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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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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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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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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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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BioPharma Reporter

MARCH 29, 2021

The European Medicines Agency (EMA) concludes that Celltrionâs monoclonal antibody, regdanvimab, can be used in COVID-19 patients not requiring oxygen and at high risk of progressing to severe disease.

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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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Drug Discovery World

SEPTEMBER 8, 2023

Applications to regulators have included pre-clinical data showing that the Omicron XBB.1.5-adapted Additional pre-clinical data demonstrate that serum antibodies induced by the updated Covid-19 vaccine, when compared to the Omicron BA.4/BA.5-adapted 1.16, and XBB.2.3, compared to the Omicron BA.4/BA.5-adapted

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BioTech 365

JANUARY 11, 2021

Sanofi to acquire Kymab, adding KY1005 to its pipeline, a human monoclonal antibody targeting key immune system regulator OX40L Sanofi to acquire Kymab, adding KY1005 to its pipeline, a human monoclonal antibody targeting key immune system regulator OX40L Sanofi to … Continue reading →

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Drug Discovery World

SEPTEMBER 1, 2022

Bio-Rad Laboratories has introduced a range of type 1 antibodies that inhibit the binding of evolocumab (Repatha) to its target, human proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that has been shown to play a key role in the regulation of cholesterol levels. .

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Drug Discovery World

JULY 6, 2023

The first patient has been dosed in the clinical Phase I evaluation of the Sema3A monoclonal antibody, part of the Evotec-Bayer multi-target research collaboration in kidney diseases. Semaphorin-3A is an extracellular guidance protein and a well-known regulator of the actin cytoskeleton.

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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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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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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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BioPharma Reporter

NOVEMBER 13, 2023

Medix Biochemicals has acquired ViroStat in an effort to provide its customers with infectious disease antibodies and antigens for their IVD immunoassay test development.

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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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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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BioSpace

OCTOBER 1, 2023

Eli Lilly’s Biologic License Application for its monoclonal antibody lebrikizumab was denied by the regulator after issues were found at a third-party contract manufacturing organization.

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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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BioSpace

AUGUST 10, 2023

overall response rate in a Phase II study, winning accelerated approval from the regulator. Despite being heavily pretreated, patients on J&J’s Talvey saw a 73.6%

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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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pharmaphorum

AUGUST 11, 2022

Figures from the UK Office for National Statistics (ONS) have revealed that the number of people with higher levels of COVID-19 antibodies in their blood is declining quickly – leading to calls for booster vaccination campaigns to be started as soon as possible. 1 Omicron subvariant – are currently under review at the regulator.

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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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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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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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Pharma in Brief

DECEMBER 17, 2023

On December 4, 2023, the Federal Court held that a patent claiming a formulation of adalimumab, a monoclonal antibody used to treat autoimmune diseases, is valid and is being infringed by a biosimilar product. The Federal Court upheld the Minister’s decision; AbbVie’s appeal of the Federal Court’s decision is pending (Court File No.

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Drug Discovery World

JULY 8, 2022

Biotechnology company Immutep has been a granted a patent for its immunosuppressive antibody by the Japanese Patent Office. . Immutep’s IMP761 is an immunosuppressive agonist antibody to LAG-3 – a cell surface molecule which plays a role in regulating T cell function, and which has been identified as a new immune-checkpoint. .

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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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The Pharma Data

AUGUST 20, 2020

Poor regulation of antibodies tests – that could indicate if someone has had coronavirus – could be putting the public at risk, doctors have warned. It is still not known whether having antibodies will protect people from a second infection. Coronavirus infection triggers the immune system to produce antibodies.

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BioPharma Reporter

JULY 17, 2023

Crossbow Therapeutics, a biotech company developing a novel class of potent and precise antibody therapies to treat a broad range of cancers, has announced a $80 million Series A funding round.

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pharmaphorum

NOVEMBER 17, 2021

The US has made a sizeable order for GlaxoSmithKline and Vir Biotechnology’s antibody-based COVID-19 treatment sotrovimab said to be worth approximately $1 billion. The post US signs $1bn order for GSK, Vir’s COVID-19 antibody appeared first on. Another phase 3 trial called COMET-STAR is assessing whether.

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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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BioPharma Reporter

MARCH 16, 2023

South Korean players, Celltrion and Genuv, are teaming up on the discovery and development of therapeutic antibodies using Genuv's mouse platform.

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BioSpace

JUNE 28, 2023

Phase I/II data on AbbVie and Genmab’s recently approved bi-specific antibody in a second cancer indication positions them to talk to regulators about filings to challenge Roche’s Lunsumio.

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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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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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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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