Get the Daily Brief
Latest Biotech News
FDA approves dordaviprone for H3(K27M) DMG – first systemic option
The FDA granted accelerated approval to dordaviprone for diffuse midline glioma (DMG) harboring the H3(K27M) mutation in patients aged one year and older with progressive disease after prior...
Mass production methods advance CAR‑iNK cell manufacturing
Researchers reported scalable methods for producing CAR‑engineered induced natural killer (CAR‑iNK) cells, advancing a route to off‑the‑shelf cellular immunotherapies. The work addresses...
Head of FDA orphan drug office reassigned – leadership shakeup
Sandra Retzky, director of the FDA’s Office of Orphan Products Development, has been removed from her role and reassigned, US officials confirmed to Endpoints News. The change affects the office...
Evommune files IPO to fund mid‑stage inflammation pipeline
Evommune filed for an initial public offering to support development of two mid‑stage assets: EVO756, an oral MRGPRX2 antagonist aimed at mast‑cell driven diseases, and EVO301, an IL‑18...
BMS buys Orbital for $1.5B – in vivo CAR‑T push
Bristol Myers Squibb agreed to acquire Orbital Therapeutics in a cash deal that commits the pharma to in vivo CAR‑T approaches. BMS confirmed the $1.5 billion purchase to gain Orbital’s lead...
Novo shutters cell‑therapy unit: broad R&D cuts follow reorg
Novo Nordisk announced it will discontinue its cell therapy research operations and lay off the majority of roughly 250 employees in the unit as part of a broader corporate restructuring. The...
AstraZeneca strikes pricing deal with White House: second pharma pact
AstraZeneca reached a drug‑pricing agreement with the White House similar in structure to the one struck by Pfizer last week, sources reported. The company has agreed to extend portfolio discounts...
Sarepta to file for gene therapy approval in ultra‑rare LGMD2E
Sarepta Therapeutics reported data showing its experimental gene therapy increased expression of the missing gene in limb‑girdle muscular dystrophy type 2E (LGMD2E) and said it plans to file for...
FDA orphan‑drug office leadership change: director reassigned
The FDA reassigned the director of the office responsible for orphan drug designations, an internal realignment confirmed to industry press. The official, Sandra Retzky, was removed from the...
FDA clears dordaviprone for H3(K27M) DMG: first systemic therapy
The FDA granted accelerated approval to dordaviprone for diffuse midline glioma (DMG) harboring the H3(K27M) mutation in patients aged one year and older with progressive disease after prior...
Chinese team implants genetically modified pig liver segment into patient
Surgeons in China reported transplanting a genetically modified pig liver segment into a patient with a liver tumor, marking what researchers describe as the first case of a xenogeneic liver graft...
Long Life Family Study taps PacBio HiFi for large‑scale longevity sequencing
The Long Life Family Study selected PacBio’s Revio HiFi long‑read sequencing platform to generate genomic and epigenomic data from up to 7,800 participants to uncover genetic contributors to...
Chiesi partners with Arbor on in vivo CRISPR for rare liver disease
Chiesi Global Rare Diseases and Arbor Biotechnologies launched a collaboration to develop an in vivo CRISPR‑based therapy targeting primary hyperoxaluria type 1 (PH1), with Chiesi committing up to...
Evommune files for IPO — public debut to fund mid‑stage immune programs
Evommune filed to go public to raise capital for development of two mid‑stage assets targeting chronic inflammatory and atopic diseases. The company seeks proceeds to advance EVO756, an oral...
Novo doubles down on MASH: $4.7B Akero takeover
Novo Nordisk agreed to acquire Akero Therapeutics in a cash deal valuing the company at $4.7 billion, plus contingent value rights that could push the total to about $5.2 billion. The deal secures...
BMS pays $1.5B for Orbital – in vivo CAR‑T enters big‑pharma fold
Bristol Myers Squibb agreed to acquire Orbital Therapeutics for $1.5 billion in cash, buying access to Orbital’s in vivo CAR‑T technology and lead autoimmune program OTX‑201. BMS said the purchase...
Novo shutters cell‑therapy unit – 250 roles cut amid reorg
Novo Nordisk announced it will discontinue its cell therapy R&D activities and lay off nearly all 250 employees in that division as part of a larger corporate reorganization led by CEO Maziar Mike...
FDA clears first DMG systemic therapy: dordaviprone approved
The FDA granted accelerated approval to dordaviprone for diffuse midline glioma (DMG) harboring the H3(K27M) mutation in patients aged one year and older with progressive disease after prior...
Sarepta files for LGMD approval – gene therapy momentum in rare muscle disease
Sarepta Therapeutics presented data showing its experimental gene therapy increased expression of the missing gene in limb girdle muscular dystrophy (LGMD) 2E and said it plans to file for...
Genetically modified pig liver supports human metabolism for 38 days
Chinese surgeons transplanted a genetically modified pig liver segment into a patient with a liver tumor at risk of rupture; the xenograft operated as an auxiliary graft and supported the...