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The FDA Thursday released long-awaited draft guidance on naming biological products, proposing that both reference products and biosimilars have nonproprietary names comprised of the core drug substance name and a different four-letter suffix. Read More
Patients who got a combination of GlaxoSmithKline’s Volibris and Eli Lilly’s Adcirca to treat pulmonary arterial hypertension had significantly less hospitalization, disease progression or death compared with those getting monotherapy in a Phase 3b/4 study, newly released data show. Read More
Just days before Sandoz is expected to launch Zarxio, its biosimilar of Amgen’s chemotherapy drug Neupogen, the FDA issued a proposed rule changing both drugs’ official names, at least temporarily. Read More
The FDA may be reconsidering its policy of only requiring black box warnings on extended-release opioids, telling lawmakers that a citizen petition to require the same warnings for immediate-release opioids is under “active consideration.” Read More
A San Diego, Calif.-based clinical researcher received an FDA warning letter over its lack of documentation of standard operating procedures for overseeing studies and details of in-service protocol and specimen handling training in a Form 483 response. Read More
Amgen is seeking FDA approval for etelcalcetide — the first calcimimetic agent for secondary hyperparathyroidism in patients with chronic kidney disease that can be administered intravenously at the end of a dialysis session. Read More
Sucampo Pharmaceuticals is paying $278 million to acquire Japanese drugmaker R-Tech Ueno, which manufactures the constipation drug Amitiza for Sucampo and its commercialization partners, Takeda, Mylan and Harbin Gloria Pharmaceuticals. Read More