Get the Daily Brief
Latest Biotech News
Anti‑AAV antibodies challenged; durability concerns linger for gene therapy
New data presented in Seville suggest that some patients with preexisting anti‑AAV antibodies may still be eligible to receive gene therapies, challenging a common exclusion criterion and...
Illumina’s genomic alliance draws pharma partners — 250K genomes live
Illumina’s Alliance for Genomic Discovery (AGD) expanded its partner roster with Alnylam Pharmaceuticals joining the project that has sequenced more than 250,000 genomes from the Vanderbilt BioVU...
Regulatory shake‑up: FDA orphan‑drug office reassignment and Biosecure Act passes Senate
Regulatory turbulence intensified as the FDA reassigned the director of its Office of Orphan Products Development and the U.S. Senate passed a new iteration of the Biosecure Act as an amendment to...
Scalable CAR‑iNK manufacturing unveiled — NK cell therapies move toward scale
Researchers reported methods to mass‑produce CAR‑engineered induced natural killer (CAR‑iNK) cells, addressing a key bottleneck for NK‑cell immunotherapies: scalable, cost‑effective manufacturing....
BMS buys Orbital for $1.5B — in‑vivo CAR‑T push
Bristol Myers Squibb agreed to acquire Orbital Therapeutics for $1.5 billion in cash, buying an in‑vivo CAR‑T platform nearing clinical entry. The deal brings BMS an IV-administered program...
CAR‑iNK scale‑up... manufacturing enters the clinic
Groups reported methods for large‑scale manufacture of CAR‑engineered induced natural killer (CAR‑iNK) cells and surfaced next‑generation engineered T‑cell innovations, aiming to broaden...
Novo shutters cell therapy unit — pivots into big MASH buy
Novo Nordisk announced it is discontinuing its cell therapy R&D, laying off most of a ~250‑person unit and ending work on a Type‑1 diabetes cell program, while simultaneously striking a major...
AstraZeneca strikes pricing deal with White House — portfolio discounts
AstraZeneca reached a drug‑pricing agreement with the Trump administration, offering discounts across its portfolio in a move aligned with recent deals between the White House and other large...
Senate folds Biosecure Act into defense bill — new biotech constraints possible
The U.S. Senate added a new iteration of the Biosecure Act as an amendment to the National Defense Authorization Act, advancing language aimed at restricting federal funding or contracts with...
Pig liver segment transplanted into human — graft supported metabolism 38 days
Chinese surgeons implanted a genetically modified pig liver segment as an auxiliary graft into a patient with a life‑threatening liver tumor; the xenograft performed metabolic functions for 38...
Sarepta to file for LGMD2E gene therapy — biomarker lift reported
Sarepta Therapeutics reported data showing its experimental gene therapy raised levels of the missing protein in patients with limb‑girdle muscular dystrophy (LGMD) 2E and said it plans to seek...
Single‑dose epigenetic edit slashes PCSK9 — durable LDL cut in primates
Researchers delivered an mRNA‑based epigenetic editor (Epi‑Reg) to nonhuman primates’ livers and achieved durable suppression of PCSK9 with sustained LDL cholesterol reductions for nearly a year,...
EVG7 halts C. difficile — spares key gut bacteria
Researchers described EVG7, a novel glycopeptide antibiotic that prevents Clostridioides difficile recurrence while selectively sparing beneficial gut commensals. In preclinical models, EVG7...
FDA reassigns orphan drug office head — leadership change confirmed
The FDA reassigned Sandra Retzky, director of the Office of Orphan Products Development, and she is no longer in that role, an administration official confirmed. The move removes a key figure...
BMS buys Orbital for $1.5B – in vivo CAR‑T push
Bristol Myers Squibb agreed to acquire Orbital Therapeutics for $1.5 billion in cash, securing in vivo CAR‑T technology that aims to reprogram patients’ cells without ex vivo manufacturing. The...
Novo halts cell therapy programs – 250 jobs cut
Novo Nordisk announced it is discontinuing its cell therapy R&D unit and laying off nearly all of the division’s roughly 250 employees as part of a companywide reorganization under new CEO Maziar...
AstraZeneca strikes pricing deal with administration – portfolio discounts
AstraZeneca reached a drug‑pricing agreement with the Trump administration that will extend portfolio‑wide discounts similar to those negotiated by other major pharma last week. The pact,...
Senate passes Biosecure Act as NDAA amendment – contracting limits loom
The US Senate voted to attach a new iteration of the Biosecure Act to the National Defense Authorization Act, adding provisions that would restrict federal funding and contracting with defined...
Genetically modified pig liver supports human metabolism for 38 days
Chinese surgeons transplanted a segment of a genetically modified pig liver into a patient with a life‑threatening hepatic tumor; the graft functioned and supported metabolic activity for 38 days...
Sarepta to seek approval: gene therapy boosts missing protein in LGMD2E
Sarepta Therapeutics reported data showing its experimental gene therapy increased expression of a protein missing in limb‑girdle muscular dystrophy 2E (LGMD2E) and said it plans to file for...