MHRA authorises Moderna’s omicron-containing bivalent booster
Pharma Times
AUGUST 15, 2022
Study results show the candidate has demonstrated significantly higher antibodies against Omicron
Syncromune and Eucure enter antibody licence deal
Pharmaceutical Technology
OCTOBER 19, 2022
Syncromune and Biocytogen Pharmaceuticals’ wholly owned subsidiary Eucure Biopharma have entered an exclusive global licence agreement for OX40 antibody YH002 and two other active ingredients. . The post Syncromune and Eucure enter antibody licence deal appeared first on Pharmaceutical Technology.
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Antibodies, Immunity, and COVID-19
JAMA Internal Medicine
NOVEMBER 23, 2020
Widespread availability of commercial assays that detect anti–severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies has enabled researchers to examine naturally acquired immunity to coronavirus disease 2019 (COVID-19) at the population level.
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UK MHRA grants authorisation for Moderna’s Covid-19 booster vaccine
Pharmaceutical Technology
AUGUST 15, 2022
The updated, Omicron-containing bivalent vaccine that acts on two coronavirus variants is indicated as a booster dose for active immunisation for the prevention of Covid-19 in people of this age group. In baseline seronegative subjects, the updated vaccine offered a superior neutralising antibody response against Omicron (BA.1)
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Maternal Antibodies: How Allergies Can be Passed from Mothers to Children
XTalks
NOVEMBER 4, 2020
It has long been known that mothers greatly influence the development of the growing fetus by not only providing nutrients through the placenta, but also a growing list of biological elements including beneficial antibodies, gut bacteria and now, allergies. They reported their findings last week in the journal Science.
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No drugs for prions: could new approaches alleviate therapeutic scarcity?
Pharmaceutical Technology
AUGUST 5, 2022
This list includes the monoclonal antibody (mAb) PRN100 developed at University College London (UCL) and ALX-002, a treatment developed by Allyx Therapeutics that is also being studied for Alzheimer’s disease. Since research needs to be done under containment conditions, samples cannot be moved across different facilities, he explains.
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Unique antibody profile sets gluten sensitivity apart from celiac disease
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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Leading freeze-drying systems suppliers for the pharmaceutical industry
Pharmaceutical Technology
MARCH 10, 2023
Pharmaceutical and biotechnology industries widely use freeze-drying systems to protect vaccines, antibodies, antibiotics such as penicillin, blood plasma, proteins, enzymes, hormones, viruses, and bacteria from heat and minimise their biological activity. The process eliminates the disadvantages of conventional drying methods or freezing.
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Covid-19 vaccines targeting Omicron variants expected to be ready for this autumn
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.
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Merck wins regulatory approval for combination therapy to treat la/mUC
Pharmaceutical Technology
APRIL 4, 2023
The combination therapy can be used to treat la/mUC patients who do not qualify for cisplatin-containing chemotherapy. Merck stated that the regulatory approval represents the first of its kind received by an anti-PD-1 therapy in combination with an antibody-drug conjugate for use in targeted patients in the US.
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Study tracks COVID-19 antibodies over time
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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Leading innovators in coronavirus vaccine components
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.
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Boehringer Ingelheim and Twist Bioscience Enter Therapeutic Antibody Discovery Collaboration
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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BioNTech Unveils Modular mRNA Factories for Africa + FDA Authorizes Eli Lilly Monoclonal Antibody Effective Against Omicron – Xtalks Life Science Podcast Ep. 49
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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ASP-2138 by Xencor for Metastatic Adenocarcinoma of The Pancreas: Likelihood of Approval
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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ASP-2138 by Xencor for Gastric Cancer: Likelihood of Approval
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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ASP-2138 by Xencor for Adenocarcinoma Of The Gastroesophageal Junction: Likelihood of Approval
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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Johns Hopkins-led study finds convalescent plasma can be effective early Covid-19 therapy
Scienmag
MARCH 30, 2022
The New England Journal of Medicine (NEJM) today published final results of a nationwide multicenter study led by researchers at Johns Hopkins Medicine and the Johns Hopkins Bloomberg School of Public Health that show plasma from patients who have recovered from COVID-19 and whose blood contains antibodies against SARS-CoV-2, the causative virus, is (..)
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Merck's Blockbuster Cancer Antibody Racks Up Another Approval
BioSpace
MAY 5, 2021
FDA approved Keytruda combined with Genentech’s Herceptin (trastuzumab), fluoropyrimidine- and platinum-containing chemotherapy, for first-line treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.
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ITM raises $273 million to fund radionuclide therapy pipeline
Pharmaceutical Technology
JUNE 5, 2023
ITM-11 is a targeted radionuclide therapy, where patients are injected with small amounts of radiopharmaceuticals that contain a targeting molecule, like antibodies or peptides, and a medical radioisotope. ITM-11 consists of the octreotide-derived somatostatin analog edotreotide and EndolucinBeta.
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BioInvent and Cantargia sign manufacturing agreement for monoclonal antibody CAN10
The Pharma Data
NOVEMBER 25, 2020
26, 2020 /PRNewswire/ — Cantargia AB (OMXS: CANTA) and BioInvent International AB (OMXS: BINV), today announced that BioInvent has been contracted as manufacturer of Cantargia’s antibody CAN10 in preclinical development for the treatment of systemic sclerosis and myocarditis. LUND, Sweden , Nov. About BioInvent. About Cantargia.
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Top 30 New Medical Devices of 2024
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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Roche launches new quantitative antibody test to measure SARS-CoV-2 antibodies, to support the evaluation of vaccines
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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Using bispecific antibodies to advance cancer immunotherapy
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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Keeping tabs on Covid-19: Thermo Fisher Scientific antibody test is granted the CE Mark Certification and pharma cargo companies prepare for temperature-controlled vaccine delivery
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.”.
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Experimental COVID-19 vaccine offers long-term protection against severe disease
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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The ABCs of Transitioning PK Assays from Preclinical to Clinical
Worldwide Clinical Trials
SEPTEMBER 29, 2022
For studies of humanized therapeutics (monoclonal antibodies [mAb], fusion protein, antibody-drug conjugates [ADC], bispecific antibodies, etc.), As such, they employ high dosages, so most samples contain highly concentrated drug levels. anti-human IgG).
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Lilly and Amgen Announce Manufacturing Collaboration for COVID-19 Antibody Therapies
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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AvantGen Announces Licensing of Its Anti-SARS-CoV-2 Antibodies to IGM Biosciences for COVID-19 Therapy Development
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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In recovering COVID-19 patients, antibodies fade quickly
Scienmag
OCTOBER 16, 2020
The blood of recovered patients contains antibodies that act against the coronavirus. Washington, DC – October 16, 2020 – In the absence of approved, effective treatments for COVID-19, some hospitals have been treating patients with severe COVID symptoms with blood plasma from recovering patients.
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Moderna Makes Headway with COVID-19 Booster, Flu Vaccine
BioSpace
JUNE 7, 2022
Moderna announced its Omicron-containing COVID-19 booster candidate, mRNA-1273.214, demonstrated superior antibody response against Omicron in its Phase II/III study.
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63 Leading injectables (commercial dose) companies in contract marketing
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. Factors driving the demand for injectables.
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Leading API biologics (cell, gene, vaccine and virus) companies in contract marketing
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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Leading innovators in CRISPR nucleases for the pharmaceutical industry
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.
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Antibody Drug Conjugates Market: The Future of Novel Therapies
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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Research Roundup: Different Antibody Responses to COVID-19 and More
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. People with severe COVID-19 have low proportions of antibodies that target the spike protein.
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Biologic Therapeutics Development, Part 1: Definition and Distinct Characteristics
Camargo
NOVEMBER 29, 2021
Essentially, a biologic is a product that is produced from living organisms or that contains components of living organisms. Monoclonal antibodies (mAbs). applicable to the prevention, treatment, or cure of a disease or condition of human beings.”. Biologics include a wide range of products , including: Vaccines. Growth factors.
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Regeneron Announces U.S. Government Agreement to Purchase Additional COVID-19 Antibody Cocktail Doses
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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Pfizer and Moderna Begin Trials for Omicron Targeting Vaccines
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.
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Pfizer takes COVID jab with ‘enhanced’ spike protein into phase 2
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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Biologic Therapeutics Development, Part 2: Regulatory Pathways and Pharmacometric Analysis
Camargo
DECEMBER 13, 2021
An application submitted under 351(a), also known as a “stand-alone” application, must contain all safety and effectiveness information for a biological product and cannot depend on any other biological product. One common characteristic for most if not all biologics is the triggering of an immune response or anti-drug antibodies.
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Regeneron Announces Encouraging Initial Data from COVID-19 Antibody Cocktail Trial in Hospitalized Patients on Low-flow Oxygen
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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Hemogenyx Pharmaceuticals PLC Announces Update on CDX Antibody Development
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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Regeneron’s Casirivimab and Imdevimab Antibody Cocktail for COVID-19 is First Combination Therapy to Receive FDA Emergency Use Authorization
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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