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Summit secures FDA date for PD‑1/VEGF bispecific
The FDA accepted Summit Therapeutics’ marketing application for ivonescimab, a PD‑1/VEGF bispecific antibody, and set a PDUFA decision date in November. Summit said regulators acknowledged its...
Tenpoint wins FDA approval for presbyopia drop — raises $235M to launch
Tenpoint Therapeutics received FDA approval for its topical presbyopia eye drop and simultaneously closed financing of approximately $235 million in combined debt and equity to support...
Thermo Fisher raises guide after strong Q4 — sees mid‑single‑digit growth for 2026
Thermo Fisher Scientific reported stronger‑than‑expected Q4 results and updated guidance for 2026, forecasting roughly 4–6% revenue growth as life sciences and bioprocessing demand remains...
Oxford Nanopore reverses phase‑out plan — P2 Solo supported through 2030
After customer backlash, Oxford Nanopore extended support for its PromethION 2 Solo (P2 Solo) sequencer through the end of 2030. The company will stop selling the P2 Solo later this year but will...
CMS opens Round 3 of IRA drug negotiations — 15 medicines named, Part B included
The Centers for Medicare & Medicaid Services published the list of 15 drugs selected for the third round of Inflation Reduction Act price negotiations, marking the first time Medicare Part B...
Cellares raises $257M as it scales automated cell‑therapy manufacturing
Cellares closed a $257 million Series D financing to expand its automated cell‑therapy manufacturing facilities and accelerate a planned commercial launch ahead of a targeted 2027 IPO. The funding...
FDA halts Regenxbio gene trials: brain tumor sparks holds
The U.S. Food and Drug Administration placed clinical holds on multiple Regenxbio gene‑therapy studies after the detection of a brain tumor in a pediatric trial participant. Regenxbio told...
FDA lifts partial hold on Intellia CRISPR trial – one study resumes
The FDA lifted a clinical hold on one of Intellia’s Phase 3 trials of its CRISPR/Cas9 candidate nexiguran ziclumeran (nex‑z), allowing the Magnitude‑2 study for ATTR‑PN (polyneuropathy) to restart...
Lilly inks $1.12B recombinase pact with Seamless – hearing loss push
Eli Lilly struck a research and licensing agreement with Seamless Therapeutics worth up to $1.12 billion to apply Seamless’s programmable recombinase gene‑editing platform to genetic forms of...
CMS names 15 drugs for round‑three price talks: Part B drugs included
The Centers for Medicare & Medicaid Services announced 15 medicines for Round 3 of Inflation Reduction Act price negotiations, marking the first time Part B (physician‑administered) drugs are...
Roche’s GLP‑1/GIP CT‑388 posts competitive Phase‑2 weight loss
Roche reported Phase‑2 data showing its dual GLP‑1/GIP agonist CT‑388 produced approximately 22.5% placebo‑adjusted weight loss at 48 weeks, prompting the company to move the candidate toward...
Tenpoint eye drop cleared: presbyopia approval paired with $235M raise
Tenpoint Therapeutics secured FDA approval for its presbyopia eye drop and announced $235 million in combined debt and equity to support commercialization. The company positioned the product as a...
Moderna/Merck mRNA‑antibody combo halves melanoma recurrence in interim read
Moderna and Merck released five‑year interim results from a personalized mRNA neoantigen therapy (intismeran autogene, mRNA‑4157) combined with pembrolizumab that showed a 49% reduction in...
Cellares grabs $257M to scale cell‑therapy manufacturing and prep IPO
Cellares raised $257 million in a Series D extension to accelerate global expansion of its automated cell‑therapy manufacturing services and prepare for a planned 2027 public listing. The company...
AbbVie pledges $100B in U.S. investment under administration deal
AbbVie reached a voluntary agreement with the U.S. administration committing up to $100 billion in U.S. research, development and manufacturing investments over the next decade tied to expanded...
Roche drops $100M fibrosis asset after futility read—pipeline pared
Roche removed vixarelimab, an anti‑OSMRβ antibody acquired via its 2022 transaction with Kiniksa, from its Phase‑2 fibrosis pipeline after an interim futility analysis concluded the study was...
FDA halts Regenxbio trials — brain tumor found in pediatric patient
The U.S. Food and Drug Administration placed clinical holds on two Regenxbio gene‑therapy programs after investigators found a brain neoplasm in a young trial participant. The holds affect an...
AbbVie pledges $100bn to US R&D — deal with Trump administration
AbbVie struck a voluntary agreement with the U.S. administration committing up to $100 billion in U.S. research, development and manufacturing investment over the next decade in exchange for...
Lilly inks up-to‑$1.12B recombinant gene-editing pact with Seamless for hearing loss
Eli Lilly entered a strategic collaboration and licensing agreement with Seamless Therapeutics to apply Seamless’s programmable recombinase gene‑editing platform to develop hearing‑restorative...
Roche’s CT‑388 posts competitive Phase 2 weight‑loss — heads to Phase 3
Roche reported Phase 2 data for CT‑388, a dual GLP‑1/GIP agonist, showing placebo‑adjusted weight loss of roughly 22.5 percentage points at 48 weeks in an obesity trial. The Swiss pharma said the...