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Ipsen pulls Tazverik after safety signal — confirmatory trial triggers withdrawal
Ipsen said it will withdraw the EZH2 inhibitor Tazverik from the market after independent monitors identified cases of secondary hematologic malignancies in a confirmatory trial for follicular...
Novo ends fight with Hims — branded GLP‑1s land on telehealth
Novo Nordisk and Hims & Hers struck a deal to list Novo’s GLP‑1 medicines on Hims’ telehealth platform at the same prices available through other telehealth providers. Under the agreement Hims...
AbbVie’s $350M amylin bet posts near‑10% weight loss at 12 weeks
AbbVie released early data from its high‑stake amylin program showing near‑10% weight loss at 12 weeks in certain patients, signalling initial efficacy for the company’s $350 million investment in...
Lonza to sell capsule and health ingredients unit in $3bn deal — pivots to CDMO
Lonza agreed to divest its Capsules & Health Ingredients (CHI) business to Lone Star Funds in a transaction valued at CHF 2.3 billion (~$3 billion), retaining a 40% stake and planning to reinvest...
Lonza expands ZYNTEGLO capacity — Genetix scales commercial gene‑therapy supply
Lonza and Genetix extended their commercial manufacturing agreement to expand production of ZYNTEGLO™ at Lonza’s Houston cell and gene therapy site. The renewed deal secures additional capacity to...
FDA turbulence lifts gene‑therapy stocks — Prasad exit fuels market swings
Stocks of gene‑therapy developers swung sharply after reports that Vinayak (Vinay) Prasad will step down as FDA CBER director, a change that followed high‑profile agency demands for additional...
Cenevo launches agentic lab AI; Primera adopts Labguru for digitization
Cenevo introduced two agentic AI tools—the AI Protocol Conversion agent and the AI Automation agent—designed to convert legacy protocols into structured, compliant digital workflows and to...
Agilent to buy Biocare Medical for $950M — pathology portfolio expands
Agilent agreed to acquire Biocare Medical for $950 million in cash, adding immunohistochemistry (IHC), in‑situ hybridization (ISH), FISH assays and a library of over 300 specialized antibodies to...
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....