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FDA accelerated approval and post-rejection turnaround for an oncolytic virus in melanoma
Replimune’s oncolytic virus Tudriqev (formerly RP1) cleared the FDA on an accelerated approval pathway for advanced melanoma, ending a back-and-forth that included two prior FDA rejections. The...
Company reshapes rare-disease development after mixed Phase 3 outcomes
BioMarin moved to discontinue BMN401, an enzyme replacement therapy for ENPP1 deficiency, after previously reporting mixed Phase 3 results and choosing not to make an immediate snap decision. The...
Clinical-stage mover: OX2R agonist wins FDA approval in narcolepsy type 1
Takeda’s selective OX2R agonist oveporexton (TAK-861) won FDA approval as Orzeyful, making it the first approved OX2R agonist. The approval follows Phase 3 results in narcolepsy type 1 showing...
US FDA advisory committee set for Grail’s failed cancer screening test
The FDA scheduled an advisory committee meeting for September to review Grail’s controversial cancer test after it failed to meet the primary endpoint in a large randomized UK trial. The agency’s...
Obesity market competition: survey shows injectable GLP-1s still win clinician satisfaction
Eli Lilly’s Zepbound remains physicians’ preferred GLP-1–based obesity treatment in a Spherix Global Insights survey of 185 U.S. specialists. Respondents reported the highest satisfaction with...
Biotech platform and financing momentum: large IPOs in pain and oncology
Biotech’s IPO pipeline stayed hot with oversubscribed debuts from newly public companies including Latigo Biotherapeutics and Blossomhill Therapeutics. Latigo priced an IPO to raise about $345.6...
Molecular tools and diagnostic access: Co-Diagnostics advances point-of-care respiratory multiplex testing
Co-Diagnostics filed a 510(k) submission to the FDA for a point-of-care upper respiratory infection test that can differentiate influenza A/B, COVID-19, and RSV using nasal swab samples. The Co-Dx...
Bioengineering and therapeutics: nanovesicles targeting METTL3 curb neuroinflammation
Engineered nanovesicles designed to target the m6A writer METTL3 reduced neuroinflammation in cell and animal models, according to a Nature Communications study led by Xu, Pan, Li and colleagues....
New degrader platform expands molecular glue discovery for cancer targets
Dana-Farber researchers described a scalable platform to discover molecular glue degraders and reported the first example of a metabolically activated molecular glue degrader. The approach is...
China-focused diagnostics and genomics industry: Illumina local MiSeq i100 launch in China
Illumina launched the MiSeq i100 Series-CN, a version of its MiSeq i100 sequencer produced in China for the domestic market, as part of its “in China, for China” strategy. The company said the...
Regulatory approval – oncolytic virus melanoma (Replimune/Tudriqev)
FDA approved Replimune’s oncolytic viral therapy Tudriqev (RP1) for advanced melanoma after a contentious path that included two prior rejections and last week’s advisory committee vote supporting...
Regulatory approval – first-in-class orexin receptor agonist for narcolepsy type 1
Takeda’s oral orexin-2 receptor agonist Orzeyful (oveporexton) received FDA approval as the first therapy designed to address the underlying biology of narcolepsy type 1. The approval follows two...
Clinical development – non-opioid pain IPO advances Nav1.8 pipeline (Latigo)
Latigo Biotherapeutics priced an IPO to raise about $345.6 million for a non-opioid pain pipeline built on Nav1.8 channel biology. The offering expands a class of therapies intended to treat pain...
IPO funding – macrocyclic oncology platform (Blossomhill)
Blossomhill Therapeutics priced a $150 million IPO to fund its macrocyclic cancer drug pipeline, including next-generation macrocyclic inhibitors targeting oncology indications such as EGFR-mutant...
Regulatory pipeline – fast-track and priority review signals across oncology
FDA granted fast track designation to multiple oncology programs in July, signaling heightened review priority across colorectal cancer, anal cancer, and malignant pleural mesothelioma, among...
Diagnostic expansion – portable, at-home molecular testing device (VPodDuo)
Researchers at the University of Illinois unveiled VPodDuo, an AirPods-sized fluorescence reader designed to enable timely molecular testing outside centralized labs. The device analyzes two...
Spatial biology – 10x Genomics raises outlook on Atera demand
10x Genomics lifted its 2026 revenue guidance, citing strong booked orders for its Atera spatial biology platform ahead of second-half shipping. CFO Adam Taich said interest materially exceeded...
Regulatory and industry policy – 340B rebate push meets bipartisan resistance
A bipartisan group of six senators introduced legislation to reform the U.S. 340B drug program, challenging HHS’s contested rebate push. The bill proposes locking in hospitals’ use of contract...
Biotech exec movement and leadership changes – BioCentury/management track merger of information (Terremoto CEO)
Mirati vet Christensen was named CEO of Terremoto, a well-funded startup, as the company signals continued emphasis on executive-led commercialization. The management change comes with references...
Cell and gene therapy tooling – AAV manufacturing improvement via helper plasmid engineering
Researchers reported a redesigned helper plasmid strategy that boosts AAV vector production by tuning expression of E4orf6 and L4-22/33K. The approach, published in Gene Therapy, targets a key...