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
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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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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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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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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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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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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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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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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Evotec Partners with Alloy Therapeutics to Expand its Antibody Discovery Platform
The Pharma Data
DECEMBER 20, 2020
PARTNERSHIP LEVERAGES COMPLEMENTARY STRENGTHS OF IN SILICO, IN VITRO AND IN VIVO ANTIBODY DISCOVERY IN A RANGE OF INDICATIONS. Alloy’s first platform, the ATX-Gx(TM) mouse platform, is a suite of transgenic mice designed for best-in-class in vivo discovery of fully human monoclonal antibodies.
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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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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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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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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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Moderna says new bivalent COVID-19 vaccine tops Spikevax
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.
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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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Federal Court refuses to issue injunction on infringed antibody formulation patent
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.
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Exploring the Market Potential of the Upcoming Therapies for the Myasthenia Gravis
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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European regulators begin rolling review of AZ’s COVID-19 vaccine
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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New England Journal of Medicine Publishes Positive Initial Regeneron Antibody Cocktail Results in Non-hospitalized Patients with COVID-19
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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Resolving challenges with product recovery in biopharma manufacturing
Pharmaceutical Technology
FEBRUARY 28, 2023
Breakthroughs in therapies containing monoclonal antibodies (mAbs) are showing ever-greater potential in treating a range of diseases, alongside biopharma manufacturers facing the challenge of keeping up with demand for production while controlling costs.
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Trial of Jazz’ cannabis drug in glioblastoma will start next year
pharmaphorum
NOVEMBER 28, 2021
The drug is – an oral spray containing cannabinoids THC and CBD which is already licensed and sold by other companies in some markets for neuropathic pain, spasticity, overactive bladder, and other symptoms of multiple sclerosis. Jazz acquired rights to Sativex when it completed its $7.2
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Moderna Reveals Positive Results for its mRNA Influenza Vaccine
XTalks
DECEMBER 14, 2021
The vaccine successfully boosted HA antibody titers against all strains 29 days after vaccination with all of the doses evaluated in both young and older adults. Antibody levels against the A strains were higher than the B subtypes. These strains of the virus were recommended by the World Health Organization (WHO).
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Going big: How cartridges are making large-volume, high-dose subcutaneous autoinjectors a reality
Pharmaceutical Technology
APRIL 16, 2023
But with the advent of injection site absorption enhancers, drug delivery device innovations, as well as the recent primary container options, the practical subcutaneous self-administration of large-volume parenterals is becoming possible. mL or less and use a prefilled syringe (PFS) with a staked needle as the drug’s primary container.
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J&J files lung cancer bispecific amivantamab for FDA approval
pharmaphorum
DECEMBER 4, 2020
Johnson & Johnson has filed its bispecific antibody amivantamab to the FDA, hoping to muscle into the big market for drugs that are used to treat EGFR-positive non-small cell lung cancer (NSCLC).
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Novavax’s COVID-19 Vaccine is Over 90 Percent Effective Overall, Including Against Variants
XTalks
JUNE 16, 2021
PREVENT-19 is a randomized, placebo-controlled, observer-blinded study that is evaluating the safety, efficacy and immunogenicity of NVX-CoV2373, which contains Novavax’s patented saponin-based Matrix-M adjuvant. Related: Latest Data from Novavax COVID-19 Vaccine Trial Involving B.1.351 1.351 Variant Shared by Protein Vaccine Maker.
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FDA approves GSK’s Blenrep for advanced multiple myeloma
pharmaphorum
AUGUST 6, 2020
Blenrep, which is predicted by analysts to produce revenues of around $1.5bn in 2026, is an antibody-drug conjugate that works by targeting B-cell maturation antigen (BCMA), a protein commonly found on the surface of the malignant B-cells that cause the disease.
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EU places firm order for AZ/Oxford Uni’s ChAdOx1 COVID-19 vaccine
pharmaphorum
AUGUST 16, 2020
The fund has already been deployed to order Gilead’s antiviral drug Veklury (remdesivir) and apheresis equipment to collect antibodies from the blood of patients who have recovered from COVID-19.
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A protein-based COVID-19 vaccine that mimics the shape of the virus
The Pharma Data
AUGUST 15, 2021
Now, researchers reporting in ACS Central Science have immunized mice with nanoparticles that mimic SARS-CoV-2 by displaying multiple copies of the receptor binding domain (RBD) antigen, showing that the vaccine triggers robust antibody and T cell responses. Although the first vaccines to receive Emergency Use Authorization by the U.S.
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Regeneron’s Inmazeb named Galien’s Best Biotech Product
pharmaphorum
OCTOBER 31, 2022
s Inmazeb (consisting of the monoclonal antibodies atoltivimab, maftivimab, and odesivimab-ebgn). Indeed, Regeneron believes that the success with Ebola could potentially have ushered in “a new era in which monoclonal antibodies could be used to fight viral diseases and global pandemics.”.
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52 Regeneron’s COVID-19 Outpatient Trial Prospectively Demonstrates that REGN-COV2 Antibody Cocktail Significantly Reduced Virus Levels and Need for Further Medical Attention
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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Regeneron’s BCMAxCD3 Bispecific Antibody (REGN5458) Shows Deep and Durable Responses in Patients with Heavily-pretreated Multiple Myeloma in Phase 1
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. These allow for the creation of bispecific antibodies that closely resemble natural human antibodies with no linkers or artificial sequences.
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