The Pharma Data

DECEMBER 29, 2020

As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes. The analysis was prospectively designed to focus on patients who had not yet mounted their own immune response to SARS-CoV-2 (i.e., Regeneron Pharmaceuticals, Inc.

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Drug Discovery World

MAY 9, 2023

Despite considerable progress in cancer drug development over the past few decades, there remains a chasm between the number of investigational new drug (IND) approvals and commercialised oncology drugs. Fewer than 5% of oncology drugs that enter clinical trials in the US receive US FDA approval.

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The Pharma Data

NOVEMBER 30, 2020

CoV2373 is a stable, prefusion protein antigen derived from the genetic sequence of the SARS-CoV-2 coronavirus spike (S) protein and adjuvanted with Novavax’ proprietary Matrix?M. pivotal Phase 3 trial update. Novavax completed enrollment of 15,000 participants in a pivotal Phase 3 clinical trial being conducted in the U.K.

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The Pharma Data

NOVEMBER 9, 2020

Novavax expects to begin its pivotal Phase 3 clinical trial in the United States and Mexico by the end of November. Data from the event-driven trial could support global authorization and approval, including in the U.S. and globally.”. About NVX-CoV2373. and Australia.

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The Pharma Data

DECEMBER 16, 2020

To this point, Moderna has only submitted two months of follow-up safety data, and the FDA typically requires six months for a full approval. intends to ship just shy of six million doses of Moderna’s vaccine once the FDA approves EUA. Both vaccines have shown about 95% efficacy in preventing novel coronavirus infections.

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STAT News

MARCH 6, 2023

Unlike most people who receive medications yet to be cleared by the Food and Drug Administration, none of these patients is getting the vaccines as part of a clinical trial. Instead, the 26 patients paid the foundation to create the vaccines and provide them through the FDA’s expanded access program.

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The Pharma Data

OCTOBER 28, 2020

Today’s data, involving an additional 524 patients from the ongoing Phase 2/3 trial, provides definitive final virology results and meets the clinical endpoint of reducing medical visits. TARRYTOWN, N.Y. , 28, 2020 /PRNewswire/ — . Regeneron has shared these results with the U.S. Regeneron Pharmaceuticals, Inc.

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pharmaphorum

APRIL 26, 2022

Research into the area is being made possible through advancements in technology, such as being able to sequence genes at scale, allowing researchers to gain more detailed genetic data on the microbiome. In the trial, Seres announced that the product candidate had met its primary endpoint, showing a statistically significant 30.2%

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Drug Discovery World

APRIL 14, 2023

He is being recognised for his revolutionary contributions to developing the first gene-edited cell-based therapy for cancer that involves the genetic re-engineering of a patient’s own T cells to combat their disease, and for demonstrating that adoptive T-cell therapy can induce remission and in some cases cure patients with advanced cancer.

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Delveinsight

AUGUST 4, 2021

Similarly, genetics, immune response, and environmental factors also influence the occurrence of Neurological Conditions. Over the past few years, certain medications have been approved worldwide for the treatment of Neurological Disorders. and Neurimmune are actively working in the Alzheimer’s Therapeutics Market.

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XTalks

AUGUST 17, 2020

Cue Biopharma is a Cambridge, Massachusetts-based clinical-stage biotechnology company that is focused on developing injectable immune biologics using its proprietary Immuno-STAT (Selective Targeting and Alteration of T cells) platform. Cell-Based Immunotherapy vs. Immune Biologics. Immune system modulators (i.e.

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The Pharma Data

DECEMBER 18, 2020

In making this determination, the FDA can assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness, and manufacturing quality information. The Moderna COVID-19 Vaccine contains messenger RNA (mRNA), which is genetic material. The vaccine was 94.1%

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The Pharma Data

DECEMBER 17, 2020

NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. TARRYTOWN, N.Y. , 17, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc.

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XTalks

JUNE 5, 2023

This interference may reduce the antiviral T-cell response or, in some cases, trigger the activation of unwanted pro-inflammatory T-cells, thus increasing the risk of severe lung infections. The genetic material of RSV (respiratory syncytial virus) encodes 11 proteins. How Does Abrysvo Work? percent compared to a placebo.

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XTalks

MARCH 13, 2023

The US Food and Drug Administration’s (FDA) Office of Tissues and Advanced Therapies (OTAT) held a recent town hall where three experts from the regulator provided guidance on how to design and conduct gene therapy clinical trials for rare diseases. There are around 300 million people worldwide living with a rare disease.

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Gene Therapy Clinical Trials Clinical Trials Gene 52

XTalks

JUNE 9, 2022

What happens when the liver is unable to process bad cholesterol due to genetic factors? It is one of the common genetic causes of premature coronary heart disease. Doortje Reijman, trial investigator and research associate in Pediatric Metabolic Diseases and Nephrology at the Amsterdam University Medical Center.

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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.,

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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.

Antibody 52

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Delveinsight

SEPTEMBER 8, 2021

The exact cause of SLE is unknown; however, factors such as sunlight and drugs may precipitate the condition, and many studies have revealed a complex genetic basis. Hydroxychloroquine and BENLYSTA are the FDA-approved therapies for SLE treatment. The severity of lupus flares ranges from moderate to severe.

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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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pharmaphorum

NOVEMBER 2, 2021

In 2019, there were 57 bsAb candidates in clinical trials, against both haematological and solid tumours. The BiTE platform is an innovative technology designed to engage the immune system against numerous stages and types of cancers. Five bsAbs delivering payloads entered clinical trials in 2019, four of which targeted solid tumours.

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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.

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Drug Discovery World

AUGUST 1, 2023

They are a promising approach for the treatment of genetic drivers of disease.” AstraZeneca’s non-alcoholic steatohepatitis (or ‘NASH’) study is a prime example of the value of ASOs 2. Though some genetic mutations are harmful, others can be protective.

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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., ” New Analyses From the LUMAKRAS Phase 2 CodeBreaK 100 Clinical Trial. Reese, M.D.,

Trials 52

Trials Clinical Trials Clinical Trials Clinical Development 52

pharmaphorum

OCTOBER 31, 2022

It is the first FDA-approved treatment for Zaire ebolavirus. Yancopoulos continued: “Our scientists realised that the science demanded they adapt these technologies to deliver the first FDA-approved recombinant monoclonal antibody treatment for any viral disease, and they picked one of the most challenging ones in Ebola.”.

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