Laboratories, Licensing, Pharmacy and Virus

Regeneron’s COVID-19 Outpatient Trial Prospectively Demonstrates that REGN-COV2 Antibody Cocktail Significantly Reduced Virus Levels and Need for Further Medical Attention

The Pharma Data

OCTOBER 28, 2020

In the overall patient group with detectable virus at baseline, the average daily reduction in viral load through day 7 was a 0.36 About REGN-COV2 REGN-COV2 is a combination of two monoclonal antibodies (REGN10933 and REGN10987) and was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19.

Virus

Virus Trials Clinical Trials Production

REGN-COV2 Independent Data Monitoring Committee Recommends Holding Enrollment in Hospitalized Patients with High Oxygen Requirements and Continuing Enrollment in Patients with Low or No Oxygen Requirements

The Pharma Data

OCTOBER 30, 2020

About REGN-COV2 REGN-COV2 is a combination of two monoclonal antibodies (REGN10933 and REGN10987) and was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19.

Hospitals

Hospitals Virus Production Clinical Trials

Regeneron Announces U.S. Government Agreement to Purchase Additional COVID-19 Antibody Cocktail Doses

The Pharma Data

JANUARY 12, 2021

. “Patients in our antibody cocktail outpatient clinical trial experienced significant reductions in virus levels and required fewer medical visits for COVID-19, suggesting the therapy can help reduce the current burden on hospitals and healthcare systems,” said George D. Yancopoulos , M.D.,

Government

Government Hospitals Virus Production

Regeneron Announces Encouraging Initial Data from COVID-19 Antibody Cocktail Trial in Hospitalized Patients on Low-flow Oxygen

The Pharma Data

DECEMBER 29, 2020

The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process and the use of the antibody cocktail remains investigational. Food and Drug Administration (FDA) in high-risk patients who have confirmed COVID-19 but are not currently hospitalized.

Hospitals

Hospitals Trials Clinical Trials Production

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies

The Pharma Data

NOVEMBER 20, 2020

Eiger licensed exclusive worldwide rights to lonafarnib from Merck, known as MSD outside of the United States and Canada. LABORATORY ABNORMALITIES. Some patients treated with ZOKINVY developed laboratory abnormalities. Lonafarnib caused retinal toxicity in monkeys at 3.7 times the human dose. Outside the U.S.,

FDA Approval

FDA Approval FDA Clinical Trials Disease

New England Journal of Medicine Publishes Positive Initial Regeneron Antibody Cocktail Results in Non-hospitalized Patients with COVID-19

The Pharma Data

DECEMBER 17, 2020

About casirivimab and imdevimab Casirivimab and imdevimab (formerly known as REGN-COV2 or REGEN-COV2) is a cocktail of two monoclonal antibodies (also known as REGN10933 and REGN10987, respectively) and was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19.

Hospitals

Hospitals Production Clinical Trials Virus

Regeneron’s BCMAxCD3 Bispecific Antibody (REGN5458) Shows Deep and Durable Responses in Patients with Heavily-pretreated Multiple Myeloma in Phase 1

The Pharma Data

DECEMBER 5, 2020

Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

Production

Production Trials Treatment Pharmaceuticals

Regeneron Reports Third Quarter 2020 Financial and Operating Results

The Pharma Data

NOVEMBER 5, 2020

“Last week, Regeneron achieved an important milestone in the fight against COVID-19 with prospective Phase 2/3 results showing REGN-COV2 significantly reduced virus levels and the need for further medical attention in non-hospitalized patients; we have shared these important data with regulatory authorities,” said Leonard S.

Production

Production FDA FDA Approval Trials

Regeneron’s Casirivimab and Imdevimab Antibody Cocktail for COVID-19 is First Combination Therapy to Receive FDA Emergency Use Authorization

The Pharma Data

NOVEMBER 20, 2020

“The casirivimab and imdevimab antibody cocktail is designed to mimic what a well-functioning immune system does by using very potent antibodies to neutralize the virus,” said George D. The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process.

Therapies

Therapies FDA Clinical Trials Hospitals

Regeneron’s REGEN-COV2 is First Antibody Cocktail for COVID-19 to Receive FDA Emergency Use Authorization

The Pharma Data

NOVEMBER 21, 2020

.” “REGEN-COV2 is designed to mimic what a well-functioning immune system does by using very potent antibodies to neutralize the virus,” said George D. The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process. Yancopoulos , M.D.,

FDA

FDA Clinical Trials Hospitals Government

Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

Agency IQ

SEPTEMBER 29, 2023

July 2023 (Under OIRA Review) Medical Devices; Laboratory Developed Tests (Proposed Rule) This proposed rule would propose to amend the Food and Drug Administration’s regulations to make explicit that laboratory developed tests (LDTs) are devices under the Federal Food, Drug, and Cosmetic Act.

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Agency IQ

OCTOBER 27, 2023

and Annex 1 Conference Joel Welch December 18 RAPS RAPS Webcast: FDA Forecast: What’s Next for the FDA in 2024 AgencyIQ Speakers December 21 HL7 REMS Public Call PDUFA Dates expected in November and December PDUFA dates represent the expected date of a regulatory decision by the FDA on a New Drug Application or Biologics License Application.

FDA

FDA Science Regulations Production

FDA Approves Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) Antibody Cocktail for Ebola (Zaire Ebolavirus)

The Pharma Data

OCTOBER 14, 2020

The three antibodies help neutralize the Ebola virus by blocking its ability to invade patients’ and/or enlisting other immune cells to target infected cells and remove them from the body. Selected grade 3 and 4 laboratory abnormalities for Inmazeb included high sodium (? mmol/L), low potassium (< 2.5

FDA Approval

FDA Approval FDA Production Vaccine

Drug Discovery Digest

Regeneron’s COVID-19 Outpatient Trial Prospectively Demonstrates that REGN-COV2 Antibody Cocktail Significantly Reduced Virus Levels and Need for Further Medical Attention

REGN-COV2 Independent Data Monitoring Committee Recommends Holding Enrollment in Hospitalized Patients with High Oxygen Requirements and Continuing Enrollment in Patients with Low or No Oxygen Requirements

Trending Sources

Regeneron Announces U.S. Government Agreement to Purchase Additional COVID-19 Antibody Cocktail Doses

Regeneron Announces Encouraging Initial Data from COVID-19 Antibody Cocktail Trial in Hospitalized Patients on Low-flow Oxygen

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies

New England Journal of Medicine Publishes Positive Initial Regeneron Antibody Cocktail Results in Non-hospitalized Patients with COVID-19

Regeneron’s BCMAxCD3 Bispecific Antibody (REGN5458) Shows Deep and Durable Responses in Patients with Heavily-pretreated Multiple Myeloma in Phase 1

Regeneron Reports Third Quarter 2020 Financial and Operating Results

Regeneron’s Casirivimab and Imdevimab Antibody Cocktail for COVID-19 is First Combination Therapy to Receive FDA Emergency Use Authorization

Regeneron’s REGEN-COV2 is First Antibody Cocktail for COVID-19 to Receive FDA Emergency Use Authorization

Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

FDA Approves Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) Antibody Cocktail for Ebola (Zaire Ebolavirus)

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