Pharmaceutical Technology

MARCH 13, 2023

With the acquisition, Sanofi will add a fully owned, first-in-class, disease-modifying treatment for the delay of Stage 3 type 1 diabetes (T1D), Tzield, to its core asset portfolio in General Medicines. Currently, it is in late-stage clinical development to treat newly diagnosed clinical T1D (Stage 3) in paediatric and adolescent patients.

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Pharmaceutical Technology

NOVEMBER 18, 2022

Under the deal, the companies will work together on the discovery activities for identifying and validating the conditionally active bispecific antibodies. This collaboration will use Regeneron’s Veloci-Bi bispecific antibody development platform and CytomX's Probody therapeutic platform.

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XTalks

MAY 9, 2024

Genmab, a trailblazer in the field of antibody therapeutics, celebrates this milestone by reflecting on its impressive journey from a small-scale startup to a global leader in cancer treatment and beyond. Since then, innovative science has been at Genmab’s core, as we harness the power of human antibodies to improve the lives of patients.

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Pharmaceutical Technology

FEBRUARY 19, 2023

STRO-002 is under clinical development by Sutro Biopharma and currently in Phase I for Refractory Acute Myeloid Leukemia. It is a monoclonal antibody conjugate that acts by targeting f olate receptor alpha (FolR alpha). Sutro Biopharma owns a manufacturing facility in San Carlos, California.

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pharmaphorum

AUGUST 5, 2022

MiroBio was formed in 2019 to develop checkpoint agonist antibodies for autoimmune and inflammatory disorders that can be used to apply the “natural brakes” of the immune system. 7 integrin, with three candidates in early-stage clinical development.

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XTalks

APRIL 2, 2025

Fordyce has built a world class team of drug developers and raised over $1 billion in capital. Dr. Fordyce previously worked in clinical development leadership roles at Gilead Sciences in the 2010s, driving innovation in treatments for HIV and hepatitis.

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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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Worldwide Clinical Trials

JULY 8, 2024

With radiopharmaceuticals emerging as a diagnostic and therapeutic (theranostics) procedure, many are in the clinical development pipeline and are expected to play a crucial role in the future of healthcare. The goal is to deliver a precise radiation dose to the diseased tissues while minimizing damage to surrounding healthy tissue.

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Pfizer

JULY 19, 2022

Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 is immunocompromised or are on a medicine that affects the immune system. 1 Adapted Bivalent Vaccine Candidate. Tue, 07/19/2022 - 11:22. has a fever.

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The Pharma Data

APRIL 15, 2022

The top protein neutralized the virus with similar or greater potency than antibody treatments with Emergency Use Authorization status from the U.S. Notably, the top protein also neutralized all tested SARS-CoV-2 variants, something that many clinical antibodies have failed to do. Food and Drug Administration (FDA).

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The Pharma Data

DECEMBER 13, 2020

Up to 1% of all solid tumors harbor NRG1 fusions, therefore, it is important to identify this patient population and develop therapies that can treat them. [1]. HMBD-001 is a uniquely differentiated anti-HER3 neutralizing antibody that was developed using Hummingbird’s proprietary Rational Antibody Discovery platform.

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FDA Law Blog

NOVEMBER 2, 2023

Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.” It finalized a draft guidance published in 2022.

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Pfizer

SEPTEMBER 28, 2022

Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.4/BA.5-Adapted Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.4/BA.5-Adapted 1-adapted bivalent vaccine, non clinical and manufacturing data from the companies’ 10-µg Omicron BA.4/BA.5-adapted

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Pharmaceutical Technology

FEBRUARY 24, 2023

Amivantamab is under clinical development by Johnson & Johnson and currently in Phase I for Colorectal Cancer. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. It is formulated as solution and concentrate for solution for intravenous infusion.

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The Pharma Data

MAY 27, 2022

Roche today announced that new pivotal data on its investigational CD20xCD3 T-cell engaging bispecific antibody, glofitamab, will be presented for the first time at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting from 3-7 June and the European Hematology Association (EHA) 2022 Congress from 9-12 June.

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Pharmaceutical Technology

JANUARY 2, 2023

Lifirafenib maleate is under clinical development by BeiGene and currently in the Phase II in clinical pathway. It is specialized in the development and commercialization of immuno-oncology medicines to treat cancers.

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The Pharma Data

NOVEMBER 29, 2020

Prior to joining Gannex, Dr. Palmer was Head of Liver Disease Clinical Development at Takeda Pharmaceuticals. She has also held senior leadership positions at Shire Pharmaceuticals and Kadmon Corporation, where she was in charge of the global development of NASH and other liver disease programs. ” About Ascletis.

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XTalks

MARCH 1, 2021

Pfizer/BioNTech are executing the three-dose study to also determine the effectiveness of a third dose against evolving variants as part of their clinical development strategy. The third dose will be administered to the participants regardless of antibody titer levels.

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Pharmaceutical Technology

FEBRUARY 18, 2023

Gevokizumab is a monoclonal antibody commercialized by Novartis, with a leading Phase I program in Metastatic Renal Cell Carcinoma. According to Globaldata, it is involved in 34 clinical trials, of which 20 were completed, 1 is ongoing, and 13 were terminated. The company offers generic medicines and biosimilars through Sandoz.

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pharmaphorum

SEPTEMBER 26, 2022

Other drugs used to treat ATL include Kyowa Kirin’s amti-CCR4 antibody Poteligeo (mogamulizumab), cleared by the MHLW for CCR4-positive ATL in 2012, as well as Bristol-Myers Squibb/Celgene’s oral therapy Revlimid (lenalidomide), which got a green light there five years ago.

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The Pharma Data

SEPTEMBER 20, 2020

20, 2020 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced that updated data from the full Phase 1 cohort of the CodeBreaK 100 clinical study, evaluating sotorasib (proposed INN for AMG 510) in 129 patients across multiple advanced solid tumors, were published in the New England Journal of Medicine (NEJM). Hong , M.D.,

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pharmaphorum

SEPTEMBER 17, 2020

The UK big pharma hasn’t revealed how much it is paying for rights to the drug candidate, originally developed by US biotech Dogma Therapeutics, which is still in preclinical development. At the moment no oral PCSK9 drugs have started clinical development, and AZ says it intends to start clinical testing of Dogma’s candidate next year.

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pharmaphorum

NOVEMBER 16, 2021

Injectable antibodies targeting PCSK9 have failed to take off as expected in the cholesterol-lowering market, but Merck & Co hopes to do much better with an oral alternative. ” AstraZeneca meanwhile is also working on an oral PCSK9 inhibitor that it acquired from Dogma Therapeutics last year and is in early clinical development.

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The Pharma Data

JANUARY 12, 2021

Dr Graham is a medicines development expert and Infectious Diseases Epidemiologist with global Biotech and Pharma R&D experience in Phase I-IV therapeutics as well as in-vivo & in-vitro diagnostics, across many modalities. He has in depth Global Development Expertise (e.g. NEW YORK and LONDON, Jan. Graham earned an M.D.,

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The Pharma Data

DECEMBER 5, 2020

NASDAQ: REGN) today announced updated data for REGN5458, a BCMAxCD3 bispecific antibody, from the Phase 1 portion of a Phase 1/2 trial in patients with relapsed or refractory (R/R) multiple myeloma. Assistant Professor of Medicine at the Icahn School of Medicine at Mount Sinai in New York and a trial investigator.

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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. CABOMETYX is already approved in the U.S.

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The Pharma Data

MARCH 21, 2021

José championed our transformative collaborations with Daiichi-Sankyo in relation to the clinical development of Enhertu (trastuzumab deruxtecan) and datopotamab deruxtecan, two medicines which have demonstrated great potential to benefit cancer patients. Source link:[link].

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pharmaphorum

MAY 13, 2022

iTeos Therapeutics has said it is evaluating with partner GlaxoSmithKline whether to conduct additional clinical trials of TIGIT drug EOS-448 following the failure of a key trial for Roche’s rival drug. Other TIGIT drugs from Merck & Co, Bristol-Myers Squibb/Agenus, Gilead/Arcus, and Mereo Biopharma are also in clinical development.

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The Pharma Data

OCTOBER 25, 2020

Company Confirms COVID-19 Antibody Home Test and Two Severity Triage Tests can be Submitted to U.S. SQI is accelerating the clinical development of its direct-to-consumer COVID-19 HOME Antibody Test, its COVID-19 RALI-dx Severity Triage Test and its COVID-19 RALI- fast Severity Triage Point-of-Care (POC) Test.

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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. Senior Vice President and Head of Global Clinical Development at Regeneron.

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XTalks

FEBRUARY 24, 2023

Lunsumio is a CD20xCD3 T-cell engaging bispecific antibody that works by targeting the protein CD20 on the surface of B cells and CD3 on the surface of T cells. Laport: Lunsumio (mosunetuzumab-axgb) is the first CD20xCD3 T-cell engaging bispecific antibody approved by the FDA.

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The Pharma Data

MAY 26, 2023

“At ASCO, Pfizer will present new data across the four key areas of our industry-leading portfolio – breast cancer, genitourinary cancer, hematology, and precision medicine – and for the first time, first-in-human data for some of our most exciting pipeline medicines,” said Chris Boshoff, M.D.,

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The Pharma Data

AUGUST 7, 2020

The governing body claims this proposal could have positive effects on mitigating burdensome requirements for gene therapy clinical trials in the future. In this light, Pharma IQ’s weekly round-up focuses on advancing therapies and clinical trials to combat Covid-19.

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pharmaphorum

NOVEMBER 12, 2020

In 2018, it bought Element Genomics – a spin-out of Duke University in the US – to add genome-editing technologies, and has also been growing its internal exercise at its Boston R&D hub, although so far it hasn’t advanced and gene therapies into clinical development.

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The Pharma Data

JUNE 25, 2021

protofibril antibody for the treatment of Alzheimer’s disease (AD). Breakthrough Therapy designation is an FDA program intended to expedite the development and review of medicines for serious or life-threatening conditions. Lecanemab selectively binds to neutralize and eliminate soluble, toxic amyloid-beta (A?)

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The Pharma Data

OCTOBER 14, 2020

Potential Development of Human Monoclonal Antibody Therapeutics to SARS-CoV-2. The research is part of an ongoing collaboration between Columbia University and Tonix that focuses on T cell and antibody responses to SARS-CoV-2 (CoV-2), the virus that causes COVID-19. CHATHAM, N.J., Ilya Trakht, Ph.D.,

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XTalks

JANUARY 17, 2024

There are many aspects of oncology drug development that are driven by the unique nature of the treatments being developed and the needs of the patients, their caregivers and the doctors that treat them.

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