Regulators in the U.K. have closed down a manufacturing operation there that was making unapproved, unlicensed globulin component macrophage activating factor, a blood product which has the potential to stimulate macrophages to kill cancer cells and stimulate the immune system but is not yet approved for use.
The U.S. FDA is hiring new inspectors in India to tackle the high rate of marketing applications made by local firms, an agency official said.
SINGAPORE-- Sometimes it must seem to Pakistan's health authorities they can do nothing right in regulating the nation's pharmaceutical industry.
The FDA approved a reformulated version of Zogenix's painkilling Zohydro ER designed to be abuse resistant, marking another step in the battle against opioid abuse and another chapter in a long-running battle over the controversial and potentially addictive medication.
Gilead Sciences' hep C drug Sovaldi (sofosbuvir) has had a stellar year, with huge sales because of cure rates that top 90%. But is it safe? According to adverse events reporting, the FDA says it appears to be, but Gilead, like many other drugmakers, has done a poor job of reporting drug side effects.
SINGAPORE-- Japan plans to temporarily suspend Novartis' pharma business in that country, according to media reports. The Ministry of Health, Labour and Welfare's order will last about 15 days and will cite repeated violations of failure to report adverse events properly, the Japan Times says.
Since its FDA approval, the all-hydrocodone painkiller Zohydro has sparked outrage from officials and advocates trying to fight the tsunami of opioid addiction. But with its new Zohydro formula now approved, Zogenix is hoping it can put out the fire.
Big Pharma has been hiring out all sorts of functions companies once did in-house: sales, manufacturing, and IT services, to name a few. But according to The Wall Street Journal, one of the fastest-growing fields for pharma contractors isn't any of these. It's drug safety.
Johnson & Johnson has fired back against former FDA chief David Kessler, who testified against the company last week in a Risperdal liability case. Kessler can't be trusted on drug safety, J&J's lawyers said, because he's a "hired gun" known for attacking drugmakers in court.
India has long been a major player in the development and manufacturing of treatments, but more and more drugmakers are outsourcing the monitoring of on-the-market drugs to vendors in the country.