Drug Development Immunity Labelling Vaccines 
Pharmacy Times
JUNE 23, 2025
CMS is issuing unique J-codes for 505(b)(2) drugs, classifying them as sole-source products if not therapeutically equivalent. This pathway reduces submission denial risk, accelerates drug development, and offers potential market exclusivity for up to 7 years.
BioPharma Dive
JUNE 27, 2025
Specifically, it removes so-called “Risk Evaluation and Mitigation Strategies” from the drugs’ labeling, which are used to help manage serious side effects of treatment. But their administration also comes with notable risks, including a hyperactive immune response known as CRS and neurological toxicity dubbed ICANS.
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PharmaTech
JUNE 26, 2025
However, the company went on to say that as many as 60% of patients treated with CAR-T cells experience “high-grade toxicities,” such as cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). Pharmaceutical Compounding Calculations, Part Two–Bulk Drugs Paul L. million (approximately US$1.99
Pharmaceutical Technology
JULY 14, 2025
How will RFK Jr’s American dream for vaccines play out? Sectors Sections Clinical Trials Drug Manufacturers Therapy Area Pricing and Market Access Latest EC approves BeOne’s Tevimbra for nasopharyngeal carcinoma Formulate Faster. MAXSHOT.PL via Shutterstock. A decision by the FDA is expected in H1 2026.
Pharmaceutical Technology
JULY 15, 2025
How will RFK Jr’s American dream for vaccines play out? LaNova’s drug development focuses on tumour immunity and the tumour microenvironment. The company has particular emphasis on antibody-drug conjugates (ADCs) and has built several platforms within this modality. The share price in the company had climbed 3.6%
BioPharma Dive
JUNE 11, 2025
Based on conversations with physicians, it “could be positioned well, and ahead of Augtyro,” he wrote, adding that Wednesday’s sell off in shares was “overdone on any potential launch and label optics concerns.” Track the deals that are happening here. Sanofi’s $9.1 Track the deals that are happening here. Sanofi’s $9.1
Pharmaceutical Technology
JULY 15, 2025
How will RFK Jr’s American dream for vaccines play out? LEO’s new asset is a monoclonal antibody that blocks the activation of the interleukin-36 (IL-36) receptor – a key signalling pathway in the immune system implicated in the pathogenesis of several autoinflammatory diseases.
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