The Pharma Data

DECEMBER 28, 2020

29, 2020 /PRNewswire/ — Moleculin Biotech , Inc., Moleculin is also engaged in preclinical development of additional drug candidates, including other Immune/Transcription Modulators, as well as WP1122 and related compounds capable of Metabolism/Glycosylation Inhibition. . HOUSTON , Dec.

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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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FEBRUARY 18, 2022

Visit this page on BMS.com for more information on Bristol Myers Squibb’s scientific approach and resources on gastrointestinal immune-mediated diseases. About Ulcerative Colitis. Symptoms include bloody stools, severe diarrhea and frequent abdominal pain.

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NIH Director's Blog: Drug Development

FEBRUARY 16, 2021

They are called immune modulators because they help to minimize the effects of an overactive immune response in some COVID-19 patients. This response, called a “cytokine storm,” can lead to acute respiratory distress syndrome, multiple organ failure, and other life-threatening complications.

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The Pharma Data

DECEMBER 29, 2020

29, 2020 /PRNewswire/ — Phase 3 program in hospitalized patients to continue based on passing futility analysis on ability to reduce incidence of death or mechanical ventilation. As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes.

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The Pharma Data

DECEMBER 31, 2020

Monthly News Roundup – December 2020. Food and Drug Administration (FDA) issued Emergency Use Authorization for two COVID-19 vaccines: Pfizer-BioNTech’s BNT162b2 and Moderna’s mRNA-1273. FDA Approves First-In-Class Topical Klisyri to Treat Actinic Keratosis . Professional. In December, the U.S.

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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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Agency IQ

DECEMBER 1, 2023

BY RACHEL COE, MSC | NOV 27, 2023 8:24 PM CST FDA’s transition away from public health emergency (PHE)-related guidance documents The Covid-19 Public Health Emergency (PHE) was activated on January 31, 2020. supplemental oxygen, mechanical ventilation). Like the first version, the updated guidance was issued as direct-to-final.

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The Pharma Data

DECEMBER 10, 2020

Thursday, December 10, 2020 – . Based on a data cut-off date of October 9, 2020, 37,706 participants had a median of at least two months of safety data available after dose 2 and contributed to the main safety dataset. The information contained in this release is as of December 10, 2020. Pfizer Disclosure Notice.

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The Pharma Data

DECEMBER 27, 2020

28, 2020 13:00 UTC. To Our Shareholders, As we reach the end of an eventful 2020, we are inspired by the many healthcare providers and biopharmaceutical companies that worked to combat the COVID-19 pandemic. CARLSBAD, Calif.–( –( BUSINESS WIRE )– Lineage Cell Therapeutics, Inc.

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The Pharma Data

JUNE 18, 2021

Food and Drug Administration (FDA) has approved PREVNAR 20 (Pneumococcal 20-valent Conjugate Vaccine) for the prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in the vaccine in adults ages 18 years and older. Following today’s FDA approval, the U.S.

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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. TARRYTOWN, N.Y. , Regeneron has shared these results with the U.S. Yancopoulos , M.D., combined dose groups; 6.5%

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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

OCTOBER 14, 2020

15, 2020 10:00 UTC. Food and Drug Administration (FDA) to begin a Phase I clinical trial of hAd5-COVID-19, the company’s novel COVID-19 vaccine candidate that targets both the inner nucleocapsid (N), engineered to activate T cells, and outer spike (S) protein, engineered to activate antibodies against the coronavirus (SARS-CoV-2).

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The Pharma Data

MARCH 16, 2021

TREMFYA is the first and only treatment approved for both adults with moderate to severe plaque PsO and for adults with active PsA that selectively inhibits IL-23, a cytokine that is a key driver of the inflammatory immune response associated with the symptoms of these chronic autoimmune diseases.

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Codon

JULY 14, 2024

This is particularly beneficial for those who need chronic transfusions and are therefore at risk of developing an immune response to transfusion products from other people, or for those with religious beliefs, like Jehovah’s Witnesses, whose faith prohibits blood transfusions from another person.

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The Pharma Data

AUGUST 17, 2021

Esophageal cancer is the eighth most common cancer and the sixth leading cause of death from cancer worldwide, with approximately 600,000 new cases and over 540,000 deaths in 2020. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers. About Opdivo.

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The Pharma Data

NOVEMBER 20, 2020

November 21, 2020 – Regeneron Pharmaceuticals, Inc. Food and Drug Administration (FDA). This benefit was greatest in patients most at risk for poor outcomes due to high viral load, ineffective immune response at baseline or pre-existing risk factors. Casirivimab and imdevimab injection is not FDA approved for any use.

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The Pharma Data

APRIL 27, 2021

due to COVID related stocking in Q1 2020 and low demand for cough and cold brands in Europe. Following the communication of our ESG strategy at the end of 2020 and embedding it into our business priorities, we have recently created the Sanofi Global Health Unit, dedicated to increasing access to 30 medicines considered essential by the WHO.

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The Pharma Data

APRIL 4, 2023

The combination therapy was granted Breakthrough Therapy designation by the FDA in February 2020. Results from Cohort K were presented in a late-breaking session at the 2022 European Society for Medical Oncology Congress, and earlier results from dose escalation and Cohort A were published in the Journal of Clinical Oncology.

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The Pharma Data

NOVEMBER 21, 2020

21, 2020 /PRNewswire/ — First treatment of any kind to have prospectively confirmed and statistically significant anti-viral activity against SARS-CoV-2. This benefit was greatest in patients most at risk for poor outcomes due to high viral load, ineffective immune response at baseline or pre-existing risk factors.

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The Pharma Data

JANUARY 4, 2021

Tiragolumab is the first anti-TIGIT molecule to be granted BTD from the FDA, and the designation is based on randomized data from the Phase II CITYSCAPE trial. CITYSCAPE provides the first evidence that targeting both immune inhibitory receptors, TIGIT and PD-L1, may enhance anti-tumor activity by potentially amplifying the immune response.

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The Pharma Data

OCTOBER 26, 2020

27, 2020 06:30 UTC. Following the unauthorized download of all abstracts on the SITC website, Transgene is communicating the content of the late-breaking poster abstract that will be presented at the SITC 35th Anniversary Annual Meeting (SITC 2020), to be held virtually November 9-14, 2020. – .

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The Pharma Data

JUNE 30, 2021

Food and Drug Administration (FDA) in July 2018 for the treatment of adult and pediatric patients 12 years and older with MSI-H or dMMR mCRC that has progressed following treatment with fluoropyrimidine, oxaliplatin and irinotecan. achieving a complete response. CheckMate -142 Efficacy and Safety Results. About Opdivo.

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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. CUE-300 Series Immuno-STATs may offer autoimmune patients therapeutic benefits without compromising their immune systems.

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The Pharma Data

JULY 15, 2021

Antibody and T-cell immune responses strong and stable at eight months after immunization Demonstrated neutralizing antibody activity against the Delta variant (B.1.617.2) variants, as well as the original SARS-CoV-2 strain (WA1/2020). There is no FDA-approved vaccine to prevent COVID-19. 1.1.7), Beta (B.1.351),

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The Pharma Data

JANUARY 10, 2021

AstraZeneca, whose vaccine was approved in the UK and India last week, hasn’t yet submitted an application to the FDA for an EUA, but it is expected to file in late January when it has new phase 3 efficacy results ( DID , Dec. 30, 2020 ). 11, 2020 ). 29, 2020 ). The company began a phase 3 study in the U.S.

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The Pharma Data

JANUARY 29, 2021

Janssen’s Vaccine Technology The investigational Janssen COVID-19 vaccine candidate leverages the Company’s AdVac® vaccine platform , which was also used to develop and manufacture Janssen’s European Commission-approved Ebola vaccine regimen and construct its Zika, RSV, and HIV investigational vaccine candidates. i] [link] [ii] The B.1.351

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