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The National Institutes of Health on Friday told EcoHealth Alliance, the study’s sponsor for the past five years, that all future funding was cut...The Trump administration abruptly cut off funding for a project studying how coronaviruses spread from bats to people after reports linked the work to a lab in Wuhan, China, at the center of conspiracy theories about the Covid-19 pandemic’s origins...The National Institutes of Health on Friday told EcoHealth Alliance, the study’s sponsor for the past five years, that all future funding was cut. The agency also demanded that the New York-based research nonprofit stop spending the $369,819 remaining from its 2020 grant...“At this time, NIH does not believe that the current project outcomes align with the program goals and agency priorities,” Michael Lauer, the agency’s deputy director for extramural research...READ MORE

The FDA has authorized the first diagnostic test with a home collection option for coronavirus disease 2019...The FDA initially issued an emergency use authorization on March 16 for LabCorp’s RT-PCR Test, which qualitatively detects nucleic acid from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in upper and lower respiratory specimens from individuals with suspected COVID-19...LabCorp has planned to make Pixel by LabCorp COVID-19 Test home self-collection kits available with a physician’s order in most states in the coming weeks. The molecular test allows samples to be collected from a patient’s nose through a designated self-collected kit containing nasal swabs and saline. After self-collection, the sample is mailed in...to be tested...READ MORE

All pharmacy staff—along with everyone entering the pharmacy—should wear face masks, according to new guidance from the CDC...The CDC’s “Guidance for Pharmacists” also says that pharmacies should postpone and reschedule some routine preventive services, such as adult immunizations, since they require face-to-face interaction...This guidance applies to all pharmacy staff to minimize their risk of exposure to the virus and reduce the risk for customers during the COVID-19 pandemic...According to the guidance, pharmacies should:

Implement universal use of face coverings.
Advise staff who are sick to stay home.
Encourage all prescribers to submit prescription orders via telephone or electronically.
Limit direct contact with customers.
Reduce risk during COVID-19 testing.
Maintain social distancing
Ensure that the waiting area is cleaned regularly.
Close self-serve blood pressure units.

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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

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

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

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

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

A panel of experts convened by the US National Institutes of Health has published treatment guidelines for the coronavirus disease 2019, providing clinical recommendations for a number of therapeutic options that are currently under investigation...Importantly, the guidelines emphasize that, even though there are several therapies being tested as potential treatments, no drug has been proven to be safe and effective for treating COVID-19. Investigational antiviral agents and host modifiers and immune-based therapies were included in the guidance...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