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Atopic dermatitis antibody race heats up
Infinimmune secured $75 million in Series A funding to advance two lead antibody programs targeting atopic dermatitis into the clinic starting in 2027. The Bay Area immunology startup is...
Rare bleeding disorder bankrolls Phase 3 push
Vaderis Therapeutics closed an oversubscribed $152 million Series B to advance engasertib (VAD-044) for hereditary hemorrhagic telangiectasia (HHT). The financing is designed to fund the Phase 3...
CRISPR gene-edited therapy safety spotlight
A reported gene-editing death in China adds to scrutiny around the clinical safety of investigational genome editing approaches. Two weeks after the disclosure of a gene editing death involving a...
FDA blocks radiopharma competitor to Lutathera
The FDA issued a complete response letter for ITM Isotope Technologies Munich SE’s radiotherapeutic ITM-11 (177Lu-edotreotide) targeting gastroenteropancreatic neuroendocrine tumors, citing...
Antibody engineering startup opens clinic data run for hot flashes
AbCellera reported positive topline Phase 2 results for ABCL-635, an injectable neurokinin 3 receptor (NK3R) antagonist antibody for menopausal vasomotor symptoms. In a randomized, double-blind,...
China clearance for FGFR2+ cholangiocarcinoma after FGFR therapy
Transthera Sciences received NMPA approval in China for Yochanra (tinengotinib), a treatment for FGFR2-positive cholangiocarcinoma that has progressed after prior FGFR inhibitor therapy. The...
Discovery platform funding: durable protein therapeutics
Remedium Bio raised an initial $10 million Series A financing to push its durable protein therapeutics platform toward first-in-human development. The company is framing the round as early runway...
Heart regeneration funding lands for USC stem-cell trial
The Marcus Foundation awarded $28.7 million to Chuck Murry, MD, PhD, director of the USC Stem Cell Center, to support a clinical trial testing a stem cell-based therapy to regenerate heart muscle...
Venture-backed gene editing competitor eyes hearing restoration
STAT+ reported that Skylark Bio dosed its first patient in a gene therapy trial targeting hearing loss associated with GJB2 mutations. The move follows renewed attention on gene therapy in...
Large insurer panel calls out AI adoption limits
A new analysis points to a performance gap in AI claims from large U.S. health insurers, arguing that operational reality is slowing adoption. The reporting describes how insurers including...
FDA narcolepsy approval
The U.S. FDA approved Takeda’s oral orexin receptor 2 agonist Orzeyful (oveporexton) for adults with narcolepsy type 1, positioning the drug as the first therapy designed to address the underlying...
China approvals in molecular oncology
Transthera Sciences won NMPA approval in China for Yochanra (tinengotinib) in FGFR2-positive cholangiocarcinoma that progressed after FGFR inhibitor therapy. The designation targets a...
Regulatory action reshapes drug program execution
The DOJ Antitrust Division announced a return to targeted Second Request investigations under the Hart-Scott-Rodino Act, along with a model timing agreement. In practice, the agency says it will...
340B payment and rebate policy
CMS proposed changes to the 340B Drug Pricing Program payment rates for drugs beginning in calendar year 2027, while HRSA updated its 340B Rebate Model Pilot Program. Together, the moves signal an...
Liquid biopsy funding for invasive fungal disease
NIAID awarded Zepto Life Technology a contract valued at up to $8.9 million to advance a plasma cell-free DNA liquid biopsy platform for invasive fungal infections. The funded work supports...
Oncology corporate development dealmaking
Bristol Myers Squibb selected Houston for a $2.3 billion multi-modal manufacturing campus intended to support drug product and finished-goods manufacturing across late development through launch....
Biotech financing and AI-driven platforms
A private financing roundup highlighted AI platform Chai and radiopharma startup Advancell among the top July raises, as biopharma deal value totaled $7.51 billion across 79 transactions in...
Rare disease gene-edited therapy safety setback
China reported another gene editing death tied to a young patient receiving HG-302 for Duchenne muscular dystrophy, according to disclosures by Huidagene Therapeutics. The report follows earlier...
Rare disease M&A: Jazz’s Actio acquisition
Jazz Pharmaceuticals agreed to acquire Actio Biosciences for up to $1.3 billion, with $820 million upfront, to expand its epilepsy pipeline. The deal is anchored by Actio’s lead program ABS-1230,...
Startup leadership + fundraising for drug discovery search
K2 Therapeutics appointed Ying Huang as its new CEO, following his departure as CEO of Legend Biotech. K2 is positioning itself as a drug discovery search and licensing platform, seeking...