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Gilead’s Cell Therapy Pullback and Lenacapavir Partner Move
Gilead reported an 11% year‑over‑year decline in cell therapy revenue for marketed CAR‑T products and disclosed a strategic decision in its early‑stage lenacapavir program: after comparing two...
Price Versus Access: GLP‑1 Economics and Retail Partnerships
New analyses and commercial moves are reshaping how GLP‑1 medicines reach patients: a health‑economics review found potency and outcomes justify higher prices for weight‑loss GLP‑1s under some...
FDA places formal hold on Intellia’s Phase 3 CRISPR trials: liver‑safety signal
The U.S. Food and Drug Administration has placed a clinical hold on two Phase 3 trials of Intellia Therapeutics’ CRISPR candidate nexiguran ziclumeran after a participant experienced a grade‑4...
Novo Nordisk ups the ante: $9B bid challenges Pfizer for Metsera
Novo Nordisk submitted an unsolicited offer valuing obesity biotech Metsera at up to $9 billion—outbidding Pfizer’s earlier agreement—and the company’s board has labeled the proposal a “superior...
Lilly leans in: tirzepatide drives revenue and a $1.2B factory push
Eli Lilly reported blockbuster demand for tirzepatide, prompting a revenue forecast raise after the drug posted record quarterly sales. The company said tirzepatide (sold as Mounjaro/Zepbound)...
FDA proposes lighter path for biosimilars: trials may no longer be required
The U.S. Food and Drug Administration published draft guidance proposing to eliminate routine comparative clinical efficacy trials for many biosimilars, a move designed to speed approvals and...
Thermo Fisher to buy Clario for up to $9.4B: data play expands clinical services
Thermo Fisher Scientific agreed to acquire clinical‑trial data and software firm Clario in a cash deal reportedly worth about $8.9 billion plus earnouts. The transaction aims to integrate Clario’s...
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...