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.
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NIAID drops Lilly antibody from ACTIV-3 COVID-19 trial
pharmaphorum
OCTOBER 27, 2020
Eli Lilly says no more patients will be treated with its COVID-19 therapy bamlanivimab in a trial run by the US National Institute of Allergy and Infectious Diseases (NIAID), as results to date suggest it is unlikely to be effective. The post NIAID drops Lilly antibody from ACTIV-3 COVID-19 trial appeared first on.
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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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US buys Lilly COVID antibody, as effectiveness questions remain
pharmaphorum
OCTOBER 28, 2020
Our goal is to ensure that Lilly antibody treatments are available to patients who need them, no matter where they live. “As As long as supply of neutralising antibodies is constrained, we believe the only way to ensure equitable access is for Lilly to contract directly with governments and pan-national philanthropic organisations. “As
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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.
Dupixent falls short in phase 3 chronic spontaneous urticaria trial
pharmaphorum
FEBRUARY 18, 2022
Sanofi and Regeneron have reported disappointing results in a trial of Dupixent in people with chronic spontaneous urticaria (CSU) who don’t respond to the only approved biologic treatment, Novartis/Roche’s Xolair. . The post Dupixent falls short in phase 3 chronic spontaneous urticaria trial appeared first on.
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Trial of Antibody Drug for COVID-19 Stopped for Lack of Effectiveness
The Pharma Data
OCTOBER 27, 2020
Trial of Antibody Drug for COVID-19 Stopped for Lack of Effectiveness. 27, 2020 — Testing of the Eli Lilly antibody drug for hospitalized COVID-19 patients has been halted because the treatment does not help them recover from their infection. Professional. TUESDAY, Oct. But the U.S.
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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. Zydus has only said that the vaccine was well tolerated by people who received it in the first phase of the trial.
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Valneva eyes first place in chikungunya vaccine race
pharmaphorum
DECEMBER 5, 2022
The French biotech says VLA1553 met its objective in the phase 3 study, with 99% of patients exhibiting an antibody response against the virus 12 months after receiving a single dose of the shot, with no evidence of a tailing off in levels in the last six months. It will continue for up to five years.
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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. The trial was paused earlier this month due to a safety issue.
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Gritstone bio supports mRNA Covid-19 vaccine plans with Phase I publication
Pharmaceutical Technology
JUNE 8, 2023
The Phase I CORAL-BOOST dose-escalation trial (NCT05148962) evaluated Gritstone’s samRNA candidate (GRT-R910) in previously vaccinated healthy older adults. GlobalData is the parent company of Clinical Trials Arena. The samRNA is delivered in a lipid nanoparticle (LNP) formulation. of these are in the pre-clinical stage.
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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 (..)
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.
Promising Interim Results from Clinical Trial of NIH-Moderna COVID-19 Vaccine
The Pharma Data
NOVEMBER 16, 2020
November 16, 2020 — An independent data and safety monitoring board (DSMB) overseeing the Phase 3 trial of the investigational COVID-19 vaccine known as mRNA-1273 reviewed trial data and shared its interim analysis with the trial oversight group on Nov. 37% of trial volunteers are from racial and ethnic minorities.
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.
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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The Lancet: Preliminary results from Russian trials find that vaccine candidates led to no serious adverse events and elicit antibody response
Scienmag
SEPTEMBER 4, 2020
The new paper reports the findings of two open-label, non-randomised phase 1/2 trials looking at a frozen formulation and a freeze-dried formulation of a two-part vaccine.
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Leo puts target on Dupixent in US as FDA clears tralokinumab
pharmaphorum
DECEMBER 29, 2021
Sanofi and Regeneron have another challenger to their big-selling drug Dupixent for atopic dermatitis, now that the FDA has approved Leo Pharma’s rival antibody tralokinumab. In trials, tralokinumab improved upon placebo on a range of outcome measures, including clearance of skin lesions and reduction of itch after 16 weeks.
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AZ, Amgen get speedy FDA review for asthma drug tezepelumab
pharmaphorum
JULY 8, 2021
The FDA has started a priority review of AstraZeneca and Amgen’s severe asthma antibody tezepelumab, setting a date for a decision in the first quarter of 2022. Overall, the antibody cut the annual asthma exacerbation rate (AAER) by 56% over 52 weeks, which was consistent with the benefit seen in the phase 2 PATHWAY trial.
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Dupixent® (dupilumab) pivotal trial meets all primary and secondary endpoints.
The Pharma Data
AUGUST 30, 2021
A pivotal Phase 3 trial evaluating Dupixent ® (dupilumab) for the treatment of children aged 6 months to 5 years with moderate-to-severe atopic dermatitis, a chronic type 2 inflammatory disease, met its primary and all secondary endpoints. Yancopoulos, M.D., President and Chief Scientific Officer at Regeneron. “
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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
Trial Also Met the Primary Endpoint in Patients With Low Levels of Eosinophils. In the subgroup of patients with baseline eosinophil counts less than 300 cells per microliter, the trial met the primary endpoint with tezepelumab demonstrating a statistically significant and clinically meaningful reduction in AAER. Outside the U.S.,
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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
efficacy overall, and met the primary endpoint in its PREVENT-19 pivotal Phase 3 trial. Our vaccine will be a critical part of the solution to COVID-19 and we are grateful to the study participants and trial staff who made this study possible, as well as our supporters, including the U.S. Government.” About PREVENT-19.
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And then there were none: Regeneron cans last late-stage NGF drug
pharmaphorum
NOVEMBER 3, 2022
As of a September update, AstraZeneca was still developing MEDI7352, a bispecific antibody that combines NGF and TNF inhibition, potentially targeting both pain and inflammation associated with osteoarthritis. The demise of fasinumab draws a line under the NGF inhibitor class, although there could be footnote.
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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.
Update On SOURCE Phase 3 Trial For Tezepelumab In Patients With Severe, Oral Corticosteroid-Dependent Asthma
The Pharma Data
DECEMBER 21, 2020
21, 2020 /PRNewswire/ — Amgen (NASDAQ:AMGN) and AstraZeneca today announced the SOURCE trial did not meet the primary endpoint of a statistically significant reduction in the daily oral corticosteroid (OCS) dose, without loss of asthma control, with tezepelumab compared to placebo. THOUSAND OAKS, Calif. , Outside the U.S.,
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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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FDA: Remdesivir (Veklury) Approval for the Treatment of COVID-19 – The Evidence for Safety and Efficacy
The Pharma Data
NOVEMBER 25, 2020
Background Randomized, controlled trials are the gold standard for evaluating the safety and effectiveness of drugs. 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.
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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. billion, to deliver the vaccine in multiple countries.
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FDA accepts Dupixent® (dupilumab) for review in children with moderate-to-severe asthma
The Pharma Data
MARCH 4, 2021
In the trial, Dupixent significantly reduced severe asthma attacks and rapidly improved lung function within two weeks in children aged 6 to 11 years. 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.
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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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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. Tell your vaccination provider about all of your medical conditions, including if you: have any allergies.
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102 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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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
This study is consistent with regulatory guidance and follows the design of the previous Phase 1/2/3 trial to evaluate further options for protection in this age group. . 5-adapted bivalent COVID-19 vaccine in children 6 months through 11 years of age. Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5),
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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 submission included data from a Phase 2/3 randomized, controlled trial that included 4,526 children 6 months to less than 5 years of age. In the trial, children received the third 3-µg dose at least two months after the second dose at a time when Omicron was the predominant variant. About the Phase 1/2/3 Trial in Children.
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81 Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 Adapted Bivalent Vaccine Candidate
Pfizer
JULY 19, 2022
The companies’ previously announced safety, tolerability and immunogenicity data from a Phase 2/3 trial that found a 30 µg booster dose of the Omicron-adapted bivalent vaccine candidate elicited a superior immune response against Omicron BA.1 1 as compared to the companies’ current COVID-19 vaccine. IMPORTANT SAFETY INFORMATION. has a fever.
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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
Joseph Kim , President and CEO of INOVIO, said, “We are very pleased to share peer-reviewed Phase 1 clinical data for INO-4800 published in The Lancet’s EClinicalMedicine , and are grateful for the support of all participants and investigator staff involved in the clinical trial.” mg and 2.0 mg and 2.0 The 1.0
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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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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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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 evaluate the use of BOTOX® (onabotulinumtoxinA) for chronic migraine –These data further demonstrate AbbVie’s commitment to harnessing and sharing innovative science and working to advance treatment options for people with migraine across the migraine spectrum.
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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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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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