The Pharma Data

AUGUST 31, 2020

Basel, 1 September 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced U.S. Food and Drug Administration (FDA) approval for the cobas® HIV-1/HIV-2 Qualitative Test for use on the fully automated cobas® 6800/8800 Systems in the U.S. Human immunodeficiency virus (HIV) is categorized into two types, HIV-1 and HIV-2.

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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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Codon

AUGUST 26, 2024

After the outbreak ended, it took another three years for the first Ebola vaccine by Merck to be approved. When COVID-19 emerged in 2019, by contrast, mRNA vaccines developed by Pfizer and Moderna took just 326 days from the initial sequencing of the virus to gaining approval for emergency use.

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The Pharma Data

JANUARY 6, 2021

The announcement, following a $98 million IPO in October 2020, comes as the company advances several programs through its pipeline. In addition to its lead program, which began Phase I testing in 2020, the company expects to nominate three clinical candidates in 2021.

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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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FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

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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 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

NOVEMBER 17, 2021

The precise mechanism of the drug against SARS-CoV-2 is not yet known, but researchers have hypothesized that it may prevent the virus from taking hold by interfering with an enzyme it requires to replicate. If disulfiram’s effect against SARS-CoV-2 is confirmed, it could become a useful tool against the virus. A Pandemic Pivot.

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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

Data support baricitinib’s ongoing Phase 3 program and potential to be the first approved medicine for people living with alopecia areata (AA). . Viral Reactivation – Viral reactivation, including cases of herpes virus reactivation (e.g., 1 Olumiant Prescribing Information, 2020. INDIANAPOLIS , Oct. J Rheumatol.

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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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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

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 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

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

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 8, 2020

8 December 2020 — Results of an interim analysis of the Phase III programme conducted by Oxford University with AZD1222, peer-reviewed and published in The Lancet today, demonstrated that the vaccine is safe and effective at preventing symptomatic COVID-19 and that it protects against severe disease and hospitalisation. AstraZeneca.

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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

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 24, 2020

24, 2020 — The United States broke a bleak record on Friday, logging the highest daily number of new coronavirus cases since the pandemic began. That’s just not possible when the virus is surging everywhere,” Eleanor Murray, an epidemiologist at Boston University, told the Post. SATURDAY, Oct.

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The Pharma Data

DECEMBER 8, 2020

9, 2020 00:15 UTC. During the call, Takeda provided a deep dive into TAK-721, which has the potential to be the first FDA-approved agent for the treatment of eosinophilic esophagitis (EoE), and TAK-003, which is a live attenuated tetravalent vaccine for prevention of dengue disease. Source link.

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The Pharma Data

OCTOBER 23, 2020

23, 2020 — The United States on Thursday recorded its second highest daily total of new coronavirus cases since the pandemic began, with 75,000 new infections, while eight states broke single-day records of new cases. Food and Drug Administration approval to fight COVID-19. Remdesivir gets full FDA approval to treat COVID.

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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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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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Agency IQ

JANUARY 19, 2024

However, this is actually relatively aligned with the number of new active substances seen prior to and during the first year of the pandemic: 39 in 2020 ; 30 in 2019 ; 42 in 2018 and 35 in 2017. for the years 2020 to 2022. Conditional approvals and accelerated assessments seem to fluctuate each year, with no clear trend.

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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

JANUARY 6, 2021

Most recently ( June 2020 ) FUJIFILM Corporation invested 100 billion yen ( 928 million USD ) in FUJIFILM Diosynth Biotechnologies’ Hillerød, Denmark site to double its large-scale cell culture manufacturing capacity and add commercial scale drug product production capabilities.

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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

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

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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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.

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The Pharma Data

NOVEMBER 21, 2020

21, 2020 /PRNewswire/ — Today, the U.S. Casirivimab and imdevimab are monoclonal antibodies that are specifically directed against the spike protein of SARS-CoV-2, designed to block the virus’ attachment and entry into human cells. acting director of the FDA’s Center for Drug Evaluation and Research.

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Codon

MAY 18, 2023

way back in August 2020, and Japan already offers a CRISPR-edited plant in grocery stores: A tomato with boosted levels of GABA, a chemical signal in the brain. Scientists removed Ashanti’s blood cells and inserted a functional copy of the ADA gene via a virus. WIRED just wrote a story about this, but it’s sorta old news.

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Codon

MAY 18, 2023

way back in August 2020, and Japan already offers a CRISPR-edited plant in grocery stores: A tomato with boosted levels of GABA, a chemical signal in the brain. Scientists removed Ashanti’s blood cells and inserted a functional copy of the ADA gene via a virus. WIRED just wrote a story about this, but it’s sorta old news.

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