Category:

Trump ordered travel from Europe to the United States restricted for 30 days, responding to mounting pressure to take action against a rapidly spreading coronavirus outbreak disrupting nearly all corners of U.S. daily life...“We are marshaling the full power of the federal government and the private sector to protect the American people,” Trump said in a prime-time televised address from the Oval Office on Wednesday...READ MORE

Some patients infected with the novel coronavirus can develop uncontrolled immune response, leading to potentially life-threatening damage to lung tissue. After seeing promising results in clinical practice, Chinese authorities now recommend a Roche arthritis drug to tackle that rampage...Roche’s blockbuster Actemra, first approved by the U.S. FDA in 2010 for rheumatoid arthritis, can now be used to treat serious coronavirus patients with lung damage, China’s National Health Commission said in its updated treatment guidelines for COVID-19...READ MORE

Chain pharmacies and US government agencies are doing everything they can to mitigate shortages of facemasks, hand sanitizers, and other products as consumers rush to purchase supplies due to coronavirus...fears..."The extreme demand in some areas certainly is affecting supplies," Chris Krese, spokesperson for NACDS, told Drug Topics®...Meanwhile, the FDA announced the first drug shortage due to COVID-19, but declined to list the drug in shortage...This information is considered proprietary...hand sanitizers and facemasks have been virtually stripped from store shelves, and that Amazon, Walmart, and other retailers’ web sites are running out of affordable hand sanitizers..."Due to high demand and to support all customers, we will be limiting the number of sanitization, cold and flu-related products to 5 each per order," Kroger said on its website...READ MORE

Nicole Grassano, PTNN, Pharmacy Week in Review, this weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

The World Health Organization described the new coronavirus as a pandemic for the first time on Wednesday, adding that Italy and Iran were now on the frontline of the disease and other countries would soon join them...“We are deeply concerned both by the alarming levels of spread and severity and by the alarming levels of inaction. We have therefore made the assessment that COVID-19 can be characterized as a pandemic,” WHO Director General Tedros Adhanom Ghebreyesus told a news conference on Wednesday...READ MORE

A suppository maker that has been a problem for the FDA in the past is at it again. An inspection of its New Jersey manufacturing facility found its equipment was “filthy” and some of it held together with tape and plastic wrap...On top of that, the warning letter for Acino Products, an over-the-counter maker of suppositories and topical solutions, said it could not come up with documents for microbiological testing...While the company pledged to make fixes and improvements, the FDA said it was not nearly enough...READ MORE

FDA Commissioner Stephen Hahn offered more details of the agency’s plans to request paper records from Chinese drugmakers and API manufacturers while inspections in China are on hold during the COVID-19 outbreak...While FDA inspections are suspended in China, the agency may ask firms for facility records ahead of or instead of inspections, allowing the agency to review records ahead of time and identify plants that most warrant an inspection...“These records will help the agency when we resume drug inspections in China,” allowing it to focus early inspections and help prevent an inspection backlog, he said...READ MORE

When an inspection of Cipla’s sterile injectable plant in Goa, India, went badly last fall, it appeared pretty certain a warning letter would follow. The inspection report, after all, went on for 38 pages, detailing equipment layered in residue and bacterial contamination. The bad news has now arrived...The Indian drugmaker confirmed in a filing...that it had received a warning letter for the September inspection of the sterile products plant in Vasco Da Gama in Goa state. It said it “will work closely with the agency to comprehensively address all the observations” but didn't mention there were a dozen of them, many targeting shoddy cleaning methods and microbial contamination...READ MORE

After the Indian government moved to limit the export of APIs, an Indian export association says fear is spreading amongst European businesses over supply...The news broke...that the Indian government had decided that the export of 26 active pharmaceutical ingredients and formulations would be placed under restriction...As a result, Dinesh Dua, chairman of the Pharmaceuticals Export Promotion Council of India, told Reuters, that European industry was ‘panicking’...“I am getting a huge number of calls from Europe because it is very sizeably dependent on Indian formulations and we control almost 26% of the European formulations in the generic space.”...READ MORE

Christina Mattina, welcome to This Week in Managed Care from the Managed Markets News Network