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FDA approvals, biotech acquisitions, and clinical trial updates are shaping today’s biopharma landscape. This episode of The BioPharm Brief covers the first approved PROTAC therapy for breast cancer, UCB’s planned acquisition of Candid Therapeutics, and new clinical data from Takeda Pharmaceutical Company in primary immunodeficiency.

The opening plenary session at this year’s AAPS National Biotechnology Conference will spotlight AI and NAMs as tools that advance predictive toxicology and human-relevant models to improve drug safety and translational research.

The FDA has approved vepdegestrant, the first PROteolysis TArgeting Chimera protein degrader therapy, for estrogen receptor gene-mutated ER+/HER2- advanced breast cancer, offering a new option for patients with endocrine-resistant disease.

UCB’s planned $2.2 billion acquisition of Candid Therapeutics strengthens its immunology pipeline with bispecific T-cell engagers, led by cizutamig, a BCMA/CD3-targeting antibody in early-stage trials for autoimmune diseases.

According to phase 2/3 trial data, Takeda’s TAK-881 demonstrates reduced infusion volume and shorter administration time while maintaining protective IgG levels in primary immunodeficiency patients.

In today’s podcast, we're seeing microbiome therapies gain FDA Fast Track status, Leo Pharma expand into gene therapy via acquisition, and automation improving AAV manufacturing efficiency.

Restore Vision Inc. reported interim Phase 1/2 data showing early vision improvements in patients with advanced retinitis pigmentosa treated with its optogenetic gene therapy RV-001.

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.

In today’s podcast, we see clinical durability, targeted combination strategies, and domestic production investment highlighting integrated approaches to meeting rising global demand for complex therapies.

Highlights at INTERPHEX 2026 include digital integration and supply chain innovation to improve scalability, resilience, and efficiency in biomanufacturing.

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.

As the biopharmaceutical industry moves increasingly toward applied AI in GMP manufacturing, emphasizing real-world use, PDA Week 2026 is expected to evolve as it further dives into risk management and data-driven quality decisions.

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.

Survodutide delivers significant Phase III weight loss results, FDA grants RMAT status to Orca-Q, and Ligand expands its portfolio with a $739 million acquisition of XOMA.

Biopharma news highlights: Henlius and Organon gain EU approval for a pertuzumab biosimilar, while Pfizer reports Phase 3 success for Elrexfio in multiple myeloma. Genexine advances GX-BP1 targeting SOX2, signaling new progress in overcoming cancer resistance and expanding oncology innovation.

Boehringer Ingelheim announced promising Phase III data showing that survodutide achieved up to 16.6% weight loss and significant metabolic improvements in adults with obesity or overweight. The dual glucagon/GLP-1 agonist may offer a new approach targeting both weight reduction and liver-related metabolic health.

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.

The BioPharm Brief covers three recent FDA developments shaping the autoimmune and inflammatory disease landscape. The agency cleared a subcutaneous autoinjector for anifrolumab in systemic lupus erythematosus, enabling at-home administration. It also granted Priority Review to nipocalimab for warm autoimmune hemolytic anemia, highlighting its potential as a targeted treatment for a rare condition. In addition, a supplemental application has been submitted for subcutaneous risankizumab as an induction therapy in Crohn disease, which could reduce the need for infusion-based initiation. Together, these updates reflect a growing focus on patient convenience, expanded access, and more precise treatment approaches in immune-mediated diseases.

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.

In the second half of an interview at the close of INTERPHEX 2026, Avantor’s Jerry Keybl explains that digital integration and AI-driven analytics enable predictive bioprocess control and can thus improve consistency, scalability, and data-driven manufacturing decisions.

Consistent fluid management across scales supports efficient bioproduction and reduces risk during scale-up of complex therapeutic modalities, says Avantor’s Jerry Keybl at INTERPHEX 2026.

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