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. Developed using pharmaceutical company GSK’s pandemic adjuvant, the vaccine targets the receptor-binding domain of the SARS-CoV-2 spike protein.

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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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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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Camargo

DECEMBER 13, 2021

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610.

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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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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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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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BioPharma Reporter

FEBRUARY 12, 2024

Just â Evotec Biologics has expanded its relationship with Advanced BioScience Laboratories (ABL), a global CDMO serving the US Government and biopharmaceutical industry.

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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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The Pharma Data

JANUARY 12, 2021

LONDON, UK / ACCESSWIRE / January 13, 2021 / Hemogenyx Pharmaceuticals plc (LSE:HEMO), the biopharmaceutical group developing new therapies and treatments for blood diseases, is pleased to announce that it has successfully completed the development of its CDX antibody with a leading global pharmaceutical company (“GlobalCo”).

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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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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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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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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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BioPharma Reporter

JULY 25, 2023

ImmunoGen, a biotech company focused on the development of antibody-drug conjugate (ADC) technology to treat cancer, has announced a multi-target license and option agreement to research novel, first-in-class ADCs with ImmunoBiochem, a biopharma firm developing novel biological therapeutics.

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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. . The post FDA fires broadside at CytoDyn over COVID-19 antibody data appeared first on.

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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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BioPharma Reporter

MARCH 31, 2022

Sanofi and IGM announce partnership to develop IgM antibody agonists against oncology and immunology/inflammation targets.

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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 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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pharmaphorum

MAY 10, 2021

The EMA has begun a rolling review of a COVID-19 antibody developed by GlaxoSmithKline and Vir BioTech which could become the fourth drug of its type cleared for early use in the EU. . At the moment the regulator is looking at the first batch of data from lab and animal studies as well as quality studies.

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BioPharma Reporter

OCTOBER 18, 2022

Antibody-drug conjugate developer, Synaffix, has signed a licensing agreement with Cristal Therapeutics to gain access to its CliCr metal-free click chemistry.

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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. Nipocalimab is an investigational monoclonal antibody that targets the neonatal Fc receptor.

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Pharmaceutical Technology

APRIL 5, 2023

It is a first-in-class monoclonal anti-human complement factor C5a antibody. Despite the availability of vaccines and other treatments for earlier disease stages of Covid-19, many patients are still developing viral sepsis and are progressing to critical status, which often requires invasive mechanical ventilation. “As

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Pharmaceutical Technology

APRIL 14, 2023

Long Covid is a health condition characterised by the continuation or development of new symptoms three months after an initial SARS-CoV-2 infection. 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.

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BioPharma Reporter

DECEMBER 16, 2020

Sterling Pharma Solutions, a global contract development and manufacturing organization (CDMO), has announced a new strategic partnership with ADC Biotechnology, a UK based company specializing in antibody-drug conjugates (ADCs).

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Drug Discovery World

JUNE 30, 2023

Whether it be a monoclonal antibody to treat peanut allergy, or using artificial intelligence (AI) to identify influenza drug targets, each discovery reflects the level of scientific innovation and diversity of approaches being employed in drug development today. The top stories: Could a monoclonal antibody treat peanut allergy?

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XTalks

MARCH 1, 2021

The study is part of a broad development plan to assess the durability of the immunogenic responses elicited by its vaccine and the emergence of new SARS-CoV-2 variants. The third dose will be administered to the participants regardless of antibody titer levels. The study will be a part of current Phase I, II and III trials.

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XTalks

APRIL 15, 2021

To put it into context, about 1 in 100,000 people a month develop blood clots. The FDA and CDC are advising that individuals who have received the J&J vaccine and develop symptoms of severe headache, abdominal pain, leg pain or shortness of breath within three weeks after vaccination, contact their health care provider.

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XTalks

OCTOBER 27, 2022

Patients are eligible for the drug if they have previously received four or more lines of therapy, including a proteasome inhibitor, immunomodulatory drug and anti-CD38 monoclonal antibody — this can include a combination of the different drugs. Tecvayli is Johnson & Johnson’s fourth approved treatment for multiple myeloma.

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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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The Pharma Data

SEPTEMBER 17, 2020

17, 2020 /PRNewswire/ — Eli Lilly and Company (NYSE:LLY) and Amgen (NASDAQ:AMGN) today announced a global antibody manufacturing collaboration to significantly increase the supply capacity available for Lilly ‘s potential COVID-19 therapies. executive vice president of research and development at Amgen. Reese , M.D.,

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The Pharma Data

JANUARY 26, 2021

In what looks like a breakthrough for COVID-19 treatments, Regeneron’s monoclonal antibody cocktail REGEN-COV (casirivimab and imdevimab) cut infection rates in half and provided full protection against symptomatic COVID-19, according to interim results from a phase 3 trial evaluating the treatment as a passive vaccine.

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pharmaphorum

JUNE 24, 2021

Just a few days after Biogen abandoned its tau-targeting Alzheimer’s disease candidate gosuranemab, Bristol-Myers Squibb has opted into a rival drug, paying $80 million for rights to Prothena’s PRX005 antibody in phase 1 testing. . The deal – which could be worth up to $2.2 Lilly cues up filing for amyloid drug donanemab.

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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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Drug Discovery World

MARCH 31, 2023

As March draws to a close, this week’s key announcements have demonstrated the breadth of international approaches to tackling cancer, with vaccines, proenzymes, immunotherapies and antibody-based treatments all currently under investigation around the world.

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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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