Biopharmaceuticals

Columbus, Ohio – September 20, 2026 -- Andelyn Biosciences has begun commercial manufacturing of FAYUVI (rebisufligene etisparvovec-hopf) at its Columbus facility, marking the first FDA-approved gene therapy produced using the company's AAV Curator Platform process. The therapy, developed by Ultragenyx Pharmaceutical Inc., recently received U.S. Food and Drug Administration approval for treating Sanfilippo syndrome type A, also known as mucopolysaccharidosis type IIIA (MPS IIIA).

FDA clears gene therapy for a rare, fatal childhood disease

MPS IIIA is a rare lysosomal storage disorder that drives rapid neurodegeneration starting in early childhood, primarily affecting the central nervous system. The disease impacts an estimated 3,000 to 5,000 patients worldwide, with a median life expectancy of 15 years.

Taipei – September 19, 2026 -- The 2026 Tang Prize Award Ceremony convened in Taipei on September 18, honoring six laureates across four categories including three scientists whose work led to FDA-approved CAR T-cell cancer therapies now used worldwide.

Three biopharmaceutical laureates trace a four-decade path from lab discovery to approved cancer drugs

Dr. Steven A. Rosenberg, who joined remotely, cited his team's work four decades ago showing that tumor-infiltrating lymphocytes (TILs) taken from patients' own tumors could drive cancer regression, establishing the concept of a patient's lymphocytes as a 'living drug.' That research laid groundwork for later T cell receptor (TCR) and chimeric antigen receptor (CAR) therapeutic strategies now deployed clinically.

Madrid – September 19, 2026 -- mAbxience and Sandoz have signed a licensing, development, manufacturing and commercialization agreement for a proposed emicizumab biosimilar targeting hemophilia A, a treatment referencing Roche's Hemlibra with an estimated global reference market of USD 5.7 billion.

mAbxience will develop and manufacture the biosimilar at GMP facilities in Spain and Argentina

Under the agreement, mAbxience is responsible for development and manufacturing through its facilities in the two countries. Sandoz will handle global commercialization.

Sandoz secures exclusive global rights excluding three South American markets

Sandoz holds exclusive commercialization rights worldwide, with the exception of Argentina, Uruguay and Paraguay. Financial terms of the deal were not disclosed.

Zurich – September 19, 2026 -- ACROBiosystems has established a dedicated office within The HIVE Innovation Center on Campus Grand Parc in Villejuif, deepening its footprint in France's oncology research corridor. The move, facilitated by real estate operator Kadans Science Partner, gives the roughly 1,000-employee biotechnology group direct proximity to biotechs, hospitals, and translational research institutes clustered around Paris-Saclay.

ACROBiosystems joins a biocluster it entered as a member last year

The company became a member of the Paris-Saclay Cancer Cluster (PSCC) in 2025, and the new HIVE office is positioned to extend those regional ties. Campus Grand Parc concentrates oncology-focused clinical partners and research teams, an environment ACROBiosystems says aligns with its role supplying reagents and services across the drug development chain -- from recombinant proteins and antibodies to GMP-grade custom production.

San Diego – September 19, 2026 -- Halozyme Therapeutics (Nasdaq: HALO) priced $1.3 billion in convertible senior notes due 2033, upsized from an initially announced $1.05 billion offering, carrying a 1.50% annual coupon.

Halozyme secures $1.275 billion in net proceeds from the notes sale

The San Diego-based biopharmaceutical company said net proceeds from the offering total approximately $1.275 billion, rising to $1.471 billion if initial purchasers fully exercise a 13-day option to buy an additional $200 million in notes. The notes, sold to qualified institutional buyers under Rule 144A, carry an initial conversion price of approximately $139.84 per share, a 27.5% premium over Halozyme's September 17, 2026 closing price of $109.68. The notes mature October 1, 2033, with closing expected September 22, 2026.

Austin, Texas – – September 19, 2026 -- Otsuka ICU Medical LLC has issued a voluntary user-level recall of one lot of 0.9% Sodium Chloride Injection, USP, 100 mL, after discovering that bags labeled as saline may actually contain highly concentrated Potassium Chloride Injection.

Mislabeled overwrap conceals lethal potassium concentrate inside saline packaging

The affected lot, NDC 0990-7984-23, Lot 1042188, carries external labeling identifying it as 0.9% Sodium Chloride Injection, USP. Internally, however, the overwrap may instead contain Potassium Chloride Inj. 10 mEq (NDC 0990-7074-26, Lot 1035181), a highly concentrated formulation intended for diluted use only.

Las Vegas – September 19, 2026 -- The paroxysmal nocturnal hemoglobinuria (PNH) market across the seven major markets was valued at approximately $1.5 billion in 2025 and is projected to grow at a compound annual growth rate of 7.1% through 2036, according to DelveInsight.

Regeneron's pozelimab-cemdisiran combination leads next wave of PNH therapies

Pozelimab, a fully human anti-C5 monoclonal antibody developed on Regeneron's VelocImmune platform, is expected to generate the highest revenue among emerging PNH therapies in the seven major markets. The drug is being tested in combination with Alnylam's siRNA therapy cemdisiran; Regeneron has said Phase III results in PNH are anticipated in the fourth quarter of 2026 or the first quarter of 2027.

South San Francisco, Calif. – September 19, 2026 -- Dualitas Therapeutics has secured a research collaboration and license agreement with Roche worth up to $1 billion, including a $36.5 million upfront payment, to develop bispecific antibody therapeutics for immunology and inflammation diseases.

Dualitas will screen over 300,000 bispecific antibody combinations for Roche

Under the agreement, Dualitas will use its proprietary DualScreen Bispecific Discovery Engine to functionally screen more than 300,000 novel bispecific combinations, in what the company describes as one of the largest-scale bispecific discovery efforts undertaken. Roche will take over all subsequent preclinical development, regulatory, manufacturing and commercial activities for candidates that emerge from the collaboration.

Shanghai – September 19, 2026 -- WuXi XDC Cayman Inc. (2268.HK) has out-licensed its proprietary WuXiTecan-2 payload-linker technology platform to Ona Therapeutics under an exclusive global agreement targeting a single antibody-drug conjugate (ADC) candidate.

Deal structure includes upfront payment, milestones and tiered royalties

The agreement grants Ona Therapeutics exclusive global rights to develop an ADC candidate using WuXi XDC's WuXiTecan-2 platform. The total potential deal value comprises an upfront payment plus development, regulatory and sales milestone payments, with WuXi XDC also eligible for tiered royalties on net sales once the resulting product reaches commercialization. WuXi XDC will additionally provide chemistry, manufacturing and controls (CMC) development and manufacturing support through its integrated ADC CRDMO platform.

London – September 19, 2026 -- Clarivate Plc (NYSE: CLVT) named 22 researchers as its Citation Laureates 2026, identifying scientists whose work the company's Institute for Scientific Information (ISI) considers Nobel-class ahead of this year's Nobel Prize announcements. Since the program began in 2002, 89 previously named Citation Laureates have gone on to win Nobel Prizes.