Regulatory

Included in President Joe Biden’s sprawling strategy document for dealing with the COVID-19 pandemic are an array of plans intended to ramp up vaccination efforts. Also included are proposals for accelerating the development of therapies such as antiviral compounds effective against SARS-CoV-2 and other coronaviruses with pandemic potential. The “full-scale, wartime” plans have considerable relevance for the…

The perpetrators of a cyberattack against the European Medicines Agency found and later released data regarding the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX).  But the cybercriminals altered the data in a manner that could undermine trust in vaccines, according to a statement from the European Medicines Agency (EMA). The disclosed documents included internal emails from late 2020 that contained…

AstraZeneca (LON:AZN) inadvertently discovered halving the first dose of its COVID-19 vaccine could boost its efficacy. Researchers at the National Institutes of Health (NIH) and Moderna (NSDQ:MRNA) are examining vaccine data to determine whether they can halve the 100-microgram dose to vaccinate twice as many people. Some data from Moderna’s clinical trial support that possibility,…

The U.K. has delayed the second dose of COVID-19 vaccines to maximize the number of people who can receive the first vaccine dose.   The move to delay administering the second dose by up to 12 weeks has prompted criticism from some physicians. The British Medical Association criticized the delay as “grossly unfair.” Dr. Anthony Fauci recently said he…

India is allowing reserved emergency use of the AstraZeneca (LON:AZN) COVID-19 vaccine and another from the domestic firm Bharat Biotech.  The country is producing both vaccines internally. Serum Institute of India has a contract to manufacture the AstraZeneca vaccine and has stockpiled between 40 and 50 million doses.  Covaxin, the vaccine from Bharat Biotech, was…

The FDA has approved the first generic of glucagon for injection for severe hypoglycemia, which can afflict some patients with diabetes.  FDA has also indicated glucagon to facilitate diagnosis in radiological exams of the digestive tract as the drug can reduce intestinal motility.  Glucagon is a hormone that, when released, triggers the liver to release…

An inexpensive COVID-19 vaccine from AstraZeneca (LON:AZN) — now authorized in the U.K. — could go on to become the most widely used in the world. It is inexpensive and easy to produce. But a major hurdle that could slow its rollout in the U.K. after yesterday’s approval is the question of how to best…

The Trump administration sued Walmart (NYSE: WMT), faulting the company for filling prescriptions from “pill-mill” physicians. The Justice Department lawsuit also alleges that Walmart attempted to maximize profits by understaffing pharmacies and emphasizing the quantity of prescriptions over quality control in its 5,000-plus retail locations across the U.S. The U.S. lawsuit also argues that Walmart lacks…

Almost immediately after President Trump indicated he planned on tying Medicare reimbursement for dozens of drugs to lower rates in other countries, it seemed certain that legal action was inevitable.   Now, Trump’s executive orders related to drug pricing are attracting a growing number of lawsuits. Earlier this month, the Pharmaceutical Research and Manufacturers of America (PhRMA),…

Health and Human Services Secretary Alex Azar stated on CNN that he has met with President-elect Joe Biden’s transition team. “I have already met with the Biden transition team. We want to make sure they get everything that they need,” Azar said in an interview with CNN’s Alisyn Camerota. Azar also noted that he would…