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Boehringer Ingelheim and the Agency for Science, Technology and Research (A*STAR) today announced a global licensing agreement under which Boehringer Ingelheim will obtain exclusive worldwide rights to research, develop and commercialize products based on a panel of innovative, tumor-specific antibodies from A*STAR. star.edu.sg.
Ltd (“Juyou”), a biotechnology company that develops and sells medical and cosmetic skincare products, for the commercialization and development of Pliaglis ® in mainland China (the “License Agreement”).
million and US$1.8 For additional information, please visit [link].
The university then licenses the IP to an existing pharmaceutical company or a biotech startup, which takes on Investigational New Drug (IND) enabling studies. In this regard, BioDAOs can be viewed as collaborative research translation engines and a novel form of biotech organization that develops IP through an online-native approach.
Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and controls (CMC).
MacroGenics , based in Rockville, Maryland, has a target action date of December 18 for its Biologics License Application (BLA) for margetuximab in combination with chemotherapy for patients with metastatic HER2+ breast cancer. Margetuximab is an investigational, Fc-engineered, monoclonal antibody targeting HER2.
This will aid clinicaldevelopment and preparation for investigational new drug (IND) and biologics license application (BLA) submissions. The project should also help clinical research sponsors take advantage of various FDA pathways for accelerated review and approval.
The company has an exclusive collaboration and license deal with CStone Pharmaceuticals for development and commercialization of pralsetinib and specific other drug candidates in Mainland China, Hong Kong, Macau and Taiwan. It holds the rights for the drug in the rest of the world. Revance Therapeutics’ DAXI to Treat Frown Lines.
SEFA’ stands for Structurally Engineered Fatty Acid, i.e. chemically engineered fatty acids, to generate compounds with differentiated physiochemical properties. This Phase 1 trial will evaluate the safety, tolerability, and pharmacokinetics of SEFA-1024 in 96 otherwise healthy volunteers with elevated plasma triglyceride levels.
These mAbs are already of human origin and functionally optimized for high potency by the donor’s immune system; hence, they technically do not require genetic engineering or further optimization to achieve full functionality. AR-711 is an in-licensed mAb that is directed against the receptor binding domain of the SARS-Cov 2 virus.
“Building on Pfizer’s established leadership position in breast cancer science and CDK 4/6 inhibition, we are excited to work with Arvinas to maximize ARV-471, the first PROTAC for breast cancer with encouraging early clinical data and a potential novel hormonal therapy backbone for HR+ breast cancer,” said Jeff Settleman, Ph.D.,
Now poised to advance a robust therapeutics pipeline to clinicaldevelopment, Nuance will use the funds for ongoing R&D of existing products and business development of potential new assets. Through its Shielded Living Therapeutics platform, the company is developing functional cures for chronic diseases.
NST) is a Dutch biotech company focused on developing structurally engineered fatty acids (‘SEFAs’) for the treatment of inflammatory, metabolic, and liver diseases. About NorthSea Therapeutics. NorthSea Therapeutics B.V.(NST) A Phase 2b study was initiated in July 2019 (ICONA) to study the efficacy of icosabutate in NASH.
platform and its patented large-capacity VV cop TK-RR- oncolytic virus, which has been engineered to encode both a Treg-depleting human recombinant anti-CTLA4 antibody generated by BioInvent’s proprietary n-CoDeR ® /F.I.R.S.T BT-001 is being co-developed through a 50/50 collaboration between BioInvent and Transgene.
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.
TNX-1500 is a third generation anti-CD40-ligand mAb that has been designed by protein engineering to decrease Fc?RII Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering.
It is also an off-the-shelf therapy, meaning that people do not have to wait for cell collection and genetic engineering before starting treatment, which could be particularly important for patients who are at a high-risk of their disease progressing. A final decision is expected from the European Commission (EC) in the near future.
Addressing unexpected manufacturing challenges, safety concerns, or efficacy issues in later stages can significantly delay clinicaldevelopment and escalate costs. In conclusion, over-reliance on healthy donor material in cell therapy development creates a precarious foundation for clinical translation.
Data from the registrational COMET-ICE trial also will form the basis for a Biologics License Application (BLA) submission to the FDA. Preclinical data suggest VIR-7831 targets a highly conserved epitope of the spike protein, which may make it more difficult for resistance to develop. About the VIR-7831 ClinicalDevelopment Programme.
Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA), under Priority Review, for Port Delivery System with ranibizumab (PDS) for the treatment of neovascular or “wet” age-related macular degeneration (nAMD). Roche (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S.
Overland management plans to execute on its strategy to form partnerships with biotechnology companies seeking to expand the development and commercialization of their innovative therapeutic programs and cutting-edge technology platforms. . Amolyt Pharma – France-based Amolyt Pharma and PeptiDream, Inc.
Additionally, Sarah Haecker Meeks, joined the Company as vice president of Business Development and Steve Nardi joined as vice president of Manufacturing and Engineering Operations. Before joining MaxCyte, Meeks served as vice president of Business Development at Synpromics, which is now part of AskBio.
Novartis has been granted an option to in-license global rights of MP0420 and MP0423 – multi-targeted direct-acting antiviral therapeutic candidates demonstrating potential efficacy against COVID-19.
Upon option exercise, Novartis would be responsible for all further development and commercialization activities.
We believe our allogenic CAR-T platform is significantly stronger with chPD1 target licensed from Longwood University. Barber’s work will give Kiromic a significant acceleration in the clinicaldevelopment of its therapy platform and an even more significant advantage over its competitors. “We believe Prof.
Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Vabysmo® (faricimab) for the treatment of macular edema following retinal vein occlusion (RVO). 1,2 Vabysmo’s safety profile was consistent with previous trials. Review by other regulatory authorities is ongoing.
Kite, a Gilead Company (Nasdaq: GILD), today announced that it has submitted a supplemental Biologics License Application (sBLA) to the U.S. Kite is engaged in the development of innovative cancer immunotherapies. The company is focused on chimeric antigen receptor and T cell receptor engineered cell therapies.
Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Horsepox and vaccinia are closely related orthopoxviruses that are believed to share a common ancestor. 1 Noyce RS, et al.
With the depth and breadth of our current portfolio, the tremendous potential of our pipeline and scientific engine, and the power of our culture of innovation, we are poised to continue delivering meaningful value to patients by addressing some of the world’s most difficult health challenges.”.
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.
He is a senior data scientist and holds a masters degree from Roma Tre University in computer engineering, where he also held the role of research fellow. He also develops and presents customised training programmes (both live and virtual) for companies seeking to improve their in- and out-licensing processes.
Addressing the long timelines and high costs of drug development is therefore critical for the advancement of medical innovation. Clinicaldevelopment failure may be due to an inability to demonstrate efficacy or sufficient safety. Unfortunately, many drug candidates fail. Unfortunately, many drug candidates fail.
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