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EVG7 glycopeptide halts C. difficile while sparing beneficial gut bacteria
Researchers described EVG7, a novel glycopeptide antibiotic that prevents Clostridioides difficile recurrence while selectively sparing key commensal gut species. Preclinical data indicate the...
FDA reassigns head of orphan drug office — regulatory office leadership changed
The FDA reassigned Sandra Retzky from her role as director of the office that oversees orphan drug designations, an administration official confirmed to Endpoints News. Retzky’s reassignment...
Illumina’s genomic alliance expands — pharma partners tap 250K+ genomes for target discovery
Illumina’s Alliance for Genomic Discovery added Alnylam Pharmaceuticals and continues to attract pharma partners seeking large, phenotyped genomic datasets for drug target discovery. The AGD has...
Hoover report demands sweeping biosecurity overhaul — policy options for securing biotech
Scholars at the Hoover Institution released 'Biosecurity Really: A Strategy for Victory,' a policy report urging immediate, broad measures to secure biotechnology. Recommendations include creating...
Regeneron to seek approval: gene therapy restores hearing in children
Regeneron reported pivotal clinical data showing a gene therapy produced significant hearing improvements in nearly a dozen children with a rare genetic form of deafness, and said it will seek...
Sarepta to file for approval – gene therapy ups missing protein in LGMD 2E
Sarepta Therapeutics announced positive clinical data showing its experimental gene therapy increased expression of a missing gene in patients with an ultra-rare limb-girdle muscular dystrophy...
FDA grants accelerated OK: dordaviprone is first systemic therapy for H3(K27M) DMG
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...
BMS pays $1.5B: Orbital buy brings in vivo CAR‑T tech
Bristol Myers Squibb agreed to acquire Orbital Therapeutics for $1.5 billion in cash, adding in vivo cell-therapy technology the buyer hopes will enable CAR‑T–style reprogramming inside patients....
Novo ends cell therapy push – shutters unit, drops Type 1 programs
Novo Nordisk announced it is discontinuing its cell therapy R&D efforts as part of a company-wide reorganization under new leadership, laying off nearly all employees in the shuttered unit and...
Chinese team implants pig liver segment: graft supports patient 38 days
Surgeons in China transplanted a genetically modified pig liver segment into a patient with cancer and reported the graft supported metabolic function for 38 days before removal due to thrombotic...
Study suggests anti‑AAV antibodies aren’t absolute barrier to gene therapy
New research presented in Seville indicates that some patients who carry anti‑AAV antibodies—traditionally considered exclusionary for AAV‑based gene therapy—may still be eligible for treatment or...
Illumina consortium lures pharma: 250k genomes plus clinical data
Illumina’s Alliance for Genomic Discovery expanded its roster of industry partners, adding companies such as Alnylam and drawing interest from pharma teams seeking diverse genomes paired with...
Senate backs new Biosecure Act iteration: NDAA amendment tightens biotech ties
The US Senate passed a reworked Biosecure Act as an amendment to the National Defense Authorization Act, seeking to restrict certain federal contracting and funding relationships with companies...
Biopharma bets billions: in vivo CAR‑T deals surge and CAR‑iNK scale methods emerge
Large biopharma firms have spent billions in 2025 on companies developing in vivo CAR‑T approaches as first human data arrive, and separate teams reported methods for mass production of...
BMS pays $1.5B for Orbital: in‑vivo CAR‑T push
Bristol Myers Squibb agreed to acquire Orbital Therapeutics for $1.5 billion, acquiring an in‑vivo CAR‑T platform intended to reprogram immune cells inside patients without ex vivo manufacturing....
AstraZeneca agrees pricing pact — White House clinches pharma deal
AstraZeneca reached a drug‑pricing agreement with the White House, following earlier deals under the administration’s pricing initiative. Reports indicated the pact mirrors discounts other...
Novo shutters cell‑therapy unit; pivots after Akero buy
Novo Nordisk discontinued its cell therapy research unit and is laying off most staff in that division while shifting strategic resources toward metabolic and liver disease programs. The company...
FDA clears dordaviprone: first systemic option for H3(K27M) DMG
The U.S. Food and Drug Administration granted accelerated approval to dordaviprone for diffuse midline glioma (DMG) harboring the H3(K27M) mutation in patients aged one year and older with...
Sarepta readies gene‑therapy filing — potential first LGMD treatment
Sarepta Therapeutics reported data showing its experimental gene therapy increased expression of the missing gene in limb‑girdle muscular dystrophy type 2E (LGMD 2E) and said it plans to file for...
Partial pig liver transplant supports human patient — xenotransplant milestone
Chinese surgeons implanted a genetically modified pig liver segment into a patient with liver cancer; the graft functioned immediately and supported metabolic activity for 38 days before being...