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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

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

Last week, the Centers for Medicare and Medicaid Services released its final Notice of Benefit and Payment Parameters for the 2021 benefit year...This final rule permits insurers to exclude the value of a pharmaceutical manufacturer’s copay support program from a patient’s annual deductible and out-of-pocket maximum obligations...Translation: CMS has confirmed that insurers have the option to use copay accumulator adjustment for their pharmacy benefit programs...Patients on specialty drugs lose big from accumulators, while plans profit from the lower spending that results. Consequently, copay maximizers have emerged as a more patient-friendly alternative to accumulators...Plan sponsors are publicly denouncing copay support programs—while they’re privately embracing them. CMS’s final rule ignores the troubling reality behind maximizers and accumulators: They encourage plans to use pharmacy benefit deductibles as a scheme that allows payers—not patients—to reap the greatest benefits from a manufacturer’s patient support program...READ MORE

Johnson & Johnson says it's pulling its talc-based powders from the U.S. and Canadian markets. But the move comes as the drugmaker faces thousands of personal injury lawsuits over the product's safety—and as demand has fallen due to years of publicity about the legal fight...In response to the COVID-19 pandemic, J&J stopped shipping certain products—including its iconic baby powder—back in March to allow its factories to make high-demand medicines and to allow workers to spread out for social distancing reasons, the company said in a statement...Now, it's permanently discontinuing about 100 products, including its talc-based powders...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

The two-month casino shutdown in Nevada seems to have an end in sight...On Friday afternoon, Gov. Steve Sisolak gave Nevada casinos a tentative date they could plan to reopen: June 4. Seventy-eight days after casinos first closed down to help stem the spread of COVID-19...The move comes as the state has faced an increasing amount of pressure to reopen; Nevada’s unemployment rate hit record highs in April, and casinos in 12 other states had opened their doors ahead of those in Sin City...Virginia Valentine, president and CEO of the Nevada Resort Association, said Sisolak’s announcement is “fantastic news” for Nevada’s gaming industry...“Our members have spent more than two months preparing for this day,” she said in an emailed statement. “They’ve put in place enhanced health and safety plans and protocols … Our members are excited to show off the enhancements they’ve made that preserve the experience while ensuring the well-being of our employees and visitors.”...Casinos have been preparing for this day for weeks, publishing updated health and safety guidelines and setting tentative booking dates online to make sure they’d have guests ready to fill rooms...READ MORE

‘We’re ready to go back’
Tourists ready to return
All eyes on the Gaming Control Board

The COVID-19 pandemic is reshaping the global supply chain, and the Trump administration has a message for established generics drugmakers: Bring your manufacturing on shore, or we will find new companies that do...two recent contracts the U.S. government signed to bring drug manufacturing to American soil. But will companies follow?...The HHS’ Biomedical Advanced Research and Development Authority just inked a $354 million four-year deal with a company called Phlow to make generic medicine and active pharmaceutical ingredients in Virginia. The Department of Defense awarded a $138 million grant to ApiJect to expand U.S. production capability for prefilled syringes, following a $450 million deal the company won from the HHS...Both deals fall in the injectables category and involve significant investments to upgrade facilities and purchase future products. They both tap relatively new companies, which appear to be using innovative manufacturing technologies...Where does that leave traditional generic players such as Teva, Novartis’ Sandoz and Mylan? They may choose to join in...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.

Before COVID-19 killed thousands of nursing home residents, about 4 in 10 homes inspected were cited for infection control problems, according to a(Government Accountability Office) government watchdog report...that finds a “persistent” pattern of lapses...“Warning signs were ignored and nursing homes were unprepared to face a pandemic,”...“There need to be big changes in the way nursing homes care for seniors.”...Nursing homes ended up bearing the brunt of the coronavirus outbreak...Most of those people were already at higher risk due to age and medical history, and they also shared dining rooms, recreation areas, bathrooms and sleeping quarters...over 34,000 coronavirus-related deaths at nursing homes and other long-term care facilities, more than one-third of all COVID-19 deaths in the country...The GAO report found that about 40% of the nursing homes inspected in each of the past two years were cited for problems with infection control and prevention...READ MORE

The U.S. Centers for Disease Control and Prevention has issued a 60-page document that provides detailed suggestions for different phases of reopening workplaces, schools and restaurants, after an earlier draft was rejected by the White House for being too prescriptive...The document, which expands on several tools the agency released last week to guide specific types of organizations, was posted on the CDC website over the weekend without fanfare. The guidelines are similar to ones included in the draft, though they pertain to fewer types of businesses and are less restrictive...READ MORE