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Second Patient Dies in Zafgen Obesity Trial
Drugmaker UniQure Drops Glybera Gene Therapy Program in U.S.
Lilly’s Trulicity Succeeds in Phase 3 Study
Roche, Upsher-Smith Unit to Develop VAP-1 Inhibitor Read More
Real-world research offers the potential to better understand a medicine’s value in a clinical setting, but to fully harness its potential, drugmakers will need to restructure the way they think. Read More
The Italian Medicines Agency has issued a noncompliance statement to Rome-based radiopharmaceutical maker Iason Italia, hitting the company over deficiencies primarily related to sterility assurance. Read More
A month after the FDA announced a nationwide sweep that resulted in criminal and civil cases against 89 makers of dietary supplements, a former owner and operator of a Montana dietary supplement maker has been sentenced to prison for selling supplements in violation of two court orders. Read More
An FDA advisory committee Tuesday erected another roadblock for getting Fabre-Kramer’s depression candidate gepirone on the market, recommending against approving a potential therapy whose fate has been in limbo for two decades. Read More
Gilead Sciences put profit over affordability when pricing its line of hepatitis C treatments, says a Senate Finance Committee report issued Tuesday. Read More
FDA Grants Rare Pediatric Disease Designation to Cellceutix’s Kevetrin
FDA Grants Orphan Drug Designation to PhaseBio for Cardiomyopathy Treatment
Advaxis Osteosarcoma Candidate Scores Orphan Drug Designation in EU
Novo Nordisk Acquires Rights to Xoma’s XMetA Program
MHRA Releases Guidance Clarifying Baseline Submissions Read More
The FDA has rejected Repros Therapeutics’ NDA for its secondary hypogonadism treatment enclomiphene, asking the drugmaker to conduct an additional Phase 3 study or studies, as the original trials are no longer adequate to demonstrate clinical benefit. Read More
The nation’s largest pharmacy benefits manager is throwing its support behind a cheaper alternative to Turing Pharmaceuticals’ expensive toxoplasmosis/HIV treatment, threatening its monopoly on the market. Read More
The FDA has underestimated the burden that would be imposed on drug manufacturers in collecting and reporting quality metrics data, industry says in comments on the agency’s quality metrics draft guidance. Read More