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FDA approves Lilly’s oral SERD combination for second-line breast cancer
The FDA approved Eli Lilly’s oral selective estrogen receptor degrader (SERD) regimen Inluriyo in combination with an additional therapy for certain patients in the second-line setting for...
Clinical safety signal triggers Xenon pause in depression trials
Xenon Pharmaceuticals paused enrollment in Phase 2 trials of its KV7 potassium channel opener azetukalner for major depressive disorder and bipolar disorder after reports of neuropsychiatric...
Biotech IPOs and fundraising momentum continue
Biopharma financing remained strong as public-market activity pushed ahead into September. Electra Therapeutics priced and launched an upsized $350 million IPO to advance ipsoprubart, a pan-SIRP...
Lilly expands CNS-and-inflammation strategy with QurCan deal
Eli Lilly signed a research and collaboration agreement with QurCan Therapeutics to develop CNS and peripheral nervous system therapeutics. The partnership targets diseases across nervous-system...
EU regulator backs Novo hemophilia A preventive drug and multiple medicines
The EMA’s CHMP backed Novo’s hemophilia A preventive therapy, recommending the drug for approval, alongside positive opinions for seven other new medicines and 11 label expansions. The CHMP...
Ultragenyx approval extends Europe-wide rare disease trajectory
Ultragenyx’s first FDA approval for MPS IIIA reinforces rare-disease momentum for gene therapy developers and highlights how regulators weigh manufacturing remediation plans after earlier...
Ariadne Bio spinout targets Parkinson’s apathy with non-hallucinogenic 5-HT2A agonist
Palomar Labs spun out Ariadne Bio to advance AB-300, a clinical-stage, non-hallucinogenic serotonin 2A receptor agonist designed to treat apathy in Parkinson’s disease. Ariadne Bio’s lead program...
Novo doubles down on AI-powered oral drugs via $1.4B Orbis partnership
Novo Nordisk teamed up with Orbis Medicines on a deal focused on developing oral alternatives to injectable cardiometabolic therapies, including obesity, diabetes, and heart disease. The...
Bioprocessing innovation: smart GMP scale-up and benchtop virus filtration
Two biomanufacturing technology announcements targeted the same pain point—speed and robustness in upstream-to-GMP workflows. GBI Biomanufacturing said it will launch SmartScale GMP Solutions, a...
FDA clears first disease-modifying gene therapy for Sanfilippo A
The FDA has approved Ultragenyx’s gene therapy rebisufligene etisparvovec (Fayuvi, formerly UX-111), marking the first approved disease-modifying treatment for Sanfilippo syndrome type A (MPS...
Lilly wins FDA nod for oral SERD combination in second-line breast cancer
Eli Lilly’s oral SERD combination regimen Inluriyo has received FDA approval for certain metastatic breast cancer patients as a second-line option. The regimen pairs Lilly’s selective estrogen...
Xenon pauses depression trials after neuropsychiatric adverse events
Xenon Pharmaceuticals announced a voluntary pause in enrolling new patients in its phase 3 major depressive disorder and bipolar disorder trials of azetukalner after reports of neuropsychiatric...
Lilly expands CNS addiction-relevant GLP-1/GIP program with brenipatide Phase 1 dose-selection data
Eli Lilly presented early clinical data supporting dose selection for brenipatide, its once-weekly dual GIP/GLP-1 receptor agonist being developed with a neuroscience and immunology rationale. At...
EMA CHMP recommends hemophilia A preventive drug plus seven other medicines
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of Novo’s hemophilia A preventive therapy, alongside positive opinions for seven...
Electra lifts $350M in upsized IPO for late-stage pan-SIRP immunology drug
Electra Therapeutics priced an upsized initial public offering that raised $350 million, using proceeds to advance ipsoprubart, its pan-SIRP monoclonal antibody in phase 2/3 development for...
Bristol Myers drops $100M Orum degrader-antibody conjugate after Phase 1 readout
Bristol Myers Squibb is ending development of a degrader-antibody conjugate it acquired from Orum Therapeutics for $100 million, citing Phase 1 data that did not support continued investment. The...
Diverse biopharma funding picture and IPO momentum
Biopharma fundraising remained strong into late summer, with total financings reaching $77.13 billion through August—close to the prior-year total and supported by a high pace of large deals. IPO...
New venture Ariadne Bio spins out to pursue non-hallucinogenic 5-HT2A agonism for Parkinson’s apathy
Palomar Labs spun out Ariadne Bio to develop AB-300, a clinical-stage, non-hallucinogenic 5-HT2A receptor agonist targeting apathy in Parkinson’s disease. Palomar positioned the spinout around...
Regulatory and reimbursement policy pressure: Medicaid drug model and ACCESS expansion
Policy moves in the US centered on Medicaid drug pricing and Medicare outcomes payments. President Donald Trump announced that all 50 states plus DC and Puerto Rico will participate in a new...
FDA approvals: Sanfilippo gene therapy lands approval after manufacturing hurdles
The FDA approved Ultragenyx’s gene therapy Fayuvi (rebisufligene etisparvovec) for Sanfilippo syndrome type A, marking the first disease-modifying treatment for MPS IIIA and ending a complex...