Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating because — you guessed it — a new round of meetings, deadlines, and whatnot has returned. You knew this was coming, yes? So please join us for the mandatory cups of stimulation as we attempt to muddle through. Meanwhile, here are a few items of interest. Hope your day goes well and do keep us in mind for interesting tidbits …
An Express Scripts committee decides which drugs should be included on its recommended list of medicines for insurance coverage but refuses to disclose the identities of the committee members, the St. Louis Post-Dispatch writes. The pharmacy benefits manager says their identities are not disclosed to shield members from lobbying, but critics say the process should be more transparent.
Santa Cruz, Calif., became the latest local government to adopt an ordinance requiring the pharmaceutical industry to pay for a drug take-back program. The move means that nine counties or cities in California and the state of Washington have created programs that require drug makers to foot the bill, and environmental activists say that more are being proposed elsewhere, such as in Cook County, Ill.
A report on new European legislation, which introduced rules for monitoring, identifying, and assessing adverse events, found that safety issues have been detected faster as a result, according to the European Medicines Agency. The rule created a Pharmacovigilance Risk Assessment Committee that helps coordinate activities of both the EMA and individual national regulators.
The US Food and Drug Administration determined that a drug tested in a clinical trial in France, which led to the death of a participant, has a “unique toxicity” and does not extend to others in the class. The FAAH inhibitor was being developed to treat chronic pain for people with cancer and other ailments. The study protocol was followed, but authorities partly blamed the drug maker and clinical research organization, and a criminal probe is under way.
Johnson & Johnson faces a batch of lawsuits in federal court in New Jersey claiming its blockbuster Levaquin antibiotic caused patients to suffer nerve damage, the New Jersey Law Journal reports. These represent a second wave of litigation, following hundreds of lawsuits linking its use to tendonitis and injured tendons. In May, the FDA warned of “disabling” side effects from Levaquin.
The FDA is holding meetings Monday to review the renewal of the Prescription Drug Use Fee Act and you can read the documents here.
Endo International is withdrawing its supplemental application seeking FDA approval for abuse-deterrent labeling for its Opana ER painkiller, Genetic Engineering & Biotechnology News says.
Novartis plans to invest $100 million to expand a production facility for monoclonal antibody drugs in France and boost capacity by 70 percent, according to PMLive.