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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...
Ebola response: WHO escalates Bundibugyo outbreak
WHO declared the Bundibugyo Ebola outbreak in the Democratic Republic of the Congo a public health emergency of international concern, escalating an outbreak now spreading across DRC and reaching...
Biopharma AI dealmaking: data platforms deepen
Collaborative Drug Discovery expanded its AI collaboration with Eli Lilly by planning tighter integration of Lilly TuneLab predictive models into CDD Vault workflows. The agreement targets ADMET...
AI in oncology prognosis: multimodal models
Researchers published a multimodal AI framework intended to improve breast cancer prognostication, combining multiple data sources into a single predictive approach. The study, led by Witowski,...
Drug development financing & IPO pipeline: Parabilis
Parabilis filed for an IPO to fund development of its Wnt/β-catenin pathway inhibitor zolucatetide for desmoid tumors, shortly after inking a research collaboration with Regeneron. The IPO filing...
Corporate deal: Regeneron expands “undruggable” modality
Regeneron and Parabilis announced a collaboration worth up to roughly $2.3 billion to develop Antibody-Helicon Conjugates aimed at historically undruggable intracellular targets. The program...
Company execution: FDA clearances for Diasorin point-of-care syndromic testing
Diasorin said the FDA granted 510(k) clearance for a customizable syndromic GI pathogen PCR panel built for its Liaison Plex platform. The Liaison Plex Gastrointestinal Flex Assay detects 24...
Immunology/oncology pipeline: FcRn inhibitor readout rebounds interest
Immunovant’s IMVT-1402 FcRn inhibitor produced “really great” responses in an ongoing Phase 2b open-label dataset in difficult-to-treat rheumatoid arthritis, according to CEO Matt Gline. Shares...
Biotech IPO/financings: cAMPfield lands major Series A
San Diego startup cAMPfield Therapeutics raised $180 million in a Series A, according to the announcement, positioning the company to develop inflammatory and immunology therapies built on...
Parabilis–Regeneron Helicon pact and IPO plans
Parabilis Medicines moved to the public markets, filing for an IPO days after signing a major strategic research collaboration with Regeneron to pursue “undruggable” targets. The Regeneron deal...
Guardant upgraded liquid CDx wins FDA approval
Guardant Health said the FDA has approved its upgraded Guardant360 Liquid CDx, a blood-based liquid biopsy intended to guide treatment decisions in advanced cancer. The company said the test...