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Scios, a division of Johnson & Johnson (J&J), has announced plans to launch a large-scale international study, involving upwards of 7,000 patients, to further assess the benefits and safety profile of its cardiovascular drug Natrecor in people with acutely decompensated heart failure (DHF).
While Merck is downplaying the significance of its misidentification of the statistical method it used to analyze data from the study that prompted the company to pull Vioxx from the market, this admission may weaken the company’s defense in the thousands of lawsuits it faces over the drug.
A provision in pending legislation granting extended market exclusivity for drugs used to address potential bioterrorism threats could undercut current law, is unnecessary and must be removed, patient advocates say.
An ambitious World Health Organization (WHO) plan to register every clinical trial conducted anywhere in the world could have a chilling effect on new drug development, according to PhRMA.
Cyberonics’ vagus nerve stimulation (VNS) therapy for treatment-resistant depression (TRD) is again at the center of controversy as a public advocacy group asked the FDA to remove an online ad the company posted, saying it exaggerates the benefits of VNS and violates FDA advertising regulations.
The SEC’s recent decision denying industry’s request to exclude smaller companies from Sarbanes-Oxley (SOX) reporting and auditing requirements has placed biotech firms are in a race against the clock to get broad SOX reforms before the next round of filings are due, an industry source says.
A Wall Street analysis tracking trends in prescription drugs shows strong growth for some of the industry’s key product areas while revealing less-than-encouraging news for several companies.