pharmaphorum

APRIL 14, 2022

Epcoritamab is a bispecific antibody which targets CD3 on white blood cells and CD20 on tumour cells, and is designed to encourage an immune response against the cancer. billion product at peak. The two companies are also running a phase 3 trial of the bispecific as a monotherapy in patients with relapsed/refractory diffuse LBCL.

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pharmaphorum

APRIL 9, 2021

The issues are holding up discussions between the agency and company about labeling and post-marketing requirements for teplizumab, and are concentrated around the pharmacokinetics data for the antibody, and whether it is comparable to the drug that its original developer Eli Lilly entered into clinical trials.

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pharmaphorum

FEBRUARY 24, 2022

It is currently the only oral small molecule RAGE inhibitor in human clinical trials. According to Cantex, azeliragon has previously been tested for Alzheimer’s disease and diabetic nephropathy, where the drug demonstrated high levels of safety in phase 3 clinical trials involving more than 2,000 patients.

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Drug Discovery World

JULY 28, 2023

To coincide with the publication of the DDW eBook ‘ Antibody discovery: Breakthroughs accelerating therapeutic antibodies ’, our news highlights this week all focus on antibodies, particularly the recommendation by the EU’s CHMP for two bispecific antibodies that treat multiple myeloma and lymphoma.

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Roots Analysis

FEBRUARY 27, 2024

Currently, product licensing agreements, technology licensing agreements, research and development agreements and clinical trial agreements are the common types of partnerships inked by developers that are currently focused on the development of ADCs pipeline.

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Pfizer

FEBRUARY 16, 2023

These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator.

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Delveinsight

JANUARY 12, 2021

Medivir, IGM Biosciences enters into an exclusive licensing agreement for Birinapant. Medivir AB has entered into an exclusive licensing agreement with IGM Biosciences to receive global, exclusive development rights for Birinapant. million after Birinapant successfully becomes a part of the Phase I trials. R on macrophages.

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Pharmaceutical Technology

JULY 7, 2022

The US Food and Drug Administration (FDA) has granted priority review to Roche’s Biologics License Application (BLA) of Lunsumio (mosunetuzumab) to treat adults with relapsed or refractory (R/R) follicular lymphoma (FL). The submission is based on positive data from the pivotal Phase I/II GO29781 clinical trial of Lunsumio.

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pharmaphorum

AUGUST 10, 2021

Seagen is a specialist in antibody-drug conjugates, but has looked to Chinese biotech RemeGen for a HER2-targeting candidate that could challenge rival drugs from AstraZeneca/Daiichi Sankyo and Roche. While the licensing deal with Seagen tops up its finances, the scale well below the $6.9 RemeGen #oncology #AntibodyDrugConjugates.

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pharmaphorum

OCTOBER 18, 2022

Gilead Sciences has made yet another rush into the oncology category, licensing a bispecific antibody from MacroGenics in development as a treatment for CD123-positive blood cancers, including acute myeloid leukaemia (AML) and myelodysplastic syndromes (MDS). It brought in $4.7

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The Pharma Data

MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. The Companies expect interim results from this trial in the third quarter of 2021. Efforts are also underway to enable the product to be stable at routine refrigerator temperature (2-8°C).

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XTalks

FEBRUARY 8, 2021

While the approval pathway for biosimilar products was established 12 years ago, there are still misconceptions about how biosimilars are approved, biosimilarity versus interchangeable status and which patients can be treated with biosimilars. What is an Interchangeable Biological Product? What is a Biosimilar?

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The Pharma Data

APRIL 12, 2023

Program uses Denali’s Antibody Transport Vehicle (ATV) technology to cross the blood-brain barrier (BBB) and aims to increase target engagement Biogen Inc. Nasdaq: DNLI) today announced that Biogen has exercised the option to license Denali’s Antibody Transport Vehicle (ATV): Amyloid beta program (ATV:Aβ).

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Pharmaceutical Technology

MARCH 23, 2023

Seagen specialises in developing antibody-drug conjugates (ADCs) which will complement Pfizer’s oncology portfolio. Adcetris is currently active in multiple clinical trials, including the ECHELON-3 Phase lll study for patients with relapsed or refractory diffuse large B-cell lymphoma.

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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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The Pharma Data

JANUARY 6, 2021

a leading global provider of immuno-oncology imaging agents, today announced it has signed a new multi-year, non-exclusive license with Pfizer Inc. Under the terms of the agreement, ImaginAb will supply clinical doses of 89Zr CD8 Immuno-PET agent to Pfizer for use in select oncology clinical trials. LOS ANGELES , Jan.

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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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pharmaphorum

NOVEMBER 10, 2021

It is competing in the US with rival oral CGRPs, namely AbbVie’s Qulipta (atogepant) which was approved for episodic migraine prevention in September and AbbVie’s Ubrelvy (ubrogepant) in the acute treatment category, as well as several CGRP-targeting antibodies delivered by injection or infusion from Amgen, Eli Lilly, Teva and Lundbeck.

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The Pharma Data

DECEMBER 22, 2020

has been using an exclusively licensed antibody complex to develop new cancer therapies based on its Illuminox TM technology platform. Rakuten Medical’s first pipeline drug developed on Illuminox is ASP-1929, an antibody-drug conjugate comprised of the antibody cetuximab and IRDye® 700DX, a light activatable dye.

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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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Roots Analysis

FEBRUARY 29, 2024

Sutro Biopharma, a California based, clinical-stage company, announced initial safety data in ovarian cancer patients from its ongoing phase I study ( NCT03748186 ) of STRO-002. Sutro Biopharma, Inc., Overall, the ADC therapeutics market is projected to be close to $15 billion by 2030.

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XTalks

FEBRUARY 20, 2024

IgA nephropathy is an autoimmune condition characterized by the deposition of clusters of antibodies in the kidneys, resulting in inflammation and kidney impairment. These clusters, primarily comprised of IgA and other antibodies, harm the glomeruli, which are small blood vessels responsible for filtering blood in the kidneys.

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The Pharma Data

JANUARY 12, 2021

million additional doses of the casirivimab and imdevimab antibody cocktail, bringing total potential U.S. Under the new agreement, the government will purchase all finished doses of the casirivimab and imdevimab antibody cocktail delivered by June 30, 2021 , up to 1.25 TARRYTOWN, N.Y. , 12, 2021 /PRNewswire/ — . million doses.

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The Pharma Data

JULY 18, 2021

Food and Drug Administration (FDA) granted Priority Review designation for the Biologics License Application (BLA) for their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. The Pfizer-BioNTech COVID-19 vaccine has not been approved or licensed by the U.S. Pfizer Inc.

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Pharmaceutical Technology

JANUARY 19, 2023

While allogeneic hematopoietic stem cell transplants (HSCT) provide long-term benefit to a subset of AML patients, other cell therapy modalities such as natural killer (NK) cells or chimeric antigen receptor (CAR)-T cells have failed to show conclusive benefit in late-stage clinical trials.

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Pharmaceutical Technology

AUGUST 17, 2022

The US Food and Drug Administration (FDA) has accepted Roche ’s supplemental Biologics License Application (sBLA) for Polivy (polatuzumab vedotin-piiq) plus Rituxan (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) to treat priorly untreated diffuse large B-cell lymphoma (DLBCL) patients.

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The Pharma Data

DECEMBER 29, 2020

As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes. First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19. Regeneron Pharmaceuticals, Inc. futility analysis). log 10 copies/mL for combined doses).

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Pharmaceutical Technology

AUGUST 23, 2022

According to pre-clinical findings, a booster dose of this vaccine elicited a robust neutralising antibody response against the variants Omicron BA.1, A clinical trial of the vaccine to assess its safety, tolerability and immunogenicity in people aged 12 years and above is anticipated to commence this month.

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Drug Discovery World

OCTOBER 3, 2023

The Serum Institute of India has already established production capacity for 100 million doses per annum, which will be doubled over the next two years. Significantly higher vaccine-induced antibody titres were observed in the five to 17-month age group compared with 18-36-month-olds.

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The Pharma Data

MAY 7, 2021

Pfizer and BioNTech initiated the BLA by submitting the nonclinical and clinical data needed to support licensure of the COVID-19 vaccine for use in individuals 16 years of age and older. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S.

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The Pharma Data

MARCH 22, 2021

Investigational antibody cocktail of casirivimab and imdevimab also significantly shortened the duration of symptoms by four days. Companion dose-ranging phase II trial showed significant and comparable viral reductions for a range of doses of casirivimab and imdevimab.

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The Pharma Data

DECEMBER 13, 2020

The FDA also recommended that Gamida Cell generate additional manufacturing-related data prior to requesting a pre-Biologics License Application (BLA) meeting. Specifically, the FDA requested that Gamida Cell demonstrate analytical and clinical comparability from the company’s planned commercial manufacturing sites.

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The Pharma Data

DECEMBER 17, 2020

NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. TARRYTOWN, N.Y. , Yancopoulos , M.D.,

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XTalks

JULY 25, 2023

Cyfendus functions by stimulating the production of antibodies targeted against the protective antigen protein. These antibodies play a crucial role in providing protection by effectively neutralizing the cytotoxic lethal toxin and edema toxin of B. The recommended administration involves two doses, each of 0.5 anthracis.

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The Pharma Data

OCTOBER 28, 2020

NASDAQ: REGN) today announced positive, prospective results from an ongoing Phase 2/3 seamless trial in the COVID-19 outpatient setting showing its investigational antibody cocktail, REGN-COV2, met the primary and key secondary endpoints. Regeneron Pharmaceuticals, Inc. Yancopoulos , M.D., combined dose groups; 6.5%

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Delveinsight

DECEMBER 1, 2020

BASE10 Collaborates with DNA Link for COVID-19 Antibody Test Research. US-based BASE10 Genetics and Korean firm DNA Link announced a collaboration on a research project to appraise the usability of the DNA Link’s antibody test, AccuFind COVID-19 IgG, in a healthcare setting.

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The Pharma Data

JANUARY 13, 2021

This is our sixth global approval for an internally-developed product, and our first approval for tislelizumab in a lung cancer indication, an area where we believe tislelizumab can have a large impact for patients.”. Tislelizumab (BGB-A317) is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to Fc?R

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