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Merck, facing threat to Keytruda, buys into new kind of cancer immunotherapy

Bio Pharma Dive

The company is paying China-based biotech LaNova Medicines $588 million for the type of dual-pronged antibody drug that recently bested Keytruda in a clinical trial.

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Sanofi, Regeneron surge as Dupixent scores in COPD trial

Bio Pharma Dive

The two companies gained billions of dollars in market value after their antibody drug succeeded against a disease that’s been difficult to treat with biologic medicines.

Antibody 293
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Key trial test begins for plasma-based COVID-19 therapy from Takeda, CSL

Bio Pharma Dive

The medicine, a concentrated infusion of blood antibodies, is different than the convalescent plasma that was recently cleared for emergency use by the FDA.

Antibody 242
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Rilzabrutinib Sets a New Benchmark in Immune Thrombocytopenia Trials

XTalks

In the trial, platelet response, defined as achieving at least 50,000 platelets per microliter or doubling baseline counts, was seen in 65 percent of patients on rilzabrutinib, compared to 33 percent on placebo. Recent advancements in ITP treatments include CM313, an anti-CD38 monoclonal antibody that achieved a 95.5

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Datroway’s Approval in Breast Cancer Solidifies Daiichi Sankyo’s Leadership in ADCs

XTalks

The FDA has approved Datroway (datopotamab deruxtecan-dlnk), a TROP2-directed antibody-drug conjugate (ADC) for adults with unresectable or metastatic HR-positive, HER2-negative breast cancer, developed through a global collaboration between Daiichi Sankyo and AstraZeneca. Datroway leverages DXd technology to precisely target cancer cells.

Antibody 105
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FDA Animal Testing Phase-Out Targets Monoclonal Antibodies

XTalks

The roadmap initially targets monoclonal antibodies (mAbs) and similar biologic therapies drugs engineered to bind precise disease targets before expanding to other drug classes. Ultimately, the FDA hopes to deliver safer medicines to patients more quickly while lowering development costs.

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FDA drug dosage optimisation guidelines signal clinical trial reform

Pharmaceutical Technology

The agency proposes that pharma move away from the common maximum tolerated dose (MTD) to trial designs that prioritise drug dosage optimisation at different stages. In clinical trials, dose-ranging is testing different drug doses against each other to establish which works best. However, in some cases, fewer patients could be needed.