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India, one of the largest drug exporters in the world, has been hit hard by the novel coronavirus pandemic as global lockdowns have complicated daily operations. On one measure—the FDA's nearly two-month ban on foreign inspections—Indian drugmakers are pushing back. And they may have come up with a novel solution...Major Indian pharmaceutical companies are asking the FDA to conduct "desk reviews" or virtual facility inspections during the pandemic in order to "ensure the continuous supply of much-needed drugs in the United States," according to a letter from the Indian Pharmaceutical Alliance...The group also requested the FDA consider recognizing inspections by foreign regulators and temporarily waiving on-site inspections "based on past inspection history and the critical nature of products, such as drug shortages or products that do not currently have generic alternatives."...READ MORE

The United States on Monday began requiring antibody tests for the new coronavirus to undergo a regulatory agency review, acknowledging that its earlier policy had opened the door to fraud...The U.S. Food and Drug Administration had previously required only that companies attest their product was valid and labeled as unapproved, attracting 170 companies to the antibody test market including unscrupulous vendors making false claims...When the FDA put the policy in place on March 16th, it had been under pressure to move fast following a slow ramp up of COVID-19 diagnostic tests that hindered public health efforts...“Flexibility never meant we would allow fraud. We unfortunately see unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans’ anxiety,” the FDA said in a statement...READ MORE

Global restrictions spawned by the coronavirus pandemic have sent transport costs skyrocketing for generics and biosimilar makers, a trade association finds. But despite the dire report, COVID-19 might not be all bad news for the industry...Average shipping costs have jumped by 224% as the pandemic added new kinks to the global drug supply chain, a survey from the Association for Accessible Medicines found..."The global pharmaceutical ecosystem is built on a highly complex supply chain,” AAM interim CEO Jeff Francer said in a release. “This ongoing crisis illustrates the importance of developing new strategies and policies that enhance the pharmaceutical supply chain in the U.S. and increase our nation’s self-sufficiency.”...READ MORE

For the first time, a major study suggests that an experimental drug works against the new coronavirus, and U.S. government officials said Wednesday that they would work to make it available to appropriate patients as quickly as possible...In a study of 1,063 patients sick enough to be hospitalized, Gilead Sciences’s remdesivir shortened the time to recovery by 31% — 11 days on average versus 15 days for those just given usual care, officials said. The drug also might be reducing deaths, although that’s not certain from the partial results revealed so far...Remdesivir was being evaluated in at least seven major studies, but this one, led by the NIH, was the strictest test. Independent monitors notified study leaders just days ago that the drug was working, so it was no longer ethical to continue with a placebo group...READ MORE

Doctors on the front lines of the COVID-19 fight really are heroes, but don’t forget about the tens of thousands of 'backline doctors' who are equally at risk, physically and financially...President Trump has compared the fight against COVID-19 to a war against a silent enemy. The soldiers on the front lines are the doctors, nurses, technicians, and others who are fighting it in hospitals across the United States...The untold story, however, is of the hundreds of thousands of doctors facing not only the health risks of caring for patients with undiagnosed COVID-19, but also ruinous financial calamity and professional catastrophe, self-inflicted by government...Now our health-care system is poised to implode...Many patients need care, and not just those with COVID-19. To ensure our system can recover, federal and state governments should implement a few basic provisions.

1. ...the federal government should indemnify doctors against frivolous lawsuits that result from this pandemic.
2. ...the federal government should make available interest-free loans to doctors who feel they cannot reopen offices because of financial hardship inflicted by COVID-19-related mandates. This is important to prevent wholesale migration of small practices to hospitals.
3. ...the federal government should seize this once-in-a-century opportunity to decimate the bureaucracy impeding innovation in medicine. Cutting red tape will stimulate a wave of doctor-led creativity, which is now constrained by onerous laws, such as Stark laws, which restrict collaboration.
4. ...the reprieves that have allowed telemedicine to expand during this pandemic should be made permanent. Doctors need to continue to be paid for these services just as they would for office visits, and be allowed to deliver these services across state lines.
5. ...the playing field in health care needs to be leveled, giving more control to doctors and less to hospitals. State lawmakers should repeal certificate-of-need laws, which prevent competition and the opening of new facilities in certain areas. We were underprepared for this pandemic in part because of hospital consolidation. More resources, not fewer, would provide helpful redundancy and protection against the next pandemic...READ MORE

The Nevada Hospital Association has reportedly threatened to stop providing state health officials with daily reports detailing acute-care hospitals’ coronavirus activity, if those officials share the information with the public...For almost four weeks, the Review-Journal has sought copies of the documents from state and local governments under Nevada’s Public Records Act in order to provide the information to the public. The NHA has refused to provide the reports, which are provided to Gov. Steve Sisolak and other top state officials as they make critical decisions during the COVID-19 outbreak...While the hospital association is a private nonprofit that is not bound to respond to record requests, (Patrick) File (Nevada Open Government Coalition president) said the daily reports became subject to the state’s public records act as soon as the government received copies...READ MORE

At least 10 different drug compounds ranging from cancer therapies to antipsychotics and antihistamines may be effective at preventing the new coronavirus from multiplying in the body, according to a multidisciplinary study conducted by a team of scientists in the United States and France...The researchers mapped the human proteins the virus interacts with inside the body when it infects cells and makes copies of itself, then looked for compounds that could block the virus from using those proteins...The result showed that 47 compounds in cell cultures had the desired effect, at least 10 of which are already in approved drugs or being studied for diverse conditions, but could be repurposed against COVID-19, the illness caused by the new coronavirus...READ MORE

Roche scored a major win with the FDA's backing for its COVID-19 antibody tests last week in a field marked by products of questionable quality...Roche will plow $459 million into its manufacturing facility in Penzberg, Germany, to boost production of the antibody test that won an emergency use authorization from the FDA last week...Roche CEO Severin Schwan blasted the current state of COVID-19 serology tests, calling many of the diagnostics "amateur."...“These tests are not worth anything, or have very little use,”...READ MORE

Officials with the FDA have issued an emergency use authorization for remdesivir for the treatment of suspected or laboratory-confirmed coronavirus disease 2019 in hospitalized adults and children, according to a press release...The EUA allows for remdesivir to be distributed in the United States and administered intravenously by health care providers, as appropriate, to treat suspected or laboratory-confirmed COVID-19...Evaluation of EUA criteria and scientific evidence indicate that remdesivir may be effective in treating the virus, for which there are currently no FDA-approved therapies. According to the FDA, “given there are no adequate, approved, or available alternative treatments, the known and potential benefits to treat this serious or life-threatening virus currently outweigh the known and potential risks of the drug’s use.”...READ MORE

Southern Nevada’s major hospitals plan to resume “medically necessary” elective surgeries and procedures Monday, according to a Nevada Hospital Association letter...The letter, dated Tuesday, was sent this week to medical staff at University Medical Center, North Vista Hospital and The Valley Health System, Dignity Health and HCA Healthcare hospital systems. The companies own and operate more than a dozen local hospitals that have more than 4,000 staffed acute-care beds...Scheduling elective surgeries and procedures can begin immediately...READ MORE