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 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.
Allergies 
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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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HIV vaccines suffer setbacks but new approaches could turn the tide
Pharmaceutical Technology
FEBRUARY 3, 2023
Only a few weeks into the new year, the prospect of getting a successful advanced HIV vaccine shrank after the discontinuation of yet another late-stage trial. This marks the second time one of Janssen’s HIV vaccines failed after another showed disappointing results in the Phase IIb Imbokodo trial in August 2021.
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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.
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Moderna’s Covid-19 shot gets Australian TGA provisional approval for kids
Pharmaceutical Technology
JULY 18, 2022
According to positive interim data from the Phase II/III KidCOVE clinical trial, the vaccine offered a strong neutralising antibody response in children of the age group of six months to five years following administration of the two-dose initial regimen of the mRNA-1273 vaccine.
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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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One dose of Regeneron’s COVID antibody protects for eight months
pharmaphorum
NOVEMBER 8, 2021
A single dose of the COVID-19 monoclonal antibody therapy developing Regeneron reduced the risk of contracting the virus by around 82% for up to eight months, according to new trial data. The post One dose of Regeneron’s COVID antibody protects for eight months appeared first on.
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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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FDA grants emergency licence for Lilly’s COVID-19 antibody combo
pharmaphorum
FEBRUARY 10, 2021
The FDA has granted an emergency licence for Eli Lilly’s COVID-19 antibody combination therapy, to reduce chances of high-risk patients progressing from mild to moderate disease to more severe symptoms that may need hospital treatment. There are a range of other antibody therapies in various stages of development.
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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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2022 in review: Drug development milestones for tropical diseases
Pharmaceutical Technology
DECEMBER 16, 2022
Spearheaded by collaborations between non-profit groups and pharma players, new treatments are edging closer to late-stage trials in malaria and neglected tropical diseases such as sleeping sickness. However, Mosquirix’s efficacy is limited, while results from a Phase III licensure trial of R21 are expected this year.
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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.
Lilly’s antibody for COVID-19 protection starts nursing home trial
pharmaphorum
AUGUST 3, 2020
While the world waits an effective coronavirus vaccine, Eli Lilly has started late-stage human testing an antibody drug as an alternative way to prevent viral transmission in high-risk locations. Staff will also be deployed to minimise the impact of the trial on facilities that don’t normally run clinical trials.
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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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US experts trial AZ’s long-acting COVID-19 antibody combination
pharmaphorum
FEBRUARY 9, 2021
An international trial led by US experts is to begin testing AstraZeneca’s long-acting antibody combination therapy to treat COVID-19. The combination known as AZD7442 is to be added to the phase 3 adaptive trial called ACTIV-3, where investigators add new sub-studies of investigational new agents.
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More malaria hope as antibody protects against infection
pharmaphorum
AUGUST 12, 2021
A single dose of a monoclonal antibody developed by scientists at the US National Institutes of Health (NIH) has provided protection for people exposed to malaria parasites for up to nine months. The post More malaria hope as antibody protects against infection 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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FDA committee recommends AstraZeneca and Sanofi’s RSV prophylactic nirsevimab
Pharmaceutical Technology
JUNE 9, 2023
Also known as palivizumab, Sobi ‘s Synagis was the first FDA-approved monoclonal antibody used in children at high risk of RSV disease. Marketed under the name Beyfortus in the EU, nirsevimab is a long-acting human recombinant monoclonal antibody. The single seasonal dosing of the drug is a large advance, he noted.
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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. That said, if one appears, it should be rigorously examined, he adds.
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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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Phase III prevention trial showed subcutaneous administration of investigational antibody cocktail casirivimab and imdevimab reduced risk of symptomatic COVID-19 infections by 81%
The Pharma Data
APRIL 11, 2021
Basel, 12 April 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today confirmed positive results from the phase III REGN-COV 2069 trial assessing the ability of the investigational antibody cocktail casirivimab and imdevimab to reduce the risk and burden of COVID-19 infection among household contacts of SARS-CoV-2 infected individuals.
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52 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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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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New Data Show Treatment with Lilly’s Neutralizing Antibodies Bamlanivimab (LY-CoV555) and Etesevimab (LY-CoV016) Together Reduced Risk of COVID-19 Hospitalizations and Death by 70 Percent
The Pharma Data
JANUARY 26, 2021
“These exciting results, which replicate positive Phase 2 data in a much larger set of patients, add valuable clinical evidence about the role neutralizing antibodies can play in fighting this pandemic. INDIANAPOLIS, Jan. Across 1,035 patients, there were 11 events (2.1 percent) in patients taking therapy and 36 events (7.0
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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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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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Lilly’s Neutralizing Antibody Bamlanivimab (LY-CoV555) Receives FDA Emergency Use Authorization for the Treatment of Recently Diagnosed COVID-19
The Pharma Data
NOVEMBER 9, 2020
Food and Drug Administration (FDA) today granted Emergency Use Authorization (EUA) for Eli Lilly and Company’s (NYSE: LLY) investigational neutralizing antibody bamlanivimab (LY-CoV555) 700 mg. INDIANAPOLIS, Nov. 9, 2020 /PRNewswire/ — The U.S. Lilly’s chief scientific officer and president of Lilly Research Laboratories.
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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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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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AZD1222 US Phase III trial met primary efficacy endpoint in preventing COVID-19 at interim analysis
The Pharma Data
MARCH 22, 2021
The AstraZeneca US Phase III trial of AZD1222 demonstrated statistically significant vaccine efficacy of 79% at preventing symptomatic COVID-19 and 100% efficacy at preventing severe disease and hospitalisation. The trial had a 2:1 randomisation of vaccine to placebo. The specific search for CVST found no events in this trial.
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Biopharma Update on the Novel Coronavirus: October 27
The Pharma Data
OCTOBER 26, 2020
Diagnostics Update : To-date the FDA has authorized 284 individual EUAs, which include 221 molecular tests, 56 antibody tests and 7 antigen tests. . Only a fraction of intravenous antibody treatments will make their way to the lungs of COVID-19 patients, which is where the infection is primarily located. Please read more here. .
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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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Lilly Announces Agreement with U.S. government to Supply 300,000 vials of Investigational Neutralizing Antibody Bamlanivimab (LY-CoV555) in an Effort to Fight COVID-19
The Pharma Data
OCTOBER 28, 2020
government to supply 300,000 vials of bamlanivimab (LY-CoV555) 700 mg, an investigational neutralizing antibody, for $375 million. The supply of Lilly’s antibody therapy is expected to increase substantially beginning in Q1 2021, as additional manufacturing resources come online throughout the year. INDIANAPOLIS, Oct.
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