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Gov. Steve Sisolak and Gov. Brian Sandoval may have come from different political parties and approached governing in different ways, but the state’s most recent governors have at least one thing in common: a bone to pick with the state’s occupational licensing boards...in recent years, occupational boards have made headlines for various failures or misconduct, ranging from failure to conduct background checks on pharmacy wholesalers for more than a decade, hiring of spuriously-qualified lobbyists, ignoring directives on maximum salaries for state employees and making “salacious and false” accusations against the governor...Much of those failures can be attributed to structural deficiencies in how the state’s decentralized occupational licensing board system works...A major...audit from last year found “lacking” oversight of boards with “inconsistent…practices that may not comply with state guidelines,” and recommended moving all boards under the umbrella of the Department of Business and Industry, in order to have a standard clearinghouse for complaints, litigation and other similar activities...READ MORE

Auro Pharmacy has had a number of run-ins with FDA investigators...The FDA has had a long and troubled history with compounding pharmacies...sometimes those facilities bring it on themselves...Auro Pharmacies operated a veritable house of horrors at its...outsourcing facility, with ants in the sterile production areas and visibly dirty work surfaces, FDA investigators found during an August 2018 inspection...Those poor conditions could have produced supposedly sterile drugs that were "contaminated with filth,"...The FDA knocked Auro with a 10-observation Form 483 in August, 2018 that led to a voluntary recall of all the pharmacy's affected drugs and a stoppage to all sterile production...Even worse for Auro, the FDA followed up its August 2018 look-in with another round of inspections in September of last year that turned up most of the same sanitary issues, including "filth" on the end of hood-cleaning wands, and cracked and scratched production hoods...That inspection lead to a separate 11-observation Form 483 sent in October...READ MORE

Treatments for peanut allergy and Parkinson’s disease are among U.S. drug launches that have been postponed by the COVID-19 pandemic as drugmakers struggle with disruptions to business...The Food and Drug Administration has approved more than 30 new medicines since January, but at least five drugmakers...have changed their launch plans...Launching drugs is an expensive and complicated process that includes sales representatives talking to doctors, coordinating supplies and treatment with pharmacies and clinics, and advertising campaigns - many of which have become harder during lockdowns or other restrictions to tackle the pandemic...That’s bad news for patients and drugmakers...Delays altogether could cost companies over a quarter of the originally estimated more than $1 billion in 2020 sales for the products approved by the FDA since January...READ MORE

Nevada on Saturday reported a record daily increase of additional confirmed COVID-19 cases. But health officials later said the bulge largely resulted from laboratory data entry errors that delayed the posting of hundreds of cases from two previous days...The state Department of Health and Human Services reported an additional confirmed 1,099 cases, mostly from metro Las Vegas...The number of additional cases reported Saturday was more than double the previous record of 507 reported Thursday. Bur the Southern Nevada Health Agency said the reported daily increase included over 600 cases that should have been reported earlier in the week but were not...READ MORE

The European Commission said on Friday it had given conditional approval for the use of antiviral remdesivir in severe COVID-19 patients following an accelerated review process, making it the region’s first authorised therapy to treat the virus...The move comes just a week after the European Medicines Agency (EMA) gave its go-ahead for the drug...to be used in adults and adolescents...The EU’s green light broadens the use of remdesivir around the world - the United States has cleared it for emergency use and it is also approved as a COVID-19 therapy in Japan, Taiwan, India, Singapore and the United Arab Emirates...The approval is valid for one year in the bloc and can be extended or converted into an unconditional marketing authorisation if all necessary data are available on its efficacy and side effects...READ MORE

The Federal Communications Commission is adding almost $200 million to a rural healthcare program to help providers buy telecommunications and broadband services...Rural healthcare providers have been hit hard by the COVID-19 pandemic due to the loss in revenue from canceled or deferred elective procedures and the additional expense of personal protective equipment...At the same time, telehealth visits have surged as patients seek virtual care options during the pandemic. The Trump administration lowered regulatory barriers for rural areas. Physicians can care for patients at rural facilities across state lines and via telemedicine...And in many places—particularly rural areas that have the most to gain from telemedicine and connectivity—broadband remains too expensive, unreliable or simply not available at the speeds required to enable innovations in care...READ MORE

The World Health Organization, together with partner organizations, aims to secure 2 billion doses of coronavirus vaccines by the end of 2021, unveiling...a creative plan to ensure high-risk groups around the world have access to any vaccine that's successfully developed... Through the WHO's plan, countries would be able to pool their resources to invest in the development a broad portfolio of experimental vaccines, obtaining in return a guaranteed share of the resulting supplies. The idea is to lessen the risk of betting on any one vaccine, while creating a mechanism by which doses are fairly allocated during the initial stages of a vaccine's availability...READ MORE

The vast majority of drugs that make it to American shelves are produced abroad, sometimes in countries that lawmakers worry don't have the nation's best interests at heart. But where are exactly are those drugs produced and how reliant is the U.S. on foreign imports? A new bipartisan Senate bill aims to find out.,,"The coronavirus pandemic has made it painfully clear that we must take decisive action to rebuild our nation's medical manufacturing sector," Rubio said. "This bipartisan bill would ensure policymakers have the necessary information to address our supply chain vulnerabilities, the consequences of foreign investment in U.S. pharmaceuticals, and reduce our over-reliance on China for pharmaceuticals."...The bill would require the FTC and Treasury to produce its report one year after it passes into law...READ MORE

Coronavirus vaccine developers now have some advice from the FDA: To win approval, any vaccine must be at least 50% effective in preventing the disease...FDA Commissioner Stephen Hahn plans to roll out that guidance...It sets a bar about on par with a flu shot's performance in a good year—but it falls short of some expert recommendations for arresting the virus' spread...The agency also won’t approve a shot based on its ability to create antibodies in patients’ blood...Despite the urgency of this particular vaccine hunt, the FDA “will not reduce its standards or cut corners in its review to approve a vaccine,”...READ MORE

Pfizer’s rare heart disease med Vyndaqel, at $225,000 a year, is too pricey for many patients. To help Medicare participants afford the expensive drug—and maintain its hefty sticker price—the Big Pharma is going as far as to argue the U.S. government’s anti-kickback policy is unconstitutional...Pfizer questions two federal regulations that prohibit drugmakers from offering direct payments to help cover a drug’s cost or working with charity programs to direct their funding—and Medicare patients—to a particular medicine...If Pfizer's argument succeeds, essentially, it would open up federal insurance programs to the sort of copay assistance drugmakers often offer to privately insured patients, particularly for pricey medications and new launches...READ MORE