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Biohaven acquires exclusive global rights to a portfolio of novel, small-molecule CGRP antagonists.
The lead candidate, HTL0022562, has advanced through preclinical development demonstrating promising and differentiated properties for further investigation in human trials.
Vlad Coric , M.D.,
Rise of the best-in-class biologics plays: Are you looking to in-license or invest in “de-risked” biology that is already in the clinic? Smallmolecule GLP1s? Whether it’s smallmolecules to target the incretins (GLP1R ± GIPR), targeting well-validated signaling nodes in I&I (e.g., Join the club.
There is a continuum of evidence for a given target – at one end are novel targets with some evidence of importance in disease, and at the other end are “de-risked” targets where the biology is precedented with an approved product or late-stage clinical asset(s). and whether a molecule’s pharmacology can help to mitigate safety risk.
Broadens company’s oncology platform of Targeted Alpha Therapies / Acquisition includes actinium-225 labeled differentiated PSMA smallmolecule for the treatment of prostate cancer. Xofigo is currently under further evaluation in a broad clinicaldevelopment program in prostate cancer and beyond.
“These data provide further evidence of efficacy and high potency of SLV213 against SARS-CoV-2 and support the clinicaldevelopment of SLV213 as a potential oral treatment for COVID-19,” said Ted Daley, President and CEO, Selva Therapeutics. “As About SLV213. About Selva Therapeutics.
At Ultimovacs, he will lead all business and corporate development efforts and continue to maintain and foster connections with leading biotechnology and pharmaceutical companies. “In Mr. Berkien is currently a board member of the Nordic Pharma Licensing Group.
Dr. Berk, commented “I am excited to join the Board of Inflection Biosciences as it advances its novel PIM/PI3K inhibitor, IBL-202, towards clinicaldevelopment for unmet needs in B-cell malignancies and other cancers.”. Dr. Berk most recently has served as a consultant to several companies developing oncology therapies.
(Nasdaq: RIGL) today announced a global exclusive license agreement and strategic collaboration to co-develop and commercialize Rigel’s R552, a receptor-interacting serine/threonine-protein kinase 1 (RIPK1) inhibitor, for all indications including autoimmune and inflammatory diseases. vice president of immunology at Lilly.
” The lead molecule, SDI-118, is a smallmolecule currently in Phase 1b studies, which is being evaluated to target nerve terminals to enhance synaptic efficiency. It has been a pleasure to partner with our investors to investigate the potential of SDI-118 in early clinical studies. Source link: [link].
Read-through therapeutic development is focused on extending mRNA half-life and increasing protein synthesis by enabling the cytoplasmic ribosome to read through premature stop codons to produce full-length proteins. ELX-02 is in the early stages of clinicaldevelopment focusing on cystic fibrosis.
HZI – Germany’s Helmholtz Centre for Infection Research (HZI) secured two awards worth up to $15 million from CARB-X to develop non-traditional approaches against antibiotic-resistant pathogens. The goal is to develop a first-in-class treatment for Staphylococcus aureus infections and thereby prevent exacerbation of pneumonia.
The mAb portfolio is complemented by a non-antibiotic novel mechanism smallmolecule anti-infective candidate being developed to treat lung infections in cystic fibrosis patients. AR-301 is a fully human IgG1 mAb currently in Phase 3 clinicaldevelopment targeting gram-positive Staphylococcus aureus ( S.
Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developingsmallmolecules and biologics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is primarily composed of central nervous system (CNS) and immunology product candidates.
Anokion is responsible for preclinical activities and Phase I clinicaldevelopment of partnered programs, and Bristol Myers Squibb will fund subsequent trials and commercial activities at clinical proof-of-concept. SmallMolecule Inhibitors. Oral, SmallMolecules.
“We expect 2021 will mark a number of key clinical and commercial milestones. By the end of the year, we expect to have five independent TransCon product candidates in clinicaldevelopment leveraging TransCon technologies through our algorithm for product innovation. Pipeline Updates.
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It is estimated that there will potentially be 13 million moderate-to-severe acne patients treated with oral antibiotics in the urban Chinese population by 2028, which represents a significant opportunity to launch an innovative product whose clinicaldevelopment is largely de-risked.
Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and smallmolecules.
Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developingsmallmolecules and biologics to treat and prevent human disease and alleviate suffering. 1 Noyce RS, et al. 2018) PLoS One. 13(1):e0188453. About Tonix Pharmaceuticals Holding Corp.
Taveras will lead all research and non-clinicaldevelopment functions supporting the company’s pipeline of investigational therapies. Prior to that, Taveras was vice president of SmallMolecule Drug Discovery and CMC Development at Biogen Idec, and Alantos Pharmaceuticals, which was acquired by Amgen in 2007.
Postapproval manufacturing changes for biological products During clinicaldevelopment or following a product’s approval , sponsors and/or manufacturers may identify the need for a change in the product, production process, quality controls, equipment, facilities, responsible personnel, or labeling. Any CMC changes (e.g.,
Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and smallmolecules.
Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and smallmolecules.
AstraZeneca has developed a broad range of technologies, initially focused on smallmolecules and biologics and with a growing focus in precision medicine, genomics, oligonucleotides and epigenetics. The FcRn extends the half-life and hence the availability of pathogenic immunoglobulin G (IgG) antibodies.
Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and smallmolecules.
In addition to the COVID-19 vaccine program, Pfizer aims to deliver five innovative vaccines by 2025, subject to clinical success and regulatory approval. Pfizer is leading further development of vupanorsen, with a focus on cardiovascular risk reduction, and plans to initiate a Phase 2b dose-ranging study in the coming weeks.
Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and smallmolecules.
The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and smallmolecules.
Pfizer and BioNTech expect to file a Biologics License Application for possible full regulatory approval in 2021.
other regulatory submissions, the anticipated timing of regulatory submissions (including the anticipated timing of filing of a Biologics License Application in the U.S.),
The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and smallmolecules.
The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and smallmolecules.
In parallel, Cytokinetics plans to conduct commercial readiness assessments and to evaluate potential partnering opportunities, including co-promotion options in North America as well as licensing in other territories. Cytokinetics will have no trailing royalty payment obligations to Amgen for either omecamtiv mecarbil or AMG 594.
It was conceived, invented and developed by Professor Stephen Neidle and his team in the School of Pharmacy at University College London with the involvement of Sygnature Discovery scientists. In January 2023, QN-302 received Orphan Drug Designation by the FDA for the potential treatment of pancreatic cancer.
Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and smallmolecules.
Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and smallmolecules.
Currently, 16 potentially registration-enabling clinical trials are being conducted in China and globally, including 12 Phase 3 trials and four pivotal Phase 2 trials. We also market or plan to market in China additional oncology products licensed from Amgen Inc., Tislelizumab is not approved for use outside of China.
billion related to certain license and collaboration agreements, and certain other items.
Companies enter into exclusive license and co-development agreement to accelerate global reach of Tukysa (tucatinib), a smallmolecule tyrosine kinase inhibitor for the treatment of HER-2 positive cancers.
It was conceived, invented and developed by Professor Stephen Neidle and his team in the School of Pharmacy at University College London with the involvement of Sygnature Discovery scientists. In January 2023, QN-302 received Orphan Drug Designation by the FDA for the potential treatment of pancreatic cancer.
Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and smallmolecules.
Together, these nine companies have collectively developed more than 70 novel vaccines that have helped to eradicate some of the world’s most complex and deadly public health threats, underscoring their experience in clinicaldevelopment and regulatory rigor, as well as their longstanding commitments to patient safety and public health.
Together, these nine companies have collectively developed more than 70 novel vaccines that have helped to eradicate some of the world’s most complex and deadly public health threats, underscoring their experience in clinicaldevelopment and regulatory rigor, as well as their longstanding commitments to patient safety and public health.
Without further ado my key themes from this years JPM as we look forward to another productive year in biotech Brave New World: China Assets are Here to Stay Despite grandstanding from Washington, China out-licenses to U.S. and EU-based biotech and Pharma have never been more abundant than in the past year (Fig.
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