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Eli Lilly’s COVID antibody drug combination gets US nod | Coronavirus pandemic News

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Eli Lilly & Co.’s combination antibody drug for Covid-19 was cleared for emergency use by U.S. regulators, providing doctors with a treatment option that is expected to be better able to combat new coronavirus mutations.

The Food and Drug Administration authorized the treatment for use in Covid-positive adults and children 12 and older who are at high risk of developing severe forms of the disease or progressing to the hospital, according to a fact sheet posted Tuesday by the agency.

The combo treatment is the second antibody therapy from the Indianapolis-based drugmaker to gain an emergency authorization from the FDA. In November, the agency cleared bamlanivimab, one of the two antibodies used in the cocktail, for use in non-hospitalized, high-risk patients with mild-to-moderate symptoms of Covid-19.

Bamlanivimab, developed with AbCellera Biologics Inc., mimics the immune system’s virus-fighting powers. Regeneron Pharmaceuticals Inc. also gained FDA authorization for a product combining two antibodies last year. Former President Donald Trump received Regeneron’s drug after contracting Covid-19.

Many drugmakers, from AstraZeneca Plc to Bristol Myers Squibb Co., are developing products to compete in the increasingly crowded field.

Lilly’s newly authorized combination includes a 700 milligram dose of bamlanivimab, and a 1,400 milligram dose of another antibody called etesevimab. The tandem will be supplied in separate single-dose vials, but administered together using a single infusion bag, according to the FDA. Patients must get the infusion as soon as possible after a positive Covid-19 test or within 10 days of symptom onset.

With additional manufacturing help from Amgen Inc., Lilly said it will produce up to 1 million doses of etesevimab for administration with bamlanivimab by mid-2021. The companies have already made 100,000 doses of etesevimab, and another 150,000 doses will be made available throughout the first quarter.

Underlying Data

In late January, Lilly reported results from a late-stage trial showing that a combination of bamlanivimab and etesevimab cut the chances of hospitalizations and deaths by 70% in high-risk patients.

Lilly’s study of the cocktail found no difference between the monotherapy and combination in such outcomes.

Despite being touted as potential bridges to a vaccine, uptake of the complicated antibody medicines has been slow. Health-care providers have struggled to put in place the proper infusion clinics necessary to administer them, doctors have been reluctant to prescribe them based on limited late-stage efficacy data, and patients have had difficulties figuring out where to get them.

On Tuesday, the FDA authorized Lilly’s monotherapy to be given in 16 minutes, a reduction from the previous requirement of an hour-long infusion. The new combination therapy can be given in 21 minutes.

The shift in regulatory guidance was made in response to feedback from nurses and doctors, and is “aimed at reducing the burden on the healthcare system,” according to Lilly.

U.S. health officials, including the top infectious disease expert, Anthony Fauci, have also said that the treatments could be less effective against new fast-spreading virus variants that first surfaced in South Africa and Brazil.

Etesevimab was licensed by Lilly from Junshi Biosciences, which developed it with Institute of Microbiology, Chinese Academy of Science. The U.S. drugmaker decided to pursue a combination of bamlanivimab and etesevimab in hopes it would prove more robust against variants.

“With the risk of resistance emerging as various strains of the virus arise, bamlanivimab and etesevimab together could potentially allow efficacy against a broader range of naturally occurring SARS-CoV-2 variants as these new strains spread around the world,” Lilly Chief Scientific Officer Dan Skovronsky said in a statement.

Skovronsky previously said he expects use of bamlanivimab to shift toward the combination around the middle of this year.



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Zooming ahead: Videoconferencing firm tops analysts’ expectations | Coronavirus pandemic News

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Revenue more than tripled to $882.5m in the fiscal fourth quarter, the company said, surpassing analysts’ estimates.

Zoom Video Communications Inc. projected annual revenue that would top analysts’ estimates, signaling the video meeting service expects to remain a ubiquitous presence in daily life even as the pandemic recedes. Shares jumped about 10% extended trading.

Sales will be as much as $3.78 billion in fiscal year 2022, the San Jose, California-based company said Monday in a statement. While the projected annual revenue growth of 43% is far short of Zoom’s 326% increase in the fiscal year ended Jan. 31, it topped the 37% average estimate of analysts, according to data compiled by Bloomberg. Profit, excluding some items, will be as much as $3.65 a share. Analysts projected $2.97.

Investors have feared the software maker couldn’t continue the dramatic growth in 2020 that came as people forced home in coronavirus lockdowns connected remotely on the service to work, school, friends and family.

While Zoom’s stock jumped almost fivefold last year as it became one of the biggest beneficiaries of the pandemic, it had gained just 11% during the first two months of 2021 before surging almost 10% Monday to close at $409.66 in New York.

Chief Executive Officer Eric Yuan has tried to diversify Zoom’s capabilities and add products such as a cloud phone system to appeal to more large enterprises and small- and mid-sized businesses.

“We believe we are well positioned for strong growth with our innovative video communications platform, on which our customers can build, run, and grow their businesses; our globally recognized brand; and a team ever focused on delivering happiness to our customers,” Yuan said in the statement.

Revenue more than tripled to $882.5 million in the fiscal fourth quarter, the company said. Analysts, on average, estimated $811 million. Profit, excluding some items, was $1.22 cents a share, compared with an average estimate of 79 cents.

“In our view, and whether you like it or not, video will continue to remain a core element of our daily lives and further be embedded in work, school, etc. Zoom will clearly benefit and report sustained levels of growth, in our view, and increasingly in the enterprise segment,” wrote Matt VanVliet, an analyst at BTIG, in a note before the results.

Zoom offers video gatherings free for 40 minutes and as many as 100 participants before users are charged for the service. Analysts have focused on the churn, the number of customers who drop monthly or annual subscriptions, particularly among corporate users.

The company said it had 467,100 customers with more than 10 employees, a jump of about 8% from the previous period and topping analysts’ average estimate of 442,570. The company also said 1,644 clients contributed $100,000 in trailing 12-month revenue. Analysts projected 1,474 such large customers.



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