Regulatory

The White House Coronavirus Task Force promised a swift rollout of COVID-19 vaccines — but one of a number of takeaways from its first briefing since July. The briefing yesterday gave the task force a chance to once again urge Americans to heed COVID-19 guidance while also providing an update on vaccines and therapeutics.   The…

A federal judge in Virginia has sentenced opioid-addiction drug maker Indivior Solutions (LON:INDV) to pay $289 million in criminal penalties linked to the marketing of the drug Suboxone, the U.S. Department of Justice announced.  In all, Indivior will pay a total of $600 million to resolve civil and criminal liabilities for downplaying safety risks tied…

While President Trump continues to refuse to concede the election, a growing number of business associations and politicians have acknowledged Biden as the president-elect. What a Biden presidency would mean for the pharmaceutical industry continues to be an open question as the Senate outcome remains undecided, but two broadly similar outcomes are likely. Ultimately, neither…

Boehringer Ingelheim has reached an agreement in principle to settle some 2,935 lawsuits tied to its blood thinner Pradaxa (dabigatran etexilate).  In a Connecticut Supreme Court filing, privately owned Boehringer (Ingelheim am Rhein, Germany) stated the settlement would resolve the lawsuits, which alleged the anticoagulant drug Pradaxa caused undisclosed bleeding risks. The company expects it will…

A National Institutes of Health clinical trial has concluded that hydroxychloroquine had no clinical benefit for hospitalized COVID-19 patients. The Journal of the American Medical Association published the results from the blinded, placebo-controlled, randomized trial. The clinical trial, known as the “ORCHID” study, treated 479 symptomatic COVID-19 patients with hydroxychloroquine in 34 hospitals in the…

Nostrum Laboratories is initiating the voluntary recall of two lots of its Metformin HCI extended-release tablets for people with diabetes. According to an FDA news release, the Metformin HCI extended-release tablets (USP 750mg) were found to contain levels of nitrosamine impurities above the ADI limit of 96ng per day, as stipulated in the FDA Guidance Document…

The pharmaceutical industry stands at a crossroads as Election Day nears in the U.S. The election could ultimately have sweeping implications for the sector, or it could yield only modest changes. While the presidential election could have a significant influence on the pharma sector, arguably more important is who gains control of Congress. A blue sweep…

Johnson & Johnson’s (NYSE:JNJ) chief scientific officer said today that the first doses of his company’s COVID-19 vaccine could be available for frontline healthcare workers in January or February, but added the company isn’t rushing it. If granted an emergency use authorization by the FDA, that’s the earliest Dr. Paul Stoffels said the single-dose vaccine developed…

The U.S. Dept. of Health and Human Services and Defense Dept. agreed to a $1 billion deal for a vaccine candidate from Johnson & Johnson (NYSE:JNJ). HHS and DoD announced the agreement with Janssen Pharmaceutical, as the J&J subsidiary is set to offer large-scale manufacturing and the delivery of its COVID-19 vaccine candidate, with the federal…

The U.S. Health and Human Services Dept. and Defense Dept. announced a joint agreement with Novavax  (NSDQ:NVAX) worth $1.6 billion to scale the manufacturing of its COVID-19 vaccine candidate. Gaithersburg, Md.-based Novavax’s commercial-scale manufacturing is expected to produce 100 million doses of the investigational vaccine that would become available for use in clinical trials or,…