s Disease
Roche’s Genentech has entered into an exclusive global licensing agreement with Alector, a South San Francisco-based clinical-stage bio/pharmaceutical company, granting Genentech worldwide rights to develop and commercialize Alector’s AL050 program, an enzyme-replacement drug for Parkinson’s disease, in a deal worth up to $1.27 billion ($100 million upfront and up to $1.17 billion in milestone payments).
Alector’s AL050 program is a brain-penetrant engineered glucocerebrosidase (GCase) enzyme-replacement therapy. It is designed to address GCase deficiency, a driver of neurodegeneration in Parkinson’s disease that is most pronounced in, but not limited to, carriers of GBA1 mutations, according to information from Alector. It combines an Alector-engineered GCase, optimized for greater enzymatic activity and a longer half-life, with Alector’s proprietary blood–brain platform, Alector Brain Carrier (ABC), which is designed to transport therapeutics across the blood–brain barrier. Delivered into the brain, the enzyme is intended to break down glucosylsphingosine and glucosylceramide, lipids that accumulate in neurons and other brain cells upon GCase deficiency and that contribute to neurodegeneration, with the aim of reducing cellular dysfunction and slowing disease progression.
Under the agreement, Alector will receive an upfront payment of $100 million and is also eligible to receive additional payments of up to $1.17 billion upon the achievement of development, regulatory, and commercial milestones. Alector is also eligible for tiered royalties on net sales. Genentech will be responsible for development, regulatory, manufacturing, and commercialization across all indications. Alector retains ownership of ABC and full rights to apply the platform across its wholly owned pipeline.
Source: Alector
CSL, Alentis in $1.56-Bn Pact for mAb for Rare Kidney Diseases
CSL, a Melbourne, Australia-based bio/pharmaceutical company, and Alentis Therapeutics, a Basel, Switzerland-based bio/pharmaceutical company, have entered into an exclusive global collaboration agreement to co-develop and co-promote Alentis’ lixudebart, a monoclonal antibody drug for treating certain rare kidney and liver diseases, in a deal worth up to $1.56 billion ($355 million upfront and $1.2 billion in milestone payments).
Lixudebart is currently being evaluated in a Phase II trial in patients with antineutrophil cytoplasmic antibodies-associated vasculitis (ANCA), a group of rare autoimmune conditions that cause inflammation and damage in small and medium blood vessels, with rapidly progressive glomerulonephritis (AAV-RPGN), a rare autoimmune disease, which can cause kidney damage and end-stage renal disease. The two companies will also advance lixudebart as a treatment for focal segmental glomerulosclerosis (FSGS), a rare progressive kidney disease, and for primary sclerosing cholangitis (PSC), an autoimmune chronic liver disease.
Under the agreement, CSL and Alentis will jointly develop and co-promote lixudebart. CSL will make an initial payment to Alentis of $355 million, with Alentis eligible to receive up to an additional $1.2 billion in commercial milestone payments. In addition to these payments, CSL will fully fund the completion of the ongoing Phase II in ANC and planned Phase III trials in AAV-RPGN, the Phase II trials in FSGS and PSC and other supporting development activities. Once commercialized, global profits will be shared 55% to CSL and 45% to Alentis.
Source: CSL
