Recent developments
Regulatory shifts
Regulators broadened access: the European Commission approved a 7.2 mg maintenance dose of Wegovy. The FDA cleared a monthly dosing schedule for RYBREVANT FASPRO in EGFR‑mutated NSCLC. EMA recommended EU withdrawal of levamisole medicines due to safety concerns.
Metabolic market dynamics
Novo Nordisk will launch Ozempic tablets in the US by Q2 2026. It also filed a lawsuit against Hims & Hers over unapproved compounded semaglutide. Lilly’s Q4 results and 2026 outlook highlighted GLP‑1‑driven growth with implications for APIs, excipients, and delivery systems.
Oncology advances
The FDA approved KEYTRUDA and KEYTRUDA QLEX for PD‑L1+ platinum‑resistant ovarian cancer. Retevmo (selpercatinib) improved event‑free survival as adjuvant therapy in early‑stage RET fusion‑positive NSCLC. Merck presented additional bladder and kidney cancer data, including KEYTRUDA combinations. Genmab’s annual report detailed portfolio expansion and guidance, reflecting sustained demand for biologics and ADC inputs.
Renal and autoimmune R&D
Obinutuzumab achieved superior remission versus tacrolimus in primary membranous nephropathy. Asahi Kasei initiated Phase I for AK1960, an endothelin A antagonist discovered on HiSAP. It expanded access through an exclusive license agreement concerning HiSAP lead compounds to pursue autoimmune indications.
Manufacturing and platforms
AptarGroup reported Q4 and 2025 results highlighting Pharma demand for elastomeric components and nasal delivery. SPIE electrified ALK’s Vandeuil plant to cut emissions and improve energy performance. Lilly agreed to acquire Orna Therapeutics, adding circular RNA and LNP capabilities relevant to in‑vivo cell engineering.