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Cybersecurity disruptions hit medical technology operations
Boston Scientific disclosed a cyberattack that disrupted global IT systems and order-shipping capabilities, leaving the company unable to provide a timeline for restoring normal operations. The...
Precision oncology services deal boosts McKesson’s clinical trial execution
McKesson signed an all-cash agreement to acquire Precision Medicine Group for about $2.25 billion, aiming to expand its oncology and biopharma commercialization capabilities. The deal brings...
Biomarker reimbursement expands for immunotherapy monitoring MRD test
NeoGenomics said its RaDar ST molecular residual disease assay received expanded CMS MolDX coverage to include immunotherapy response monitoring for patients with late-stage solid tumors. The...
Liquid-biopsy platform meets ADC trial monitoring
Natera partnered with Angiex to incorporate the Signatera minimal residual disease test into Angiex’s Phase 1 trial of AGX101, a TM4SF1-directed nuclear-delivered antibody-drug conjugate. The...
FDA Trialblazer-style IND efficiency prompts BIO pushback
BIO responded to the FDA’s request for information on its Expedited Investigational New Drug (IND) Pilot Program under Trialblazer, praising the concept of rolling review but warning that a...
Company deal: SK Biopharmaceuticals buys Biohaven’s epilepsy asset
SK Biopharmaceuticals agreed to acquire Biohaven’s Kv7.2/7.3 potassium channel activator opakalim (BHV-7000) in a $795 million deal, positioning the asset as a potential follow-on epilepsy...
Aging and immunology: persistent tumor/immune signals may link bone marrow and heart dysfunction
A new study in Nature Communications reported that changes to the bone marrow microenvironment can create immune memory that persists and continues damaging the heart after an initial injury or...
Scientific platform: AI-designed antibodies land among top performers in blinded benchmark
Researchers affiliated with UTHealth Houston competed as Novamab AI in the international AIntibody Challenge, a blinded, prospective benchmark published in Nature Biotechnology. The team placed...
Company funding: Faro raises Series B to speed AI-enabled clinical trials
Faro raised $37 million in a Series B round to accelerate AI-enabled clinical trial execution, focusing on reducing time and cost once programs move into the trial phase. The company aims to build...
FDA approvals and regulatory action in oncology
The FDA has approved Revolution Medicines’ daraxonrasib (Rasonque) for metastatic pancreatic ductal adenocarcinoma in patients previously treated with chemotherapy, positioning it as the first RAS...
Phase trial and label updates for cardio-metabolic drugs
Survodutide, Boehringer Ingelheim’s investigational dual GLP-1/glucagon agonist, has produced significantly greater weight loss than placebo in a phase 3 trial in adults with obesity without...
Venture and funding for digital health and clinical infrastructure
Metriport raised $26 million to help clinicians retrieve patient data more efficiently, using a platform approach aimed at easing the administrative friction behind modern care coordination. The...
Partnerships to expand MRD testing into new modalities and indications
Natera is partnering with Angiex to incorporate Signatera minimal residual disease (MRD) testing into Angiex’s Phase I trial of AGX101, a nuclear-delivered antibody-drug conjugate targeting...
Reimbursement wins for molecular diagnostics tied to immunotherapy
NeoGenomics said its RaDar ST molecular residual disease assay gained expanded coverage under the US Centers for Medicare and Medicaid Services’ MolDX program, adding immunotherapy response...
Biomanufacturing and workforce capacity investments
The Canadian Alliance for Skills and Training in Life Sciences (CASTL) said the Government of Canada is investing up to $8.7 million through the Sectoral Workforce Solutions Program to expand...
Clinical development setbacks and trial terminations
Regeneron has terminated its TITAN Phase I/IIa trial of REGN7041, an anti-CD3 monoclonal antibody in noninfectious uveitis, after a safety event triggered an unfavorable risk-versus-benefit...
Cell therapy manufacturing deal breaks and dispute risk
Bristol Myers Squibb terminated its $380 million collaboration with Cellares, a contract development and manufacturing organization focused on CAR T logistics and manufacturing systems. Cellares...
Dealmaking to build commercial and late-stage epilepsy franchises
SK Biopharmaceuticals agreed to acquire Biohaven’s Phase II/III epilepsy candidate opakalim (BHV-7000, Kv7.2/7.3 activator) in a deal valued at up to $795 million. The payment includes $400...
Public markets compliance and reverse split execution
Interspace Biosciences will implement a 1-for-5 reverse stock split to regain compliance with Nasdaq’s minimum bid price listing requirement. The reverse split became effective shortly after...
FDA Approval: RAS inhibitor in pancreatic cancer
The FDA approved Revolution Medicines’ daraxonrasib (Rasonque), the first RAS inhibitor cleared for pancreatic ductal adenocarcinoma, targeting metastatic patients with disease progression after...