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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...
Beam launches BEAM‑304 base edit program for PKU – Backed by $500M deal
Beam Therapeutics announced BEAM‑304, a liver‑targeted base‑editing program intended to correct PAH mutations that cause phenylketonuria (PKU). The company plans a mutation‑specific multi‑editor...
Astellas, Vir ink $1.3B pact for masked CD3 engager – Oncology push
Astellas Pharma and Vir Biotechnology signed a global co‑development agreement worth up to $1.3 billion to advance VIR‑5500, Vir’s PRO‑XTEN dual‑masked CD3 T‑cell engager targeting PSMA for...
FDA halts MacroGenics trial after death – Safety probe underway
Regulators ordered a pause on enrollment in MacroGenics’ Phase 2 study of lorigerlimab following a patient death and multiple life‑threatening adverse events, prompting the company to report a...
New polymers target 'undruggable' MYC and KRAS – Proteomimetic degraders
Researchers at Northwestern unveiled HYDRACs, heterobifunctional proteomimetic polymers that recruit cellular degradation machinery to eliminate traditionally undruggable oncogenic drivers MYC and...
CareDx pivots to cell‑therapy surveillance — LCD draft poses headwind
CareDx reported a 25% year‑over‑year revenue increase and said it will prioritize its cell‑therapy surveillance testing pipeline in 2026, citing validation data from the ACROBAT observational...
FDA resurrects Loargys for ARG1‑D – Accelerated approval granted
Immedica Pharma won accelerated FDA approval for Loargys (pegzilarginase) to treat arginase‑1 deficiency (ARG1‑D) in patients aged two and older, reviving a once‑rejected enzyme replacement...
Gilead buys Arcellx for $7.8B – doubles down on CAR‑T
Gilead Sciences agreed to acquire Arcellx in a deal valued at about $7.8 billion to secure full control of anito‑cel, a BCMA‑directed CAR‑T therapy for multiple myeloma. The acquisition converts...
Novo’s next‑gen stumble: CagriSema falls short – price cuts follow
Novo Nordisk reported that its next‑generation obesity candidate CagriSema failed to show noninferiority to Eli Lilly’s Zepbound in a head‑to‑head Phase 3 study, weighing on the company’s market...