Topic:

Drug Safety

Latest Headlines

Latest Headlines

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.

Another Turkish man sentenced for smuggling fake cancer drugs into U.S.

With the sentencing of a second man from Turkey, federal authorities have essentially brought to a close a case stemming from the appearance in the U.S. of counterfeit and unapproved cancer drugs. The drugs were sold to wholesalers and physician practices throughout the U.S., in some cases making patients ill.

J&J again faces off-label marketing claims in Risperdal case of boy who grew breasts

Last week opening arguments were made in a case in which Johnson & Johnson is accused of marketing the antipsychotic drug Risperdal for use in young boys and then not sufficiently warning patients that the side effects for some included the possibility they would grow breasts like a woman.

India's GVK Biosciences gets harsh accusations from EMA on fake generic trials

In a no-holds-barred action, the European Medicines Agency has accused India-based CRO GVK Biosciences of systematically faking clinical trials for about 700 generic drugs marketed throughout the world. The products of dozens of generic makers are among the drugs involved, including popular antidepressants.