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May 01, 2020___

Today's Rundown

Featured Story

Gilead's remdesivir scores emergency FDA nod in COVID-19 days after big data reveal

Days after U.S. officials reported the first positive controlled data for Gilead's remdesivir in COVID-19, the FDA has given the drug an emergency use authorization.

Top Stories

Primary care practices struggle with inconsistent payment for telehealth, still lack testing, PPE

Changes in telehealth reimbursement and federal relief funding might not be enough to bolster many primary care practices during the COVID pandemic. Low patient volume and inconsistent reimbursement are hampering cash flow, resulting in furloughs and layoffs, according to a survey of 1,000 primary care clinicians in 48 states and Washington D.C.

Moderna aims for a billion COVID-19 shots a year with Lonza manufacturing tie-up

Moderna Therapeutics has partnered with the federal government to create an mRNA-based COVID-19 vaccine it hopes to speed through clinical trials and right into production. One problem with that plan? The partners couldn't find a manufacturer willing to take on the risks for little financial reward—until now. 

Amgen's anti-inflammatory Otezla makes its foray into COVID-19

At the J.P. Morgan Healthcare Conference in January—back when few could predict the looming destruction of COVID-19—Amgen CEO Bob Bradway vowed the company would find new ways to make its $13.4 billion acquisition of Celgene’s psoriasis drug Otezla worth the investment. Now, COVID-19 is presenting one such opportunity.

Blue Cross MN CEO: Why COVID-19 may be making the case for value-based care 

COVID-19 may be making the case for accelerating the move to more value-based models of care. 

Gilead in talks to expand COVID-19 hopeful remdesivir supply chains with outside partner

Gilead Sciences scored a massive win earlier this week with its first positive data readout for investigational candidate remdesivir in treating patients with severe COVID-19. Gilead already has its own supply of the drug humming in anticipation of high demand, but opportunities are out there for a partner to join in. 

COVID-19: T cells offer clues to the potential power of Roche's Actemra

The successful activation of T cells is critical to the immune system's ability to clear infections. A retrospective study in China found that COVID-19 patients had remarkably low T-cell counts in their blood, while some pro-inflammatory cytokines such as IL-6—which Roche’s Actemra targets—were elevated.

Hospital and provider groups cheer new CMS flexibility on telehealth, capacity and ACO losses

Hospital and provider groups applauded a series of changes from CMS aimed at increasing regulatory flexibility for providers fighting the COVID-19 pandemic.

NIH begins taking pitches for its $1.5B COVID-19 diagnostics competition

The National Institutes of Health kicked off what it describes as a “Shark Tank”-like effort to select and fund new diagnostic tests for the novel coronavirus, and its offering a total of $1.5 billion to be divvied up among the winners.

Biopharma roundup: T cells could provide hint to how Roche's Actemra treats COVID-19 patients

A new study out of China has tied T cell activation to Roche's IL-6 inhibitor Actemra, which has shown some early effect in treating cytokine storm in severe COVID-19 patients.

Federal charges filed for theft of PPE, sanitizer and drugs from Indiana hospital

Two women were charged with thefts from Central Indiana Cancer Center that included stolen morphine.

EMA starts reviewing Gilead's remdesivir data to accelerate approval of COVID-19 antiviral

The European Medicines Agency has begun a rolling review of data on Gilead’s remdesivir, positioning it to cut the time it takes to decide whether to approve the drug in COVID-19 patients.

AbbVie CEO: Don't worry, Allergan's aesthetics clients still have money—and 'strong desire' for treatment

AbbVie may be working through COVID-19, but it's pressing ahead with its Allergan merger, too—and taking stock of products hit by pandemic lockdowns. That puts Allergan’s aesthetics business top of mind, but AbbVie CEO Rick Gonzalez figures customers are ready and able to return quickly for treatment.

Inovio's COVID-19 vaccine claims echo Theranos, says short attack

Inovio Pharmaceuticals’ stock has climbed higher and higher over the past month since it said it was working on a speedy COVID-19 vaccine.

COVID-19 the focus, but Pfizer isn't ignoring other vaccine R&D as its pens new deal

Pfizer and partner BioNTech are right in the middle of one of the most important vaccine trials in the world right now, but that doesn’t mean the Big Pharma is taking its eyes off the inoculation ball elsewhere.