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AstraZeneca created a COVID-19 vaccine data controversy this week by reportedly selecting the most favorable data to tout on its program, a move independent data monitors publicly flagged in a middle-of-the-night missive. Now, with a speedy data update and analysis, AstraZeneca says it can “confirm” the vaccine’s phase 3 success...In a newly released primary analysis, AstraZeneca says its vaccine was 76% effective against symptomatic COVID-19 and 85% effective against symptomatic disease in people 65 and over. The shot was also 100% effective against severe disease and hospitalization in the phase 3 trial...READ MORE

Shoddy manufacturing practices triggered FDA warning letters for a pair of foreign producers of over-the-counter drugs...Dibar of Mexico, a CDMO for nutritional and self-care products, and Foshan Biours Biosciences of China, which specializes in gel patches, were cited for failure to fix problems the FDA raised in April of last year...The companies have been barred from importing their products to the U.S. since last fall...READ MORE

China only approved its first biosimilar drug in 2019, but the market is already looking too crowded for one Big Pharma company...Pfizer has halted its biosimilar programs in China and is selling a biologics facility there to Chinese CDMO giant WuXi Biologics...The “difficult decision” came after a “comprehensive review of the biosimilars market and the company’s global manufacturing network,” Pfizer said...READ MORE

From the moment Marilyn Jerominski walks into her pharmacy every morning, her time is in demand. As pharmacy manager of a busy 24-hour Walgreens in Palm Desert, California, she is responsible for the safety and accuracy of the thousands of prescriptions the store dispenses every week..."There's so much stress," Jerominski said. "You're not only running to the drive-thru but to the front, to the vaccination station to give a vaccination, then to the phone. ... It's almost impossible for any human to keep that momentum day in and out."...Jerominski is one of an estimated 155,000 pharmacists working at chain drugstores who, over the past decade, have found themselves pushed to do more with less. They're working faster, filling more orders and juggling a wider range of tasks with fewer staff members at a pace that many say is unsustainable and jeopardizes patient safety...READ MORE

Democrats...are united behind an idea that Republican lawmakers and major drugmakers fiercely oppose: empowering the Department of Health and Human Services to negotiate the prices of brand-name drugs covered by Medicare...Democrats hope to authorize Medicare negotiations on payments for at least some of the most expensive brand-name drugs and to base those prices on the drugs’ clinical benefits...READ MORE

Amazon is taking its health care offerings to new places. The company announced plans to roll out Amazon Care, its on-demand healthcare service across the United States this summer...The move follows the launch 18 months ago of Amazon Care to provide Amazon employees and their families immediate access to high-quality medical care...Amazon Care has two components. The first is virtual care, which connects patients to medical professionals via the Amazon Care app...The second component is in-person care, where Amazon Care can dispatch a medical professional to a patient’s home for additional care...READ MORE

Drug names often draw curiosity and confusion—and they always get a once-over by the FDA. The agency is more than usually interested these days, though...After a round of new guidance issued in December, the FDA is dipping back into the issue by reopening a proposed study to determine how drug names influence consumers and healthcare providers...Its December report “Best Practices in Developing Proprietary Names for Human Prescription Drug Products” includes suggestions for drugmakers and their naming agency partners to avoid misbranding violations...READ MORE

In an unusual move... officials with the National Institute of Allergy and Infectious Diseases urged AstraZeneca to ensure it is providing the most recent efficacy data on its coronavirus vaccine. The statement came 1 day after the manufacturer released interim data from its U.S. trials...NIAID...said an independent monitoring board informed it that AstraZeneca's disclosures of the study results may have been based on outdated evidence. The agency's response to the company...READ MORE

The United States plans to send roughly 4 million doses of AstraZeneca's COVID-19 vaccine that it is not using to Mexico and Canada in loan deals with the two countries, yielding to requests to share vaccines with allies...Mexico will receive 2.5 million doses of the vaccine and Canada is to receive 1.5 million doses...The Biden administration has come under pressure from countries around the world to share vaccines, particularly its stock of AstraZeneca’s vaccine, which is authorized for use elsewhere but not yet in the United States...READ MORE

The U.S. Federal Trade Commission will join European, British and Canadian regulators, as well as with counterparts at the U.S. Justice Department and states attorneys general, to update their approach to reviewing pharmaceutical acquisitions, a move the commission's acting chair said was prompted by the "high volume of these mergers," increasing drug prices and other anti-competitive issues...Antitrust regulators watch drugmaker mergers closely to determine whether tie-ups could impede development of newer and potentially better medicines...READ MORE