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Seagen specialises in developing antibody-drug conjugates (ADCs) which will complement Pfizer’s oncology portfolio. Seagen will maintain its operations in the Seattle area and will leverage Pfizer’s protein-engineering capabilities to develop next-generation biologics.
Sanofi has added to its rare disease pipeline by licensing an antibody-RNA conjugate (ARC) for facioscapulohumeral muscular dystrophy (FSHD), a genetic muscle disorder, from US biotech miRecule. The aim will be to identify promising candidates in areas of “unmet patient need.”
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].
Swiss pharma giant Roche has moved to strengthen its position in the KRAS-mutated cancer space through a $25 million licensing and collaboration agreement with Austrian arenaviral technology firm Hookipa Pharma. Roche also has the option to license a second, undisclosed, novel arenaviral immunotherapy.
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).
The University of Michigan spinoff’s NanoDisc technology relies on the use of synthetic, high-density lipoproteins that can be engineered to carry a payload of antigens, presenting them for recognition by the immune system – specifically, dendritic cells within lymph nodes.
Gilead Sciences has forged closer ties to its cancer drug partner Arcus Biosciences , although a licensing deal doesn’t go as far as the takeover that some market commentators have been predicting. “Gilead has been encouraged by early clinical data generated for each of the three programmes,” said the company in a statement.
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.
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.
“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.
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.
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.
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.
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.
KaliVir, Astellas Pharma forms a licensing deal for VET2-L2 oncolytic virus. KaliVir Immunotherapeutics and Astellas Pharma entered into a worldwide exclusive licensing agreement for the development, research, and commercialization of VET2-L2 to widen the horizon of therapeutic approaches available in the Immuno-Oncology market.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.”.
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.
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.
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.
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