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Today's Rundown

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Gilead gets WHO cold shoulder for remdesivir in COVID-19, launches speedy defense

Gilead Sciences’ Veklury, better known as remdesivir, is so far the only COVID-19 therapy officially approved by the FDA, but the World Health Organization has some other ideas about the drug’s worth. Guideline development experts at the international body have recommended against the drug's use in any hospitalized patients.

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White House promises bolstered strategic stockpile as COVID-19 cases soar across country

The White House Coronavirus Task Force said that it has increased surge capacity for critical medical supplies as hospitals face mounting virus cases.

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Lilly scores FDA emergency authorization for Olumiant in COVID-19, its 2nd therapeutic option

While the list of authorized medicines to treat COVID-19 remains quite short, with a new nod this week, Eli Lilly stands alone in having two therapeutic options. Lilly’s Olumiant, already approved as a rheumatoid arthritis treatment, scored an FDA emergency use authorization in combination with Gilead’s Veklury in COVID-19 patients who are hospitalized and needing oxygen.

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The case for value-based pricing for COVID-19 vaccines, therapies

As planning for the distribution of a COVID-19 vaccine begins in earnest, experts say policymakers should include value-based pricing in those considerations.

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Novartis licenses phase 3 COVID-19 cell therapy from Mesoblast

Novartis has secured a global license to Mesoblast’s cell therapy remestemcel-L in the treatment of COVID-19. The deal lands Mesoblast $50 million upfront and the support of a partner that could help address critical quality attribute concerns raised by the FDA.

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Cue Health's 'NBA Bubble' rapid COVID-19 test deployed to 5 states in HHS pilot program

HHS will work with the governors and state health departments of Alaska, Florida, Louisiana, New Jersey and Texas to allocate tests to local and regional facilities, while Cue will provide onboarding and training support for healthcare workers.

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Biopharma roundup: Novartis bags license for Mesoblast's cell therapy; Cue Health test pegged for HHS pilot program

Novartis paid $50 million upfront to develop and market Mesoblast's phase 3 COVID-19 cell therapy. Cue Health's rapid molecular test is going out to five states in an HHS pilot program. Adagio's experimental antibody charted positive animal results against SARS-CoV-2 and other coronaviruses. And SII is eyeing Indian authorization plans for AstraZeneca's shot.

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Mayo Clinic generates $288M in profits for Q3 as volumes remain below pre-COVID-19 levels

Mayo Clinic generated $288 million in profits for the third quarter after the system quickly took action to plug massive financial holes caused by COVID-19.

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ApiJect snares $590M government loan for 'Gigafactory' to produce billions of pre-filled vaccine injectors per year

ApiJect Systems was approved for a $590 million loan from the U.S. government to build a so-called 'gigafactory' designed to crank out upward of 3 billion pre-filled injectors per year. The single-use devices, meant to offer an alternative to glass vials and syringes, are expected to be used to package and deliver COVID-19 vaccines.

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Adagio's COVID-19 antibody protects mice and zaps related viruses in lab tests

A precursor of Adagio Therapeutics' lead drug candidate protected mice from COVID-19, and in lab tests, it neutralized two related coronaviruses known to be circulating in bats. The company aims to show that the antibody could be used to combat future viruses that cross over from animals to people.

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CommonSpirit 'not anticipating' canceling or postponing all surgeries due to COVID-19 surges

CommonSpirit Health is trying to avoid another wholesale shutdown of elective procedures as COVID-19 surges across the country but has already curtailed surgeries in some hot spots.

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