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Eli Lilly moves deeper into non-viral genetic medicines via Engage acquisition
Eli Lilly agreed to buy Engage Biologics in a deal worth up to $202 million to expand its non-viral DNA delivery capabilities for genetic medicines. Engage’s preclinical platform, dubbed...
Parabilis targets IPO and Phase 3 funding after Regeneron pact for Helicon modality
Parabilis Medicines filed for an initial public offering after inking a strategic collaboration with Regeneron focused on Helicon-based antibody-peptide conjugates. Parabilis’ IPO filing follows a...
Oorja Bio launches with new financing to pursue fibrosis reversal in idiopathic pulmonary fibrosis
Oorja Bio launched with $30 million in seed funding to develop a novel approach for idiopathic pulmonary fibrosis, a disease with limited treatment options. The new company’s strategy focuses on...
Antibody therapy trial signals in tough rheumatoid arthritis using next-gen FcRn inhibition
Immunovant shares jumped after the company disclosed early Phase 2b findings for IMVT-1402, a next-generation FcRn inhibitor in difficult-to-treat rheumatoid arthritis (D2T RA). The study includes...
Relay’s zovegalisib posts Phase 2 signal in PIK3CA-driven vascular anomalies
Relay Therapeutics reported a Phase 2 efficacy signal for zovegalisib (RLY-2608) in PIK3CA-driven vascular anomalies, a group of rare disorders with limited approved options. The company said the...
Diagnostics expansion: Diasorin pushes syndromic molecular GI testing and US molecular growth
Diasorin is accelerating US molecular diagnostics and point-of-care positioning, disclosing plans to raise its US molecular market share over the next four years. At an investor day, the company...
Clinical trial and regulatory emphasis in Ebola as outbreak worsens and WHO declares PHEIC
The WHO declared the Bundibugyo Ebola outbreak in the Democratic Republic of the Congo a public health emergency of international concern, reflecting the fast escalation and geographic spread into...
AI partnerships deepen: Qiagen integrates Nvidia BioNeMo into biomedical knowledge platform
Qiagen said it is working with Nvidia to integrate accelerated computing and Nvidia BioNeMo into its Qiagen Digital Insights curated biomedical knowledgebases. The company said the goal is to...
Regulatory approvals: oncology diagnostics and liquid biopsy scale-up
FDA has approved Guardant Health’s upgraded Guardant360 Liquid CDx, extending the same companion-diagnostic indications from the earlier test to a broader genomic footprint. The new blood-based...
Clinical readouts: immunology and oncology signals in hard-to-treat disease
Immunovant surged after releasing early but “compelling” Phase 2b data for IMVT-1402, its next-generation FcRn inhibitor in difficult-to-treat rheumatoid arthritis (D2T RA). The open-label 16-week...
Startup financing: mature capital infusions for late-stage clinical momentum
Parabilis filed for an IPO as it prepares for Phase 3 progress on zolucatetide (FOG-001) in desmoid tumors, following a high-value strategic alliance with Regeneron. The IPO plan is framed around...
Strategic partnerships and M&A: Eli Lilly accelerates genetic medicine with a DNA-delivery acquisition
Eli Lilly agreed to buy Engage Biologics, paying up to $202 million to add a preclinical non-viral DNA delivery platform to its genetic medicine pipeline. Engage’s Tethosome approach uses lipid...
Big healthcare investing: GHO Capital and CBC Group form a $21B specialty investment giant
GHO Capital and CBC Group announced a planned merger that would create a dedicated healthcare investment firm with combined assets under management of about $21 billion. The firms said the...
Diagnostics innovation: scalable syndromic GI testing expands at point of care
Diasorin received 510(k) clearance from the FDA for a customizable syndromic gastrointestinal pathogen PCR panel designed for its Liaison Plex platform. The Liaison Plex Gastrointestinal Flex...
Clinical supply and trial enablement: antibody access for colorectal cancer Phase 3
Exelixis secured supplies of subcutaneous Keytruda for a planned Phase 3 colorectal cancer trial after completing the funding and contributor setup that includes Merck’s supply commitment. The...
Regulatory shifts in clinical research administration: EMA proposes contract templates to unblock EU trial starts
The European Medicines Agency proposed a centralized contract platform and template resources to help sponsors and CROs negotiate EU clinical trial agreements more efficiently. In its clinical...
Public health emergency: WHO declares Bundibugyo Ebola outbreak a PHEIC
The WHO declared the Bundibugyo Ebola outbreak in the Democratic Republic of the Congo a public health emergency of international concern (PHEIC) as case counts and suspected clusters rose and...
Emerging platform science: AI systems that automate parts of the scientific method
New research reported that autonomous AI systems can assist across the scientific workflow—generating hypotheses, designing experiments, analyzing data, and refining conclusions—suggesting a shift...
Regulatory approval: liquid biopsy expansion
Guardant Health’s upgraded Guardant360 Liquid CDx won FDA approval, expanding the blood-based, tumor-informed genomic/epigenomic test’s clinical reach. The new assay evaluates a 100-fold larger...
Oncology diagnostics & MRD coverage
Personalis said CMS expanded Medicare coverage for its NeXT Personal minimal residual disease (MRD) test to include monitoring response to neoadjuvant therapy in stages II to III triple-negative...