XTalks

MAY 1, 2023

Last week, the US Food and Drug Administration (FDA) granted accelerated approval to Biogen’s Qalsody (tofersen) for the treatment of adult patients with amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 ( SOD1 ) gene. How Does Qalsody Work?

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FDA Approval Gene Genetics Protein 89

XTalks

FEBRUARY 24, 2023

The US Food and Drug Administration (FDA) granted accelerated approval to Genentech’s Lunsumio (mosunetuzumab) for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) who have undergone two or more lines of systemic therapy. New treatment options are critically needed for FL.

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The Pharma Data

JANUARY 12, 2021

million additional doses of the casirivimab and imdevimab antibody cocktail, bringing total potential U.S. Doses are being supplied for use pursuant to the FDA Emergency Use Authorization for high-risk patients with mild to moderate COVID-19 in order to reduce the risk of progression to severe COVID-19 and/or hospitalization.

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XTalks

JUNE 30, 2023

It’s been a big week for cell and gene therapy approvals in the US, including a much-awaited approval for one to treat hemophilia A, the most common form of hemophilia. The approval came after a couple of setbacks, including a rejection in 2020 and a delay earlier this year.

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XTalks

NOVEMBER 30, 2023

New FDA-Approved Treatments For HIV HIV treatment involves the administration of combined antiretroviral therapy (ART) to effectively suppress the viral load, maintain or enhance immune function and reduce the risk of opportunistic infections and cancers commonly associated with HIV. aiming to end the HIV epidemic by 2030.

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The Pharma Data

DECEMBER 29, 2020

First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19. NASDAQ: REGN) today announced encouraging initial data from an ongoing Phase 1/2/3 clinical trial of the Regeneron antibody cocktail, casirivimab and imdevimab, in hospitalized COVID-19 patients requiring low-flow oxygen. futility analysis).

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XTalks

JUNE 15, 2022

The Novavax candidate NVX-CoV2373 is a protein-based vaccine developed using recombinant nanoparticle technology. protein that triggers the immune system to generate antibodies against the virus. If approved, NVX-CoV2373 would become the first available protein-based vaccine against COVID-19 in the US.

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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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The Pharma Data

DECEMBER 5, 2020

(NASDAQ: REGN) today announced updated data for REGN5458, a BCMAxCD3 bispecific antibody, from the Phase 1 portion of a Phase 1/2 trial in patients with relapsed or refractory (R/R) multiple myeloma. BCMA (B-cell maturation antigen) is a protein that is typically over-expressed on multiple myeloma cells.

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The Pharma Data

OCTOBER 28, 2020

NASDAQ: REGN) today announced positive, prospective results from an ongoing Phase 2/3 seamless trial in the COVID-19 outpatient setting showing its investigational antibody cocktail, REGN-COV2, met the primary and key secondary endpoints. Regeneron Pharmaceuticals, Inc. Yancopoulos , M.D., President and Chief Scientific Officer of Regeneron.

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XTalks

MARCH 28, 2024

For CRC, treatment options that are targeting genetic mutations such as BRAF , KRAS and HER2 have been developed. Furthermore, the introduction of multi-targeted kinase inhibitors and monoclonal antibodies is also being examined as a possible form of therapy. Yang Liu and CFO Abid Ansari – Xtalks Life Science Podcast Ep.

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XTalks

MARCH 6, 2024

This includes discussions on cutting-edge technologies and methodologies in brain research, such as neuroimaging, genetic engineering and artificial intelligence. Despite the disappointing launch of Aduhelm and questions around Leqembi, companies like Eli Lilly are continuing to pursue their beta-amyloid monoclonal antibody therapies.

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The Pharma Data

NOVEMBER 9, 2020

Food and Drug Administration (FDA) has granted Fast Track Designation for NVX-CoV2373, the Company’s COVID-19 vaccine candidate. Currently in late-phase clinical development, NVXCoV2373 is a stable, prefusion protein made using Novavax’ nanoparticle technology and includes its proprietary MatrixM adjuvant. About NVX-CoV2373.

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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. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. The award is funding the U.S.

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XTalks

MAY 10, 2023

The exact cause of lupus is not entirely understood, but it is thought to be from a combination of genetic, environmental and hormonal factors. GSK’s Benlysta (belimumab) is a monoclonal antibody that was approved by the US Food and Drug Administration (FDA) in 2011 for the treatment of SLE.

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XTalks

FEBRUARY 5, 2024

Revlimid (Lenalidomide) Revlimid 2022 sales: $9.978 billion Company/Developer: Bristol Myers Squibb Date of first FDA approval: December 27, 2005 Indications Revlimid is FDA-approved for: Myelodysplastic disease (MDS), multiple myeloma, mantle cell lymphoma (MCL), follicular lymphoma and marginal zone lymphoma.

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XTalks

AUGUST 17, 2020

protein-based biologics) and vaccine treatments. Monoclonal antibodies : these are antibodies that are designed to bind to specific targets on cells. protein-based biologics) : are those which bind to specific components (i.e. chimeric receptor antigen [CAR] T cell) immune modulators (i.e. Immune system modulators (i.e.

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The Pharma Data

DECEMBER 8, 2020

Since partnering with Eli Lilly to produce the first monoclonal antibody therapy approved for mild-to-moderate COVID-19 patients, antibody discovery company AbCellera is going big on the Nasdaq. The promise to partners is to “move quickly. Reduce cost. Tackle the toughest problems in drug development.” Nuance Pharma .

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The Pharma Data

OCTOBER 30, 2020

NASDAQ: REGN) received today a recommendation from the independent data monitoring committee (IDMC) for the REGN-COV2 antibody cocktail treatment trials for COVID-19 that the current hospitalized patient trial be modified. TARRYTOWN, N.Y. , Regeneron Pharmaceuticals, Inc.

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XTalks

FEBRUARY 5, 2024

Revlimid (Lenalidomide) Revlimid 2022 sales: $9.978 billion Company/Developer: Bristol Myers Squibb Date of first FDA approval: December 27, 2005 Indications Revlimid is FDA-approved for: Myelodysplastic disease (MDS), multiple myeloma, mantle cell lymphoma (MCL), follicular lymphoma and marginal zone lymphoma.

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XTalks

JUNE 5, 2023

Abrysvo is an unadjuvanted vaccine and is composed of two preF proteins selected to optimize protection against RSV A and B strains. “A The genetic material of RSV (respiratory syncytial virus) encodes 11 proteins. The F-protein facilitates the fusion of the virus with the membrane of the host cell. How Does Abrysvo Work?

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Drug Discovery World

MAY 29, 2024

He says: “If you compare that with what’s happening within the monoclonal antibody space, for instance, everybody’s got standardised processes with standardised equipment. That takes a lot of effort, and some very clever people to get that amount of genetic information into a single plasmid DNA.

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The Pharma Data

JUNE 7, 2022

. “We look forward to providing an important new medicine and helping patients find the relief they so desperately seek from the varied and debilitating symptoms of this disease, contingent upon FDA approval.” EASI=Eczema Area and Severity Index, EASI-75=75 percent reduction in EASI from baseline to Week 16.

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Drug Discovery World

JULY 8, 2024

For decades, the life sciences community held the belief that RNA was merely the intermediary messenger (mRNA) between DNA and protein, a dogma that has been the foundation of biology. By silencing transthyretin (TTR) mRNA, patisiran decreases the production of TTR protein, the molecule responsible for causing the disease.

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XTalks

NOVEMBER 7, 2022

Immunofluorescent staining of CTCs is a CTC isolation method that has been used since the first US Food and Drug Administration (FDA) approval in 2013 for the CellSearch ® CTC enumeration platform. Another method to isolate CTCs is by antibody targeting of white blood cells for removal, followed by collection of untagged CTCs.

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XTalks

SEPTEMBER 17, 2020

Nizoral is prescribed off-label, while the others are FDA approved. Dietary changes, including restriction of salt and animal protein, are also recommended. It’s caused by mutations in the DMD gene, which encodes the dystrophin protein; dystrophin plays an important role in supporting muscle fibers. Lipodystrophy.

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pharmaphorum

NOVEMBER 2, 2021

Dr Laura Moriarty, senior marketing manager at Bio-Rad, looks at the impressive immuno-therapeutic potential of bispecific antibodies (bsAbs). Though their bispecific nature complicates large-scale production and purification workflows, with challenges such as antibody chain mispairing, bsAbs have come a long way since first developed.

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Worldwide Clinical Trials

MAY 30, 2024

Tofersen (Intrathecal injection) This is an antisense oligonucleotide (ASO) that targets SOD1 mRNA to reduce the synthesis of SOD1 protein. An area of interest has been deciphering ALS’s genetic underpinnings and delivering functional copies of dysfunctional genes to the patient.

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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. Food and Drug Administration (FDA). TARRYTOWN, N.Y.,

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XTalks

AUGUST 10, 2022

The US Food and Drug Administration (FDA) has approved AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab-deruxtecan) for the treatment of patients with unresectable or metastatic HER2-low breast cancer. HER2 is a tyrosine kinase receptor that is overexpressed and genetically amplified in approximately 20 percent of breast cancers.

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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. government allocation program. Regeneron Pharmaceuticals, Inc.

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XTalks

JANUARY 4, 2024

The adeno-associated viral (AAV) vector-based gene therapy received approval in Canada for the treatment of adults aged 18 years or older with moderately-severe to severe hemophilia B who are negative for neutralizing antibodies to variant AAV serotype Rh74, Pfizer Canada revealed in its announcement of the approval.

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The Pharma Data

JUNE 7, 2022

New Indication for Amgen’s Fifth FDA-approved Biosimilar. Now Approved to Treat All Available Rituxan ® Indications. Overall, 311 patients were randomized and treated with RIABNI, rituximab RP approved in the EU (rituximab-EU) or rituximab RP approved in the US (rituximab-US).

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Drug Discovery World

MAY 11, 2023

Kerstin Pohl , Senior Global Marketing Manager, Gene Therapy & Nucleic Acid at SCIEX, looks at the application of liquid chromatography-mass spectrometry for analysing host cell proteins. Host cell proteins (HCPs) – proteins derived from the host cells used for viral production—are one class of process-related impurities.

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The Pharma Data

JULY 6, 2021

GlaxoSmithKline plc (LSE/NYSE: GSK) and Alector (Nasdaq: ALEC), today announced a strategic global collaboration for the development and commercialisation of two clinical-stage, potential first-in-class monoclonal antibodies (AL001 and AL101) designed to elevate progranulin (PGRN) levels. ” Arnon Rosenthal, Ph.D.,

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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. Evkeeza — generically known as evinacumab — is a monoclonal antibody. The ANGPTL3 protein inhibits the enzyme activity of lipoprotein lipase (LPL).

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Drug Discovery World

AUGUST 10, 2022

Next, the advent of antibody treatments in 1997 created the first targeted cancer therapy 2. Finally, in 2017, after years of improving T cell engineering techniques, the first chimeric antigen receptor (CAR) T cell therapy received FDA approval. CAR T cells are T cells that have been trained to attack tumours.

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