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Spain’s Agency of Medicines and Medical Devices has suspended the manufacturing authorization for finished processing of Madrid-based Inmunotek over GMP deficiencies. Read More
Sen. Claire McCaskill (D-Mo.) is taking the FDA to task for its delayed reaction in targeting companies marketing supplements containing oxilofrine, a stimulant banned by the World Anti-Doping Agency for athletes. Read More
Weighing the risks and benefits of Intercept Pharmaceuticals’ obeticholic acid, an FDA advisory committee voted unanimously 17-0 on the significance of alkaline phosphatase levels as evidence to justify an accelerated approval of the primary biliary cirrhosis candidate. Read More
FDA Puts Clinical Hold on Ionis Candidate
BI Snags Additional Indication for Giotrif in EU
FTC Frees Pfizer From 2010 Restriction
Shire to Continue With Baxalta Merger Despite Treasury Inversion Regs
Allergan, Heptares Enter Licensing Agreement
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With the completion of the Senate HELP Committee’s third and final markup on biomedical innovation legislation, a complete cures package is expected to hit the full Senate shortly. Read More
Gaping GMP holes in Swedish contract manufacturer Apotek Produktion & Laboratorier’s processes resulted in a seven-item Form 483 following an Oct. 5 to 9, 2015 inspection. Read More
Apricus Biosciences has cut 30 percent of its workforce — including part of its executive team — following an unsuccessful Phase 2b trial evaluating fispemifene in men with secondary hypogonadism and sexual dysfunction. Read More
A federal judge has dismissed a major portion of the lawsuits accusing Pfizer of failing to warn about possible birth defects associated with taking the antidepressant Zoloft during pregnancy. Read More