Delveinsight

AUGUST 17, 2021

Food and Drug Administration gave a red flag to FibroGen’s anemia pill roxadustat, for the use in patients suffering from kidney diseases owing to safety concerns that arose after results, which in turn are concluded for the presentation of further clinical studies to assess safety for future medicinal use.

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Pharmaceutical Technology

FEBRUARY 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.

In-Vivo 162

In-Vivo Genomics Genome Gene Editing 162

Scienmag

AUGUST 31, 2020

NEW YORK, NY–A new study of the antibodies produced by people with gluten sensitivity may lead to a better way to detect the condition and treat it.

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Antibody Doctor Doctors Containment 60

Medical Xpress

DECEMBER 1, 2022

In 2021, a group of scientists led by researchers at the University of North Carolina at Chapel Hill, Weill Cornell Medicine and NewYork-Presbyterian reported that the Moderna mRNA vaccine and a protein-based vaccine candidate containing an adjuvant, a substance that enhances immune responses, elicited durable neutralizing antibody responses to SARS-CoV-2 (..)

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Vaccination Vaccine Immune Response Containment 75

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

Vaccination 98

Vaccination Vaccine Antibody Regulation 98

Pfizer

JULY 19, 2022

Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 is immunocompromised or are on a medicine that affects the immune system. The information contained in this release is as of July 19, 2022.

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Vaccination Vaccine Medicine Clinical Trials 100

The Pharma Data

APRIL 18, 2022

The antibodies generated by Pfizer’s COVID-19 vaccine rise more slowly and decline more quickly than those generated by the Moderna vaccine, according to a new study from UVA Health. The researchers determined that both vaccines generated similar peak levels of COVID-fighting antibodies. ” Tracking the COVID-19 Vaccines.

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Antibody Vaccination Vaccine Doctors 52

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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Antibody Medicine Production Trials 52

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

Antibody 52

Antibody Vaccination Vaccine In-Vitro 52

Pfizer

SEPTEMBER 28, 2022

Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.4/BA.5-Adapted Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.4/BA.5-Adapted The information contained in this release is as of September 28, 2022. Tue, 09/27/2022 - 16:15. Pfizer Disclosure Notice.

Vaccination 101

Vaccination Vaccine Medicine Clinical Trials 101

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.,

Antibody 52

Antibody Manufacturing Production Sales 52

Camargo

NOVEMBER 29, 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. Essentially, a biologic is a product that is produced from living organisms or that contains components of living organisms.

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Development Protein Production Hormones 180

The Pharma Data

DECEMBER 11, 2020

The test has been designed to quantitatively measure of immunoglobulin G (IgG) antibodies to aid clinicians in identifying patients with an immune Covid-19 response pre- and post-vaccination. As we follow individuals over the course of a year, we are repeatedly testing them for both virus and antibodies.”.

Antibody 52

Antibody Vaccination Vaccine Containment 52

pharmaphorum

MAY 11, 2021

Called eRNA for short, this class of medicines is programmable and can continuously express therapeutic proteins inside the body. This makes the body into a “drug factory”, allowing for long-lasting medicines that allow for repeat redosing and can be administered easily by several routes.

RNA 98

RNA Drugs Protein Immune Response 98

pharmaphorum

JUNE 9, 2022

mRNA-1273.214 stimulated almost twice the neutralising antibody levels against the Omicron strain than Spikevax , with a significantly higher response also seen against other variants of concern, one month after administration, according to the company. It has predicted sales of COVID-19 vaccines will be around $21 billion this year.

Vaccine 105

Vaccine Vaccination Containment Clinical Trials 105

The Pharma Data

DECEMBER 31, 2020

Antibodies Respond Differently to Severe Versus Mild COVID-19. Researchers at Stanford Medicine found that COVID-19 antibodies preferentially target different parts of the SARS-CoV-2 virus in mild COVID-19 cases than they do in severe cases. In milder cases, the antibodies seem to do a better job of binding to the spike protein.

Antibody 52

Antibody Research Bacteria Genetics 52

XTalks

JANUARY 31, 2022

The third group will contain unimmunized individuals who will get three doses of the omicron shot. Neutralizing Antibody Data for Omicron Targeting. The study showed that antibody neutralization against omicron decreased by 6.3-fold Moderna will be evaluating its omicron targeting booster through extension of an earlier study.

Vaccine 98

Vaccine Vaccination Trials Antibody 98

pharmaphorum

OCTOBER 2, 2020

It’s an historic announcement, bringing hope that the vaccine could be approved in the near future, although the European Medicines Agency did not say how long the process will take. But this does not mean that the CHMP is ready to make a conclusion on the safety and efficacy of the vaccine.

Regulation 105

Regulation Vaccine Vaccination Protein 105

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. One common characteristic for most if not all biologics is the triggering of an immune response or anti-drug antibodies.

Development 161

Development Production Immune Response Licensing 161

The Pharma Data

APRIL 3, 2021

The study aimed to determine whether an investigational anti-coronavirus hyperimmune intravenous immunoglobulin (H-Ig) medicine (referred to by the Alliance as CoVIg-19) could reduce the risk of disease progression when added to standard of care treatment including remdesivir in hospitalized adult patients at risk for serious complications.

Clinical Trials 52

Clinical Trials Clinical Trials Medicine Trials 52

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.

Antibody 52

Antibody Production Manufacturing Clinical Trials 52

Pharmaceutical Technology

JULY 29, 2022

Pfizer completed a submission to the European Medicines Agency (EMA) for an Omicron-adapted bivalent Covid-19 vaccine candidate, based on the BA.1 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.”

Manufacturing 130

Manufacturing Vaccination Vaccine Packaging 130

XTalks

AUGUST 18, 2023

Both are bispecific antibodies, administered as subcutaneous infusions, that directly engage CD3+ T cells to target cancer cells that express BCMA. Multiple myeloma is an aggressive blood cancer that affects plasma cells, which make antibodies that help the immune system fight infections.

FDA Approval 98

FDA Approval Drugs Antibody Trials 98

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).

Antibody 52

Antibody Trials Production Clinical Trials 52

Pharmaceutical Technology

MAY 24, 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.

Protein 130

Protein Antibody Medicine Development 130

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.

Antibody 130

Antibody DNA Genomics Genome 130

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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Antibody Development Licensing Licensing 40

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. INDIANAPOLIS, Nov. 9, 2020 /PRNewswire/ — The U.S. Lilly’s chief scientific officer and president of Lilly Research Laboratories.

Antibody 52

Antibody Medicine Manufacturing Trials 52

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. The Federal Court upheld the Minister’s decision; AbbVie’s appeal of the Federal Court’s decision is pending (Court File No.

Antibody 52

Antibody Production Regulation Marketing 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.

Antibody 52

Antibody Production Clinical Trials Clinical Trials 52

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

Marketing 85

Marketing Antibody Drugs Sales 85

The Pharma Data

JANUARY 26, 2021

. “These exciting results, which replicate positive Phase 2 data in a much larger set of patients, add valuable clinical evidence about the role neutralizing antibodies can play in fighting this pandemic. Lilly’s chief scientific officer and president of Lilly Research Laboratories. have reached record highs.

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Antibody Trials Clinical Trials Clinical Trials 52

The Pharma Data

SEPTEMBER 20, 2020

20, 2020 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced that updated data from the full Phase 1 cohort of the CodeBreaK 100 clinical study, evaluating sotorasib (proposed INN for AMG 510) in 129 patients across multiple advanced solid tumors, were published in the New England Journal of Medicine (NEJM). THOUSAND OAKS, Calif.

Medicine 52

Medicine Production Sales Clinical Trials 52

Pharmaceutical Technology

DECEMBER 9, 2022

Beyond our expertise in small molecules, we have built a solid reputation with biopharmaceutical companies for the characterisation and analysis of monoclonal antibodies, therapeutic proteins and biosimilars. All our equipment is in line with the latest European Medicines Agency (EMA) and FDA methods.

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The Pharma Data

OCTOBER 28, 2020

government to supply 300,000 vials of bamlanivimab (LY-CoV555) 700 mg, an investigational neutralizing antibody, for $375 million. “Lilly has leveraged our deep scientific capability to fight this pandemic and we are proud of our efforts to develop potential medicines to combat COVID-19. INDIANAPOLIS, Oct. “The U.S.

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pharmaphorum

NOVEMBER 16, 2020

The EMA’s human medicines committee has recommended approval of a fixed-dose combination of Roche’s breast cancer drugs Herceptin and Perjeta – part of the company’s defense against Herceptin biosimilars. Despite the impact of the pandemic on cancer care, Perjeta grew 17% to CHF 2.9 billion ($3.2

Production 98

Production Containment Drugs Sales 98

The Pharma Data

JANUARY 19, 2021

19, 2021 — For patients hospitalized with COVID-19 and not receiving mechanical ventilation, the risk for death is reduced with transfusion of plasma with higher versus lower levels of anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) immunoglobulin G (IgG) antibodies, according to a study published online Jan.

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Antibody Containment Medicine Research 52