Get the Daily Brief
Latest Biotech News
Clinical progress for oncology supportive care to cut EGFR-mutant NSCLC dermatologic toxicity
Interim results from the phase II COCOON trial showed a reduction in dermatologic adverse events for patients with EGFR-mutant non-small cell lung cancer (NSCLC) when proactive skincare is added...
AI and multi-omics data deals for drug discovery and development
TriNetX will link with Regeneron to provide the company exclusive, secure access to de-identified health data from approximately 300 million individuals, aimed at supporting drug discovery and...
FDA and global review reforms around new approach methodologies (NAMs) for toxicity testing
The European Medicines Agency (EMA) gave initial endorsement to a new approach methodology that replaces live animal controls in early toxicity testing with “virtual counterparts” derived from...
Massive biopharma M&A reshaping biotech sentiment and quarter-end momentum
M&A drove a rebound in biotech market performance heading into Q2, with Eli Lilly’s acquisition of Centessa Pharma and Biogen’s purchase of Apellis Pharma cited as key deal catalysts. The stock...
Regulatory and competitive battle in oral GLP-1 weight-loss drugs
The FDA’s approval of Eli Lilly’s oral weight-loss drug Foundayo has set up a direct competitive push from Novo Nordisk to defend oral Wegovy. Novo highlighted differences in weight-loss outcomes,...
Court ruling closes a CRISPR patent battle and potentially clears guide-RNA modification IP barriers
The U.S. Supreme Court declined to hear an appeal from Agilent Technologies over the invalidation of two CRISPR-related patents tied to chemical modifications of guide RNAs used in CRISPR-Cas...
Biologics manufacturing and supply agreements for late-stage PD-L1 antibody candidate
ImmuneOncia Therapeutics and Lonza signed a manufacturing agreement for late-stage clinical supply of Danburstotug (IMC-001), a fully human PD-L1 immune checkpoint antibody in clinical...
Biomarker diagnostics funding for non-invasive endometriosis testing
Northwell Health’s Feinstein Institutes for Medical Research received a $500,000 RADx Tech award to develop a non-invasive endometriosis biomarker test using menstrual samples. The project, part...
Immunology platforms and next-generation preclinical models
FDA endorsement of animal-replacement toxicity testing is moving from policy to practice. The EMA is poised to approve its first “new approach methodology” (NAM) to replace live animal controls in...
Oncology supportive care
Interim results from the phase II COCOON trial show a targeted strategy to reduce dermatologic toxicity in EGFR-mutant frontline NSCLC. The study, led by Bishal Tiwari of Nassau University Medical...
Cell therapy manufacturing and regulation
The U.K. clinical cell-therapy pipeline continues to internationalize as manufacturing and scale-up collaborations expand. In one spotlight, iXCells Biotechnologies announced a multi-party effort...
Diabetes therapeutics: funding and translational push
Aspect Biosystems, a Canadian cell-therapy startup, secured $79 million from the Canadian government to support its diabetes programs. The funding is positioned as a way to keep next-generation...
Cancer immunotherapy and innate immune targeting
A new line of cancer immunotherapy research centers on restoring immune “gatekeeper” function. In a Science study, researchers at St. Jude Children’s Research Hospital reported that tumors can...
Biopharma M&A momentum
Takeover activity kept exerting upside pressure on biotech investors as deals accelerated into a new quarter. A STAT+ recap attributed the sharp end-of-quarter rebound in the XBI to major...
Regulatory and policy: U.S. pharma tariffs shift
U.S. policy makers escalated tariff pressure on imported branded drugs, but carveouts and “most-favored nation” agreements are shaping the near-term impact. Trump signed an executive order...
CRISPR intellectual property: Supreme Court ends Agilent challenge
The U.S. Supreme Court denied Agilent Technologies’ request to revisit CRISPR patent invalidation in its dispute with Synthego. The decision leaves intact a June 2025 Federal Circuit ruling that...
Oncology biomarker and treatment monitoring
Relapsed or refractory SCLC testing is getting a sharper biomarker focus as early trial data emerge for AZD2811. A phase I dose-expansion study reported how biomarker analysis tracked treatment...
Peptide drug platforms: major Series B closes
Syneron Bio closed a $150 million Series B round to support its macrocyclic peptide drug discovery platform. The company said the financing follows a prior round of nearly $100 million and...
US drug tariff crackdown targets branded medicines—carveouts hinge on domestic manufacturing deals
The Trump administration signed an executive order imposing 100% ad valorem tariffs on imported brand-name drugs and active pharmaceutical ingredients, positioning the policy as a national...
FDA decision timeline looms for COVID-19–era MCED adoption after endpoint miss in NHS trial
Clinicians are offering early access to Grail’s multi-cancer early detection (MCED) test while awaiting a full NHS trial readout and a concurrent FDA regulatory decision after the program missed a...