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EU regulatory review: CHMP backs multiple new therapies including hemophilia A preventive drug
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended approvals for Novo’s preventive hemophilia A therapy and seven other medicines in a September wave...
Biopharma funding: Electra’s upsized IPO fuels late-stage inflammation program
Electra Therapeutics priced and launched an upsized IPO, raising $350 million on Nasdaq as investors look for a pipeline boost in inflammation. The proceeds are earmarked for advancing...
Xenon Pharmaceuticals: depression trial enrollment pause over neuropsychiatric adverse events
Xenon Pharmaceuticals halted enrollment in phase 3 major depressive disorder studies of azetukalner after reports of neuropsychiatric adverse events emerged in the broader patient population....
Cardiometabolic oral biologics: Novo and Orbis expand AI-enabled macrocycle platform deal to $1.4B
Novo Nordisk deepened its push for oral alternatives to injectable cardiometabolic drugs through a strategic partnership with Orbis Medicines. The multi-target deal could total up to $1.4 billion...
Immunology platform deal: Roche brings first partner into Dualitas’ bispecific discovery engine
Roche signed on as the first partner for Dualitas Therapeutics’ Dualscreen bispecific discovery engine, committing to screen more than 300,000 bispecific antibody combinations. Dualitas will...
Neurodegeneration drug discovery: Ariadne Bio spinout targets Parkinson’s apathy with AB-300
Palomar Labs (formerly Negev Labs) launched its first portfolio company, Ariadne Bio, via a spinout designed around candidates with prior human validation. The company’s lead program, AB-300, is a...
Bioprocessing operations: Sartorius and NIBRT set up training for intensified continuous manufacturing
Sartorius and Ireland’s National Institute for Bioprocessing Research and Training (NIBRT) are partnering to create a Process Intensification Training Center in Dublin. The hub will use...
AI + biology publishing: study finds AI-assisted writing signatures now dominate biomedical papers
A new analysis in biomedical literature reports that AI-assisted writing signatures are increasingly common in PubMed Central–archived publications. Researchers led by Dmitry Kobak (Ghent...
Biotech innovation funding: Mithrl raises $20M to scale biomedical world model workflows
Mithrl raised a $20 million Series A led by Obvious Ventures to expand a biomedical “world model” and agentic workflow for accelerating R&D from idea to IND. The company says Mithrl-1 integrates...
FDA approval: first disease-modifying gene therapy for Sanfilippo A
The FDA approved Ultragenyx’s gene therapy Fayuvi (rebisufligene etisparvovec) for Sanfilippo syndrome type A, making it the first treatment intended to address the underlying cause of the...
Biopharma pricing policy: Medicaid “most favored nation” expansion
President Donald Trump announced that all 50 U.S. states, Washington, DC, and Puerto Rico will participate in a new drug pricing model under Medicaid that relies on supplemental rebates from...
Eleven-year IPO/financing cycle: Electra’s $350M Nasdaq debut
Electra Therapeutics priced an upsized $350 million IPO as the company targets commercialization-ready funding for its inflammation-focused pipeline. The listing also reflects how receptive...
Clinical risk event: Xenon pauses depression program for neuropsychiatric events
Xenon Pharmaceuticals voluntarily paused enrollment in its major depressive disorder and bipolar disorder trials of azetukalner after reports of neuropsychiatric adverse events emerged in the...
Regulatory: CHMP backs Novo’s hemophilia A preventive drug
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion supporting Novo’s hemophilia A preventive therapy and also recommended approval of...
Venture and reverse merger capital: North Immunology raises $180M for eczema program
North Immunology is going public via a reverse merger with Aethlon Medical, positioning the inflammation-and-immunology startup for clinical advancement of an atopic dermatitis drug. The deal...
Partnership: Roche inks up to $1B screening deal with Dualitas
Roche signed a deal with Dualitas Therapeutics to use Dualitas’s Dualscreen bispecific discovery engine, aiming to screen more than 300,000 bispecific antibody combinations. The agreement includes...
Neuropsychiatry therapeutics: Palomar spins out Ariadne Bio for Parkinson’s apathy
Palomar Labs spun out Ariadne Bio to advance AB-300, a clinical-stage, non-hallucinogenic serotonin 2A receptor agonist aimed at Parkinson’s apathy. The venture studio said Ariadne’s focus is...
Manufacturing operations: GBI SmartScale GMP solutions for first-in-human timelines
CDMO GBI Biomanufacturing said it will launch SmartScale GMP Solutions, an accelerated small-scale cGMP platform designed to deliver material for first-in-human studies faster. The company said...
Gene editing frontier science: discovery of CRISPR’s viral precursor
Two studies published in Science described an RNA-guided immune system in viruses that appears to predate modern CRISPR, providing evidence of an evolutionary bridge from viral defense to...
FDA approvals: Sanfilippo gene therapy
The FDA approved Ultragenyx’s single-dose gene therapy Fayuvi (rebisufligene etisparvovec) for Sanfilippo syndrome type A, delivering the first disease-modifying treatment for the ultra-rare...