Drug Target Review

OCTOBER 26, 2023

Genome engineering and gene therapies that manipulate DNA sequences in cells have driven a biotechnological revolution over the past decade. 9 In addition, host immune responses further add to the complexity of developing cell-specific AAV capsids for clinical applications. Molecular Therapy 20 , 1831-1832 (2012).

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Codon

JULY 27, 2023

Their cone cells, which are responsible for color vision, don’t work like normal. But what happens if you restore these cone cells, using gene therapy? approved a gene therapy for hemophilia A for the first time. The therapy works by replacing beta-cells with “fresh” cells taken from a, err…dead person.

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Codon

JULY 27, 2023

Their cone cells, which are responsible for color vision, don’t work like normal. But what happens if you restore these cone cells, using gene therapy? approved a gene therapy for hemophilia A for the first time. The therapy works by replacing beta-cells with “fresh” cells taken from a, err…dead person.

Therapies 52

Therapies RNA DNA Engineering 52

The Pharma Data

NOVEMBER 20, 2020

NASDAQ: REGN) today announced that the antibody cocktail casirivimab and imdevimab administered together (formerly known as REGN-COV2 or REGEN-COV2), a therapy currently being investigated for use in COVID-19 , has received Emergency Use Authorization (EUA) from the U.S. TARRYTOWN, N.Y., November 21, 2020 – Regeneron Pharmaceuticals, Inc.

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The Pharma Data

MARCH 9, 2021

“While results from the CANOPY-2 trial are not what we hoped for in patients with advanced or metastatic non-small cell lung cancer who have been treated with other lines of therapy, these data give us valuable insights into IL-1? inhibition,” said John Tsai, MD, Head of Global Drug Development and Chief Medical Officer at Novartis.

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Drug Target Review

APRIL 26, 2023

With further research, these innovative nanoparticles could represent a major breakthrough in the fields of gene therapy and personalised medicine. The researchers are optimistic that, with additional improvements, these nanoparticles could be used as an inhalable therapy to treat a range of lung ailments, including cystic fibrosis.

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RNA Medical Schools Engineering DNA 98

Codon

OCTOBER 27, 2024

million people with TB went undetected in 2019, but these estimates are uncertain due to inaccuracies in testing. In 2019, physicians were unable to tailor effective antibiotic regimens for 39 percent of new TB cases because the assessments they relied on could not gauge which antibiotics the strains would be susceptible to.

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The Pharma Data

JUNE 2, 2022

.” In the adult phase I/II clinical trials, AFX3772 was well tolerated in participants and demonstrated good immune responses compared to the current standard of care. In July 2021, the US Food and Drug Administration granted Breakthrough Therapy designation for AFX3772 to prevent S. About MAPSTM technology platform.

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The Pharma Data

MAY 31, 2022

In the adult phase I/II clinical trials, AFX3772 was well tolerated in participants and demonstrated good immune responses compared to the current standard of care. In July 2021, the US Food and Drug Administration granted Breakthrough Therapy designation for AFX3772 to prevent S. MAPS TM technology platform.

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The Pharma Data

JANUARY 6, 2021

Quantitative imaging of CD8 T cells enables quicker identification of drug efficacy, therefore potentially reducing the length of clinical trials, reducing costs and helping new therapies to advance to market faster, which ultimately will improve treatment and care of cancer patients. About ImaginAb. ImaginAb Inc.

Licensing 52

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The Pharma Data

MARCH 8, 2021

“While results from the CANOPY-2 trial are not what we hoped for in patients with advanced or metastatic non-small cell lung cancer who have been treated with other lines of therapy, these data give us valuable insights into IL-1? inhibition,” said John Tsai, MD, Head of Global Drug Development and Chief Medical Officer at Novartis.

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Immune Response Clinical Trials Trials Treatment 52

The Pharma Data

JANUARY 11, 2021

Testing Therapies, Antivirals and Vaccines. The advancing rollout of currently approved coronavirus disease 2019 (COVID-19) vaccines provides hope to many that existing lockdowns and social restrictions will soon be lifted, but experts suggest a “return to normal” likely won’t occur until herd immunity is achieved.

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The Pharma Data

OCTOBER 26, 2020

The corticosteroid then works to relieve swelling, redness and itching by targeting the immune response that drives dry eye disease flares. . As the prevalence of dry eye disease increases, there is a tremendous need for new therapies to manage mild-to-moderate dry eye disease patients, many of whom currently go untreated.

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Disease Treatment FDA FDA Approval 52

The Pharma Data

FEBRUARY 24, 2022

The Committee considered that the available evidence was sufficient to conclude that the immune response to a booster dose in adolescents would be at least equal to that in adults. No new safety concerns were identified from the data available.

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Vaccine FDA Small Molecule Immune Response 52

The Pharma Data

NOVEMBER 19, 2020

The findings were that the death rate in several demographics exceeded the same period in 2019. The 2019 full data is not yet publicly available, but they calculated the 2019 death estimates using 2018 CDC data and 2019 population estimates from the U.S. The data was from the U.S. Source link.

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The Pharma Data

OCTOBER 26, 2020

Testing Therapies, Antivirals and Vaccines. based company said the preventative medication boosts immune responses in older and younger adults against the novel coronavirus. Moderna has fully enrolled its late-stage coronavirus disease 2019 (COVID-19) vaccine trial by hitting its target of 30,000 participants.

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Vaccine FDA Approval FDA Clinical Trials 52

The Pharma Data

NOVEMBER 12, 2020

The CALAVI trials were launched based on preclinical and early clinical evidence that Calquence could decrease the hyperinflammatory immune response and improve clinical outcomes in patients hospitalised with respiratory symptoms of COVID-19.1 Wilmington, DE; AstraZeneca Pharmaceuticals LP; 2019. Available online.

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Trials Clinical Trials Immune Response FDA Approval 52

The Pharma Data

OCTOBER 9, 2021

Due to the innovative design of deucravacitinib, Bristol Myers Squibb earned recognition with the 2019 Thomas Alva Edison Patent Award for the science underpinning the clinical development of deucravacitinib. Many patients have an inadequate response or do not respond at all to currently available therapies.

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Disease Trials Science Immune Response 52

The Pharma Data

AUGUST 11, 2020

.–( BUSINESS WIRE )– Bristol Myers Squibb (NYSE: BMY) today announced the Phase 3 CheckMate -577 trial evaluating Opdivo (nivolumab) as an adjuvant therapy for patients with resected esophageal or gastroesophageal junction (GEJ) cancer met its primary endpoint of disease-free survival (DFS) at a pre-specified interim analysis.

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Therapies Trials Disease Treatment 52

The Pharma Data

DECEMBER 23, 2020

All 38 subjects who were evaluable for immunogenicity had balanced cellular and humoral immune responses following the second dose of INO-4800. The antigen is processed naturally in the cell and triggers the desired T cell and antibody-mediated immune responses. About INOVIO.

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DNA Vaccine Clinical Trials Immune Response 40

The Pharma Data

NOVEMBER 10, 2020

We’re excited to be collaborating with Tiziana to support the development of a novel, oral therapy that could provide Crohn’s patients with another option in their repertoire of treatments to combat this devastating disease.”. Crohn’s & Colitis 360, Volume 1, Issue 2, July 2019, otz009. NEW YORK and LONDON, Nov. Weiner, H.

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Clinical Trials Science Disease Trials 40

The Pharma Data

JANUARY 31, 2021

Clover’s S-Trimer antigen adjuvanted with CpG 1018 plus alum demonstrated low reactogenicity while providing high levels of neutralizing antibodies and a strong Th1-biased cell-mediated immune response. Dynavax developed CpG 1018 to provide an increased vaccine immune response, which has been demonstrated in HEPLISAV-B.

Vaccine 52

Vaccine Trials Virus RNA 52

The Pharma Data

SEPTEMBER 15, 2020

Based on the acceptable safety profile and the favorable immune response data, including the 4th dose response data, Pfizer received Breakthrough Therapy Designation. These data represent the longest period of durability observed to date by a gene therapy for hemophilia B patients.

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The Pharma Data

NOVEMBER 29, 2020

Antiviral therapies are used to help control disease, but they are limited by toxicity and the emergence of viral resistance. Participants receive either pre-emptive or prophylactic antiviral therapy post-transplant and are followed for a 12-month observation period. 2019; 102: 900-931. 2019, vol 15, no 11, 2673-2683.

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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. First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19. TARRYTOWN, N.Y. , Regeneron Pharmaceuticals, Inc. futility analysis). . In the U.S.

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The Pharma Data

SEPTEMBER 9, 2020

producing CD8+ T cell responses, which is thought to promote an anti-viral effect. In a preclinical murine model, a single IM immunization of BNT162b2 (0.2, CD4+ and CD8+ T-cells from splenocytes isolated from BNT162b2-immunized mice were strongly positive for IFN? billion doses by the end of 2021.

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New Drug Approvals

DECEMBER 16, 2023

3 Additionally, iptacopan has the benefit of targeting factor B, which only affect the alternative complement pathway, leaving the classic and lectin pathway untouched for the body to still mount adequate immune responses against pathogens. April 2019). 1] It is a complement factor B inhibitor that was developed by Novartis. [1]

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FDA Small Molecule FDA Approval Treatment 62

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. CARLSBAD, Calif.–( –( BUSINESS WIRE )– Lineage Cell Therapeutics, Inc.

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Therapies Clinical Trials Production Treatment 52

The Pharma Data

SEPTEMBER 10, 2021

OS data cut-off date was 12 March 2021; PFS data cut-off date was 24 July 2019. Imfinzi is the only approved immunotherapy in the curative-intent setting of unresectable, Stage III NSCLC after chemoradiation therapy and is the global standard of care based on the PACIFIC Phase III trial. Hazard ratio (95% CI). 1 Investigator-assessed.

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Treatment Immune Response Trials Clinical Trials 52

The Pharma Data

MAY 12, 2021

Additional data to be shared on rilzabrutinib, an investigational, peripheral Bruton’s tyrosine kinase (BTK) inhibitor with Tailored Covalency ® technology intended to treat immune thrombocytopenic purpura (ITP). 4 Currently there are no approved therapies for CAD. Sutimlimab has been granted Breakthrough Therapy by the U.S.

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Disease FDA Treatment Therapies 40

The Pharma Data

SEPTEMBER 17, 2020

This is the focus of vaccines in development and convalescent plasma therapy. 1 Specifically, the test targets antibodies which are directed against the particular region of the viral spike protein responsible for binding to the host cell receptor, which is required for the virus to enter the host cell. In 2019, Roche invested CHF 11.7

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Vaccine Virus Clinical Trials Immune Response 52

The Pharma Data

OCTOBER 28, 2020

Adults with COVID-19 ARDS As cases of COVID-19 surge in the United States and globally, deaths continue to increase from ARDS in ventilator-dependent patients as a result of an overactive immune response in the lungs to COVID-19. million for quarter ended September 30, 2019. million for quarter ended September 30, 2019.

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Treatment Trials Production Disease 40

The Pharma Data

AUGUST 20, 2020

T cell immune responses elicited by BNT162b2 are being evaluated in the German study and the companies expect to submit the data for peer review and potential publication. trial and we look forward to sharing T cell immune response data from the German trial in the near future.”. “It View the full release here: [link].

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The Pharma Data

NOVEMBER 21, 2020

NASDAQ: REGN) today announced that the antibody cocktail casirivimab and imdevimab administered together (also known as REGN-COV2 or REGEN-COV2), a therapy currently being investigated for use in COVID-19, has received Emergency Use Authorization (EUA) from the U.S. Regeneron Pharmaceuticals, Inc. Food and Drug Administration (FDA).

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The Pharma Data

NOVEMBER 1, 2020

Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Clinical and immunological features of severe and moderate coronavirus disease 2019. . Huang C, Wang Y, Li X, et al. Lancet 2020; 395: 497–506. doi:10.1016/S0140-6736(20)30183-5. Chen G, Wu D, Guo W, et al. doi:10.1172/JCI137244.

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Clinical Trials Trials Medical Schools Hospitals 52

The Pharma Data

DECEMBER 17, 2020

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. , Authorized Emergency Use Casirivimab and imdevimab injection is an investigational combination therapy and has been authorized by FDA for the emergency use described above.

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The Pharma Data

SEPTEMBER 9, 2020

During preclinical and clinical studies, BNT162b1 and BNT162b2 emerged as strong candidates based on assessments of safety and immune response. At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. and Germany as well as animal immunogenicity studies.

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