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ARPA‑H awards $38M: UTSA’s Barshop named national aging hub
The Sam and Ann Barshop Institute for Longevity and Aging Studies at UT San Antonio secured up to $38 million from ARPA‑H to establish a multi‑year program focused on aging and healthy longevity....
FDA pivots: single pivotal trial plus evidence now acceptable
The U.S. Food and Drug Administration announced a policy shift that allows approvals on the basis of one well‑controlled pivotal trial supplemented by confirmatory evidence, replacing the...
FDA halts MacroGenics trial after patient death – enrollment frozen
The FDA placed a partial clinical hold on MacroGenics’ Phase II lorigerlimab study in gynecologic cancers following one patient death and multiple life‑threatening adverse events, ordering a stop...
BreezeBio raises $60M: polymer nanoparticles to carry mRNA diabetes program
BreezeBio closed a $60 million financing to advance its polymer nanoparticle delivery platform and initiate clinical testing of its lead mRNA program for diabetes. The company, which refocused...
PacBio, DNAstack launch federated HiFi data hub for rare disease
Pacific Biosciences and DNAstack launched a secure, federated environment to share HiFi whole‑genome sequencing data and metadata across the HiFi Solves Global Consortium, aimed at accelerating...
FDA approves Loargys for ARG1‑D: accelerated nod for ultrarare disorder
The FDA granted accelerated approval to Immedica Pharma’s Loargys (pegzilarginase) to treat arginase‑1 deficiency (ARG1‑D) in patients aged two and older, addressing a disorder that affects...
Gilead buys Arcellx for $7.8B—takes full control of anito‑cel
Gilead Sciences agreed to acquire Arcellx for $7.8 billion to secure full ownership of anito‑cel, the BCMA‑directed CAR‑T therapy now under FDA review. The deal converts an existing collaboration...
Novo Nordisk inks Vivtex pact—slashes GLP‑1 list prices
Novo Nordisk signed a collaboration with Vivtex to license oral drug‑delivery technology aimed at converting injectable biologics into pills, with deal economics worth up to $2.1 billion in...
FDA ends two‑trial dogma: single well‑controlled trial may suffice
The U.S. Food and Drug Administration announced a policy shift allowing approval on the basis of one well‑controlled trial plus confirmatory evidence, a change framed as an end to the longstanding...
GSK buys pulmonary asset, doubles down on oligos—$950M and $1B bets
GSK is expanding its pipeline with two strategic external deals: a $950 million cash acquisition of Canadian 35Pharma to obtain HS235, a protein therapeutic for pulmonary hypertension, and an...
Beam launches BEAM‑304 for PKU—base editors aim to correct PAH mutations
Beam Therapeutics expanded its liver‑targeted gene‑editing portfolio with BEAM‑304, a multi‑editor program designed to correct common PAH mutations that cause phenylketonuria (PKU). The company...
BreezeBio raises $60M—retools delivery for mRNA diabetes and T1D tolerance work
BreezeBio closed a $60 million financing to propel clinical testing of its first mRNA program for diabetes and to pivot from earlier GenEdit plans toward proprietary therapeutics. The startup—now...
CareDx moves into cell‑therapy surveillance—AlloHeme predicts relapse signals
CareDx reported a 25% year‑over‑year revenue gain and signaled a strategic pivot to cell‑therapy surveillance with its AlloHeme assay. Validation data from the ACROBAT observational trial showed...
PacBio, DNAstack federate HiFi genomes—global rare‑disease data sharing
Pacific Biosciences partnered with DNAstack to build a secure federated platform for sharing HiFi long‑read whole‑genome sequencing data across the HiFi Solves Global Consortium. The environment...
Northwestern reveals HYDRAC polymers—targets MYC and KRAS for degradation
Northwestern University researchers published a proof‑of‑concept for HYDRACs—heterobifunctional proteomimetic polymers that bind undruggable oncoproteins like MYC and KRAS and recruit cellular...
FDA freezes MacroGenics trial after fatal event—enrollment halted
The U.S. FDA halted enrollment in MacroGenics' Phase II trial of lorigerlimab following a patient death and other severe adverse events. The agency's partial hold requires the company to address...
Gilead agrees $7.8B buyout of Arcellx – Anito‑cel in focus
Gilead Sciences agreed to acquire Arcellx for $7.8 billion to secure full control of anito‑cel, the BCMA‑directed CAR‑T therapy the companies have been co‑developing. The deal consolidates...
Novo halves GLP‑1 list price for 2027 – Pricing and program shakeup
Novo Nordisk announced it will cut U.S. list prices for Wegovy, Ozempic and related GLP‑1 products by as much as 50% starting in 2027, targeting patients with high deductibles and copays. The...
FDA reverses two‑trial dogma: single pivotal study now viable
The U.S. Food and Drug Administration signaled a major shift in approval standards, saying a single well‑controlled trial plus confirmatory evidence can suffice for approval in many cases. The...
GSK to buy 35Pharma for $950M – Pulmonary hypertension pick‑up
GlaxoSmithKline agreed to acquire Canadian biotech 35Pharma for $950 million to add the company’s pulmonary hypertension drug program to GSK’s cardiovascular and rare‑disease pipeline. The...