“Unexplained Illness’ in one patient leads to halt On Monday, Johnson & Johnson announced they would be temporarily pausing dosing in all COVID-19 vaccine trials, including their Phase III ENSEMBLE trial, due to an unexplained illness in a participant. Adverse events – illnesses, accidents,…
Final approval decision for Xolair expected by mid-2021 Genentech, a member of the Roche Group, announced last week the U.S. Food and Drug Administration (FDA) accepted the company’s supplemental Biologics License Application (sBLA) for a new self-administration option for Xolair® (omalizumab) across all approved…
Report says that the CDC’s projected number is 14 times the average purchase After the announcement that the CDC would be greatly increasing their purchases of adult flu vaccines, major manufacturers are increasing production in anticipation of a particularly pivotal flu season. The Washington…
Agency focused on generic drug applications Editor’s Note: The following information was reviewed from the FDA’s website. Last week, the U.S. Food and Drug Administration published a revision to Manual of Policies and Procedures (MAPP) 5240.3, Prioritization of the Review of Original ANDAs, Amendments,…
Move represents ‘shift in operation model’ Epic Pharmacies Inc. and ERX-Direct, two industry leaders, have merged to form ERX-Direct, representing a bold shift in the operational model. ERX-Direct, a newly formed community pharmacy venture, is part of a comprehensive primary health network, Health in…
New rule from Trump Administration aimed at improving transparency We’ve all seen the average prescription drug ad on television: a calm, peaceful voice talks about the benefits of a particular medication while in the background, actors enjoy a peaceful, serent setting or romantic outing.…
Action reflects commitment to monitoring pharma landscape Earlier this month, the U.S. Food and Drug Administration issued a warning letter to Inova Genomics Laboratory of Falls Church, VA for illegally marketing certain genetic tests that have not been reviewed by the FDA for…
Why we are seeing drug shortages and the impact on patients and professionals For at least the past couple of years, the American public has been affected by a prescription drug shortage. Despite action and the commissioning of FDA initiatives and task forces, by…
More than 250 medications impacted by hikes The nation’s largest drugmakers kicked off 2019 with price increases in the United States. More than 250 prescription drugs were impacted. Humira, the world’s top-selling medicine, headlined the list. But perhaps most surprising was the fact that…
As legalization efforts continue in many states, experts weigh in on the significance Less than 50 years ago—1970, to be exact—the United States Congress declared marijuana a Schedule I substance in the Controlled Substances Act, indicating that it had “no accepted medical use.” It…