Topic:

Drug Safety

Latest Headlines

Latest Headlines

FDA approves tamper-resistant reformulation of Zohydro in continuing battle against opioid abuse

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.

FDA study spanks drugmakers for poor adverse events reporting

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.

Novartis faces suspension in Japan after series of trial data scandals

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.

New Zohydro formula gets FDA's blessing, but abuse-deterrent label has to wait

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 farms out safety monitoring to $2B-and-growing industry

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.

J&J lawyers aim to discredit ex-FDA chief in Risperdal breast-development case

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.

Drugmakers look to India for drug safety monitoring

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.

Amid new drug negotiations, China puts price-management vet in charge of CFDA

SINGAPORE-- A change in leadership at the China Drug and Food Administration was announced on the Communist Party website last week: Bi Jingquan, who has more than 20 years of experience in pricing and management, will take over from Zhang Yong as CFDA minister.

Ex-FDA chief testifies against J&J in Risperdal liability case

Johnson & Johnson knew as early as 2001 that its antipsychotic drug Risperdal could cause boys to grow breasts, former FDA chief David Kessler testified in Philadelphia court Wednesday. That's 5 years before the company added a warning about the side effect to the drug's official label.

Chinese Pharmacopoeia venture up and running as safety push continues

The Chinese Pharmacopoeia Commission and Waters launched their Joint Open Laboratory on Jan. 28 in Beijing that aims to produce the first official compendium of drugs.