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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...
Biopharma M&A accelerates with major acquisition moves
Biogen agreed to pay about $5.6 billion to acquire Apellis Pharmaceuticals, a deal that expands Biogen’s footprint in nephrology and builds on an existing pipeline, including a HI-Bio program in...
Clinical pipeline readouts and trial outcomes
Immunovant’s batoclimab (FcRn inhibition) failed to meet primary endpoints in two Phase 3 trials in thyroid eye disease, with Roivant signaling it will review future development plans with partner...
Precision oncology trial signal: SCLC biomarker analytics
A Phase I dose-expansion study reported biomarker analysis that tracks AZD2811 in relapsed or refractory small-cell lung cancer, with the findings presented as evidence that biomarker monitoring...
Cell therapy and regenerative innovation at the FDA threshold
The University of Colorado Anschutz Gates Institute received FDA IND clearance for a novel CAR T-cell therapy, described as the first campus-developed CAR T program to reach that regulatory...
Launch platform and data partnerships in drug discovery
TriNetX agreed to link its genomic and proteomic data capabilities with Regeneron under a deal granting exclusive, secure access to de-identified health data covering roughly 300 million...
Gene therapy momentum: early approvals and emerging targets
A report from the USC-led AI initiative highlights continued NIH investment into Alzheimer’s code-cracking efforts, while separate regulatory and pipeline developments show broader momentum toward...
Biotech funding and platform expansion
Syneron Bio closed a $150 million Series B to support its macrocyclic peptide development platform, following a multibillion-dollar biobucks deal with AstraZeneca and nearly $100 million raised...
Regulatory science and new approach methodologies in toxicity testing
The EMA gave initial endorsement to a new approach methodology (NAM) that replaces live animal control groups in early toxicity testing using “virtual” controls derived from historical...