GSK antibody drug reduces COPD attacks in trial
Bio Pharma Dive
SEPTEMBER 6, 2024
regulators rejected GSK’s submission in 2018. New trial results could offer support for an expansion of Nucala’s label after U.S.
Regeneron says antibody drug may speed recovery of patients with mild COVID-19
Bio Pharma Dive
SEPTEMBER 29, 2020
Preliminary study data suggest the treatment could help people whose bodies aren't already fighting off infection, a finding the biotech is discussing with regulators.
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AstraZeneca pursues approval for COVID-19 antibody cocktail
Pharma Times
OCTOBER 7, 2021
AstraZeneca has submitted an emergency approval to the US drug regulators for its COVID-19 antibody cocktail, which would be the first non-vaccine protection from the virus to be granted approval.
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STAT+: Drugmakers ask regulators to change standards on new Covid antibody drugs for most vulnerable
STAT News
DECEMBER 15, 2022
and European regulators on Thursday to adopt new standards for approving antibody drugs against Covid, particularly for immunocompromised and other vulnerable patients. Biotech executives and a handful of academics pleaded with U.S.
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Innovation in immuno-oncology: Leading companies in tumour antibody serum compositions
Pharmaceutical Technology
MARCH 9, 2023
In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Immuno-oncology in Pharmaceuticals: Tumour antibody serum compositions. The production of antibodies in response to proteins expressed during cancer development serves as a biomarker.
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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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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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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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First monoclonal antibody treatment for COVID-19 approved for use in UK
BioPharma Reporter
AUGUST 20, 2021
The UK health regulator has today given approval for the first monoclonal antibody treatment for the prevention and treatment of COVID-19 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. The NDS was based on the findings obtained from the Phase IIb clinical study (Study 201) and the Phase III Clarity AD study.
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Researchers Discover Genetic Errors and Rogue Antibodies in Cases of Severe COVID-19 Infection
XTalks
SEPTEMBER 30, 2020
The research shows that the activity of the immune messenger type 1 interferon (IFN) protein is diminished, either by genetic mutations or an autoimmune attack by neutralizing antibodies against it, in a subset of COVID-19 patients. These rogue antibodies blocked interferon action and were not present in patients with mild COVID-19 cases.
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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. The post European regulators begin rolling review of AZ’s COVID-19 vaccine appeared first on.
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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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FDA Lifts Hold on Mersana’s Antibody-Drug Conjugate Following Patient Death
BioSpace
OCTOBER 31, 2023
The regulator has released Mersana Therapeutics’ antibody-drug conjugate XMT-2056 from its clinical hold, allowing the biotech to proceed with Phase I studies of the candidate with a lower starting dose.
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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.
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Exploring genetic regulation of immunoglobulin A
Medical Xpress
JANUARY 5, 2023
Increased levels of the antibody immunoglobulin A (IgA) are correlated with the manifestation of several diseases as well as African ancestry, according to findings published in Nature Communications. The findings provide new insights into the genetic regulation of IgA levels and its potential role in human disease.
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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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Celltrion: COVID-19 antibody treatment effective against Delta variant
BioPharma Reporter
JULY 19, 2021
Celltrion Group has reported that data from an in vivo efficacy study shows that its monoclonal antibody treatment for COVID-19, regdanvimab (CT-P59), has a strong neutralizing effect against the rapidly spreading Delta variant.
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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%. ” REGEN-COV already has an emergency approval from the FDA and Regeneron will share the data with regulators immediately to ask for it to be included in the emergency licence.
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ExeVir ready for clinic with variant-targeting llama antibody
pharmaphorum
MARCH 9, 2021
Last year, Belgium’s ExeVir Bio raised 23 million euros ($27 million) to finance development of llama antibodies – and now it is ready to begin clinical development of a potential treatment that could be effective against emerging COVID-19 variants. ExeVir is not the first company to spin out of VIB to focus on camelid antibodies.
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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. reported with placebo. Feature image courtesy of Rocky Mountain Laboratories/NIH.
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EU Antitrust Regulators Clear Pfizer’s $43B Acquisition of Seagen
BioSpace
OCTOBER 19, 2023
Despite increasing antitrust scrutiny across the biopharma industry, the European Commission on Thursday said it found no competitive issues with Pfizer’s buyout of the antibody-drug conjugate company.
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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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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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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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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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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. The work is supported by the role of foralumab in dampening activated microglia cells, said to be an important component of the pathogenesis of this disease.
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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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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.
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Roche’s bispecific antibody treatment for blood cancer nabs first approval in Canada
BioPharma Reporter
MARCH 30, 2023
A T-cell engaging bispecific antibody developed by Roche has got its first green light in Canada for the treatment of relapsed or refractory forms of the blood cancer diffuse large B-cell lymphoma (DLBCL).
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Data shows antibody persistence for Moderna COVID-19 vaccine
BioPharma Reporter
APRIL 8, 2021
Moderna today highlighted the publication of antibody persistence data out to six months following the second dose of its COVID-19 vaccine in The New England Journal of Medicine.
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FDA Approves Sanofi and AstraZeneca’s RSV Antibody for Newborns, Infants
BioSpace
JULY 16, 2023
regulator Monday approved the Beyfortus single-dose monoclonal antibody, developed jointly by the two companies, for the pediatric prevention of respiratory syncytial virus.
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FDA Authorizes Invivyd’s Pemgarda to Prevent COVID-19 in Immunocompromised People
BioSpace
MARCH 24, 2024
The regulator has allowed for emergency use of Invivyd’s monoclonal antibody Pemgarda as a COVID-19 pre-exposure prophylaxis for moderately or severely immunocompromised patients.
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Astellas to support development of Taysha’s gene therapy programmes
Pharmaceutical Technology
OCTOBER 25, 2022
Astellas chief strategy officer Naoki Okamura said: “Gene therapy is the cornerstone of Astellas’ Primary Focus, Genetic Regulation; our goal is to bring new transformative treatment options to patients living with serious genetic diseases and limited treatment options.
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Monoclonal antibodies: GSK and Vir to seek US approval for their COVID-19 candidate, EMA starts rolling review of Lilly's medicines
BioPharma Reporter
MARCH 11, 2021
GSK and its partner, Vir Biotechnology, report that their jointly developed monoclonal antibody, VIR-7831, reduces hospitalization and risk of death in early treatment of adults with COVID-19.
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Lilly’s monoclonal antibody is the first to be authorized for use in treating COVID-19
BioPharma Reporter
NOVEMBER 10, 2020
Lilly's monoclonal antibody therapy, bamlanivimab (LY-CoV555), has received emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for the treatment of adults and children with recently diagnosed, mild to moderate COVID-19.
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Celltrion: ‘We plan to provide our treatment at a more affordable price than other monoclonal antibodies’
BioPharma Reporter
NOVEMBER 18, 2021
This last week saw the EU Commission approve two monoclonal antibodies for the treatment of COVID-19.
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CHMP backs Celltrion’s regdanvimab antibody for COVID-19
pharmaphorum
MARCH 29, 2021
The EU looks set to approve emergency use of a third antibody therapy for COVID-19 after its human medicines committee backed use of Celltrion’s regdanvimab at its March meeting. . The EU’s medicines regulator is also reviewing COVID-19 antibodies from AstraZeneca , GlaxoSmithKline/Vir Biotechnology, and Brii Biosciences.
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Rapid COVID immune status test launched in UK, Ireland
pharmaphorum
JULY 26, 2021
The test – originally developed by US manufacturer Chembio Diagnostics – has been introduced into the UK and Irish markets by Guilford-based Luas Diagnostics and tests for the presence of SARS-CoV-2-targeting antibodies in the blood.
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US FDA makes EUA changes to Pfizer-BioNTech and Moderna Covid-19 vaccines
Pharmaceutical Technology
APRIL 19, 2023
However, the regulator has enforced temporary restrictions on those who have already received a single bivalent vaccine dose. Those with certain kinds of immunocompromise who have previously received a bivalent vaccine can receive an additional bivalent Covid-19 vaccine dose at least two months after a bivalent vaccine dose.
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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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Celltrion Wins FDA Approval for First Subcutaneous Version of IBD Drug Infliximab
BioSpace
OCTOBER 23, 2023
The regulator has approved the first-ever subcutaneous version of infliximab, an IgG1 monoclonal antibody, commonly sold by Johnson & Johnson under the brand name Remicade.
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US Regulators Recommend Pause on J&J’s COVID-19 Vaccine, But Just as a Precaution
XTalks
APRIL 15, 2021
The types of blood clotting events included vaccine-induced prothrombotic immune thrombocytopenia (VIPIT), a condition associated with the development of antibodies that activate platelets to stimulate the formation of clots and resulting in thrombocytopenia, as well as 18 cases of CVST as of March 17.
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FDA starts swift review of tumour-agnostic use of Enhertu
pharmaphorum
JANUARY 29, 2024
The US regulator has started a priority review of the HER2-targeting antibody-drug conjugate (ADC) for the treatment of adults with unresectable or metastatic HER2-positive solid tumours who have been treated previously or have limited treatment options.
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