BioBusiness

MRM Health’s MH002 gains FDA fast track, advancing microbiome-based therapy targeting immune modulation in ulcerative colitis patients.

LEO Pharma has acquired U.S.-based gene therapy company Replay to strengthen its rare disease dermatology pipeline through a novel herpes simplex virus-based platform. The deal adds a preclinical gene therapy program targeting dystrophic epidermolysis bullosa and expands LEO Pharma’s long-term strategy in genetic skin disease innovation.

Automated density gradient ultracentrifugation boosts the efficiency of AAV purification.

Novartis has finalized its US manufacturing and R&D expansion plan with a seventh new facility in North Carolina, reinforcing domestic drug production capabilities. The investment is part of a broader $23 billion strategy to enable end-to-end manufacturing across advanced therapeutic platforms.

BeOne Medicines’ tislelizumab and zanidatamab show improved survival in HER2+ GEA, highlighting combination immunotherapy advances in gastroesophageal cancer.

Zealand Pharma and Roche will advance the amylin analog petrelintide into Phase 3 trials for chronic weight management following positive mid-stage data. The move positions petrelintide as a potential differentiated obesity therapy with a focus on tolerability and sustained weight loss.

Pfizer’s Elrexfio significantly improved progression-free survival in the Phase 3 MagnetisMM-5 trial for relapsed or refractory multiple myeloma. The results strengthen its potential as an earlier-line therapy in a difficult-to-treat patient population.

Genexine’s first-in-class SOX2 degrader GX-BP1 demonstrated up to 96% tumor growth inhibition in preclinical models presented at AACR 2026. The bioPROTAC candidate also prevented tumor relapse and restored drug sensitivity, positioning it as a promising next-generation oncology therapy.

Henlius and Organon have secured approval in Europe for its pertuzumab (POHERDY) biosimilar, expanding biosimilar access for HER2-positive breast cancer treatment across oncology settings.

The FDA has granted RMAT designation to Orca-Q, an investigational allogeneic T-cell therapy for high-risk hematologic malignancies, based on early phase 1 data.

Ligand’s acquisition of XOMA Royalty expands the royalty model, supporting late-stage drug development and diversifying access to oncology and rare disease therapies.

Mid-stage data suggest Oruka Therapeutics’ ORKA-001 may deliver high levels of skin clearance with the potential for once-yearly dosing in plaque psoriasis. However, limited study details and lack of safety data make the findings preliminary.

FDA approved a AstraZeneca's subcutaneous anifrolumab autoinjector for adults with moderate to severe systemic lupus erythematosus on standard therapy.

FDA has granted priority review to Johnson & Johnson's nipocalimab for warm autoimmune hemolytic anemia, a rare disorder with no approved US therapies.

AbbVie seeks FDA approval for subcutaneous risankizumab induction in adults with moderately to severely active Crohn disease.

Alphamab Oncology is set to unveil Phase I data for its bispecific ADC JSKN016 at the American Society of Clinical Oncology Annual Meeting (ASCO) 2026 in HER2-negative breast cancer. The early clinical readout highlights encouraging antitumor activity and a manageable safety profile in heavily pretreated patients, supporting continued development across multiple settings.

AbbVie has received a Complete Response Letter from the FDA for trenibotulinumtoxinE (TrenibotE), citing manufacturing-related questions but no safety or efficacy concerns. The company plans a timely resubmission, underscoring continued momentum for this short-acting neurotoxin candidate in facial aesthetics.

Minaris Advanced Therapies’ Dr. Eytan Abraham joins the discussion on how the biopharmaceutical industry is revolutionizing the design, durability, and global scalability of new biotherapeutic modalities through innovations in molecule design and next-generation delivery platforms.

CHMP has supported intrathecal onasemnogene abeparvovec, Novartis' gene therapy for 5q SMA in patients aged 2 years and older in the EU.

Phase 3a PIONEER TEENS data show oral semaglutide significantly improved glycemic control in adolescents with type 2 diabetes, addressing a major unmet need in pediatric care. Novo Nordisk plans regulatory submissions in the US and EU, positioning the therapy as a potential first oral GLP-1 option for this population.

The FDA’s approval of Dupixent (dupilumab) for the pediatric patient population extends the biologic’s use beyond its previous indication in adults and adolescents aged 12 years and older, marking the first biologic option available in the United States for younger children with uncontrolled chronic spontaneous urticaria.

Dr. Alan Smith of Charles River Laboratories explains why early manufacturing planning and scalable processes are critical to ensure successful commercialization of complex cell and gene therapies as part of his panel discussion at INTERPHEX 2026.

CytoDyn Inc. reported early Phase 2 data at the American Association for Cancer Research Annual Meeting 2026 showing that leronlimab in combination with TAS-102 and bevacizumab demonstrated biomarker activity, including reductions in circulating tumor DNA, in patients with metastatic colorectal cancer.

Johnson & Johnson reported that nipocalimab (Imaavy) demonstrated sustained disease control and reductions in pathogenic IgG levels through more than two years in patients with generalized myasthenia gravis. Patients who achieved sustained minimal symptom expression showed greater quality-of-life improvements, while a new head-to-head trial comparing nipocalimab with another FcRn inhibitor is now underway.

Amneal’s acquisition of Kashiv is expected to advance biosimilar development capacity, which in turn would support access to biologics amid an anticipated wave of loss-of-exclusivity patents globally.