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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The U.S. Food and Drug Administration issued draft guidance proposing to remove the routine requirement for comparative clinical efficacy (Phase 3) trials for biosimilars, a move intended to...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...
Tubulis ups Series C to $401M — doubling down on ADC platform
ADC specialist Tubulis expanded its Series C to $401 million with an additional $40 million injection two weeks after closing the original tranche. The Munich‑based company said the funds will...
Evommune prices IPO to fund two phase‑2 inflammation programs
Evommune filed to go public, targeting roughly $150 million in an IPO priced between $15 and $17 per share to advance its two phase‑2 clinical assets. The proceeds will support EVO756, an oral...
Google AI proposes validated cancer drug combo — AI reaches discovery milestone
Google announced that a large foundation model in its Gemma family—Cell2Sentence‑Scale—proposed and validated a novel drug combination for cancer, marking an AI‑driven discovery advance. The firm...
Novo Nordisk’s $9B bid topples Pfizer – Metsera board flags superior offer
Novo Nordisk submitted an unsolicited offer valuing Metsera at roughly $9 billion, prompting Metsera’s board to deem the proposal “superior” to Pfizer’s earlier agreement. The two-step bid...
FDA puts Intellia’s phase 3 CRISPR trials on hold – liver safety probe
The U.S. Food and Drug Administration placed a clinical hold on two late-stage Phase 3 trials of Intellia Therapeutics’ CRISPR candidate nexiguran ziclumeran (nex‑z) after a Grade 4 liver adverse...
FDA plan: cut efficacy trials to speed biosimilars
The FDA proposed draft guidance to remove the routine requirement for comparative clinical efficacy trials in many biosimilar applications, aiming to shorten development timelines and lower costs...
Lilly’s tirzepatide drives $17.6B quarter – sales surge 54%
Eli Lilly reported a blowout third quarter with $17.6 billion in revenue, driven by tirzepatide sales that topped $10.1 billion across diabetes and obesity brands (Mounjaro and Zepbound)....
Illumina posts flat Q3: nudges up full‑year guidance
Sequencing giant Illumina reported $1.08 billion in third‑quarter revenue, effectively flat year‑over‑year, and modestly raised its full‑year 2025 revenue and EPS guidance. CEO Jacob Thaysen...
4DMT sells APAC rights to Otsuka: $85M upfront, $420M upside
4D Molecular Therapeutics agreed to sell Asia‑Pacific commercialization rights for its retinal gene therapy 4D‑150 to Otsuka Pharmaceutical, securing $85 million upfront and potential milestone...
Nanobiotix gets $71M lifeline: royalty‑backed loan fuels phase 3
Nanobiotix secured $71 million in non‑dilutive financing from HealthCare Royalty to support its cash runway into early 2028 and advance a Johnson & Johnson‑partnered radiotherapy‑activated...
Google AI proposes new cancer drug combo: lab validation reported
Google unveiled an advanced foundation model in the Cell2Sentence‑Scale family that proposed and (per company reports) experimentally validated a novel drug combination for cancer. Built on the...