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Lilly commercial moves and tirzepatide momentum: retail pickup and blockbuster sales
Eli Lilly expanded distribution for its GLP‑1 tirzepatide obesity drug Zepbound by enabling retail pharmacy pick-up at Walmart through its LillyDirect platform, broadening access beyond home...
Diagnostics market expands: Guardant scales multi‑cancer blood screening as FDA clearances proliferate
Guardant Health launched its Shield multi‑cancer detection (MCD) test into broader clinical use and signaled plans to gather real‑world adoption data for multi-cancer screening, while Diasorin...
Funding and PE activity: Tubulis upsizes Series C; GHO Capital closes largest European healthcare PE fund
ADC developer Tubulis expanded its Series C to $401 million to accelerate proprietary antibody‑drug conjugate programs, reflecting investor appetite for differentiated oncology platforms....
Metsera M&A War: Novo Nordisk Counters Pfizer With $9B Bid
Novo Nordisk launched a surprise unsolicited bid for Metsera that outvalues Pfizer’s previously agreed acquisition, setting off a rapid escalation in the obesity M&A sweepstakes. Novo offered...
FDA Halts Intellia Phase‑3 CRISPR Trials: Liver Safety Signal
Regulators put two late‑stage clinical trials of Intellia Therapeutics’ CRISPR therapy nexiguran ziclumeran on formal hold after a participant developed severe liver injury, deepening scrutiny of...
Human kidney organoids scaled: Transplanted into perfused pig kidneys
Teams led by the Institute for Bioengineering of Catalonia and collaborators reported a reproducible, scalable method to generate thousands of human kidney organoids and successfully integrate...
Targeted immunotherapy advances: IL‑12 nanoparticles and myeloid resistance mechanisms
Two preclinical findings offer complementary routes to improve checkpoint immunotherapy. MIT engineers reported polymer‑coated nanoparticles that deliver IL‑12 directly into ovarian tumors; in...
AI accelerates discovery: Google finds drug lead; CZI and NVIDIA scale virtual cell models
AI is moving from hypothesis generation toward actionable biomedical outputs. Google announced a large foundation model that proposed a novel cancer drug combination which the company validated...
FDA deregulation push: Commissioner signals loosening; biosimilar trial rule proposed
Senior FDA leadership signaled further 'deregulatory' actions following recent steps to relax biosimilar clinical requirements, and the agency formally proposed removing mandatory clinical...
Illumina navigates China headwinds: flat Q3 but guidance nudged higher
Illumina reported flat third‑quarter revenues and slightly raised full‑year guidance while continuing to grapple with Chinese export restrictions that have depressed instrument sales. Management...
Lilly’s tirzepatide era: $10B quarter powers upgraded outlook
Eli Lilly disclosed blockbuster demand for tirzepatide, reporting about $10.1 billion in third‑quarter sales and raising its full‑year outlook as the medicine becomes the world’s top‑selling drug....
340B rebate pilot approved: HRSA greenlights drugmaker models, hospitals push back
The Health Resources and Services Administration approved eight drugmaker applications to test a 340B rebate pilot that replaces upfront drug discounts with post‑dispensed rebates. HRSA and...
Bespoke gene‑editing pathway: Baby KJ team publishes FDA interactions
Scientists and clinicians behind the custom CRISPR therapy for 'Baby KJ' published their interactions with the FDA, offering a de‑facto roadmap for tailored gene‑editing treatments for ultra‑rare...
Novo Nordisk’s $9B counteroffer for Metsera — Pfizer threatens legal action
Novo Nordisk unveiled an unsolicited up-to-$9 billion proposal for obesity biotech Metsera, signaling a sudden escalation in a deal Pfizer had previously agreed to buy. Metsera’s board...
FDA proposes slashing biosimilar trial burden — Phase 3 studies may be optional
The U.S. Food and Drug Administration issued draft guidance proposing to remove the routine requirement for comparative clinical efficacy (Phase 3) trials for biosimilars, a move intended to...
FDA halts Intellia’s phase 3 CRISPR trials — liver safety signal stalls program
The FDA placed clinical holds on two Phase 3 trials of Intellia Therapeutics’ in‑vivo CRISPR candidate nexiguran ziclumeran (nex‑z) after a grade‑4 adverse event—marked liver enzyme and bilirubin...
Illumina posts flat Q3 as China export restrictions continue to bite
Illumina reported flat third‑quarter revenue and slightly raised its full‑year guidance even as export restrictions and partial instrument sales bans in China continued to depress results. Greater...
4D Molecular inks APAC deal with Otsuka — $85M upfront to fuel retinal phase 3
4D Molecular Therapeutics sold Asia‑Pacific rights to its retinal gene therapy 4D‑150 to Otsuka Pharmaceutical, receiving $85 million upfront and potential development and commercial milestones of...
Thermo Fisher to buy Clario for roughly $8.9B — data consolidation for trials
Thermo Fisher Scientific signed a definitive agreement to acquire Clario Holdings for $8.88 billion in cash, plus potential earnouts tied to performance. Clario provides endpoint data and...
Nanobiotix secures $71M royalty‑backed loan to fund late‑stage program
Nanobiotix obtained $71 million in non‑dilutive financing from HealthCare Royalty to sustain development of its radiotherapy‑activated nanoparticle NBTXR3 (JNJ‑1900) as it runs a Phase 3...