Pharmaceuticals & Biopharmaceuticals

Indianapolis – September 21, 2026 -- The U.S. Food and Drug Administration has granted full approval to Eli Lilly and Company's (NYSE: LLY) Inluriyo (imlunestrant) in combination with Verzenio (abemaciclib) for adults with estrogen receptor-positive (ER+), HER2-negative, ESR1-mutated locally advanced or metastatic breast cancer whose disease progressed after at least one line of endocrine therapy.

EMBER-3 trial shows combination doubles progression-free survival

The approval rests on Phase 3 EMBER-3 data in 159 patients with ESR1-mutated metastatic breast cancer who had previously received an aromatase inhibitor, with or without a CDK4/6 inhibitor. Patients randomized to Inluriyo plus Verzenio (n=67) achieved a median progression-free survival of 11.1 months, versus 5.5 months for Inluriyo alone (n=92), a hazard ratio of 0.53 (95% CI, 0.35–0.80).

Huntersville, N.C. – September 21, 2026 -- BioCytics, Inc. has engaged Eremid Genomic Services to perform single cell transcriptomic and TCR sequencing analysis on immune cells central to its autologous cancer cell therapy program.

Eremid will characterize immune precursor cells before clinical deployment

The North Carolina-based genomics contract research organization will run scRNA-Seq and TCR sequencing on an autologous immune cell fraction supplied by BioCytics. The analysis is designed to confirm whether expanded immune cells are biologically fit for cancer-killing activity and to map their mechanism of action ahead of reinfusion into patients.

Seoul – September 20, 2026 -- NAVER D2SF, the in-house corporate venture arm of NAVER, has joined a $10 million Series A2 bridge round for Silicon Valley-based precision medicine company ImpriMed, backing its push toward U.S. regulatory clearance and Asian market expansion.

ImpriMed targets FDA clearance and CLIA certification by Q1 2027 for its blood cancer platform

The company is preparing to commercialize diagnostic products for blood cancers and blood infection in the United States, having already established business partnerships with major U.S. hospitals. ImpriMed's xCellSense platform keeps patient-derived cancer cells viable outside the body for extended periods, allowing evaluation of drug sensitivity alongside genomic, immunophenotypic and clinical data. The company's AI models are trained on more than 3.5 million data points combining real-world data with functional cell analysis.

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 20, 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 20, 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 20, 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 20, 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 20, 2026 closing price of $109.68. The notes mature September 20, 2026, with closing expected September 20, 2026.

Austin, Texas – – September 20, 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 20, 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.