Get the Daily Brief
Latest Biotech News
Large-scale oncology dealmaking and licensing monetization
Dimerix Ltd. signed an exclusive licensing deal with Everest Medicines to commercialize DMX-200, its phase III kidney disease candidate. The agreement is valued at up to AU$481 million (US$340...
FDA expands Alzheimer’s and immunology tools for trial and evidence design
FDA issued Bayesian guidance aimed at clinical trial planning, signaling a broader shift toward more flexible statistical approaches for conditions where classic designs can be difficult—such as...
Regulatory turning point: Merck’s Welireg plus Keytruda gets adjuvant kidney cancer nod
Merck’s Welireg (belzutifan) combined with Keytruda (pembrolizumab) secured a new FDA approval in adjuvant clear cell renal cell carcinoma (ccRCC). The authorization establishes the PD-1 plus...
Pipeline race in prostate cancer: immune reprogramming with programmable mRNA
Researchers unveiled a programmable RNA engineering platform designed to restore major histocompatibility complex class I (MHC-I) expression, aiming to improve immune recognition in...
Biotech finance: Isomorphic Labs lands mega-round for AI drug design
DeepMind-linked spinout Isomorphic Labs raised $2.1 billion in a Series B funding round, one of the largest private biotech rounds on record. The round was led by Thrive Capital, with...
CAR T climbs a development ladder in liver cancer
Oricell moved its glypican-3 (GPC3)-targeted autologous CAR T therapy into a confirmatory registration phase II program in patients with GPC3-positive advanced hepatocellular carcinoma. The...
HCM drug advances: Edgewise heads to Phase III after Phase 2 update
Edgewise Therapeutics advanced EDG-7500 toward phase III for both obstructive and nonobstructive hypertrophic cardiomyopathy (HCM) after reporting improved phase II topline data. The company cited...
Regulatory and cybersecurity risk: Novo Nordisk discloses clinical trial data breach
Novo Nordisk disclosed that it experienced “unauthorized access” to clinical trial data for its Ozempic and Wegovy programs. The company said direct identifiers such as patients’ names were not...
Clinical failure and workforce restructuring at Neumora
Neumora Therapeutics discontinued navacaprant, its oral kappa opioid receptor (KOR) antagonist program for major depressive disorder, after failing to meet primary and key secondary endpoints in...
FDA and mRNA flu vaccine approval pathway
The FDA and Moderna appear aligned as the agency heads into its June 18 Vaccines and Related Biological Products Advisory Committee meeting for the seasonal mRNA-1010 shot, now marketed as...
Biotech cost cuts and late-stage clinical failures
Neumora Therapeutics announced it is discontinuing navacaprant, its kappa opioid receptor antagonist for major depressive disorder, after two Phase 3 failures. The KOASTAL-2 and KOASTAL-3 studies...
Depression drug developer restructures alongside Phase 3 setbacks
As part of a broader wave of 2026 cost-saving moves, the layoff tracker reports that enGene Therapeutics is halving its workforce while preparing an eventual BLA submission for its sole clinical...
Cardiometabolic pipeline accelerates toward registrational study
Edgewise Therapeutics said it plans to move its heart disease candidate into Phase 3 after an update to its Phase 2 data package. The company is advancing a genetic cardiomyopathy program, framing...
Germany backs away from variable drug discount pricing
Germany has reportedly scrapped a plan to introduce variable discount pricing for branded pharmaceuticals after strong pushback from drugmakers, according to Reuters. The initiative was part of a...
PBM and pharmacy access litigation over FAIR Rx Act
Express Scripts and the PBM trade group PCMA have filed suit to block implementation of Tennessee’s FAIR Rx Act, following complaints similar to those submitted by CVS Caremark. The legislation,...
Merck gains adjuvant kidney cancer label expansion with Welireg-Keytruda combo
The FDA approved Merck & Co.’s Welireg plus Keytruda combination as an adjuvant treatment for intermediate-high or high-risk clear cell renal cell carcinoma following kidney removal surgery. The...
Adaptive Biotechnologies restructures immune medicine business
Adaptive Biotechnologies said it will shed its immune medicine business and offer up to $287.5 million in senior notes, aiming to recalibrate toward its MRD-focused platform. The company expects...
Drug pricing and reimbursement negotiations: Medicare proposal closes evergreening loophole
A proposed CMS rule would clarify and tighten how Medicare Drug Price Negotiation applies to fixed combination therapies, potentially affecting lifecycle management strategies used by large...
AI drug design funding: DeepMind-linked Isomorphic Labs raises mega-round
Isomorphic Labs, an Alphabet-affiliated AI drug design company with ties to DeepMind, raised $2.1 billion in a Series B round led by Thrive Capital with participation from Alphabet. The financing...
FDA prepares once-weekly HIV PrEP pill decision for lenacapavir
Gilead said the FDA accepted its supplemental New Drug Application for Yeztugo (lenacapavir) 300-mg tablets as a potential once-weekly oral pre-exposure prophylaxis (PrEP) option. The agency...