GSK antibody drug reduces COPD attacks in trial
Bio Pharma Dive
SEPTEMBER 6, 2024
New trial results could offer support for an expansion of Nucala’s label after U.S. regulators rejected GSK’s submission in 2018.
Antibody Regulation Trials 
WHO grants emergency use listing to SK bioscience’s SKYCovione
Pharmaceutical Technology
JUNE 20, 2023
SKYCovione is a self-assembled nanoparticle vaccine and the 12th Covid-19 vaccine to receive a EUL from the regulator. In a Phase III clinical trial, SKYCovione showed neutralising antibody responses against the SARS-CoV-2 parental strain.
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Summit, Akeso's antibody triumphs over Keytruda in China lung cancer trial, sending shares skyrocketing
Fierce Pharma
MAY 31, 2024
Just one week after Summit Therapeutics and Akeso’s bispecific antibody ivonescimab passed muster with Chinese regulators, the drug has pulled off another feat by staring down the PD-1 king Keytrud | In the phase 3 HARMONi-2 trial, solo ivonescimab delivered a statistically significant and clinically meaningful improvement in progression-free survival (..)
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Regeneron’s antibody cocktail cuts COVID hospitalisation in large trial
pharmaphorum
MARCH 26, 2021
Regeneron has posted findings from a large trial of its COVID-19 antibody cocktail showing the therapy reduced risk of hospitalisation or death by 70%. Data from the phase 3 trial will also be used to convert an Emergence Use Authorisation into a permanent licence, Regeneron said.
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Celltrion closes in on COVID-19 antibody market after trial success
pharmaphorum
JANUARY 15, 2021
South Korea’s Celltrion has announced encouraging top-line results for its potential antibody therapy for COVID-19, with the first part of a phase 2/3 trial showing it could cut recovery times and chances of progression from moderate to more severe disease. days shorter than placebo, the company said. reported with placebo.
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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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Lilly and GSK/Vir antibody pairing offers resistant COVID-19 hope
pharmaphorum
MARCH 30, 2021
Two antibodies targeting different parts of the COVID-19 virus spike protein, from Eli Lilly and GlaxoSmithKline/Vir Biotech, can cut viral load dramatically within a week. . GSK and Vir say they are discussing emergency use authorisation of VIR-7831 with the EMA and other regulators, including possible co-administration with bamlanivimab.
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Three regulators accept Bristol Myers’ applications for myeloma therapy
Pharmaceutical Technology
APRIL 18, 2023
Three regulators in different jurisdictions have accepted Bristol Myers Squibb’s applications for Abecma (idecabtagene vicleucel) for earlier use to treat triple-class exposed relapsed and/or refractory multiple myeloma in adult patients. Abecma treatment showed improvement in progression-free survival and overall response rate.
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Tiziana Life Sciences plans to assess intranasal foralumab for long Covid
Pharmaceutical Technology
APRIL 14, 2023
Foralumab is a fully human anti-CD3 monoclonal antibody, which works by binding to the T-cell receptor and regulating T-cell function to reduce pulmonary inflammation. Phase II trials of intranasal foralumab are anticipated to commence in the third quarter of 2023 in inactive secondary progressive multiple sclerosis (SPMS) patients.
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European regulators begin rolling review of AZ’s COVID-19 vaccine
pharmaphorum
OCTOBER 2, 2020
European regulators have started a first ‘rolling review’ of a COVID-19 vaccine, which is being developed by AstraZeneca in collaboration with the University of Oxford. In a separate announcement, AstraZeneca said that a trial of the vaccine has resumed in Japan after a safety scare in the UK.
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Health Canada accepts Eisai-Biogen’s NDS for Alzheimer’s disease antibody
Pharmaceutical Technology
MAY 16, 2023
Lecanemab is an investigational anti-amyloid beta (Aβ) protofibril antibody directed against aggregated soluble (protofibril), as well as insoluble forms of Aβ. This approval was based on data obtained from the Phase II trial, which showed that the therapy minimised Aß plaque accumulation in the brain – a defining feature of AD.
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US FDA approves Incyte’s merkel cell carcinoma therapy
Pharmaceutical Technology
MARCH 23, 2023
The regulator granted approval for Zynyz’s Biologics License Application (BLA) under accelerated approval based on the duration of response (DOR) and tumour response rate. Zynyz (retifanlimab-dlwr) is a humanised monoclonal antibody targeting programmed death receptor-1 (PD-1).
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STAT+: Still hoping for looser FDA rules, Regeneron says it will test durable antibody for Covid
STAT News
JANUARY 10, 2023
SAN FRANCISCO — For months, drugmakers have been pleading with regulators to lower the bar for authorizing antibody drugs for Covid. The virus, they noted, had evolved fast enough to render every previous antibody obsolete. Continue to STAT+ to read the full story…
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CytoDyn scores $12M in legal battle win: A huge breakthrough for its antibody drug trials
BioPharma Reporter
JULY 11, 2024
Amid a period of clinical holds and legal tangles, the US antibody specialist CytoDyn has reached a settlement to resolve legal disputes with its former contract research organization (CRO) Amarex Clinical Research.
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US FDA grants EUA to InflaRx’s Covid-19 treatment
Pharmaceutical Technology
APRIL 5, 2023
It is a first-in-class monoclonal anti-human complement factor C5a antibody. The regulator granted the EUA based on data obtained from the multicentre Phase III PANAMO trial, which was conducted in Covid-19 patients who are invasively mechanically ventilated in intensive care units.
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World Pneumonia Day 2024: New Treatments and Innovations
XTalks
NOVEMBER 12, 2024
Thus, to address drug-resistant infections, pharma and biotech companies are developing novel treatments such as bacteriophage therapies, immunomodulators and monoclonal antibodies. Monoclonal Antibody Therapies Monoclonal antibodies are gaining traction as targeted treatments for bacterial and viral infections.
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Roche’s Actemra gets Health Canada approval for Covid-19 treatment
Pharmaceutical Technology
OCTOBER 31, 2022
Actemra is claimed to be the first humanised interleukin-6 receptor-antagonist monoclonal antibody which received approval from Health Canada for intravenous and subcutaneous administration in rheumatoid arthritis. Actemra remains a part of national and international guidelines for therapy.
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Innovative Nipocalimab Trial for HDFN Treatment Powered by BillionToOne
XTalks
DECEMBER 28, 2023
BillionToOne, a company specializing in molecular diagnostics, has partnered with Janssen Research & Development, LLC, a Johnson & Johnson division, to conduct the AZALEA Phase III clinical trial globally. The trial is set to occur across the US, the European Union (EU) and selected global locations.
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Astellas to support development of Taysha’s gene therapy programmes
Pharmaceutical Technology
OCTOBER 25, 2022
TSHA-102 is the first gene therapy in the clinical development stage for Rett syndrome currently while TSHA-120 is being analysed in a Phase I/II clinical trial for treating GAN. Astellas will also receive specific rights linked to any possible change of Taysha’s control.
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Eli Lilly’s Bamlanivimab-Etesevimab Antibody Duo Cuts COVID-19 Hospitalizations and Deaths by 87 Percent
XTalks
MARCH 15, 2021
Eli Lilly (NASDAQ: LLY ) shared the latest results from a late-stage study which show its combination antibody COVID-19 treatment can reduce hospitalizations and deaths by an impressive 87 percent, compared with placebo. The study is part of Lilly’s ongoing Phase III BLAZE-1 trial evaluating the antibody duo.
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GSK will pull Blenrep from US market after failed trial
pharmaphorum
NOVEMBER 22, 2022
GSK confirmed this morning that the disappointing readout from the DREAMM-3 trial of multiple myeloma therapy Blenrep reported earlier this month means that it will take the drug off the US market. The post GSK will pull Blenrep from US market after failed trial appeared first on.
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FDA Puts Mersana’s Ovarian Cancer Trials on Partial Clinical Hold
BioSpace
JUNE 14, 2023
Following cases of serious bleeding in patients, five of which were fatal, the regulator has put Mersana’s investigational antibody-drug conjugate UpRi on partial clinical hold in two ovarian cancer trials.
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Exploring the Future of Oncology with ADCs and TILs: Key Insights From ASCO
Worldwide Clinical Trials
JUNE 21, 2024
Worldwide Clinical Trials attends each year to hear from the research community, connect with our sponsors and sites, and explore potential partnerships to drive forward novel treatments. Linker Stability : The stability of the linker, which attaches the chemotherapy agent to the antibody, is essential for efficient and precise drug-delivery.
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What Are the Top Oncology Clinical Trial Trends Through the Lens of ESMO?
XTalks
JANUARY 17, 2024
Given this hotbed of activity, innovation in the space to drive faster decisions and more efficient trials is intense. They discussed the top new trends in oncology trial design that sponsors are either incorporating into clinical trials or need to start planning to include.
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Lilly's COVID-19 antibody trial on hold over safety concerns
BioPharma Reporter
OCTOBER 14, 2020
Enrollment is temporarily on hold in the ACTIV-3 clinical trial, which is evaluating Lilly's investigational neutralizing antibody bamlanivimab (LY-CoV555) as a treatment for COVID-19 in hospitalized patients. The pause was recommended by the study's independent Data and Safety Monitoring Board (DSMB).
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Biogen and Eisai seek UK’s marketing authorisation for lecanemab
Pharmaceutical Technology
MAY 22, 2023
Lecanemab is an investigational anti-amyloid beta (Aβ) protofibril antibody that will be used to treat mild cognitive impairment caused due to AD and mild AD dementia in people with the confirmed presence of amyloid pathology in the brain. The regulator has also designated the therapy for the innovative licensing and access pathway (ILAP).
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Pfizer/BioNTech say COVID-19 jab on track for approval by year-end
pharmaphorum
AUGUST 21, 2020
Pfizer and BioNTech have said their COVID-19 vaccine could be ready for regulators to review by October and approved by the end of the year after releasing more favourable data from an early-stage trial. times more neutralising antibodies than in younger patients aged 18-55 recovering from SARS-CoV-2 infection.
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Romark eyes FDA okay for COVID antiviral despite mixed trial results
pharmaphorum
APRIL 14, 2021
A phase 3 trial of Romark’s antiviral drug NT-300 has missed the main objective in a phase 3 trial in mild to moderate COVID-19 patients, but could still have a shot at emergency use authorisation (EUA), according to the US company. . Severe disease was seen in 0.5% of the NT-300 group (one patient), compared to 3.5%
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COVID-19 Antibody Treatments Exceed Expectations in Early Trials
The Pharma Data
JANUARY 27, 2021
COVID-19 Antibody Treatments Exceed Expectations in Early Trials. 27, 2021 — Promising new data on two antibody cocktails suggest these therapies can keep COVID-19 patients out of the hospital and even prevent illness altogether in some people. Professional. WEDNESDAY, Jan. At the same time, Regeneron Pharmaceuticals Inc.
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Q32 Bio and Horizon partner to develop autoimmune disease treatment
Pharmaceutical Technology
AUGUST 16, 2022
According to the deal, Horizon will provide the funding to develop the therapy until the conclusion of its two Phase II clinical trials. Under the agreement, Horizon will hold an option for the acquisition of the ADX-914 programme, which is exercisable through a period after concluding the Phase II trials. A fully human anti-IL-7R?
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Altimmune ditches nasal COVID vaccine on weak trial data
pharmaphorum
JUNE 30, 2021
Just a few months after starting clinical trials of its nasal spray vaccine for COVID-19, US biotech Altimmune is abandoning the project, saying that it generated weaker than expected immune responses in a phase 1 trial. . The post Altimmune ditches nasal COVID vaccine on weak trial data appeared first on.
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South Korea authorises Novavax Covid-19 vaccine as booster dose
Pharmaceutical Technology
JANUARY 19, 2023
The expanded manufacturing and marketing approval was based on the data obtained from the Phase II trial, conducted in Australia and the US; a separate Phase II trial held in South Africa; and the UK-sponsored COV-BOOST trial. It has been developed using the company’s recombinant nanoparticle technology.
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MHRA okays GSK’s Xevudy as data suggest it works against Omicron
pharmaphorum
DECEMBER 2, 2021
The UK medicines regulator has approved GlaxoSmithKline and Vir Biotech’s antibody for COVID-19, Xevudy, which has been shown to be effective against the new Omicron strain of SARS-CoV-2 in lab testing. The antibody was found to reduce the risk of hospitalisation and death by 79% in this patient group in a clinical trial.
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FDA fires broadside at CytoDyn over COVID-19 antibody data
pharmaphorum
MAY 19, 2021
In a rare move, the FDA has publicly accused US biotech CytoDyn of misrepresenting clinical trial results for leronlimab, an antibody being developed for COVID-19. . Leronlimab was also no better than placebo when it came to secondary endpoints including survival, time to symptom resolution, and time to return to normal activity.
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STAT+: Pharmalittle: Second clinical trial death may be linked to Eisai-Biogen Alzheimer’s drug; pharma presses the U.K. over ‘out of control’ levy
STAT News
NOVEMBER 28, 2022
The clinical trial death, described in an unpublished case report obtained by the news site, is the second thought to be associated with the Eisai and Biogen antibody drug, called lecanemab. The woman suffered a stroke and a type of swelling and bleeding previously seen with such antibodies.
LIB Therapeutics’ Cholesterol Lowering Med Lerodalcibep Receives FDA BLA Acceptance
XTalks
FEBRUARY 12, 2025
Current PCSK9 inhibitors on the market include Regenerons monoclonal antibody Praluent (alirocumab), Amgens Repatha (evolocumab) and Novartiss Leqvio (inclisiran), which is a small RNA interference (siRNA) therapy designed to lower LDL-C. Results from the trials demonstrated that lerodalcibep achieved significant reductions in LDL-C levels.
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Novartis’ oral drug iptacopan tops injectables in head-to-head PNH trial
pharmaphorum
OCTOBER 24, 2022
Novartis has chalked up another clinical trial win for its targeted factor B inhibitor iptacopan as it strives to position the drug as a patient-friendly, oral alternative to big-selling injectable rivals. The post Novartis’ oral drug iptacopan tops injectables in head-to-head PNH trial appeared first on.
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AffaMed signs deal for Lilly’s Galcanezumab in Mainland China
Pharmaceutical Technology
JANUARY 18, 2023
The monoclonal antibody selectively attaches to calcitonin gene-related peptide (CGRP). The regulator also granted approval for Galcanezumab to treat episodic cluster headaches in adults in June 2019. In September 2018, the US Food and Drug Administration (FDA) approved Galcanezumab as the preventive treatment of migraine in adults.
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Failed trial nixes another FDA approval, this time for BMS’ Istodax
pharmaphorum
AUGUST 4, 2021
Bristol-Myers Squibb’s HDAC inhibitor Istodax has been on the US market for a decade as a treatment for peripheral T-cell lymphoma (PTCL), but will now be withdrawn from sale after a failed phase 3 trial. The post Failed trial nixes another FDA approval, this time for BMS’ Istodax appeared first on.
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Patient Safety and Radiopharmaceuticals Administration: Minimizing Radiation Exposure and Risks
Worldwide Clinical Trials
JULY 8, 2024
Radiolabeled Antibodies : Various antibodies are being radiolabeled to target specific cancer antigens, enhancing both diagnostic accuracy and therapeutic efficacy. European Medicines Agency (EMA) The EMA regulates radiopharmaceuticals within the European Union (EU) through its Committee for Medicinal Products for Human Use (CHMP).
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COVID-19: Celltrion’s therapeutic option
pharmaphorum
JULY 22, 2021
Celltrion’s COVID-19 therapeutic, CT-P59, is a monoclonal antibody (mAb) with activity against COVID-19. It was identified as a potential treatment through the screening of antibody candidates from recovered patients and selecting those that showed the highest potency in neutralising the SARS-CoV-2 virus.
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Y-mAbs claims FDA OK for neuroblastoma drug Danyelza
pharmaphorum
NOVEMBER 26, 2020
Danyelza (naxitamab) is an antibody that targets GD2, a protein found on the surface of some tumour cells, and it has been cleared by the US regulator for use alongside GM-CSF – a cytokine drug – as a second-line neuroblastoma treatment after a priority review. Both the antibodies stem from research carried out at the institution.
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FDA approves AbbVie-Genmab’s Epkinly to treat DLBCL
Pharmaceutical Technology
MAY 22, 2023
Epkinly has been approved as the first and only T-cell-engaging bispecific antibody to treat adults with DLBCL not otherwise specified (NOS), including DLBCL arising from indolent lymphoma and high-grade B–cell lymphoma (HGBL), following two or more lines of systemic therapies.
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First Phase 3 data to be reported from a trial evaluating an anti-LAG-3 antibody
The Pharma Data
MARCH 25, 2021
today announced primary results from the Phase 2/3 RELATIVITY-047 (CA224-047) trial evaluating the fixed-dose combination of relatlimab, an anti-LAG-3 antibody, and Opdivo (nivolumab) versus Opdivo alone in patients with previously untreated metastatic or unresectable melanoma. About RELATIVITY-047 (CA224-047).
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