Good morning, everyone, and nice to see you today. A warm and shiny sun is enveloping the Pharmalot campus, which is rather quiet now that the shortest of short people has left for the local schoolhouse and the official mascots have tired themselves out frolicking around the grounds. As for us, we are doing the usual — brewing cups of stimulation and foraging for interesting items. Here are a few, in fact, to get you started. Have a great day and do keep in touch …
A congressional committee is probing the US Food and Drug Administration’s Office of Criminal Investigations amid questions about its management and handling of cases, Reuters reports. In a Sept. 20 letter to the FDA commissioner, the committee wrote it is “examining management concerns” and “possible morale concerns” with OCI field offices. The move comes after Reuters reported FDA agents complained OCI managers forced them to pursue cases involving mislabeled foreign-imported injectable drugs, at the expense of cases with more potential to protect the public health.
Mylan Pharmaceuticals chief executive officer Heather Bresch faced tough questioning Wednesday from both Republicans and Democrats at a congressional hearing called to probe price increases for the EpiPen allergy treatment, according to STAT. Bresch argued Mylan profited much less than the $608 list price would suggest, although the House Oversight and Government Reform committee asked her to submit a raft of pricing data.
At the same time, Dr. Janet Woodcock, who heads the FDA drug review division, told the Senate Appropriations Subcommittee that it is often difficult for the agency to approve the first generic drugs to enter the market. Her colleague, Dr. Douglas Throckmorton, was similarly grilled by the House committee over concerns that the agency does not move quickly enough to approve medicines for which there is little or no competition, such as EpiPen.
In a setback for Sanofi, UnitedHealth Group, which is the largest US health insurer, will no longer cover the Lantus insulin treatment, along with several other brand-name drugs next year. As a result of this decision and a similar move by CVS Caremark, Leerink analyst Seamus Fernandez estimates that Lantus reimbursement will no longer be accessible for as many as 19 percent of people who have commercial health insurance.
Purdue Pharma, the drug maker that developed OxyContin, has been vilified for triggering the opioid crisis that kills an estimated 78 Americans a day. But the role of Abbott Laboratories in pushing the drug has largely escaped notice, STAT reports. Newly disclosed documents reveal the company was a crucial partner in an aggressive — and misleading campaign — to sell OxyContin during its first decade on the market.
Six of the eight investigators in the federal Office of Research Integrity have signed a letter suggesting they may leave due to morale, the Washington Post reports. The move could confound efforts to detect data manipulation and other misconduct by lab researchers. The conflict apparently began last December when a new director arrived at ORI, which had been without a permanent director for about two years.
More than 190 countries signed a United Nations declaration to combat antimicrobial resistance, PharmaTimes writes. The nations committed to developing surveillance and regulatory systems for the use and sales of antibiotics for humans and animals; encouraging new ways to develop novel antibiotics; and improving rapid diagnostics. By 2050, an estimated 10 million people a year will be dying due to resistance at a cost to the global economy of $100 trillion.
Gilead Sciences suspended a combined Phase 2/3 study of a drug being tested for patients with moderately to severely active ulcerative colitis after apparently failing to meet an efficacy endpoint. The move is “unlikely to significantly impact revenue forecasts for the company,” writes Leerink analyst Geoff Porges in an investor note. But he adds, “the bad news does come as another blow to the sentiment about the company’s R&D prospects.”
Astra Zeneca is closing an office in Fort Washington, Pa., and shifting 134 jobs to Wilmington, Del., according to the Philadelphia Inquirer.
Aurobindo Pharma and Cadila Healthcare recalled over 25,500 bottles of two different drugs in the US due to presence of foreign tablets and failed dissolution specifications, the Economic Times says.
Moderna Therapeutics plans to spend $110 million to build a manufacturing facility to make active pharmaceutical ingredients, InPharma Technologist writes.