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FDA unveils plausible‑mechanism pathway: draft guidance for individualized therapies
The FDA released draft guidance formalizing the 'plausible mechanism' framework to accelerate development of individualized gene, cell, and other bespoke therapies for extremely rare genetic...
Gossamer’s Phase III miss in PAH sends shares tumbling – seralutinib falls short
Gossamer Bio announced that its Phase III Prosera trial testing inhaled tyrosine kinase inhibitor seralutinib in pulmonary arterial hypertension (PAH) failed to meet its primary endpoint, citing...
Merck splits oncology into standalone unit as Keytruda exclusivity approaches
Merck announced a reorganization that separates its oncology operations into a standalone unit while moving non‑cancer products, vaccines and specialty medicines into a second division. The...
Drug‑controlled CAR T cells: researchers build a venetoclax‑switchable CAR platform
EPFL researchers reported DROP‑CAR, a CAR‑T cell design that can be rapidly and reversibly switched off using the approved cancer drug venetoclax. In preclinical mouse models the system enabled...
AI maps hidden pancreatic features linked to type 2 diabetes
A team at the German Center for Diabetes Research trained explainable deep‑learning models on gigapixel pancreatic slide images from living donors and identified subtle tissue traits associated...
Syndex Bio raises $15.5M to commercialize methylation‑preserving PCR
Syndex Bio closed a $15.5 million seed round led by Arch Venture Partners to commercialize mcPCR, a methylation‑preserving amplification method that copies 5‑methylcytosine onto the complementary...
mRNA‑encoded nanobodies curb colorectal tumors in preclinical models
Researchers reported an mRNA‑LNP approach encoding anti‑PD‑L1 nanobodies that controlled tumor growth in preclinical colorectal cancer models. The study demonstrated delivery of single‑domain...
Illumina upgrades NovaSeq X… promises higher throughput and Q50+ read quality
Illumina outlined an 18‑month roadmap of improvements to the NovaSeq X platform that will raise flow‑cell output, shorten run times, and introduce higher‑quality kits targeting Q50 Phred scores...
Gilead to buy Arcellx for $7.8B — bets on BCMA CAR‑T
Gilead Sciences agreed to acquire Arcellx for $7.8 billion to secure full control of anito‑cel, a BCMA‑directed CAR‑T therapy for relapsed or refractory multiple myeloma. The deal covers $115 per...
FDA drafts plausible‑mechanism pathway for individualized therapies
The U.S. Food and Drug Administration released draft guidance formalizing the "plausible mechanism" framework to support approvals of individualized cell and gene therapies when randomized trials...
Novo’s CagriSema falls short vs Lilly’s Zepbound — Phase 3 head‑to‑head
Novo Nordisk’s next‑generation obesity candidate CagriSema failed to demonstrate non‑inferiority to Eli Lilly’s Zepbound in an open‑label Phase 3 head‑to‑head study, with CagriSema producing lower...
Merck splits human‑health unit: oncology becomes standalone
Merck reorganized its human‑health operations, creating a standalone oncology business and a separate specialty, pharma and infectious‑disease unit. The move assigns Keytruda and the oncology...
Sequencing race heats up: Illumina upgrades while Ultima unveils UG200
Illumina announced a roadmap of NovaSeq X enhancements to boost output, accuracy and kit options — including plans for Q50 and duplex‑based workflows for high‑precision applications. The vendor...
Flagship’s Generate eyes big IPO to fund antibody phase‑3 trials
Generate:Biomedicines filed for a large IPO to raise capital for late‑stage development of its lead antibody programs, targeting up to $425 million in proceeds and a potential valuation exceeding...
Gossamer’s PAH candidate misses Phase 3 — trial failure sends shares tumbling
Gossamer Bio’s Phase 3 PROSERA study of seralutinib in pulmonary arterial hypertension failed to meet its primary endpoint on six‑minute walk distance, producing a placebo‑adjusted improvement...
Syndex raises $15.5M to commercialize methyl‑preserving PCR for epigenetics
Syndex Bio closed a $15.5 million seed round led by Arch Venture Partners to advance mcPCR, a methyl‑copying PCR that preserves DNA methylation during amplification. The company plans to deploy...
Korsana pulls in $175M to advance brain‑penetrant Alzheimer antibody
Korsana Biosciences disclosed a $175 million financing to push its platform for brain‑penetrating antibodies into preclinical and early clinical development for Alzheimer’s disease. The company’s...
Swiss Rockets to acquire Complete Genomics — sheds Chinese ownership
Swiss Rockets signed a definitive agreement to acquire Complete Genomics from Chinese parent MGI, moving the U.S. sequencing company out of Chinese ownership and preserving its U.S. base of...
Gilead pays $7.8B to buy Arcellx: Secures BCMA CAR‑T
Gilead Sciences agreed to acquire Arcellx for $7.8 billion in cash and contingent value rights, taking full control of anito‑cel, a BCMA‑directed CAR‑T therapy for relapsed or refractory multiple...
Merck splits oncology from specialty unit – Keytruda cliff looms
Merck reorganized its human health business into a standalone oncology unit and a separate specialty, pharma and infectious disease division as Keytruda’s U.S. loss of exclusivity approaches. The...