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Months after FDA said it was investigating the carcinogenic ingredient N-Nitrosodimethylamine (NDMA) in metformin products, the agency’s testing has found elevated levels of NDMA (N-Nitrosodimethylamine) in extended release (ER) metformin but not in the immediate release (IR) formulation...FDA is contacting companies with ER metformin above the acceptable level and will continue to take quick and appropriate action...READ MORE

One drug that has shown promise for treating COVID-19 is remdesivir, an experimental antiviral product...The drug that buoyed expectations for a coronavirus treatment and drew international attention for Gilead Sciences, remdesivir, started as a reject, an also-ran in the search for antiviral drugs. Its path to relevance did not begin until Robert Jordan cleared it…To make progress, Gilead needed help from U.S. taxpayers. Lots of help. Three federal health agencies were deeply involved in remdesivir's development every step of the way, providing tens of millions of dollars of government research support. Now that big government role has set up a political showdown over pricing and access...federal agencies have not asserted patent rights to Gilead's drug, potentially a blockbuster therapy worth billions of dollars. That means Gilead will have few constraints other than political pressure when it sets a price in coming weeks..."Without direct public investment and tax subsidies, this drug would apparently have remained in the scrap heap of unsuccessful drugs...READ MORE

U.S. pharmacy chains are preparing a big push for flu vaccinations when the season kicks off in October, hoping to curb tens of thousands of serious cases that could coincide with a second wave of coronavirus infections...CVS Health Corp...said it is working to ensure it has vaccine doses available for an anticipated surge in customers seeking shots to protect against seasonal influenza...Rival chain Rite Aid Corp has ordered 40 percent more vaccine doses to meet the expected demand. Walmart Inc and Walgreens Boots Alliance said they also are expecting more Americans to seek these shots...READ MORE

The COVID-19 pandemic has forced companies and organizations worldwide to change courses, and the U.K.’s Vaccines Manufacturing and Innovation Centre is no different. With a new £131 million contribution from the U.K. government, the center aims to both speed up and expand upon its prior ambitions...“This is a transformational moment for our organization to be part of a national and global response, and we’re very proud to be part of that,” Duchars said. Even beyond COVID-19, VMIC also aims to be a partner for vaccine developers worldwide that could tap its manufacturing and development expertise for various diseases...READ MORE

CVS Health will try delivering prescriptions with self-driving vehicles in a test that begins next month...The drugstore chain said...that it will partner with the Silicon Valley robotics company Nuro to deliver medicines and other products to customers near a Houston-area store...A CVS spokesman said the prescriptions will routinely be delivered within an hour of being ordered...Nuro has previously started partnerships to test the delivery of pizzas for Domino’s or groceries for Kroger, also in the Houston area. This is the company’s first venture into health care...READ MORE

The National Association of Boards of Pharmacy released the May 2020 Rogue Rx Activity Report, Rogue Online Pharmacies in the Time of Pandemic: Capitalizing on Misinformation and Fear. The report highlights how illegal online pharmacies use COVID-19 to expand operations and prey on consumer fears...NABP has identified dozens of rogue online pharmacies claiming to sell prescription drugs marketed for COVID-19 treatment. Drugs such as chloroquine, hydroxychloroquine, lopinavir, and ritonavir are being sold online after they gained media attention; however, these are unproven treatments for COVID-19 and are dangerous when taken without proper medical supervision...READ MORE

Attempting to capitalize on the pandemic, illegal online pharmacies are:

-adding coronavirus-related images to preexisting websites,
-purchasing domain names that include COVID-19 words and phrases,
-registering domain names with fraudulent “safe haven” registrars, and
-creating new website facades linking to non-coronavirus-related stores.

Dr. Scott Atlas, senior fellow at Stanford University's Hoover Institution and former chief of neuroradiology at Stanford University Medical Center, repeats call to end coronavirus lockdowns...WATCH VIDEO

Requiring patients to visit a hospital, clinic or medical office to get an abortion pill is needlessly risking their health during the COVID-19 pandemic, a group of physicians allege in a lawsuit that seeks to suspend the federal rule...The federal lawsuit, which the American Civil Liberties Union filed...in Maryland, questions why patients can’t fill a prescription for mifepristone by mail. The U.S. Food and Drug Administration approved mifepristone to be used in combination with a second drug, misoprostol, to end an early pregnancy or manage a miscarriage...“Of the more than 20,000 drugs regulated by the FDA, mifepristone is the only one that patients must receive in person at a hospital, clinic, or medical office, yet may self-administer, unsupervised, at a location of their choosing,” the lawsuit says...READ MORE

Walgreens has taken a big first step in meeting the growing need for mental health resources in the wake of the COVID-19 pandemic. The company’s health outcomes pharmacists have completed the first phase of training in mental health first aid, administered by the National Council for Behavioral Health...Mental health first aid training... includes information about mental health literacy and understanding the risk factors and warning signs of mental health and addiction concerns, as well as strategies to help someone in both crisis and non-crisis situations...“With the prevalence and rise of incidents of depression, anxiety, addiction, PTSD and others, specialized training can be key to identifying warning signs, and working with other providers, even finding gaps in care or treatment. We’ve long believed pharmacists can play an even greater role as part of patient’s care teams, and we’re proud to be at the forefront of our industry expanding our efforts in the area of mental health to help meet this growing need.”...READ MORE

The new coronavirus moved around the world with lightning speed. Since December, when it was first identified in Wuhan, China, nearly every country has reported cases of infection. More than 4.9 million cases have been confirmed...and over 327,000 people have died...Dozens of drugmakers have started work on vaccines to protect against the virus or medicines to treat COVID-19...Hundreds of studies are underway in search of an effective treatment, testing mostly repurposed HIV or influenza drugs...For the biopharma industry, the virus has disrupted business on a broad scale. Many companies source chemicals or pharmaceutical ingredients from factories across the globe, creating supply chain challenges...The epidemic's impact on clinical trials was significant, causing numerous delays to enrollment or postponements to studies of treatments for other diseases...BioPharma Dive compiled a roundup of our coronavirus coverage so far. There are many unanswered questions, and the drug industry's response is only in its opening stages...READ MORE