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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

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

With a major Indian production hub now locked down in a COVID-19 containment zone, the spotlight on pharma's emerging markets suppliers will likely shine even hotter...Drug manufacturing facilities in Baddi, Himachal Pradesh, India—a key source of drug supplies—have shut down or reduced capacity since the region locked down in mid-April...Fifty facilities reportedly have shuttered, including at least one operated by top generics player Sun Pharmaceuticals...A slew of others are hobbled by the lockdown...The U.S. supply of generic and branded medicines, heavily reliant on emerging markets in India and China, has come under close scrutiny as COVID-19 sends shockwaves through the industry...the FDA said it would temporarily allow hospitals to source hard-to-find drugs from compounding pharmacies to treat certain patients hospitalized with severe COVID-19...READ MORE

Dogged by whistleblower kickback claims over its multiple sclerosis med Gilenya for years, Novartis has run off a recent string of court wins to escape the allegations...But in one New Jersey suit, Novartis will now be forced to confront a former employee's claims that he was fired without cause for bringing a kickback scheme to light...Novartis must face claims it retaliated against one of its employees for raising concerns the drugmaker engaged in a pharmacy benefit manager kickback scheme...former Novartis employee Joseph Perri alleged he was terminated after notifying management about "disparities" between the drugmaker's commercial and Medicare Part D rebates paid to a PBM for Gilenya...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

A bipartisan letter has urged Congress to consider including provisions permanently prohibiting pharmacy direct and indirect remuneration (DIR) clawbacks by pharmacy benefits managers (PBMs) in future coronavirus relief packages...The published letter cited increased demand and existing financial strain being amplified during the current pandemic as reasons for the bipartisan push for pharmacy DIR reform...The majority of neighborhood pharmacies are already experiencing negative cash flow issues and, for their efforts to help through this pandemic, will get a big bill months from now as PBMs come calling for DIR fees. Eliminating these fees and reining in PBMs has never been more vital if pharmacies are to continue operating now and when this emergency passes...READ MORE

Antimalarial hydroxychloroquine has raked in support as a potential wonder drug to treat COVID-19...But small-scale studies have been less than definitive on the drug's chances—and new data haven't cleared matters up much...Department of Veterans Affairs study found that severe COVID-19 patients treated with antimalarial hydroxychloroquine alone or in combination with antibiotic azithromycin showed "no evidence" of reduced risk of death or mechanical ventilation over supportive care, according to data...The researchers noted their analysis was not randomized nor controlled and cautioned patience for several ongoing clinical studies to read out before drawing conclusions on hydroxychloroquine's use for COVID-19...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

The Alliance for Pharmacy Compounding announced the launch of its free resource, which serves as a liaison between hospitals with 503B outsourcing facilities, or 503A sterile compounding pharmacies, that can supply treatments currently in shortage due to the COVID-19 pandemic...APC’s Compounders’ Shortage Drug Source for Hospitals mimics its earlier online bulletin board...The news release provided information to hospitals interested in utilizing the resource:

• FDA-registered 503B outsourcing facilities and qualified, board of pharmacy-approved 503A sterile compounders may provide the resource with information about their available supplies. Only those shortage drugs listed by FDA in appendices to its recent temporary guidance document for 503Bs and 503As may be listed.

• Data submitted by outsourcing facilities and 503A pharmacies will post this information for hospitals to access.

• If hospitals are unable to source the needed drug(s) from a 503B, they may access a secondary page listing information submitted by 503A pharmacies about shortage drugs they can prepare...

• APC has asked the American Hospital Association and the American Society of Health System Pharmacists to make its hospital members aware of the resource...READ MORE

The FDA is easing its lockdown on compounded drugs to help ease COVID-19 drug shortages...After a series of high-profile failures in the early 2010s, the compounding pharmacy industry took its share of body blows from an FDA looking to impose its will...The FDA will temporarily allow hospitals to source hard-to-find drugs from compounding pharmacies to treat certain patients hospitalized with severe COVID-19...The regulation, meant to last as long as hospitals continue to encounter shortages of key drugs, applies to compounding pharmacies that aren't already sanctioned by the FDA as "outsourcing facilities." To qualify, the copycat drugs must be listed on the FDA's shortages list, and hospitals must have exhausted all other options to access a commercial version of the drug...READ MORE