Regeneron and Sanofi withdraw FDA application for Libtayo in advanced cervical cancer

Regeneron Pharmaceuticals (NSDQ:REGN) and Sanofi (NSDQ:SNY) have voluntarily withdrawn the supplemental Biologics License Application (sBLA) for Libtayo (cemiplimab-rwlc) as a second-line treatment for advanced cervical cancer.

A press release noted that the agency and the sponsors were unable to “align on certain post-marketing studies” that would have been required to greelight the sBLA.

FDA first approved the drug in 2018 for advanced cutaneous squamous cell carcinoma.

Regeneron/Sanofi

The agency approved indications of Libtayo as a first immunotherapy for patients with advanced basal cell carcinoma in 2021 and as a first-line advanced non-small cell lung cancer with PD-L1 expression of ≥50%.

Regeneron and Sanofi are continuing discussions with regulators outside of the U.S. regarding Libtayo’s potential as a second-line advanced cervical cancer therapy.

REGN shares increased 2…

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Regeneron readies new COVID-19 monoclonal antibodies after the emergence of Omicron

Regeneron Pharmaceuticals (NSDQ REGN) plans to develop antibodies that hold up to the Omicron SARS-CoV-2 variant. Lab results from German researchers indicate that the company’s REGEN-COV/Ronapreve (casirivimab and imdevimab) antibody cocktail lost potency against the variant. 

REGN shares fell almost 4% to $631.74 today. 

“Our antibody cocktail works against Delta. Delta is still surging,” said Dr. Len Schleifer, CEO of Regeneron, in an interview with CNBC. “But if Omicron starts to surge, we need antibodies that work against Omicron.”

The company has a “whole host” of antibodies in its pipeline that could work against Omicron and Delta. 

WHO has reported that Omicron is spreading faster than earlier strains when they first emerged. 

The variant makes up roughly 3% of U.S. cases at present. 

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REGEN-COV cuts viral load within 7 days in COVID-19 patients

Regeneron Pharmaceuticals (NSDQ:REGN) and Roche (OTCQX: RHHBY) are touting positive results from a Phase 2/3 study investigating the potential of REGEN-COV (casirivimab and imdevimab) antibody cocktail in hospitalized COVID-19 patients. The study met its primary endpoint of reducing viral load within one week in seronegative patients needing low-flow or no supplemental oxygen.

REGEN-COV, known as Ronapreve outside of the U.S., led to a 36% reduced risk of death by day 29 in the overall treatment population.

“These new results, combined with the nearly 10,000-patient RECOVERY trial, further validate how REGEN-COV can change the course of illness for patients even after they are hospitalized with COVID-19,” said Dr. George D. Yancopoulos, president and chief scientific officer at Regeneron, in a statement.

Roche has partnered with Regeneron (NSDQ: REGN) to help manufacture and distribute REGN-COV2, which Regeneron first developed.

Roche’s chief medi…

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Regeneron uncovers genetic mutations that guard against obesity

Regeneron Pharmaceuticals (NSDQ:REGN) has announced that its Regeneron Genetics Center (RGC) has discovered rare genetic mutations associated with protection against obesity.

RGC researchers learned that people with at least one inactive copy of the GPR75 gene tend to weigh about 12 pounds less than those without that mutation. In addition, those individuals faced a 54% reduced risk of obesity.

The center made the finding after sequencing 640,00 exomes, which are part of the genome composed of exons.

A study published in Science that summarized the findings concluded that inhibiting “GPR75 may be a therapeutic strategy for obesity.”

Regeneron is working with partners such as Alnylam Pharmaceuticals to develop drug candidates that mimic the genetically afforded protection.

The mutations were only present in roughly one out of every 3,000 people. Some 645,000 volunteers from the U.K., U.S. and Mexico, participated in the study.

Regener…

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50 of 2020’s best-selling pharmaceuticals

Drug sales in 2020 proved more resilient than many experts anticipated in the early days of the pandemic. Still, the impact on many injectable drugs was tangible in the first half of the year as hospitals initially dissuaded patients from seeking in-person treatment. But sales were generally strong for the full year.

AbbVie’s injectable biologic Humira brought in nearly $20 billion in sales in 2020, with $16 billion in the U.S. alone. A year earlier, sales of the drug were $19.17 billion.

Get the full story from our sister site, Drug Discovery & Development. 

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Pharma’s top 20 R&D spenders in 2020

[Lab image by Michal Jarmoluk from Pixabay]The past year has been an unprecedented time for the pharmaceutical industry.

On the one hand, the pandemic resulted in substantial delays to clinical trials while also forcing sponsors to rethink clinical trial design to protect participants. But on the other hand, the pandemic underscored the importance of the pharma industry in society. 

While the pandemic certainly was a driver for substantial R&D spending in the industry in 2020, a significant expense for many companies last year was licensing fees and other acquisition costs. That trend is not just apparent for Incyte, which tops this list, but also for several other companies in this ranking of 20 firms, which are ranked below based on the percent of revenue they invest in R&D. (To find out the top 50 pharma companies, check out our recently published ranking here.)

Get the full picture from our sister site, Drug Discovery & Development. 

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Pharma’s top 20 R&D spenders in 2020

[Lab image by Michal Jarmoluk from Pixabay]

The past year has been an unprecedented time for the pharmaceutical industry.

On the one hand, the pandemic resulted in substantial delays to clinical trials while also forcing sponsors to rethink clinical trial design to protect participants. But on the other hand, the pandemic underscored the importance of the pharma industry in society. 

While the pandemic certainly was a driver for substantial R&D spending in the industry in 2020, a significant expense for many companies last year was licensing fees and other acquisition costs. That trend is not just apparent for Incyte, which tops this list, but also for several other companies in this ranking of 20 firms, which are ranked below based on the percent of revenue they invest in R&D. (To find out the top 50 pharma companies, check out our recently published ranking here.)

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