The Pharma Data

OCTOBER 27, 2020

Founded and led for over 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 Target Review

SEPTEMBER 19, 2023

Some of the complex 3D models such as organoids and organ-on-chips have brought in realistic make-over to the drug screening and paved way into implementing high content screening, laboratory automation and miniaturisation in primary drug screening process. Microengineered physiological biomimicry: Organs-on-Chips.

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The Pharma Data

SEPTEMBER 7, 2021

Volunteers for the trial are being enrolled at Columbia University in New York City and Clinilabs Drug Development Corporation, based in Eatontown, New Jersey.

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The Premier Consulting Blog

APRIL 15, 2024

We will use the term, nonclinical, to refer to any in vitro, ex vivo, or animal study conducted to support any stage of research and development of a new drug, such as proof-of-concept pharmacology studies through Good Laboratory Practice (GLP) toxicology studies. neurotoxicity) that require special assessments.

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PerkinElmer

APRIL 21, 2020

Using the isolated ZIKV MEX_I_7 strain, researchers got a head start on potential leads by interrogating a library of existing, FDA-approved drugs that can be used off-label for treatment of Zika. High-content imaging was used in a recent study aiming to identify novel ZIKV inhibitors from a pool of 774 compounds.

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The Pharma Data

JANUARY 13, 2021

Fast Track designation facilitates the development and expedites the review of drugs that are intended to treat serious and life-threatening conditions and show the potential to fill an unmet medical need. Brilacidin antiviral research to date has been limited to laboratory-based experiments.

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The Pharma Data

DECEMBER 28, 2020

” The FDA grants orphan drug designation to drugs and biologics that are intended for the treatment of rare diseases that affect fewer than 200,000 people in the U.S. About Moleculin Biotech, Inc. Moleculin Biotech, Inc.

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The Pharma Data

OCTOBER 22, 2020

With today’s FDA approval, and regulatory approvals or temporary authorizations in approximately 50 additional countries around the world, Veklury® (remdesivir) is one of the tools available today. [ii] Perform hepatic laboratory testing in all patients (see Dosage and administration). Adverse reactions.

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Drug Target Review

DECEMBER 5, 2024

1 In 2017, the US Food and Drug Administration (FDA) approved the first AAV-based gene replacement therapy (Luxturna), for Leber congenital amaurosis type 2. 2 Since then, the FDA has approved four more AAV-based gene therapies—Zolgensma, Hemgenix, Elevidys and Rocktavian—for treating various diseases.

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The Premier Consulting Blog

SEPTEMBER 11, 2024

However, the success of a 505(b)(2) application hinges on a tailored development strategy that carefully considers the specific characteristics of the newly proposed drug product, and the nature of the changes made in comparison to a prior US FDA-approved listed drug (LD) or the drug reported in literature.

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The Pharma Data

MAY 31, 2022

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

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FDA Disease Trials FDA Approval 52

The Pharma Data

MARCH 4, 2021

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

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The Pharma Data

JUNE 26, 2021

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

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Trials Treatment Therapies Disease 52

The Pharma Data

JUNE 26, 2021

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

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Treatment Trials Disease FDA Approval 52

The Pharma Data

JANUARY 6, 2021

Cyto-111 was conceived, expressed and purified in the laboratory of Konstantin Ichtchenko, Ph.D., The approach used to turn botulinum toxin into a kind of Trojan horse that delivers a cargo into neurons has enormous potential for future drug development,” noted Thomas C. Südhof, M.D.,

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The Pharma Data

DECEMBER 1, 2020

In our diligence process, we were impressed not only by the rigor of their platform and the extensive AI and drug development accomplishments of their team, but also by the nascent yet powerful applications of their platform to laboratory experiments for their drug discovery pipeline.

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The Pharma Data

FEBRUARY 19, 2022

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

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Trials Disease Treatment FDA Approval 40

The Pharma Data

FEBRUARY 13, 2022

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

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FDA Disease Treatment FDA Approval 40

The Pharma Data

MARCH 15, 2021

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

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Trials Disease FDA Treatment 52

The Pharma Data

NOVEMBER 20, 2020

Casirivimab and imdevimab injection is an investigational combination therapy and has been authorized by FDA for the emergency use described above. Casirivimab and imdevimab injection is not FDA approved for any use. REGN-COV2 (casirivimab and imdevimab) FDA Approval History. Source: Regeneron. Source link.

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The Pharma Data

AUGUST 30, 2021

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

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Trials Disease Treatment Clinical Trials 52

The Pharma Data

OCTOBER 30, 2020

Founded and led for over 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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The Pharma Data

DECEMBER 17, 2020

Authorized Emergency Use Casirivimab and imdevimab injection is an investigational combination therapy and has been authorized by FDA for the emergency use described above. Casirivimab and imdevimab injection is not FDA approved for any use. 360bbb-3(b) (1), unless the authorization is terminated or revoked sooner.

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The Pharma Data

DECEMBER 29, 2020

All patients entering the trial were hospitalized with laboratory-confirmed COVID-19 requiring low-flow oxygen, and all received other background standard-of-care as required. Casirivimab and imdevimab injection is not FDA approved for any use. 360bbb-3(b) (1), unless the authorization is terminated or revoked sooner.

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The Pharma Data

NOVEMBER 30, 2020

Moderna’s partner PPD (Nasdaq: PPD), a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services, has also been essential to the successful execution of the COVE study. MRNA-1273 (SARS-CoV-2 vaccine) FDA Approval History.

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Vaccine FDA Clinical Trials Disease 52

The Pharma Data

NOVEMBER 16, 2020

Moderna’s partner PPD (Nasdaq: PPD), a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services, has also been essential to the successful execution of the COVE study. MRNA-1273 (SARS-CoV-2 vaccine) FDA Approval History.

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Vaccine Clinical Trials FDA Disease 52

Agency IQ

DECEMBER 1, 2023

FDA’s guidance on developing products to prevent or treat Covid-19 Of the five guidance documents that received an extension, one addresses the development of drugs and biological products for Covid-19. Lastly, the revised guidance briefly discussed trials meant to assess drugs intended for prevention of Covid-19.

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The Pharma Data

JANUARY 12, 2021

Casirivimab and imdevimab injection is an investigational combination therapy and has been authorized by FDA for the emergency use described above. Casirivimab and imdevimab injection is not FDA approved for any use. 360bbb-3(b) (1), unless the authorization is terminated or revoked sooner.

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The Pharma Data

OCTOBER 28, 2020

Founded and led for over 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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The Pharma Data

OCTOBER 18, 2020

PhD, Head of the Department of Drug Development and Innovation (D3i) at the Curie Institute, and a world expert in drug development and head and neck cancers, is the Principal Investigator of the study. This indication is approved under accelerated approval based on tumor response rate and duration of response.

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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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Production Trials Treatment Disease 40

The Pharma Data

NOVEMBER 21, 2020

Casirivimab and imdevimab injection (REGEN-COV2) is an investigational combination therapy and has been authorized by FDA for the emergency use described above. Casirivimab and imdevimab injection is not FDA approved for any use. 360bbb-3(b) (1), unless the authorization is terminated or revoked sooner.

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FDA Clinical Trials Hospitals Production 40

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 trial in the COVID-19 outpatient setting met primary and key secondary endpoints. Regeneron Pharmaceuticals, Inc.

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The Pharma Data

OCTOBER 26, 2020

Christophe Le Tourneau, MD, Head of the Department of Drug Development and Innovation (D3i) at the Curie Institute, and Principal Investigator of the trial , added: “We have seen very encouraging efficacy results in this hard-to-treat patient population, as well as a satisfying safety profile. Christophe Le Tourneau, M.D.,

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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

The proposed rule will identify certain bulk drug substances that FDA has considered and is proposing to place on the 503A Bulks List and certain bulk drug substances that FDA has considered and is proposing not to include on the 503A Bulks List.

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Drug Target Review

FEBRUARY 15, 2024

Investigations into the origins of the COVID-19 pandemic have drawn attention to the risk of researchers potentially becoming infected while working with pathogens in a laboratory 7 and subsequently spreading infections in the broader community. All of these factors are being further accelerated by climate change.

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