Search Results for “EU” – Page 19 – media

Lonza, NeuroSense Strike Deal Focused on Exploring Biological Markers for Neurodegenerative Diseases

Don Tracy, Associate Editor Collaboration aims to advance the development of treatments for multiple neurodegenerative conditions, including amyotrophic lateral sclerosis. Lonza and NeuroSense Therapeutics have announced a collaboration focused on evaluating biological markers in neurodegenerative diseases, such as amyotrophic lateral sclerosis (ALS). According to both companies, the joint venture intends to utilize Lonza’s expertise in extracellular vesicles in combination with NeuroSense’s experience in biomarker utilization for neurodegenerative diseases. The overall goal of this partnership is to enhance development of neurodegenerative disease treatments. This deal comes amid NeuroSense revealing positive results from the Phase IIb PARADIGM trial for PrimeC, focused on treating adults living with ALS. Under terms of the agreement, Lonza will focus on utilizing neuron-derived exosomes (NDEs) for assimilation into the development of PrimeC.1 “We believe this collaboration could be a game-changer for the ALS and neurodegeneration field, as findings in such biomarkers may advance early diagnosis and treatment, ...
- Source: drugdu
- 109
- April 12, 2024
Diagonal Therapeutics’ New Slant Attracts $128M to Reactivate Antibody Drug R&D

Diagonal Therapeutics develops agonist antibodies to treat rare cardiovascular conditions. Using artificial intelligence, the startup’s technology sorts through billions of antibody/receptor combinations to identify the ones that reactivate signaling pathways lost to disease.In a drug discovery career spanning more than two decades, Alex Lugovskoy has seen a lot of antibodies come and go. The vast majority of them work by inhibiting a cellular function. Lugovskoy, now the CEO of startup Diagonal Therapeutics, said he long hoped someone would come up with a way to develop antibodies that activate their targets. With each passing year, no one did. So he took up the challenge himself. Diagonal uses computational and experimental techniques to understand what happens when an antibody binds to a receptor and which binding combinations will yield the desired effect. After developing its platform for the past two years, the startup this past week pulled back the curtain on its ...
- Source: drugdu
- 93
- April 9, 2024
Study reveals new aptamer targeting tool can detect early signs of motor neurone disease

Researchers from the University of Edinburgh and the University of Aberdeen have revealed that an aptamer (biological molecules) tool can successfully detect early signs of motor neurone disease (MND). Published in Acta Neuropathologica, the aptamer was collaboratively developed by scientists at the University of Edinburgh, the Instituto Italiano di Tecnologia, King’s College London and the Centre for Genomic Regulation in Spain. Currently affecting around 5,000 people in the UK, MND is a fatal, rapidly progressing neurological condition caused by the accumulation of proteins in the brain that clump together to gradually stop cells from working. The new method works to detect MND by targeting the protein association with the disease in brain tissue before the onset of symptoms. It uses small biological molecules to bind to protein clumps that accumulate in the brains of people living with MND. Funded by Target ALS, researchers from Edinburgh and Aberdeen discovered that the ...
- Source: drugdu
- 165
- April 9, 2024
Jazz Pharmaceuticals Completes Biologics License Application for Zanidatamab for HER2-Positive Metastatic Biliary Tract Cancer

Don Tracy, Associate Editor Approval would mark first HER2-targeted therapy for biliary tract cancer in the United States. Jazz Pharmaceuticals announced that it has completed its Biologics License Application (BLA) for zanidatamab, an investigational bispecific antibody treatment targeting HER2-positive metastatic(BTC). Aiming for accelerated approval, zanidatamab has the potential to be the first HER2-targeted therapy indicated for BTC in the United States. According to the company, the BLA was based on findings from the Phase IIb HERIZON-BTC-01 trial for zanidatamab. The primary study endpoint of confirmed objective response rate (cORR) by independent central review (ICR) was deemed a success, as the 80 enrolled patients demonstrated a cORR of 41.3%. The HERIZON-BTC-302 Phase III started recently and is currently in the process of enrollment.1 “This important milestone brings us one step closer to delivering zanidatamab, a targeted treatment option, to patients living with HER2-positive BTC, a type of cancer that is associated ...
- Source: drugdu
- 133
- April 5, 2024
FDA Clears the First Digital Therapeutic for Depression, But Will Payers Cover It?

The Otsuka Pharmaceutical and Click Therapeutics mobile app Rejoyn received FDA clearance for use as an adjunct to medication in the treatment of major depressive disorder. But Otsuka must overcome hurdles facing digital therapeutics products, which have yet to gain traction among payers. By FRANK VINLUAN A software app that modifies behavior through a series of lessons and exercises has received FDA clearance for treating patients with major depressive disorder, making it the first prescription digital therapeutic for this indication. The product, known as CT-152 during its development by partners Otsuka Pharmaceutical and Click Therapeutics, will be commercialized under the brand name Rejoyn. Rejoyn is an alternative way to offer cognitive behavioral therapy, a type of talk therapy in which a patient works with a clinician in a series of in-person sessions. In Rejoyn, the cognitive behavioral therapy lessons, exercises, and reminders are digitized. The treatment is intended for use ...
- Source: drugdu
- 125
- April 4, 2024
YolTech Therapeutics to Participate in 2024 Cell & Gene Meeting on the Mediterranean

SHANGHAI, March 27, 2024 /PRNewswire/ — YolTech Therapeutics, a trailblazing biopharmaceutical company specializing in gene editing, is delighted to announce its participation in 2024 Cell & Gene Meeting on the Mediterranean. The event will take place from April 9th to 11th, 2024, at the esteemed Rome Cavalieri, A Waldorf Astoria Hotel, situated at Via Alberto Cadlolo, 101, 00136 Roma RM, Italy. The Cell & Gene Meeting on the Mediterranean stands as the premier conference uniting the ATMP (Advanced Therapy Medicinal Products) community from Europe and beyond. Covering an extensive array of commercialization topics spanning market access, regulatory issues, manufacturing, and financing within the sector, this program boasts expert-led panels, extensive one-on-one partnering capabilities, exclusive networking opportunities, and over 60 dedicated presentations by leading publicly traded and privately held companies in the space. YolTech is poised to make a significant impact at this event, showcasing its pioneering advancements in in vivo ...
- Source: drugdu
- 104
- April 4, 2024
Gilead, Xilio Therapeutics Ink Exclusive Licensing Agreement to Develop Early Phase Tumor-Activated IL-12

Don Tracy, Associate Editor Deal aims to commercialize XTX301 for treating advanced solid tumors by leveraging Xilio’s tumor-activated immuno-oncology therapies. Gilead Sciences and Xilio Therapeutics announced that they have agreed to terms on a licensing agreement regarding XTX301, Xilio’s Phase I tumor-activated IL-12. According to Gilead, the partnership aims to expand the company’s focus in immuno-oncology, leveraging Xilio’s novel tumor-activation platform to improve its therapeutic nature and build a consistent pipeline of tumor-activated molecules. As per the deal, Xilio will receive an upfront payment of $43.5 million, with $30 million in cash and an equity investment of $13.5 million provided by Gilead in common stock. Overall, Xilio will have the opportunity to earn up to $604 million based on specified development, regulatory, and sales-based milestones.1 “Xilio’s novel tumor-activation platform naturally complements Gilead’s clinical development program in difficult-to-treat cancers and expands our focus in immuno-oncology,” said Bill Grossman, MD, PhD, SVP, ...
- Source: drugdu
- 97
- April 3, 2024
IASO Bio Announces NMPA’s IND Approval for Equecabtagene Autoleucel in Second- and Third-Line Treatment of Multiple Myeloma

SHANGHAI and NANJING, China and SAN JOSE, Calif., March 29, 2024 /PRNewswire/ — IASO Bio, a biopharmaceutical company engaged in discovering, developing, manufacturing and marketing innovative cell therapies and antibody products, today announced that China National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for Equecabtagene Autoleucel (IASO Bio R&D code: CT103A), a self-developed fully-human anti-B cell maturation antigen (BCMA) chimeric antigen receptor (CAR) autologous T-cell injection, for an expanded indication in treating relapsed and/or refractory multiple myeloma (R/RMM) patients who have undergone 1-2 lines of prior therapies and are refractory to lenalidomide. The New Drug Application (NDA) for FUCASO ® (Equecabtagene Autoleucel) was approved by NMPA for the treatment of relapsed and/or refractory multiple myeloma (R/R MM) who received ≥3 lines of prior therapies containing at least one proteasome inhibitor and an immunomodulatory agent on June 30, 2023. The NDA approval was based on the ...
- Source: drugdu
- 92
- April 3, 2024
Altamira Therapeutics partners with Univercells Group on nanoparticle-delivered mRNA vaccines

Under the terms of the agreement, Univercells will test in vitro and in vivo a proprietary mRNA vaccine delivered with Altamira’s SemaPhore nanoparticle platform Altamira Therapeutics, a company providing nanoparticle-based technology for efficient RNA delivery to extrahepatic targets has announced that it has entered into a collaboration agreement with Univercells Group to evaluate the use of the Company’s proprietary SemaPhore platform for the delivery of mRNA vaccines. Univercells is a global life sciences company creating platforms for developing and manufacturing biologics, including mRNA vaccines and therapeutics, in a simple, scalable and cost-efficient way. Under the terms of the agreement, Univercells will test in vitro and in vivo a proprietary mRNA vaccine delivered with Altamira’s SemaPhore nanoparticle platform. Should the experiments prove successful, Univercells and Altamira intend to discuss and negotiate a commercial agreement for the development and manufacturing of nanoparticle-based mRNA vaccines using Univercells’ production platform. Covadonga Pañeda, PhD, Altamira’s ...
- Source: drugdu
- 81
- April 2, 2024
Novo Nordisk to acquire Cardior Pharmaceuticals to strengthen pipeline in cardiovascular disease

The agreement includes Cardior’s lead compound CDR132L, currently in phase 2 clinical development for the treatment of heart failure Novo Nordisk and Cardior Pharmaceuticals has announced that Novo Nordisk has agreed to acquire Cardior for up to 1.025 billion Euros, including an upfront payment and additional payments if certain development and commercial milestones are achieved. The agreement includes Cardior’s lead compound CDR132L, currently in phase 2 clinical development for the treatment of heart failure. Martin Holst Lange, executive vice president for Development at Novo Nordisk said, “By welcoming Cardior as a part of Novo Nordisk, we will strengthen our pipeline of projects in cardiovascular disease where we already have ongoing programmes across all phases of clinical development. We have been impressed by the scientific work carried out by the Cardior team, especially on CDR132L, which has a distinctive mode of action and potential to become a first-in-class therapy designed to ...
- Source: drugdu
- 95
- April 2, 2024

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