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The FDA handed Baxter Healthcare a six-observation FDA Form 483 for lapses in sterile process controls and failure to review batch discrepancies at its Puerto Rico manufacturing plant. The drugmaker has been plagued in recent months over recalls of sterile IV solutions. Read More
The FDA Thursday released long-awaited draft guidance on naming biological products, proposing that both reference products and biosimilars have nonproprietary names comprised of the core drug substance name and a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
Mylan scored a potential win from the U.S. Patent and Trademark Office when it agreed to review challenges to two patents on Teva’s blockbuster multiple schlerosis drug Copaxone. Read More
Biologics makers developing drugs based on bacteria and viruses should conduct preclinical and clinical studies to determine if infection could be unintentionally transmitted from treated patients to other individuals, the FDA says. Read More
The FDA submitted Designation of Official Names and Proper Names for Certain Biological Products as a proposed rule to the Office of Management and Budget on Friday, but would not comment on whether it is the expected guidance on naming biosimilars. Read More