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Adjuvant oncology approval and combination strategy
The FDA approved Merck’s Welireg (belzutifan) plus Keytruda (pembrolizumab) as an adjuvant combination for high-risk clear cell renal cell carcinoma after surgery, according to a...
Biotech financing scale-up and capital markets momentum
Parabilis Medicines completed an IPO with a $770.5 million closing after underwriters fully exercised their overallotment option, capping a major week for public-market fundraising in biotech,...
Gene therapy platform first-in-human momentum
Life Biosciences disclosed it dosed the first participant in a gene therapy trial built on partial cellular reprogramming to coax aged cells toward a younger identity. The approach turns on three...
Ultrasound-mediated genetic medicines funding
SonoThera raised $125 million in an oversubscribed Series B to advance ultrasound-mediated genetic medicines into the clinic. The round was led by Vida Ventures, with participation from Otsuka...
Primary care and clinical risk signals in GLP-1 therapy
New safety and behavior findings tied to GLP-1 receptor agonists are raising clinical monitoring questions. Northwestern Medicine research linked GLP-1s to a higher incidence of fainting and...
Oncology trial readouts and therapeutic rivalry
Cadonilimab in combination with chemotherapy delivered positive Phase II results for first-line treatment of PD-L1-negative advanced non-small cell lung cancer, according to trial reporting. The...
Clinical-grade gene editing reaches late-stage milestone
Researchers reported the first Phase 3 completion of an in vivo CRISPR-based therapy at Amsterdam University Medical Center and partner hospitals, marking a late-stage milestone for gene editing...
Adaptive cancer immunotherapy engineering in CAR T and beyond
Oricell advanced its GPC3-directed cellular therapy program by moving its first pivotal-stage CAR T for liver cancer into a confirmatory registration Phase II trial. The therapy, Ori-C101, targets...
Precision oncology diagnostics via MRD test rebrand and expansion
Roche’s Foundation Medicine rebranded Saga Diagnostics’ MRD test and is seeking new indications beyond its initial breast cancer use, according to reporting on the test update. The assay uses...
Regulatory milestone in kidney cancer adjuvant therapy
FDA has approved Merck’s adjuvant combination of Welireg (belzutifan) plus Keytruda (pembrolizumab) for patients with clear cell renal cell carcinoma after surgery, setting a new standard for...
New IPO wave—record public funding for biotech pipelines
Parabilis Medicines surged to a blockbuster Nasdaq debut, raising about $670 million as the company drives its tumor-focused pipeline forward. The listing follows another record set by obesity...
Funding surge for ultrasound-mediated gene delivery
SonoThera raised an oversubscribed $125 million in a Series B to advance ultrasound-mediated genetic medicines into clinical development. The financing was led by Vida Ventures and includes...
First-in-human partial cell reprogramming enters glaucoma trial
Life Biosciences has dosed the first participant in a gene therapy trial testing partial cellular reprogramming for glaucoma. The approach turns on three genes intended to “partially reprogram”...
Late-stage performance in psoriasis—Takeda’s zasocitinib vs Sotyktu
Takeda reported that its oral TYK2 inhibitor zasocitinib (TAK-279) showed statistical superiority over Bristol Myers Squibb’s Sotyktu (deucravacitinib) in a Phase 3 top-line readout for moderate...
CAR T expansion—Oricell advances GPC3-directed liver cancer into registration phase II
Oricell Therapeutics said its GPC3-targeted autologous CAR T, Ori-C101, is entering a confirmatory registration Phase 2 trial for patients with GPC3-positive advanced hepatocellular carcinoma. The...
RNA/protein delivery innovation in Duchenne—non-viral full-length mRNA in vivo
Researchers reported a systemic, non-viral strategy for delivering full-length DMD mRNA using skeletal-muscle-targeted extracellular vesicles (EVs) engineered with targeting tags. In a murine DMD...
Oncology research—engineered oncolytic VSV targets metastatic ovarian cancer
Researchers unveiled ErbB-OSV, an engineered vesicular stomatitis virus (VSV) variant designed to selectively kill metastatic ovarian cancer cells while sparing normal tissue. The study reports a...
Drug development—Cachexia biology points to GDF15 as lead target
Biocentury reported that GDF15 is emerging as the lead target in cancer-associated cachexia development, with Pfizer and CatalYm both advancing programs through Phase II/III studies. GDF15 is a...
Biopharma governance—WuXi AppTec fights Pentagon military designation
WuXi AppTec moved to challenge its inclusion on a U.S. military-linked list, filing a lawsuit that disputes the government’s characterization and argues the designation has already caused “severe...
Regulatory approval – renal cell carcinoma (adjuvant combo)
The FDA has approved an adjuvant combination of pembrolizumab and belzutifan for adults with high-risk clear cell renal cell carcinoma following surgery, according to a Dana-Farber-backed report....