Tag:

drug safety

Latest Headlines

Latest Headlines

Hackers target top pharma execs for financial gain

A group of hackers is looking for information related to drug safety, clinical trials, regulatory decisions and legal issues that's significant enough to move the global financial markets--and it's raiding top pharma execs' email accounts to find it, The New York Times reports.

Contrary to popular belief, side-effect reports on new meds keep a steady pace, study finds

Side-effect reports to the FDA are a contentious subject. Despite a series of efforts to improve adverse-event reporting, numbers from the agency's database tend to be quoted with an accompanying list of disclaimers. But is the Federal Adverse Event Reporting System more reliable than we think?

Critics call for harsher treatment of foreign drugmakers who sell faulty drugs

The FDA reported last week that for about 6 months it has been testing some generic drugs to see how they stack up to the branded products they mimic. That $20 million effort is laudable, but it isn't enough to ensure the generics that fill the medicine cabinets of U.S. consumers are both safe and effective, according to critics of foreign-made pharmaceuticals.

Ranbaxy inks record-setting $500M manufacturing settlement with the feds

The India-based generics maker pleaded guilty to U.S. drug safety violations and agreed to pay $500 million in penalties, in the largest-ever federal settlement with a maker of copycat drugs.

Pfizer has another recall tied to smelly drugs

Smelly pills have led to another recall by Pfizer and this time a drug shortage. Last year Pfizer recalled more than 650,000 bottles of Advil gel tabs from stores because they had a strong odor. This time it is Pfizer subsidiary King Pharmaceuticals recalling 52,000 bottles of its thyroid pill Levoxyl because of a bad odor.

Chinese court wants tougher clinical trial regs

India's struggles to regulate its booming clinical research industry are well told, but now China could be headed down the same path, as a Beijing court has taken issue with how trial-runners pay compensation to patients.

Troubled BioCryst dumps HCV preclinical program

Troubled BioCryst Pharmaceuticals has ditched its preclinical hepatitis C virus program of BCX5191 and its backup compounds after results of a low-dose chimpanzee study, according to documents filed with the SEC.

Generic Reglan user can sue Pfizer for damages

It's a state court ruling. It directly affects only one drugmaker. But the Alabama Supreme Court's decision to allow a patient to sue Pfizer for damages could ripple through the industry--and not in a good way for branded drugmakers.

Pakistan investigates cough syrup tied to 35 deaths

An investigation into the deaths of 35 people in Gujranwala, Pakistan, tied to a cough syrup has sparked a controversy over who is to blame.

Congressional bills would toughen safety labeling for generic drugmakers

Congressional Democrats are ramping up two bills intended to put generic drugmakers on par with their Big Pharma counterparts as far as governing how they change product labeling to report updated safety information.