Food Allergy Awareness Week 2024: How can new treatments target an unmet need?
Pharmaceutical Technology
MAY 16, 2024
IgGenix is planning to initiate a clinical trial later this year investigating its peanut allergy monoclonal antibody IGXN001.
Allergies Antibody Clinical Trials 
Omlyclo Becomes First Biosimilar to Rival Xolair
XTalks
MARCH 10, 2025
Originally approved by the FDA over two decades ago for the treatment of moderate to severe persistent asthma, Xolair recently also gained approval for managing food allergies. Omalizumab is an anti-IgE antibody that works by blocking the effects of IgE, a key driver in many allergic reactions. billion by 2030.
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Large NIH clinical trial will test polyclonal antibody therapeutic for COVID-19
Scienmag
APRIL 21, 2021
Credit: NIAID A Phase 2/3 trial to evaluate a new fully-human polyclonal antibody therapeutic targeted to SARS-CoV-2, called SAB-185, has begun enrolling non-hospitalized people with mild or moderate cases of COVID-19.
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Antibody treatment improves chronic food allergy symptoms in young adults, study finds
Medical Xpress
DECEMBER 22, 2022
A weekly dose of dupilumab, a monoclonal antibody, led to a reduction of symptoms and tissue improvement in young adults and adolescents with eosinophilic esophagitis (EoE), according to a new study published in the New England Journal of Medicine.
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NIAID Halts Eli Lilly COVID-19 Antibody Trial
The Pharma Data
OCTOBER 27, 2020
The NIH’s National Institute of Allergy and Infectious Diseases (NIAID) has halted a clinical trial evaluating Eli Lilly’s investigational monoclonal antibody, LY-CoV555 (bamlanivimab), in combination with remdesivir for the treatment of COVID-19 patients. Source link.
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Temperature-stable tuberculosis vaccine safe, prompts immune response in first-in-human trial
Medical Xpress
MARCH 6, 2023
A clinical trial testing a freeze-dried, temperature-stable experimental tuberculosis (TB) vaccine in healthy adults found that it was safe and stimulated both antibodies and responses from the cellular arm of the immune system. A non-temperature stable form of the candidate previously had been tested in several clinical trials.
Keeping tabs on Covid-19: Cell and gene clinical trials advance despite Covid-19…
The Pharma Data
AUGUST 7, 2020
The governing body claims this proposal could have positive effects on mitigating burdensome requirements for gene therapy clinical trials in the future. In this light, Pharma IQ’s weekly round-up focuses on advancing therapies and clinical trials to combat Covid-19.
Topline Results from NIH-Sponsored Clinical Trial of Investigational COVID-19 Hyperimmune Globulin Medicine
The Pharma Data
APRIL 3, 2021
The CoVIg-19 Plasma Alliance today announced that the Phase 3 Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC) clinical trial sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), did not meet its endpoints. About the ITAC Trial.
Gritstone bio supports mRNA Covid-19 vaccine plans with Phase I publication
Pharmaceutical Technology
JUNE 8, 2023
With respect to immunogenicity, neutralising antibody titers against ancestral Spike and variants of concern were boosted by the samRNA candidate, and contrasting to authorised vaccines, persisted through at least 6 months following the booster dose. of these are in the pre-clinical stage.
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Promising Interim Results from Clinical Trial of NIH-Moderna COVID-19 Vaccine
The Pharma Data
NOVEMBER 16, 2020
and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. As part of the arrangement under OWS, representatives from NIAID, BARDA and Moderna are part of the oversight group that receives recommendations from the trial’s independent DSMB. El Sahly, M.D., El Sahly, M.D.,
First patients in NIH ACTIV-3 clinical trial enroll in Dallas
Scienmag
AUGUST 11, 2020
Baylor Scott & White Research Institute becomes first site in the world to conduct new trial testing experimental monoclonal antibodies as a treatment for hospitalized COVID-19 patients Credit: Baylor Scott & White Research Institute DALLAS, Texas – On Wednesday, August 5, in Dallas, just one day after the initiative was launched by (..)
NIAID Halts Eli Lilly COVID-19 Antibody Trial | 2020-10-28
The Pharma Data
OCTOBER 26, 2020
The NIH’s National Institute of Allergy and Infectious Diseases (NIAID) has halted a clinical trial evaluating Eli Lilly’s investigational monoclonal antibody, LY-CoV555 (bamlanivimab), in combination with remdesivir for the treatment of COVID-19 patients.
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Zydus starts Phase II COVID-19 vaccine trial; Taysha raises $95M; FDA declines DBV’s peanut allergy patch; Combating COVID-19 with decoy target
Delveinsight
AUGUST 6, 2020
Zydus starts phase 2 COVID-19 vaccine trial after clearing safety test. Zydus Cadila has finished a phase 1 clinical trial of its COVID-19 vaccine ZyCoV-D, setting it up to move straight into a 1,000-subject phase 2 study. FDA turns back peanut allergy patch of DBV Technologies. The agency raised no safety concerns.
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New Research Shows IBS Symptoms May be Caused by Gut Infections
XTalks
JANUARY 20, 2021
However, IBS patients do not have allergies to any given foods, nor any gastrointestinal conditions, such as celiac disease. Ovalbumin led to increased dietary-antigen-specific IgE antibodies in the mice that were limited to the intestine. Moreover, the response did not induce symptoms typical of a food allergy.
Moderna’s COVID-19 Vaccine Effective Against New Variants
XTalks
JANUARY 27, 2021
The company used in vitro neutralization antibody studies to evaluate the activity of Moderna’s vaccine-generated antibodies in human sera against several variants of the novel coronavirus, including the B.1.1.7 The in vitro study evaluated the ability of mRNA-1273-generated antibodies to neutralize the new SARS-CoV-2 variants.
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Moderna’s COVID-19 vaccine trial; Freenome secures $270 M; CRISPR treats obesity in mice; Breast cancer research updates
Delveinsight
AUGUST 27, 2020
The phase 1 study that is being run by the National Institute of Allergy and Infectious Diseases tests three dose levels of the vaccine, mRNA-1273, given in two injections a month apart in 120 adults. Freenome secures USD 270 Million to boost its colorectal cancer blood test.
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Pfizer and BioNTech Announce U.S. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age
Pfizer
JULY 8, 2022
Favorable safety profile observed across more than 2,200 adolescents who participated in the clinical trial. Today’s approval is based on data from a Phase 3 clinical trial of 2,260 participants 12 through 15 years of age. NEW YORK and MAINZ, GERMANY, July 8, 2022 — Pfizer Inc. have completed a primary series.
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Aurobindo Pharma and COVAXX Sign an Exclusive Agreement to Develop and Commercialize COVID-19 Vaccine UB-612 for India and UNICEF
The Pharma Data
DECEMBER 23, 2020
24, 2020 /PRNewswire/ — COVAXX’s UB-612 is the first multitope, synthetic peptide-based COVID-19 vaccine candidate in clinical trials and it utilizes normal refrigeration (no freezing required) for distribution. COVAXX is currently conducting a Phase 1 clinical trial for the vaccine candidate. .
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COVAXX and Aurobindo Pharma Announce COVID-19 Vaccine Partnership
The Pharma Data
DECEMBER 23, 2020
COVAXX is currently completing a Phase 1 clinical trial of UB-612 in Taiwan and will begin Phase 2/3 clinical trials in Asia, Latin America and the U.S. Preclinical studies have shown that the UB-612 vaccine candidate generated high titers of neutralizing antibodies. UB-612 Fact Sheet: www.covaxx.com/vaccine.
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52 Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design
Pfizer
JULY 26, 2022
Tell your vaccination provider about all of the vaccine recipient’s medical conditions, including if the vaccine recipient: has any allergies. The Pfizer-BioNTech COVID-19 Vaccine authorized for use in children 6 months through 11 years of age should not be used interchangeably with COMIRNATY® (COVID-19 Vaccine, mRNA). has a fever.
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FDA: Remdesivir (Veklury) Approval for the Treatment of COVID-19 – The Evidence for Safety and Efficacy
The Pharma Data
NOVEMBER 25, 2020
FDA’s approval of remdesivir (Veklury) was supported by the agency’s independent, in-depth analysis of data from three randomized, controlled clinical trials that included patients hospitalized with mild-to-severe COVID-19. Researchers evaluated the clinical status of subjects on Day 14. The design of ACTT-1 (i.e.,
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Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.4/BA.5-Adapted Bivalent Vaccine Booster in Children 5 Through 11 Years of Age
Pfizer
SEPTEMBER 28, 2022
Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bispecific immune checkpoint modulators, targeted cancer antibodies and small molecules. Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5),
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Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 Adapted Bivalent Vaccine Candidate
Pfizer
JULY 19, 2022
Tell your vaccination provider about all of the vaccine recipient’s medical conditions, including if the vaccine recipient: has any allergies. IMPORTANT SAFETY INFORMATION. has had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart). has a fever. has received another COVID-19 vaccine.
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FDA accepts Dupixent® (dupilumab) for review in children with moderate-to-severe asthma
The Pharma Data
MARCH 4, 2021
Adverse events in the Phase 3 trial that were more commonly observed with Dupixent included injection site reactions, viral upper respiratory tract infections and eosinophilia. Detailed results from this Phase 3 trial will be published later this year. Dupilumab development program.
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Advantages of intranasal vaccination against SARS-CoV-2
Bioengineer
JULY 23, 2021
“Given the respiratory tropism of the virus, it seems surprising that only seven of the nearly 100 SARS-CoV-2 vaccines currently in clinical trials are delivered intranasally,” Lund and Randall said. The seventh vaccine candidate is an inert protein subunit.
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INOVIO Announces Publication of Phase 1 Data from its COVID-19 DNA Vaccine Candidate, INO-4800 in The Lancet’s EClinicalMedicine
The Pharma Data
DECEMBER 23, 2020
Additionally, Phase 1 clinical data found INO-4800 to have a favorable safety and tolerability profile with no serious adverse events reported; only six Grade 1 adverse events (AEs) were observed, primarily minor injection site reactions. ” Findings from the Phase 1 Clinical Trial. mg and 2.0
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Pfizer and BioNTech Submit a Variation to EMA for the Vaccination of Children 6 Months to less than 5 Years with COMIRNATY®
Pfizer
JULY 8, 2022
The Phase 1/2/3 trial has enrolled more than 10,000 children ages 6 months to under 12 years of age in the United States, Finland, Poland, Spain and Brazil from more than 90 clinical trial sites. has had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart). has a fever.
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81 Novavax COVID-19 vaccine demonstrates 90% overall efficacy and 100% protection against moderate and severe disease in PREVENT-19 Phase 3 trial
The Pharma Data
JUNE 25, 2021
The CDC has defined Variant of Interest (VoI) as a variant with genetic markers that have been associated with changes to receptor binding, reduced neutralization by antibodies generated against previous infection or vaccination, or predicted increase in transmissibility or disease severity. BARDA is providing up to $1.75 About NVX-CoV2373.
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Tezepelumab NAVIGATOR Phase 3 Trial Met Primary Endpoint Of A Statistically Significant And Clinically Meaningful Reduction In Exacerbations In A Broad Population Of Patients With Severe Asthma
The Pharma Data
NOVEMBER 9, 2020
About Tezepelumab Tezepelumab is an investigational, potential first-in-class human monoclonal antibody that works on the primary source of inflammation: the airway epithelium, which is the first point of contact for viruses, allergens, pollutants, and other environmental insults. 10 World Allergy Organization (WAO).
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Dupixent® (dupilumab) pivotal trial meets all primary and secondary endpoints.
The Pharma Data
AUGUST 30, 2021
These results add to the extensive LIBERTY AD clinical program – the largest Phase 3 clinical trial program in atopic dermatitis involving approximately 3,500 children, adolescents, and adults to date. It is not an immunosuppressant and does not require lab monitoring. Dupilumab Development Program.
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52 Switzerland Exercises Increased Option for 7.5 Million Doses of mRNA Vaccine Against COVID-19 (mRNA-1273)
The Pharma Data
DECEMBER 8, 2020
and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. About Moderna.
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Update On SOURCE Phase 3 Trial For Tezepelumab In Patients With Severe, Oral Corticosteroid-Dependent Asthma
The Pharma Data
DECEMBER 21, 2020
About Tezepelumab Tezepelumab is an investigational, potential first-in-class human monoclonal antibody that works on the primary source of inflammation: the airway epithelium, which is the first point of contact for viruses, allergens, pollutants, and other environmental insults. Amgen will record sales in the U.S. Outside the U.S.,
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Mymetics to Advance Preclinical Studies for Virosome-based COVID-19 Vaccine through Innosuisse Grant
The Pharma Data
NOVEMBER 17, 2020
The Company is thereby partnering with leading academic institutions to explore and select the best SARS-CoV antigens incorporated into virosome particles, while optimizing the route of administration and thermostability of the vaccine, before moving into human clinical trials. ” About Mymetics.
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AbbVie to Highlight Its Leadership in Movement Disorders at the.
The Pharma Data
SEPTEMBER 10, 2021
Neutralizing Antibody Conversion with OnabotulinumtoxinA from Global Studies Across Multiple Indications with a Focus on Movement Disorders: A Meta-Analysis. Adult Patients treated for overactive bladder due to neurologic disease: In clinical trials, 30.6% BOTOX ® Abstracts. of patients (7/104) treated with placebo.
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Israeli Ministry of Health Authorizes COVID-19 Vaccine Moderna for Use in Israel
The Pharma Data
JANUARY 4, 2021
The Moderna COVID-19 Vaccine is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was co-developed by Moderna and investigators from National Institute of Allergy and Infectious Diseases’ (NIAID) Vaccine Research Center.
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AbbVie to Present Data From Its Migraine Portfolio at the.
The Pharma Data
SEPTEMBER 8, 2021
Results from a post-hoc analysis of the Phase 3 PREEMPT trials evaluating the use of BOTOX ® for chronic migraine will also be presented. Related Peptide Monoclonal Antibody Therapy Added to OnabotulinumtoxinA Treatment. Adult Patients treated for overactive bladder due to neurologic disease: In clinical trials, 30.6%
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Are we entering the era of biologics for COPD?
Pharmaceutical Technology
JANUARY 8, 2023
In 2023, the pharmaceutical industry will mark 20 years since Xolair, an anti-IgE antibody, became the first biologic approved to treat asthma. Since then, the US FDA, EMA, and other agencies have approved several biologic antibodies targeting the inflammatory cytokines IL-4, IL-13, IL-5, and others for asthma. Ongoing efforts.
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298 Low on antibodies, blood cancer patients can fight off COVID-19 with T cells
Scienmag
MAY 27, 2021
New Penn Medicine study shows how T cells compensate when other immune cells go down PHILADELPHIA–Antibodies aren’t the only immune cells needed to fight off COVID-19 — T cells are equally important and can step up to do the job when antibodies are depleted, suggests a new Penn Medicine study of blood cancer patients with […]. (..)
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COVID-19 antibody tests, even rapid finger pricks, are effective, new study finds
Scienmag
MARCH 31, 2021
New findings from a Michigan Medicine study reveal that antibody testing is predictive of prior COVID-19 infection, and rapid screening methods – even from finger pricks – are effective testing tools. Researchers analyzed antibody tests conducted on more than 500 subjects […].
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Team assessing if dual-antibody injection prevents COVID-19 illness
Scienmag
SEPTEMBER 25, 2020
A combination antibody treatment for preventing COVID-19 illness in individuals who have had sustained exposure to someone with the virus is being studied by researchers at The University of Texas Health Science Center at Houston (UTHealth). The clinical trial is enrolling patients at Harris Health System’s Lyndon B.
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UTHealth joins trial to test antibodies and other experimental outpatient COVID treatments
Scienmag
SEPTEMBER 15, 2020
A study on the effectiveness of multiple treatments, including laboratory-made antibodies, at preventing mild COVID-19 from advancing to severe illness in the outpatient setting is underway by researchers at The University of Texas Health Science Center at Houston (UTHealth). Johnson Hospital.
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World AIDS Day 2023: New and Promising Treatments for HIV/AIDS
XTalks
NOVEMBER 30, 2023
The safety and efficacy of Cabenuva were established through two randomized, open-label, controlled clinical trials involving 1,182 HIV-infected adults who were virologically suppressed (HIV-1 RNA less than 50 copies/mL) before initiating Cabenuva treatment. The Phase I trial for HB-500 is scheduled to start in the first half of 2024.
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GSK announces FDA approval for Nucala (mepolizumab) for use in adults with chronic rhinosinusitis with nasal polyps
The Pharma Data
JULY 29, 2021
today announced that the US Food and Drug Administration (FDA) has approved Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), as a treatment for patients with chronic rhinosinusitis with nasal polyps (CRSwNP). With 41 clinical trials, mepolizumab has been studied in over 4,000 patients.
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No drugs for prions: could new approaches alleviate therapeutic scarcity?
Pharmaceutical Technology
AUGUST 5, 2022
According to GlobalData’s Pharma Intelligence Center, there are only six drugs in active development for CJD, of which only one has been in clinical trials. There are only a few antibodies that can specifically recognize the (abnormal) version of the prion protein.
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