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. futility analysis). The results passed the futility analysis (p<0.3

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The Pharma Data

DECEMBER 17, 2020

These follow-on data provided the first definitive prospective evidence demonstrating anti-viral activity for a treatment regimen now available for COVID-19, and also further documented the ability of this treatment to decrease the need for further medical attention,” said George D. Yancopoulos , M.D.,

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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

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. Serious adverse events were numerically more frequent with placebo than REGN-COV2 treatment (0.8% There was a 1.08

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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

SEPTEMBER 8, 2021

Phase 3 data from RELATIVITY-047 demonstrate prolonged benefit beyond initial treatment of the LAG-3 blocking antibody relatlimab and PD-1 inhibitor nivolumab fixed-dose combination for patients with previously untreated unresectable or metastatic melanoma. Summary of Presentations. All times noted are Central European Summer Time (CEST).

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Broad Institute

OCTOBER 11, 2023

Manguso, who’d recently graduated from college and was conducting research at the University of Copenhagen as a Fulbright scholar, moved back to the Boston area to be with his mother as she underwent treatment. His mother had a presentation of the disease that suggested her immune system was already on the job.

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Codon

JULY 14, 2024

However, this dropped under 10% in 2021. The transfusion of platelets thus seems like an obvious treatment to stem bleeding. Despite the initial promise of PFCs and FDA approval of a product called Fluosol-DA in 1989, PFCs have many drawbacks. However, the process is actually a system-wide effort.

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Drug Discovery World

MAY 11, 2023

Gene-based therapeutics and vaccines hold immense potential for more efficient and personalised treatment and prevention of complex diseases. Another dangerous consequence can occur when the therapeutic or vaccine introduces proteins that can activate an uncontrolled immune response. ” haematologica 107.4 2022): 947.

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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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Vaccine Production FDA FDA Approval 52

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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Vaccine FDA Approval FDA Disease 52

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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Treatment Immune Response Trials FDA Approval 52

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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Vaccine Trials Clinical Trials Therapies 52

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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FDA Approval Vaccine FDA Immune Response 52

The Pharma Data

NOVEMBER 20, 2020

Food and Drug Administration (FDA). 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.

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Therapies FDA Clinical Trials Hospitals 52

The Pharma Data

JULY 6, 2021

PGRN is a key regulator of immune activity in the brain with genetic links to multiple neurodegenerative disorders, making it one of the most attractive genetically validated targets for the development of new immuno-neurology treatments. ” Arnon Rosenthal, Ph.D., About Frontotemporal Dementia (FTD).

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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. The ultimate goal of treatment in earlier stages of cancer is to prevent the disease from coming back as we work towards a cure for these patients. vs 8.9%; OR 5.70, 95% CI: 3.16-10.26),

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Trials Treatment Immune Response Clinical Trials 52

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. Food and Drug Administration (FDA). In the first quarter of 2021, we expect to increase available REGEN-COV2 global supply as we continue our collaboration with Roche.”

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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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The Pharma Data

DECEMBER 15, 2020

The human monoclonal antibody targets specific immune plasma cells. Treatment induced sustainable clinical responses and reduced systemic inflammation. Daratumumab already is approved for the treatment of multiple myeloma. The FDA has set an action date of July 7, 2021. Oral, Small Molecules.

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Disease Clinical Trials Small Molecule Trials 52

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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Treatment Trials Therapies FDA Approval 52

The Pharma Data

SEPTEMBER 8, 2021

Amgen (NASDAQ: AMGN) today announced results from two analyses of the Phase 2 CodeBreaK 100 clinical trial evaluating LUMAKRAS™ (sotorasib), the first and only KRAS G12C inhibitor approved in the U.S., in the treatment of previously treated patients with advanced or metastatic KRAS G12C-mutated non-small cell lung cancer (NSCLC).

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