The Pharma Data

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. About Bristol Myers Squibb.

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The Pharma Data

DECEMBER 11, 2020

Government to supply doses in 2020 & 2021. In collaboration with Operation Warp Speed, Pfizer and BioNTech, as well as other vaccine companies are expected to deliver hundreds of millions of vaccine doses to Americans by the end of 2021. immediately, with delivery fulfillment expected to be completed in 2021.

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The Pharma Data

DECEMBER 27, 2020

(NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today provided a year-end review and an outline of its plans for 2021.

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The Pharma Data

DECEMBER 17, 2020

Regeneron continues to increase in-house production of casirivimab and imdevimab, and the company has partnered with Roche to increase the global supply beginning in 2021. If the therapy proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will manufacture and distribute it in the U.S. ,

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The Pharma Data

DECEMBER 15, 2020

Also in September, the FDA accepted a new drug application ( NDA ) from ChemoCentryx seeking approval for its investigational candidate, avacopan, for treating anti-neutrophil cytoplasmic antibody-associated vasculitis (ANCA-associated vasculitis), a rare autoimmune disease. The FDA has set an action date of July 7, 2021.

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The Pharma Data

OCTOBER 28, 2020

“We continue to see the strongest effects in patients who are most at risk for poor outcomes due to high viral load, ineffective antibody immune response at baseline, or pre-existing risk factors. Regeneron has partnered with Roche to increase the global supply of REGN-COV2 beginning in 2021. Yancopoulos , M.D.,

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Broad Institute

OCTOBER 11, 2023

As a first step, Manguso set his sights on treatments called PD-1 checkpoint inhibitors, which at the time had shown tremendous promise in clinical trials and would receive their first FDA approval in 2014. The findings suggest a complex, context-dependent relationship between IFNγ signaling and the anti-tumor immune response.

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The Pharma Data

SEPTEMBER 8, 2021

today announced that data reinforcing the potential of immunotherapies to impact clinical outcomes for patients will be featured at the European Society for Medical Oncology (ESMO) 2021 Virtual Congress from September 16-21. Yervoy is approved for unresectable or metastatic melanoma in more than 50 countries. About Opdivo.

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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

NOVEMBER 20, 2020

The clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as casirivimab and imdevimab have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load. As part of Operation Warp Speed, in July the U.S.

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The Pharma Data

AUGUST 17, 2021

Results from CheckMate -648 were presented in an oral session during the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting and were selected for the official ASCO press program. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

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The Pharma Data

APRIL 11, 2021

Data selected for an oral presentation in a Clinical Trials Plenary Session at the American Association for Cancer Research Annual Meeting 2021. Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response.

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The Pharma Data

DECEMBER 29, 2020

The analysis was prospectively designed to focus on patients who had not yet mounted their own immune response to SARS-CoV-2 (i.e., The company expects to complete the manufacture of these doses on schedule in January 2021 and is in discussions with the U.S. Casirivimab and imdevimab injection is not FDA approved for any use.

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The Pharma Data

NOVEMBER 21, 2020

The clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as REGEN-COV2 have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load. As part of Operation Warp Speed, in July the U.S.

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The Pharma Data

SEPTEMBER 8, 2021

3,4 Acapatamab engages PSMA on cancer cells and CD3 on T cells, inducing T-cell activation, proliferation and target cell lysis to prompt a cancer-fighting immune response. In May 2021, LUMAKRAS was the first KRAS G12C inhibitor to receive regulatory approval anywhere in the world with its approval in the U.S.,

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The Pharma Data

DECEMBER 10, 2020

The Phase 3 trial is designed as a 1:1 vaccine candidate to placebo, randomized, observer-blinded study to obtain safety, immune response, and efficacy data needed for regulatory review. BNT162b2 (SARS-CoV-2 vaccine) FDA Approval History. Germany, Turkey, South Africa, Brazil and Argentina. Source: Pfizer Inc. .

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The Pharma Data

JANUARY 29, 2021

January 29, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, demonstrating that the investigational single-dose COVID-19 vaccine in development at its Janssen Pharmaceutical Companies met all primary and key secondary endpoints. Source link.

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The Pharma Data

MARCH 11, 2021

Food and Drug Administration (FDA) will hold a public meeting of the Oncologic Drugs Advisory Committee (ODAC) between April 27-29, 2021 to discuss accelerated approvals in oncology impacted as part of the Agency’s industry-wide review. 1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

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The Pharma Data

MARCH 16, 2021

These data will be presented virtually in abstract, poster, and video form during the Innovations in Dermatology: Virtual Spring Conference, March 16–20, 2021. 1,2 TREMFYA is the first and only IL-23 inhibitor therapy approved in the U.S. TREMFYA was approved in the U.S. TREMFYA q4w is not currently FDA-approved.

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The Pharma Data

APRIL 27, 2021

Paris, April 28, 2021. Strong increase in Q1 2021 business EPS ( 1) at CER. Q1 2021 sales increase of 2.4% Q1 2021 business EPS ( 1) growth at CER driven by efficiency and sales performance, supported by a one-time payment. Progress on implementation of the Corporate Social Responsibility strategy. Change at CER.

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Codon

JULY 14, 2024

However, this dropped under 10% in 2021. Despite the initial promise of PFCs and FDA approval of a product called Fluosol-DA in 1989, PFCs have many drawbacks. Before the COVID-19 pandemic, people aged 24 years and under contributed 20% of all blood in the United States.

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The Pharma Data

OCTOBER 26, 2020

FDA Actions. FDA Approval: Last week the FDA approved Veklury (remdesivir) for the treatment of COVID-19 requiring hospitalization in adults and pediatric patients (12 years of age and older). They expect to launch a Phase III trial of the drug in the first quarter of 2021. . Other Industry News.

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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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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. About one year after its initial publication, FDA updated the guidance in February 2021.

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The Pharma Data

JULY 18, 2021

Clinical Data Supporting Approval Demonstrated Non-Inferior Immune Responses for the Serotypes Shared with PCV13 (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F). VAXNEUVANCE Elicited Superior Immune Responses for Serotypes 3, 22F and 33F Compared to PCV13, Which Are Major Causes of Disease.

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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) The Company announced topline preprint study results from this Phase 1/2a sub-study on July 1, 2021. What is the Janssen COVID-19 Vaccine?

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The Pharma Data

JANUARY 4, 2021

5, 2021 06:00 UTC. Food and Drug Administration (FDA) , in combination with Tecentriq ® (atezolizumab) for the first-line treatment of people with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression with no EGFR or ALK genomic tumor aberrations. SOUTH SAN FRANCISCO, Calif.–(

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New Drug Approvals

APRIL 8, 2025

Vimseltinib 1628606-05-2 DCC-3014 2/14/2025 FDA APPROVED, Romvimza 3-methyl-5-[6-methyl-5-[2-(1-methylpyrazol-4-yl)pyridin-4-yl]oxypyridin-2-yl]-2-(propan-2-ylamino)pyrimidin-4-one C 23 H 25 N 7 O 2 , 431.5 Food and Drug Administration (FDA) granted the application for vimseltinib priority review designation. [2] MCT-21-0361.

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The Pharma Data

DECEMBER 31, 2020

The vaccine teaches the cells to make a piece of the spike protein, which triggers an immune response to help prevent illness if later exposed to the virus. In mid-December, the FDA approved Orgovyx (relugolix), the first oral gonadotropin-releasing hormone (GnRH) receptor antagonist for men with advanced prostate cancer.

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The Pharma Data

JANUARY 10, 2021

The European Commission, which will receive the same data, is not expected to approve the AZ/Oxford University vaccine until February or later ( DID , Dec. Moncef Slaoui, chief adviser to the Trump administration’s Operation Warp Speed, said he believes FDA approval of the AZ/Oxford vaccine won’t occur until early April ( DID , Jan.

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