The Pharma Data

DECEMBER 28, 2020

Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Annamycin for treatment of soft tissue sarcomas. .

FDA

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

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

The Pharma Data

NOVEMBER 16, 2020

This is a pivotal moment in the development of our COVID-19 vaccine candidate. Since early January, we have chased this virus with the intent to protect as many people around the world as possible. MRNA-1273 (SARS-CoV-2 vaccine) FDA Approval History. All along, we have known that each day matters. Source: Moderna, Inc.

Vaccine

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

The Pharma Data

FEBRUARY 25, 2022

Several FDA-approved drugs – including for type 2 diabetes, hepatitis C and HIV – significantly reduce the ability of the Delta variant of SARS-CoV-2 to replicate in human cells, according to new research led by scientists at Penn State. Pfizer’s COVID-19 therapy Paxlovid, for example, targets Mpro.

FDA Approval

PerkinElmer

APRIL 21, 2020

Although the novel coronavirus is the subject of nearly every media story right now, several years ago it was the Zika virus (ZIKV) gathering a great deal of attention. Here, we describe the novel use of high content imaging solutions (HCS) in a study to identify possible Zika virus inhibitors that could be translated into therapeutic form.

Virus

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

EG Life Sciences

FEBRUARY 15, 2023

The year 2022 reflected a transformative path for the drug development industry. Every year, the FDA’s Center for Drug Evaluation and Research (CDER) clarifies to drug developers required study design elements, as well as other data needed on the drug application to support a full and comprehensive assessment.

Drug Development

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. Casirivimab and imdevimab injection is an investigational combination therapy and has been authorized by FDA for the emergency use described above.

Therapies

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. REGEN-COV2’s development and manufacturing has been funded in part with federal funds from BARDA under OT number: HHSO100201700020C. Yancopoulos , M.D.,

FDA

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., In July 2020 , the U.S.

Production

The Pharma Data

DECEMBER 29, 2020

About Regeneron Antibody Cocktail Casirivimab and imdevimab 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. Casirivimab and imdevimab injection is not FDA approved for any use.

Hospitals

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.

Vaccine

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. FDA has proposed to amend the 503A Bulks List by placing additional bulk drug substances on the list.

FDA

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. 27, 2020 06:30 UTC.

Vaccine

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.

Vaccine

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. On November 23, the FDA published a new, direct-to-final post-PHE version of the document.

FDA

NIH Director's Blog: Drug Development

FEBRUARY 16, 2021

ACTIV-2 : A Phase 2/3 trial is enrolling adults with COVID-19 who are not hospitalized to evaluate the safety of multiple monoclonal antibodies (Lilly’s LY-CoV555, Brii Biosciences’s BRII-196 and BRII-198, and AstraZeneca’s AZD7442) used to block or neutralize the SARS-CoV-2 virus.

Clinical Trials

Vial

DECEMBER 11, 2023

Hepatitis C virus (HCV) infection is a global health problem with complications that place a significant economic burden on national health systems. Since HCV was identified more than 30 years ago, significant investment has been dedicated to developing HCV antiviral drugs.

Clinical Research

Agency IQ

SEPTEMBER 29, 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.

FDA

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. A Randomized, Controlled Trial of Ebola Virus Disease Therapeutics.

FDA Approval

The Pharma Data

APRIL 26, 2021

At present, drug development operations are continuing with manageable disruptions (see the Innovation Review Section of the Condensed Interim Financial Report for further information), with our range of digital technologies allowing us to proactively manage our clinical trials portfolio and rapidly mitigate any disruptions.

Production

Drug Target Review

FEBRUARY 15, 2024

Since the 20 th century, all known viral pandemics, including HIV, influenza, SARS CoV-1, SARS, CoV-1, and mpox, have resulted from a virus ‘spilling over’ from animals into humans. For example, scientists cannot accurately predict which town or village will have the next Nipah virus outbreak.

Drug Development

The Pharma Data

NOVEMBER 23, 2020

23, 2020 – Americans were greeted with possible advances against coronavirus as Thanksgiving week began: A third vaccine candidate shows good results in shielding recipients against the virus, and an antibody therapy used by President Donald Trump against COVID-19 got emergency use approval by the U.S. Food and Drug Administration.

FDA Approval

Drug & Device Law

SEPTEMBER 1, 2023

At issue are life-saving antiretroviral drugs used to treat patients with HIV, and we have written on similar cases involving the same drugs and legal theories before. That is the group of drugs that the plaintiffs allegedly used and that allegedly caused harmful side effects. See, e.g., here and here. In Brown v.

Production

Drug & Device Law

JANUARY 12, 2024

The drugs at issue are life-saving antiretroviral drugs used to treat patients with HIV. The defendant in Gilead has developed multiple drugs used to treat or prevent infection with the AIDS virus, including several containing tenofovir disoproxil fumarate (“TDF”). at *48-*50. at *31, *32. That is important.

FDA Approval

Drug Target Review

APRIL 25, 2025

Addressing the gaps associated with liver-on-chips, a recent 3D hepatic spheroid study predicted DILI liabilities of 152 FDA-approved small molecules using a high-throughput 384 well plate-based system with a sensitivity of 72 percent and specificity of 89 percent.

Clinical Development

Codon

MAY 29, 2025

The way we typically prepare white beans completely deactivates the mild toxin that could otherwise cause food poisoning, the highly venomous cone snail that produced that shell was long gone by the time you picked it up, and Botox has been safe to inject by licensed healthcare professionals since FDA approval in 1991.

Drugs