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.

Antibody 52

Antibody Medicine Production 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

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

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

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.

FDA Approval 98

FDA Approval Medicine Vaccination Vaccine 98

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

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 Genome Genomics Gene Editing 162

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

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

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”).

Antibody 40

Antibody Development Licensing Licensing 40

Pharmaceutical Technology

JUNE 24, 2022

1 variant, on 22 June, Moderna said its booster also showed a “potent” antibody response against Omicron subvariants BA.4 The mRNA-1273.214 booster contains the original Spikevax vaccine and a candidate targeting Omicron BA.1 In addition to providing protection against the Omicron BA.1 1 variant of concern.

Vaccination 264

Vaccination Vaccine Antibody Medicine 264

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

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

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

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

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 Genome Genomics 130

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. Assistant Professor of Medicine at the Icahn School of Medicine at Mount Sinai in New York and a trial investigator.

Antibody 40

Antibody Production Trials Medicine 40

Drug Discovery World

AUGUST 9, 2023

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted Aleta Biotherapeutics a clinical trial authorisation (CTA) to evaluate biologic ALETA-001 in a Phase I/II clinical trial in patients with B-cell malignancies who are relapsed/refractory to CD19 CAR T cell therapy.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Licensing 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

Drug Discovery World

JANUARY 9, 2024

2024 is anticipated to be a transformational year for the pharma industry, with new modalities like antibody drug conjugates and AI/machine learning providing therapies for patients with limited treatment options. The 2024 Drugs to Watch, are: 1. Due to a delayed US launch it remains a drug to watch for 2024.

Drugs 69

Drugs Antibody Gene Editing Medicine 69

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.

Antibody 40

Antibody Trials Production Clinical Trials 40

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.

Antibody 52

Antibody Containment Medicine Research 52

The Pharma Data

JUNE 17, 2022

Sandoz, a global leader in generic and biosimilar medicines, today announced that the European Medicines Agency (EMA) has accepted the application for high concentration formulation 100 mg/mL (HCF) of its biosimilar Hyrimoz ® (adalimumab) for regulatory review. Our ambition is to be the world’s leading and most valued generics company.

Medicine 52

Medicine Generic Pharmaceutical FDA Approval Packaging 52

XTalks

JANUARY 9, 2024

New treatments being evaluated in these cancers include Eli Lilly’s Retevmo (selpercatinib) and Blueprint Medicines and Genentech’s Gavreto (pralsetinib), which target mutations in the rearranged during transfection ( RET ) gene. Blocking BAFF interaction : Belimumab, which is an anti-BAFF monoclonal antibody in a Phase II trial.

Hormones 105

Hormones Antibody Trials Production 105

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

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 Vaccination Vaccine Protein 105

The Pharma Data

OCTOBER 29, 2020

Tokyo, Japan) today announced that the European Medicines Agency (EMA) has confirmed it has accepted for review, following a standard timetable, the Marketing Authorization Application (MAA) for aducanumab, an investigational treatment for Alzheimer’s disease. CAMBRIDGE, Mass. and TOKYO, Oct. About Aducanumab. please visit [link].

Medicine 40

Medicine Marketing Clinical Trials Clinical Trials 40

The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) to begin a Phase I clinical trial of hAd5-COVID-19, the company’s novel COVID-19 vaccine candidate that targets both the inner nucleocapsid (N), engineered to activate T cells, and outer spike (S) protein, engineered to activate antibodies against the coronavirus (SARS-CoV-2).

Antibody 52

Antibody Vaccination Vaccine Trials 52

The Pharma Data

JANUARY 17, 2021

The medicine, an anti-SARS-CoV-2 immunoglobulin, given subcutaneously, would provide immediate protection after exposure to the virus and could be used to protect the elderly and healthcare workers. It could also help contain outbreaks in places where the vaccination hasn’t begun or is still underway.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Containment 52

The Pharma Data

APRIL 4, 2023

The approval includes all indications covered by the reference medicine*: rheumatic diseases, Crohn’s disease, ulcerative colitis, plaque psoriasis, uveitis and hidradenitis suppurativa. About adalimumab Adalimumab is a human immunoglobulin G1 (IgG(1)) monoclonal antibody targeting tumor necrosis factor alpha (TNF-a).

Medicine 40

Medicine Generic Pharmaceutical FDA Approval Marketing 40

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

JUNE 25, 2021

protofibril antibody for the treatment of Alzheimer’s disease (AD). Breakthrough Therapy designation is an FDA program intended to expedite the development and review of medicines for serious or life-threatening conditions. Lecanemab selectively binds to neutralize and eliminate soluble, toxic amyloid-beta (A?)

Antibody 40

Antibody Clinical Trials Clinical Trials Development 40

The Pharma Data

JANUARY 12, 2021

Dr Graham is a medicines development expert and Infectious Diseases Epidemiologist with global Biotech and Pharma R&D experience in Phase I-IV therapeutics as well as in-vivo & in-vitro diagnostics, across many modalities. THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION (EU) NO 596/2014.

Life Science 52

Life Science Antibody In-Vivo In-Vitro 52

Roots Analysis

OCTOBER 24, 2023

Owing to the advancement in clinical pharmacology and oncology domain, and the rising demand for targeted therapeutics and precision medicines, high potency active pharmaceutical ingredients (HPAPIs) and cytotoxic drugs have become one of the key areas of interest to researchers and drug manufacturers across the globe.

Manufacturing 40

Manufacturing Hormones Contamination Containment 40

The Pharma Data

DECEMBER 10, 2020

Food and Drug Administration and the European Medicines Agency. Food and Drug Administration (FDA) and have submitted the final Conditional Marketing Authorization Application (CA) following rolling submissions with the European Medicines Agency (EMA) and several other regulatory agencies around the world.

Vaccination 52

Vaccination Vaccine Trials Medicine 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.

Development 130

Development Manufacturing Production Vaccination 130