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Reimbursement and dispute pressure heats up around 340B and CMS DSH safety-net payments
The regulatory and reimbursement fight continued on multiple fronts: the U.S. Department of Justice weighed in favor of pharma positions in a yearslong 340B contract pharmacy dispute, adding...
CRISPR patent battle reaches a final stop as Supreme Court denies Agilent appeal
The U.S. Supreme Court denied Agilent Technologies’ request to review invalidation of two CRISPR-related patents in its legal battle with Synthego. The denial leaves in place a Federal Circuit...
Next-gen obesity race: FDA clears Eli Lilly’s oral GLP-1 Foundayo as Novo pushes oral Wegovy narrative
The FDA approved Eli Lilly’s oral obesity pill Foundayo (orforglipron), formally extending the market’s shift to oral GLP-1 receptor agonists. Analysts and company messaging immediately set up a...
Major biotech M&A shakes sentiment as Biogen prepares to buy Apellis for $5.6B
Biogen agreed to acquire Apellis Pharmaceuticals in a $5.6 billion deal, extending Biogen’s push into nephrology and complement-driven disease biology. The acquisition follows Biogen’s earlier...
Ambrosia raises $100M Series B to push oral obesity small-molecule pipeline into Phase 1
Ambrosia Biosciences secured an oversubscribed $100 million Series B to advance its preclinical oral obesity drug pipeline into Phase 1. The financing will support development of the company’s...
FDA clearance for campus-developed CAR T marks a milestone for next-gen academic cell therapy
The University of Colorado Anschutz Gates Institute received IND clearance from the FDA for a campus-developed CAR T-cell therapy, described as the first CAR T therapy developed entirely within a...
Proactive supportive care in EGFR-mutant lung cancer cuts dermatologic toxicity by half
The phase II COCOON trial reported interim results showing proactive skincare reduced dermatologic toxicity by 50% in patients with EGFR-mutant non-small cell lung cancer (NSCLC) receiving...
TriNetX and Regeneron expand data link-up to scale genomic and proteomic discovery
TriNetX and Regeneron announced a data partnership to link genomic and proteomic information for drug discovery and development. TriNetX will provide Regeneron exclusive, secure access to...
US pharmaceutical tariffs and pricing carveouts
The Trump administration signed an executive order imposing a 100% ad valorem duty on imported brand-name drugs, citing US “import reliance” and linking the policy to Section 232 national security...
FDA approves Eli Lilly’s oral GLP-1 Foundayo and sparks a competitive response
The FDA approved Eli Lilly’s oral obesity pill orforglipron (Foundayo), positioning a second oral incretin therapy for commercial launch soon after Novo Nordisk’s oral Wegovy start earlier this...
Biogen buys Apellis for $5.6B to expand nephrology footprint
Biogen agreed to acquire Apellis Pharmaceuticals in a $5.6 billion deal aimed at accelerating the company’s expansion in nephrology. The acquisition follows Biogen’s prior investment in immunology...
Grail MCED test implementation stalls after endpoint miss
Clinicians offering early access to Grail’s multi-cancer early detection (MCED) blood test are waiting for full NHS trial readouts after a key endpoint miss. The situation is unfolding ahead of an...
TriNetX and Regeneron connect genomic and proteomic real-world data
TriNetX will link genomic and proteomic data with Regeneron through exclusive, secure, licensed access to de-identified health data from roughly 300 million individuals. The deal is designed to...
Syneron closes a $150M Series B to expand macrocyclic peptide platform
Syneron Bio closed a $150 million Series B to support its macrocyclic peptide development platform, months after securing a multibillion-dollar biobucks deal with AstraZeneca and raising nearly...
Landmark EV construction for oral peptides—Syneron plus manufacturing attention
The biotech pipeline’s manufacturing and development focus sharpened with complementary platform movement and preclinical-to-clinic readiness work. Alongside funding for peptide modalities, the...
CAR T breakthrough at University of Colorado earns first US FDA approval for campus-developed therapy
The University of Colorado Anschutz Gates Institute received Investigational New Drug (IND) clearance from the FDA for a novel CAR T-cell therapy and, in parallel, is reported as the first...
Drug pipeline setback—Alto halts schizophrenia program after Phase 2 miss
Alto Neuroscience halted its skin-delivered PDE4 inhibitor ALTO-101 after a Phase 2 trial failed to meet the primary cognition endpoint in schizophrenia-related cognitive impairment. The trial of...
US IP finality for CRISPR gRNA modifications as Supreme Court denies Agilent review
The US Supreme Court denied Agilent’s request to review the invalidation of two CRISPR-related patents covering specific chemical modifications of guide RNAs. The decision effectively ends a...
Regulatory & trade shocks to drug pricing and access
President Trump signed an executive order imposing a 100% tariff on imported brand-name drugs and associated active pharmaceutical ingredients, with carveouts tied to manufacturing commitments and...
Obesity drugs enter the oral GLP-1 race
The FDA approved Eli Lilly’s oral obesity pill Foundayo (orforglipron), positioning a second daily oral GLP-1 receptor agonist to compete with Novo Nordisk’s recently launched oral Wegovy. The...