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Roche’s oral SERD flunks first‑line trial — questions on mechanism
Roche reported that its oral selective estrogen receptor degrader (SERD) missed the primary endpoint in a Phase 3 first‑line breast cancer trial. The drug, giredestrant, had shown promise in...
FDA’s pressure on uniQure spurs stock swings — CBER boss to exit
uniQure’s gene‑therapy program for Huntington’s disease has been thrust into the spotlight after the FDA recommended a prospective, randomized, sham‑surgery‑controlled trial for AMT‑130, prompting...
Agilent buys Biocare for $950M — fluorescence, IHC and FISH added
Agilent agreed an all‑cash acquisition of Biocare Medical for $950 million, expanding the company’s pathology product set with immunohistochemistry (IHC), in‑situ hybridization (ISH/FISH) assays...
Lonza narrows focus—sells Capsules & Health Ingredients in $3B deal
Lonza agreed to divest its Capsules & Health Ingredients (CHI) business to Lone Star Funds for CHF 2.3 billion (about $3 billion), marking a major step in the firm’s pivot to a pure‑play CDMO...
FDA issues CRL to Incyte tied to third‑party plant problems
The FDA issued a complete response letter to Incyte, blocking a label expansion for the company’s monoclonal antibody product due to problems at a third‑party manufacturing site in Indiana...
Xenon posts Phase‑3 win — azetukalner cuts seizure frequency
Xenon Pharmaceuticals reported that azetukalner met the primary endpoint in a Phase 3 trial, significantly reducing the frequency of a common seizure type versus placebo and exceeding the effect...
Big pharma obesity bets show traction — AbbVie and Regeneron report gains
AbbVie released first data tied to its $350 million amylin program showing nearly 10% mean weight loss at 12 weeks in certain patients, while Regeneron’s Chinese partner reported Phase 3 results...
Daraxonrasib posts high responses — moves toward Phase‑3 in PDAC
Revolution Medicines’ daraxonrasib, a RAS(ON) tri‑complex inhibitor, showed objective response rates of 47% in a first‑line cohort of RAS‑mutant metastatic pancreatic cancer and disease control in...
HIV adapts to lenacapavir — new resistance routes mapped
A Nature Communications study detailed recurrent and novel evolutionary pathways by which HIV‑1 can acquire resistance to lenacapavir, the long‑acting capsid inhibitor. Researchers identified...
High‑throughput DnD assay spots hidden antibiotic resistance
Researchers Ma and Kim published a dilution‑and‑delay (DnD) susceptibility assay that detects hidden and heterogeneous antibiotic resistance at high resolution and throughput. The method reveals...
Lonza sells CHI to Lone Star — Company pivots to pure‑play CDMO
Lonza announced the sale of its Capsules & Health Ingredients (CHI) business to Lone Star Funds in a CHF 2.3 billion ($3 billion) agreement that marks the latest step in the Swiss CDMO’s strategic...
FDA shuns advisory panels: uniQure gene therapy faces fresh agency scrutiny
The FDA has moved away from public advisory‑committee engagements in a high‑profile dispute with uniQure over its Huntington’s disease gene therapy candidate, according to reporting by STAT....
Roche’s breast‑cancer pill fails first‑line Phase 3 — Program setback
Roche reported a failure in a pivotal Phase 3 first‑line trial for its oral breast‑cancer candidate, undercutting expectations that the drug could become a major revenue driver. The company said...
Daraxonrasib posts high responses — Moves toward Phase 3 in RAS‑mutant pancreatic cancer
Revolution Medicines reported daraxonrasib produced objective response rates of 47–55% in early cohorts of RAS‑mutant metastatic pancreatic ductal adenocarcinoma (PDAC), outperforming historical...
DNA‑repair mutations modulate pancreatic cancer response — Treatment stratification insight
New research identified DNA‑repair gene alterations as modifiers of response to combination chemotherapy in metastatic pancreatic ductal adenocarcinoma (PDAC). The study examined how defects in...
New resistance pathways mapped for lenacapavir — HIV drug under evolutionary pressure
Researchers published findings in Nature Communications mapping recurring and novel evolutionary routes by which HIV‑1 acquires resistance to lenacapavir, a long‑acting capsid inhibitor. The work...
High‑throughput DnD assay exposes hidden antibiotic resistance — Diagnostic leap
A team led by Ma and Kim unveiled the dilution‑and‑delay (DnD) susceptibility assay in Nature Communications, a high‑resolution, high‑throughput method that uncovers cryptic antibiotic resistances...
Wireless retinal implant restores reading for geographic atrophy patients
Clinical researchers reported that a wireless subretinal implant (PRIMA) restored functional central vision in patients with late‑stage geographic atrophy from age‑related macular degeneration. In...
MRI‑steered catheter and mid‑IR fiber probe — New tools for real‑time tissue access and monitoring
Two independent device advances promise finer intraprocedural control and noninvasive biochemical sensing. A concentric‑tube catheter steered under MRI guidance enables precise endoluminal...
PPQ strategies for cell and gene therapies — Preventing quality and compliance setbacks
Quality lifecycle planning for process performance qualification (PPQ) remains a critical bottleneck for cell and gene therapy developers. Guidance and case studies highlight common failure...