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South Korea has asked Gilead Sciences Inc’s to supply enough of its anti-viral drug remdesivir to treat more than 5,000 COVID-19 patients in preparation for a potential second wave of infections...remdesivir is in high demand, but there are concerns about its availability after Gilead allocated nearly all of its supply to the United States over the next three months..In a letter sent to Gilead on June 3, South Korea had requested doses for 360 patients who are in urgent need of the drug, and for enough to have ready for an additional 5,000 patients in the event of a second wave of infections...READ MORE

Doctors at Henry Ford Health System in southeast Michigan said that 26% of patients who did not receive the antimalarial drug died, compared to 13% of patients who received hydroxychloroquine during their stay in the hospital...The team published their findings in the International Journal of Infectious Diseases, adding that patients who were given hydroxychloroquine alone did even better than the ones who received this drug along with azithromycin...Other studies have shown no benefits of taking hydroxychloroquine for COVID-19, and some said that it may increase the risk for cardiovascular complications...“Our results do differ from some other studies,” Dr. Marcus Zervos, division head of infectious diseases at Henry Ford, said. “What we think was important in ours is that patients were treated early. For hydroxychloroquine to have a benefit, it needs to begin before the patients begin to suffer some of the severe immune reactions that we have with COVID-19,”...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

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

The Trump administration has formally notified the United Nations of its withdrawal from the World Health Organization, although the pullout won’t take effect until next year, meaning it could be rescinded under a new administration or if circumstances change...The withdrawal notification makes good on President Donald Trump’s vow in late May to terminate U.S. participation in the WHO, which he has harshly criticized for its response to the coronavirus pandemic and accused of bowing to Chinese influence...The move was immediately assailed by health officials and critics of the administration, including numerous Democrats who said it would cost the U.S. influence in the global arena...READ MORE

...CureVac has reportedly snared a big partner to help build its game-changing RNA "printers" that could turn global interest back in its favor...Tesla CEO Elon Musk tweeted Thursday that the electric carmaker had signed on with CureVac to make portable molecular RNA printers—what Musk called "RNA microfactories"—to help produce doses of the German vaccine maker's COVID-19 shot candidate...CureVac has previously touted its work on portable "printers" for its mRNA-based vaccines, which would allow the company to produce shots at scale in farflung locations without the standard logistical concerns...CureVac says its mRNA vaccine candidates direct cells to make proteins or antigens against various diseases. The platform encapsulates mRNA in a shell of lipid nanoparticles to protect it for delivery. The RNA printer itself—essentially a vaccine production device—can make “more than a hundred thousand doses” in a couple of weeks, the biotech says. It could work in a hospital pharmacy to help produce personalized medicines, for instance, as well as in outbreak regions...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

Mylan NV said...it would launch a generic version of Gilead Sciences Inc’s COVID-19 antiviral remdesivir in India at 4,800 rupees ($64.31), about 80% below the price tag on the drug for wealthy nations...California-based Gilead has signed licensing deals with several generic drugmakers in an effort to make remdesivir available in 127 developing countries...two Indian drugmakers, Cipla Ltd and privately-held Hetero Labs Ltd, also launched generic versions of the treatment. Cipla will price its version, Cipremi, at less than 5,000 rupees, while Hetero has priced Covifor at 5,400 rupees...Gilead...priced remdesivir at $2,340 per patient for rich nations and agreed to send nearly all of its supply of the drug to the United States over the next three months...READ MORE

Public health experts...criticized the U.S. for securing a large supply of the only drug licensed so far to treat COVID-19...The U.S. government announced this week that it had an agreement with Gilead Sciences to make the bulk of their production of remdesivir for the next three months available to Americans. The Department of Health and Human Services said it had secured 500,000 treatments through September...Ohid Yaqub, a senior lecturer at the University of Sussex, called the U.S. agreement “disappointing news.”...“It so clearly signals an unwillingness to cooperate with other countries and the chilling effect this has on international agreements about intellectual property rights,” Yaqub said...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