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HHS approves 340B rebate pilot participants: Merck, BMS and others join
The U.S. Department of Health and Human Services approved applications from eight drugmakers to participate in a pilot testing a new 340B reimbursement rebate model. The decision allows companies...
USDA clears first large‑scale cultivated meat facility: Believer Meats wins label and export access
Believer Meats announced USDA approval of its North Carolina cultivated‑chicken facility and product labeling, clearing the way for commercial production and U.S. sales as well as exports. The...
Illumina posts flat Q3 revenue, raises 2025 guidance: clinical segment supports recovery
Sequencing leader Illumina reported $1.08 billion in third‑quarter revenue—flat year‑over‑year—and beat adjusted EPS expectations, prompting a modest upward revision to its 2025 guidance....
Evommune prices IPO as inflammation biotech eyes Phase 2 progress
Evommune has set IPO pricing after filing to raise around $150 million, aiming to fund development of two Phase 2 programs targeting mast‑cell and IL‑18 pathways. The company said it will use...
BridgeBio scores another rare‑disease win: encaleret meets Phase 3 endpoints in ADH1
BridgeBio reported positive Phase 3 results for encaleret in autosomal dominant hypocalcemia type 1 (ADH1), with 76% of treated patients meeting combined serum and urine calcium targets at 24...
FDA halts Intellia phase‑3 CRISPR trials — safety letters expected
The FDA placed a formal clinical hold on two Phase 3 trials of Intellia Therapeutics’ CRISPR candidate nexiguran ziclumeran after a Grade 4 liver‑toxicity event prompted the company to pause...
Novo bids $9B for Metsera — Pfizer cries foul
Novo Nordisk submitted an unsolicited, two‑step proposal valuing Metsera at up to about $9 billion — topping Pfizer’s earlier $7.3 billion agreement — and Metsera’s board declared the offer a...
Illumina posts flat Q3 — nudges 2025 guidance up
Illumina reported $1.08 billion in Q3 revenue, roughly flat year‑over‑year, but beat adjusted EPS estimates and raised full‑year 2025 guidance modestly. CEO Jacob Thaysen said revenue acceleration...
Lilly’s tirzepatide smashes records — company doubles down on capacity
Eli Lilly reported tirzepatide sales of $10.1 billion in Q3, making the molecule the world’s best‑selling drug and prompting the company to raise revenue forecasts. The drug’s branded uses...
FDA signals easier path for biosimilars — industry to get faster routes
The FDA proposed a draft framework to lower the clinical development bar for biosimilars, including removing the routine requirement for comparative Phase 3 efficacy studies for some products....
Thermo Fisher to buy Clario for clinical‑trial data muscle — deal tops $9B
Thermo Fisher Scientific agreed to acquire Clario for approximately $8.9 billion in cash plus additional consideration, positioning Thermo to broaden its footprint in clinical‑trial data and...
BridgeBio’s encaleret clears Phase 3 — rare disease readout succeeds
BridgeBio reported that encaleret met primary and key secondary endpoints in a global Phase 3 study for autosomal dominant hypocalcemia type 1 (ADH1). Treated patients achieved normalization of...
Tubulis upsizes Series C to $401M — ADC platform gets heavy backing
Tubulis increased its Series C to $401 million to accelerate development of next‑generation antibody‑drug conjugates (ADCs). The Munich‑based startup said the fresh capital will fund preclinical...
10x Genomics launches next‑gen Flex — single‑cycle, high‑throughput single‑cell push
10x Genomics unveiled a next‑generation Chromium Flex assay that enables automation‑compatible, plate‑based multiplexing at 384 samples and throughput to profile tens of millions of cells per...
Recursion delivers microglia phenomap — Roche pays $30M milestone
Recursion and Roche/Genentech delivered a whole‑genome microglia phenomap — a dataset of roughly 46 million microglial cell images from massive perturbation screens — triggering a $30 million...
FDA places Intellia phase‑3 CRISPR trials on hold: regulator steps in after liver injury
The FDA has imposed a clinical hold on two Phase 3 trials of Intellia Therapeutics’ CRISPR candidate nexiguran ziclumeran (nex‑z) after a study participant developed a grade‑4 liver event that...
Novo jumps into Metsera bidding war – Pfizer threatens legal fight
Novo Nordisk submitted a surprise counterbid for Metsera, offering $56.50 per share plus contingent value rights that lift the deal to roughly $9 billion in potential equity value. Metsera’s board...
Lilly’s tirzepatide era: sales surge and factory push to secure supply
Eli Lilly reported tirzepatide sales of $10.1 billion in Q3, making the diabetes and obesity drug the world’s top seller for the quarter and prompting the company to raise revenue forecasts....
FDA moves to speed biosimilars: clinical trial bar lowered – policy shift ahead
The FDA published draft guidance proposing to remove routine clinical efficacy study requirements for biosimilars, aligning biosimilar approval pathways more closely with small‑molecule generics....
Thermo Fisher to buy Clario in major market play: $8.9B cash deal
Thermo Fisher Scientific agreed to acquire Clario, a clinical‑trial data and patient‑facing software company, for $8.9 billion in cash plus potential earnouts, a deal that expands Thermo Fisher’s...