Drug Discovery World

MAY 24, 2024

Atara Biotherapeutics has submitted a Biologics License Application (BLA) for Tabelecleucel (Tab-cel), a for treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) with the US Food and Drug Administration (FDA). There are currently no FDA approved therapies in this treatment setting.

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The Pharma Data

DECEMBER 29, 2020

Food and Drug Administration (FDA) in high-risk patients who have confirmed COVID-19 but are not currently hospitalized. 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.

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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.

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The Pharma Data

OCTOBER 29, 2020

“Alopecia areata is a challenging disease that currently has no FDA-approved treatment options, making it difficult for healthcare providers to best serve the needs of these patients,” said Brett King , MD, PhD associate professor of Dermatology at Yale School of Medicine. Monitor patients for TB during Olumiant treatment.

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Agency IQ

NOVEMBER 3, 2023

Although this guidance document is mostly focused on chemistry, manufacturing and control (CMC) information, it clarifies that LBPs are considered biologics, and will thus need to utilize the Biologics License Application (BLA) pathway. These reasons tend to become self-evident when the other regulatory classifications are understood.

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The Pharma Data

JANUARY 13, 2021

Germany-based Cevec Pharmaceuticals GmbH signed a licensing agreement with Biogen for the use of its proprietary ELEVECTA Technology for the manufacturing of adeno-associated virus (AAV) vectors for gene therapy applications. Vivity received FDA approval in February 2020. Mogrify – U.K.-based

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The Pharma Data

NOVEMBER 5, 2020

FDA accepted for priority review Libtayo ® (cemiplimab-rwlc) for both advanced non-small cell lung cancer and basal cell carcinoma. FDA approved Inmazeb for Ebola ( Zaire ebolavirus). REGN-COV2 , a dual antibody therapy to SARS-CoV-2 virus. Regeneron Pharmaceuticals, Inc. Schleifer , M.D., Oncology Program.

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The Pharma Data

JANUARY 21, 2021

Food and Drug Administration (FDA) has approved CABENUVA (consisting of Janssen’s rilpivirine and ViiV Healthcare’s cabotegravir), the first and only once-monthly, long-acting regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults.

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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.

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Drug Discovery World

SEPTEMBER 16, 2022

In particular these SMEs wanted affordable workspace; better provision of wet laboratory and clean room space in London, available at higher specification but not necessarily at great scale; universities and hospitals to make their equipment and facilities more usefully available; and more endeavour to grow skills and talent,” Patel said. . “The

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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.

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Codon

APRIL 2, 2023

A giant dataset about the rat brain, and how neurons connect to each other, was collected and pooled together from 20 different research laboratories. Therapeutic neutralizing monoclonal antibody administration protects against lethal yellow fever virus infection. Nature Neuroscience. Read You love to see it! Ricciardi M.J.

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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.,

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The Pharma Data

MARCH 4, 2021

There are currently no FDA-approved treatments for AA. ” Baricitinib is an oral JAK inhibitor discovered by Incyte and licensed to Lilly. It is approved and commercially available as OLUMIANT in the U.S. Viral Reactivation – Viral reactivation, including cases of herpes virus reactivation (e.g.,

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The Pharma Data

JANUARY 26, 2021

Lilly’s chief scientific officer and president of Lilly Research Laboratories. It is designed to block viral attachment and entry into human cells, thus neutralizing the virus, potentially treating COVID-19. Bamlanivimab FDA Approval History. have reached record highs. Securities and Exchange Commission.

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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.

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Agency IQ

OCTOBER 27, 2023

Title Type Date Cleared by OIRA Legal Deadline None Notable FDA Comment Periods Closing in November and December FDA comment periods are typically open for 30-60 days, unless they are extended. The following PDUFA dates were obtained from publicly available sources.

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The Pharma Data

NOVEMBER 30, 2020

“I want to thank the thousands of participants in our Phase 1, Phase 2 and Phase 3 studies, as well as the staff at clinical trial sites who have been on the front lines of the fight against the virus. MRNA-1273 (SARS-CoV-2 vaccine) FDA Approval History. Source: Moderna, Inc. . Posted: November 2020. Source link.

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The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) approved Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) for the treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including newborns of mothers who have tested positive for the infection. TARRYTOWN, N.Y., NASDAQ: REGN) announced today that the U.S.

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