Camargo

DECEMBER 13, 2021

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610.

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Pharmaceutical Technology

SEPTEMBER 15, 2022

The increase in the production of biological drugs such as vaccines, gene and cell therapies, and monoclonal antibodies, is increasing the volume of injectable drug products in the global healthcare market. Discover the top commercial dose injectables companies in contract marketing. Factors driving the demand for injectables.

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Pharmaceutical Technology

FEBRUARY 25, 2023

The therapeutic candidate is a bispecific antibody targeting CD3 and claudin 18.2 Xencor overview Xencor is a clinical stage biopharmaceutical company that focused on discovering and developing engineered monoclonal antibody and cytokine therapeutics to treat patients with cancer and autoimmune diseases.

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Pharmaceutical Technology

FEBRUARY 25, 2023

The therapeutic candidate is a bispecific antibody targeting CD3 and claudin 18.2 Xencor overview Xencor is a clinical stage biopharmaceutical company that focused on discovering and developing engineered monoclonal antibody and cytokine therapeutics to treat patients with cancer and autoimmune diseases.

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Pharmaceutical Technology

FEBRUARY 25, 2023

The therapeutic candidate is a bispecific antibody targeting CD3 and claudin 18.2 Xencor overview Xencor is a clinical stage biopharmaceutical company that focused on discovering and developing engineered monoclonal antibody and cytokine therapeutics to treat patients with cancer and autoimmune diseases.

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Pharmaceutical Technology

SEPTEMBER 8, 2022

The information contained within the download document is designed for pharmaceutical executives, developers, research scientists and associates, regulatory solutions consultants, and any other individual involved in API biologics production in the pharmaceutical industry.

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The Pharma Data

JANUARY 29, 2021

(MedMira) (TSXV: MIR) announces the development of a rapid antibody test prototype that detects the presence of the neutralizing antibodies against the SARS-CoV-2 virus. At this time, there is no guarantee that this product will meet all regulatory requirements and receive a subsequent regulatory approval. About MedMira.

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XTalks

FEBRUARY 23, 2022

The modular production units are housed in containers that come equipped with raw starting materials and state-of-the-art technology for producing mRNA-based vaccines from start to finish, except for the fill-and-finish step, which will be carried out by local manufacturers.

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The Pharma Data

SEPTEMBER 17, 2020

17, 2020 /PRNewswire/ — Eli Lilly and Company (NYSE:LLY) and Amgen (NASDAQ:AMGN) today announced a global antibody manufacturing collaboration to significantly increase the supply capacity available for Lilly ‘s potential COVID-19 therapies. INDIANAPOLIS and THOUSAND OAKS, Calif. Reese , M.D.,

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The Pharma Data

SEPTEMBER 11, 2021

Boehringer Ingelheim believes Twist’s ability to generate potent, diverse therapeutic antibodies by mining its comprehensive libraries, combined with our extensive capabilities and experience in drug discovery and development, will enable us to deliver breakthrough opportunities to patients,” said Clive R. About Twist Bioscience Corporation.

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Pharmaceutical Technology

FEBRUARY 1, 2023

AstraZeneca’s Synagis (palivizumab), which was approved in 1998, was the only monoclonal antibody (mAb) available for use to prevent RSV in high-risk infants for the past two decades. However, specific antibody-resistant mutations have already been documented within the RSV- F protein after prophylactic administration of nirsevimab.

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Roots Analysis

DECEMBER 11, 2022

Antibody drug conjugates (ADCs) are an upcoming class of targeted therapeutic agents that have garnered the attention of pharmaceutical companies, and academic / research institutions across the world. Antibody drug conjugates market is presently an established therapeutic concept with 11 approved products.

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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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XTalks

JANUARY 21, 2025

The liquid portion of the blood (serum or plasma) containing antibodies is separated and tested using the Liason Biotrin parvovirus B19 IgG plus test on a Liason XL analyzer. If parvovirus B19 antibodies are present, they bind to the chemicals and particular particles in the test, producing a light signal.

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XTalks

AUGUST 16, 2022

The vaccine, known as mRNA-1273.214 or Spikevax Bivalent Original/Omicron, is a next-generation bivalent vaccine that contains mRNA-1273 (Spikevax) and a vaccine candidate targeting the Omicron variant of concern (BA.1). Additionally, the vaccine elicited robust neutralizing antibody responses against the Omicron subvariants BA.4

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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. Under the new agreement, the government will purchase all finished doses of the casirivimab and imdevimab antibody cocktail delivered by June 30, 2021 , up to 1.25 TARRYTOWN, N.Y. , 12, 2021 /PRNewswire/ — . million doses.

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Pharmaceutical Technology

DECEMBER 9, 2022

M&A – Commended PRODUCT LAUNCHES – Commended RESEARCH AND DEVELOPMENT – Commende d. The company is ranked in the M&A, PRODUCT LAUNCHES and RESEARCH AND DEVELOPMENT categories in the 2022 Pharmaceutical Technology Excellence Rankings. Pharmaceutical Technology Excellence Rankings – The Verdict.

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The Pharma Data

SEPTEMBER 17, 2020

The new Elecsys Anti-SARS-CoV-2 S test can quantitatively measure the level of antibodies against SARS-CoV-2 in patients who have been exposed to the virus. The test targets antibodies against the spike protein. The majority of current candidate vaccines aim to induce an antibody response against the spike protein. “As

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pharmaphorum

JULY 27, 2022

Clinical data show strong neutralising antibody responses against Omicron BA.1, 1-containing boosters, but last month the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) concluded that future booster campaigns against COVID-19 should ideally include vaccines with a component targeting BA.4

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The Pharma Data

JANUARY 11, 2021

a San Diego-based biotechnology company with an array of technology platforms for antibody discovery and optimization, and novel NK and T cell engager generation, today announced licensing of a panel of its anti-SARS-CoV-2 antibody clones to IGM Biosciences for COVID-19 therapy development.

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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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Pharmaceutical Technology

JULY 29, 2022

And we are very prepared and have data that will answer those questions, what would be the advantage of shifting to an Omicron-containing vaccine, whether it's monovalent or bivalent.” The booster dose elicited a significantly higher neutralising antibody response against Omicron subvariants BA.4

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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. TARRYTOWN, N.Y., November 21, 2020 – Regeneron Pharmaceuticals, Inc.

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Pharma in Brief

DECEMBER 17, 2023

On December 4, 2023, the Federal Court held that a patent claiming a formulation of adalimumab, a monoclonal antibody used to treat autoimmune diseases, is valid and is being infringed by a biosimilar product. JAMP’s product was the eighth adalimumab biosimilar to come to market in Canada. collectively, AbbVie ) product.

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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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pharmaphorum

OCTOBER 2, 2020

All that the agency has is preliminary data from pre-clinical and early clinical studies suggesting the vaccine triggers the production of antibodies and T-cells that target the virus. But this does not mean that the CHMP is ready to make a conclusion on the safety and efficacy of the vaccine.

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The Pharma Data

JANUARY 12, 2021

LONDON, UK / ACCESSWIRE / January 13, 2021 / Hemogenyx Pharmaceuticals plc (LSE:HEMO), the biopharmaceutical group developing new therapies and treatments for blood diseases, is pleased to announce that it has successfully completed the development of its CDX antibody with a leading global pharmaceutical company (“GlobalCo”).

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Roots Analysis

APRIL 15, 2024

These complex entities, such as antibodies, antibody drug conjugates, cell therapies, gene therapies, and therapeutic proteins, are highly specific molecules that are designed to precisely target biomarkers associated with a particular disease pathway.

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The Pharma Data

JANUARY 13, 2021

This is our sixth global approval for an internally-developed product, and our first approval for tislelizumab in a lung cancer indication, an area where we believe tislelizumab can have a large impact for patients.”. Tislelizumab (BGB-A317) is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to Fc?R

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Delveinsight

OCTOBER 1, 2021

This disease is associated with antibodies directed against the acetylcholine receptor, muscle-specific kinase (MUSK), lipoprotein-related protein 4 (LRP4), or agrin in the postsynaptic membrane at the neuromuscular junction. Prograf is available for oral administration in the form of capsules (tacrolimus capsules USP) containing 0.5

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XTalks

DECEMBER 14, 2021

After the success of its first and very timely commercial product Spikevax — Moderna’s mRNA vaccine for COVID-19 — Moderna leveraged the same mRNA technology to create a vaccine against influenza. Antibody levels against the A strains were higher than the B subtypes.

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The Pharma Data

NOVEMBER 9, 2020

Food and Drug Administration (FDA) today granted Emergency Use Authorization (EUA) for Eli Lilly and Company’s (NYSE: LLY) investigational neutralizing antibody bamlanivimab (LY-CoV555) 700 mg. For media resources, including product images and fact sheets, please click here. INDIANAPOLIS, Nov.

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The Pharma Data

FEBRUARY 18, 2022

The company has introduced its approach to establishing scalable vaccine production by developing and delivering turnkey mRNA manufacturing facilities based on a container solution. Each module is built of six ISO sized containers (2.6m

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XTalks

JANUARY 9, 2024

Types of Thyroid Conditions There are several different thyroid conditions, with each affecting thyroid hormone production or the gland’s structure, leading to a range of health issues. Hyperthyroidism is often treated with medications, radioactive iodine, or surgery to reduce hormone production.

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Pharmaceutical Technology

MAY 15, 2023

Adeno-associated virus vectors, alcohol dehydrogenase compositions, and antibody serum stabilisers are some of the accelerating innovation areas, where adoption has been steadily increasing. Among maturing innovation areas are anti-influenza antibody compositions and anti-interleukin-1, which are now well established in the industry.

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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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The Pharma Data

DECEMBER 22, 2020

has been using an exclusively licensed antibody complex to develop new cancer therapies based on its Illuminox TM technology platform. Rakuten Medical’s first pipeline drug developed on Illuminox is ASP-1929, an antibody-drug conjugate comprised of the antibody cetuximab and IRDye® 700DX, a light activatable dye.

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