The Pharma Data

DECEMBER 23, 2020

While the overall understanding of the condition is as novel as the virus that causes it, a recent survey from the U.K.’s Leronlimab, which is a viral-entry inhibitor against the CCR5 receptor, is originally intended as an HIV drug, though it has yet to receive FDA approval in this disease area. said in a statement.

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The Pharma Data

DECEMBER 15, 2020

15, 2020 — The first non-prescription COVID-19 test that enables people to collect samples and get results at home has received emergency use authorization from the U.S. ” Last week, the FDA approved a different at-home test, but it requires samples to be mailed to a lab to get the results. © 2020 HealthDay.

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The Pharma Data

OCTOBER 29, 2020

29, 2020– Alexion Pharmaceuticals, Inc. NASDAQ:ALXN) today announced financial results for the third quarter of 2020. Non-GAAP diluted EPS for the third quarter of 2020 was $3.24 , a 16 percent increase versus the third quarter of 2019. ” Third Quarter 2020 Financial Highlights. in the prior year.

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The Pharma Data

DECEMBER 10, 2020

11, 2020 02:48 UTC. In the study, immunization with the hAd5-COVID-19 vaccine inhibited SARS-CoV-2 virus replication in 100% (10 of 10) of Rhesus macaques, with a drop in viral replication starting on the first day of vaccine administration, and undetectable viral levels as early as three to five days post-challenge in most of the animals.

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The Pharma Data

NOVEMBER 9, 2020

09, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. Food and Drug Administration (FDA) has granted Fast Track Designation for NVX-CoV2373, the Company’s COVID-19 vaccine candidate. NVX-CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. Posted: November 2020.

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The Pharma Data

DECEMBER 30, 2020

30 December 2020 — AstraZeneca’s COVID-19 vaccine has been approved for emergency supply in the UK, with the first doses being released today so that vaccinations may begin early in the New Year. The data were also published in The Lancet on 8 December 2020. Posted: December 2020. Source: AstraZeneca.

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The Pharma Data

NOVEMBER 23, 2020

23 November 2020 . Trial participants to date are aged 18 years or over, who are healthy or have medically stable chronic diseases and are at increased risk for being exposed to the SARS-CoV-2 virus. Posted: November 2020. AZD1222 (SARS-CoV-2 vaccine) FDA Approval History. AstraZeneca. Source: AstraZeneca.

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The Pharma Data

OCTOBER 28, 2020

28, 2020 /PRNewswire/ — . FDA, which is reviewing an Emergency Use Authorization submission for the REGN-COV2 low dose in adults with mild-to-moderate COVID-19 who are at high risk for poor outcomes. In the overall patient group with detectable virus at baseline, the average daily reduction in viral load through day 7 was a 0.36

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The Pharma Data

DECEMBER 3, 2020

4, 2020 08:00 UTC. A global Phase 2/3 efficacy study of the S-Trimer vaccine candidate in combination with GSK’s pandemic adjuvant system is expected to begin in December 2020. FDA approval for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.

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The Pharma Data

DECEMBER 28, 2020

29, 2020 /PRNewswire/ — Moleculin Biotech , Inc., . HOUSTON , Dec. Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors and viruses.

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The Pharma Data

OCTOBER 21, 2020

21 October 2020 — ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. These findings were presented today at the 2020 Infectious Diseases Society of America (IDSA) IDWeek. CABENUVA (cabotegravir and rilpivirine extended release injectable suspensions) is currently only approved in Canada.

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The Pharma Data

NOVEMBER 30, 2020

30, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. About NVX-CoV2373 NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. is undertaking clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19.

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The Pharma Data

JANUARY 6, 2021

The authorization is based upon the recommendation of the European Medicines Agency (EMA) for use of the COVID-19 Vaccine Moderna for active immunization to prevent COVID-19 caused by SARS-CoV-2 virus in individuals 18 years of age and older. “I On December 18, 2020, the U.S. MRNA-1273 (SARS-CoV-2 vaccine) FDA Approval History.

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The Pharma Data

NOVEMBER 23, 2020

Food and Drug Administration (FDA) approved the combination of ipilimumab and nivolumab (Yervoy and Opdivo) for the first-line treatment of MPM based on mOS of 18.1 months (Baas 2020), and this is expected to serve as a benchmark for further approvals. OSLO, Norway , Nov. Recently, the U.S. References.

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The Pharma Data

OCTOBER 30, 2020

30, 2020 /PRNewswire/ — The IDMC also recommends continuation of enrollment in the REGN-COV2 outpatient trial. 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. TARRYTOWN, N.Y. ,

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The Pharma Data

DECEMBER 17, 2020

17, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. 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. TARRYTOWN, N.Y. ,

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The Pharma Data

JANUARY 31, 2021

In August of 2020, Convergent began a second Phase 1b /2a trial to test the efficacy of multiple ascending doses of CONV 01-?. If FDA approved, CONV 01-? would be the first antibody drug approved to direct a radioisotope into prostate cancer cells, and the first drug approved for the use of 225 Ac in cancer treatment. .

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The Pharma Data

NOVEMBER 16, 2020

16, 2020– Moderna, Inc. Since early January, we have chased this virus with the intent to protect as many people around the world as possible. By the end of 2020, the Company expects to have approximately 20 million doses of mRNA-1273 ready to ship in the U.S. Posted: November 2020. CAMBRIDGE, Mass.–(BUSINESS

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The Pharma Data

JANUARY 12, 2021

The first clinical batch, which was funded by the Coalition for Epidemic Preparedness Innovations, was completed on February 7, 2020 and underwent analytical testing; it was shipped to the NIH on February 24, 42 days from sequence selection. MRNA-1273 (SARS-CoV-2 vaccine) FDA Approval History. About Moderna. Source link.

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Metabolite Tales Blog

JULY 5, 2023

Metabolism of de novo-designed macrocyclic drugs approved by the FDA By Julia Shanu-Wilson To date, only 4% (67) of FDA approved drugs are macrocycles [1]. Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders. Ayushi Jain and Khalid Mumtaz, 2022.

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Metabolite Tales Blog

JULY 5, 2023

Metabolism of de novo-designed macrocyclic drugs approved by the FDA By Julia Shanu-Wilson To date, only 4% (67) of FDA approved drugs are macrocycles [1]. Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders. Ayushi Jain and Khalid Mumtaz, 2022.

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The Pharma Data

DECEMBER 11, 2020

Friday, December 11, 2020. FDA authorizes COVID-19 mRNA vaccine for emergency use; companies are prepared to deliver first doses in the U.S. Government to supply doses in 2020 & 2021. Pfizer and BioNTech expect to file a Biologics License Application for possible full regulatory approval in 2021.

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The Pharma Data

DECEMBER 5, 2020

5, 2020 /PRNewswire/ — 63% response rate in patients treated with the highest reported dose. The results were shared in an oral presentation at the virtual 2020 American Society of Hematology (ASH) Annual Meeting. and the world, respectively, in 2020. TARRYTOWN, N.Y. ,

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The Pharma Data

DECEMBER 15, 2020

In late 2020, the effort received $200,000 in seed funding from the Baker Department of Cardiometabolic Health at the University of Melbourne’s medical school. Scientists will be testing a drug class targeting the C-reactive protein (CRP) marker of acute inflammation in the body. Patient Recruitment.

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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

NOVEMBER 5, 2020

5, 2020 /PRNewswire/ — Third quarter 2020 revenues increased 32% to $2.29 Third quarter 2020 EYLEA ® U.S. Third quarter 2020 Dupixent ® global net sales (2) , which are recorded by Sanofi, increased 69% to $1.07 Third quarter 2020 Dupixent ® global net sales (2) , which are recorded by Sanofi, increased 69% to $1.07

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The Pharma Data

OCTOBER 30, 2020

Monthly News Roundup – October 2020. Gilead’s Veklury (remdesivir) is First Approved Treatment for COVID-19 . In October, the US Food and Drug Administration (FDA) approved the first treatment for COVID-19, Gilead’s antiviral drug Veklury (remdesivir). Sklice is not approved for any other use.

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Broad Institute

APRIL 25, 2024

A new model Formally launched in early 2020, Sentinel is a new model of pathogen surveillance that its leaders say could be used anywhere in the world. The Sentinel team put an early version of their system to the test in 2020 to respond to COVID-19 and again in 2022 for Mpox surveillance and response efforts.

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The Pharma Data

NOVEMBER 20, 2020

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies. 20, 2020 /PRNewswire/ — Eiger BioPharmaceuticals, Inc. Eiger’s lead clinical programs target Hepatitis Delta Virus (HDV) infection, the most serious form of human viral hepatitis.

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The Pharma Data

DECEMBER 12, 2020

12, 2020 – The U.S. Food and Drug Administration approved Pfizer’s coronavirus vaccine for emergency use on Friday, clearing the way for the launch of a national campaign to inoculate enough Americans to stem the spread of COVID-19. “More than 100,000 in long-term care have died from this virus in the U.S.

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The Pharma Data

JULY 29, 2021

for the same period in 2020. This was primarily driven by the impact of higher in-process research and development (“IPR&D”) expenses in the second quarter 2020 related to the Forty Seven, Inc. billion as of December 31, 2020. billion compared to the same period in 2020. Second Quarter 2021 Financial Results.

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The Pharma Data

DECEMBER 30, 2020

The year 2020 will certainly go down in history as the year of COVID-19. Gilead Sciences Makes Multiple Bets : When Gilead Sciences wasn’t working on remdesivir in COVID-19, the company seemed to be constantly flexing its M&A muscle over the course of 2020. It began in May with the $4.9

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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.,

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The Pharma Data

JANUARY 6, 2021

We hope this effective, well-tolerated and simple-to-administer vaccine will now begin to have a real impact on this deadly virus. After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body. AZD1222 (SARS-CoV-2 vaccine) FDA Approval History.

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The Pharma Data

NOVEMBER 20, 2020

November 21, 2020 – Regeneron Pharmaceuticals, Inc. Food and Drug Administration (FDA). “The 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. TARRYTOWN, N.Y., Yancopoulos, M.D.,

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The Pharma Data

DECEMBER 18, 2020

Action Follows Thorough Evaluation of Available Safety, Effectiveness, and Manufacturing Quality Information by FDA Career Scientists, Input from Independent Experts. 18, 2020 /PRNewswire/ — Today, the U.S. Director of the FDA’s Center for Biologics Evaluation and Research. SILVER SPRING, Md. , The EUA Process.

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PLOS: DNA Science

JANUARY 4, 2024

The end-of-year FDA approval of the first CRISPR-based therapy , for sickle cell disease, came a mere dozen years after Jennifer Doudna and Emmanuelle Charpentier introduced the technology. They shared the Nobel Prize in Chemistry in 2020. CRISPR is one of the better abbreviations in genetics. It restores vision in just days.

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