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Oct 29, 2025, 08:34 ET GeneVentiv Therapeutics Announces Positive FDA INTERACT Feedback Supporting Advancement of GENV-HEM Gene Therapy for Hemophilia A with or without Inhibitors
VIII). The INTERACT meeting confirmed alignment on GeneVentiv's IND-enabling development plan, including an IND-enabling study and CMC strategy. "This positive and constructive meeting with the FDA represents a key regulatory milestone for GeneVentiv," said Damon
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Oct 29, 2025, 05:49 ET Thousand Oaks Biologics Showcases Integrated ADC CRDMO Solutions & Media Innovation for Industrialization at CPHI Frankfurt 2025
is strengthening its global supply network and creating a cost-competitive, vertically integrated supply chain. Integrated ADC CMC Technology Platform: Driven by AI, this platform features a co-located production layout for naked antibody, ADC drug substance, and ADC drug product
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Oct 28, 2025, 10:00 ET Pomerantz Law Firm Announces the Filing of a Class Action Against Savara Inc. and Certain Officers - SVRA
of the MOLBREEVI BLA, Savara must submit, among other things, information regarding MOLBREEVI's chemistry, manufacturing, and controls ("CMC"). Specifically, the CMC section of a BLA must provide a detailed account of a product's manufacturing process—including process validation runs, stability testing,
More news about: Pomerantz LLP
Oct 28, 2025, 09:15 ET New open-source American College of Lifestyle Medicine program brings culinary skills and nutrition education into medicine
Culinary Medicine Curriculum (CMC), addressing the long-standing gap in nutrition education for physicians and other healthcare professionals. Together, the open-source resources provide
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Oct 28, 2025, 08:00 ET Acurx Announces New Data on its DNA pol IIIC Inhibitor Antibiotics Demonstrating a Potential Class Effect of Gut Microbiome Selectivity Presented at IDWeek 2025 Scientific Conference
it had received positive regulatory guidance from the EMA during its Scientific Advice Procedure which confirmed that the clinical, non-clinical and CMC (Chemistry Manufacturing and Controls) information package submitted to EMA supports advancement of the ibezapolstat Phase 3 program and if the Phase
More news about: Acurx Pharmaceuticals, Inc.
Oct 27, 2025, 09:01 ET Granata Bio Corporation and Georgetown Equity Partners Announce Joint Venture to Develop a Novel, Next-Generation Form of Follicle-Stimulating Hormone (FSH)
Venture to Accelerate DevelopmentThe new joint venture, GTE Bio, LLC, will provide funding, and Granata Bio will lead development, including CMC (chemistry, manufacturing, and controls), preclinical, and clinical programs to advance hypoglycosylated FSH into first-in-human studies.
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Oct 27, 2025, 08:00 ET Acurx Pharmaceuticals to Discuss Third Quarter 2025 Financial Results on November 12, 2025 Conference Call and Provide Business Update
it had received positive regulatory guidance from the EMA during its Scientific Advice Procedure which confirmed that the clinical, non-clinical and CMC (Chemistry Manufacturing and Controls) information package submitted to EMA supports advancement of the ibezapolstat Phase 3 program and if the Phase
More news about: Acurx Pharmaceuticals, Inc.
Oct 24, 2025, 11:00 ET ChemDiv Continues R&D Services Support for Clywedog Therapeutics Following Merger with Barinthus Therapeutics
ChemDiv's ongoing collaboration includes accelerated CMC research, AI-enabled pharmacology, computational modeling, and translational biology, extending the successful transition of Clywedog's programs to the
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Oct 24, 2025, 08:00 ET ChemDiv Extends Discovery and Early Development Partnership with Mondego Bio on Best-in-Class PTPN2 Immuno-Oncology Program
provide: Medicinal chemistry and discovery biology for backup series, CMC process research and large-scale manufacturing of the lead candidate for non-GLP and GLP animal studies, Computational and
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Oct 24, 2025, 02:00 ET TetraScience startet wissenschaftliches KI-Leuchtturmprogramm mit Takeda als Gründungspartner
Takeda als Erster Zugang zu TetraSciences komplettem Spektrum an Daten und KI-Fähigkeiten, um die KI-gestützte Arzneimittelentdeckung zu beschleunigen, CMC-Zykluszeiten zu reduzieren, In-Silico-Modellierung zu ermöglichen sowie die Produktivität der Wissenschaftler durch den Einsatz von agentenbasierter
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Oct 24, 2025, 02:00 ET TetraScience lanceert Scientific AI Lighthouse-programma met Takeda als stichtend partner
eerste toegang tot het volledige scala data en AI-mogelijkheden van TetraScience om de ontdekking van geneesmiddelen op basis van AI te versnellen, CMC-cyclustijden te verkorten, in silico modellering mogelijk te maken en de productiviteit van wetenschappers te verhogen door het gebruik van agentic AI.
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Oct 24, 2025, 02:00 ET TetraScience lance le programme Scientific AI Lighthouse avec Takeda comme partenaire fondateur
complète de données et de capacités d'IA de TetraScience pour accélérer la découverte de médicaments alimentée par l'IA, réduire les temps de cycle CMC, permettre la modélisation in silico et augmenter la productivité des scientifiques grâce à l'utilisation de l'IA agentique. Le programme est conçu pour
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Oct 23, 2025, 19:30 ET HanchorBio Presents Phase 1 HCB101 Clinical Results at FACO 2025 Demonstrating Safety and Early Antitumor Activity
animal models. By making breakthroughs in multi-functional innovative molecular configurations in R&D and improving the manufacturing process in CMC, HanchorBio develops transformative medicines to address unmet medical needs. For more information, please visit:
More news about: HanchorBio Inc.
Oct 23, 2025, 10:00 ET Pomerantz Law Firm Announces the Filing of a Class Action Against Savara Inc. and Certain Officers - SVRA
of the MOLBREEVI BLA, Savara must submit, among other things, information regarding MOLBREEVI's chemistry, manufacturing, and controls ("CMC"). Specifically, the CMC section of a BLA must provide a detailed account of a product's manufacturing process—including process validation runs, stability testing,
More news about: Pomerantz LLP
Oct 23, 2025, 08:00 ET TetraScience Launches Scientific AI Lighthouse Program with Takeda as Founding Partner
partner, Takeda will have first-mover access to TetraScience's full range of data and AI capabilities to accelerate AI-powered drug discovery, reduce CMC cycle times, enable in silico modeling, and increase scientist productivity through the use of agentic AI. The program is designed to enable biopharma
More news about: TetraScience
Oct 23, 2025, 08:00 ET TetraScience Launches Scientific AI Lighthouse Program with Takeda as Founding Partner
partner, Takeda will have first-mover access to TetraScience's full range of data and AI capabilities to accelerate AI-powered drug discovery, reduce CMC cycle times, enable in silico modeling, and increase scientist productivity through the use of agentic AI. The program is designed to enable biopharma
More news about: TetraScience
Oct 23, 2025, 07:00 ET HanchorBio's Novel CD47-SIRPα Therapeutic HCB101 Accepted for Publication in Prestigious Journal of Hematology & Oncology
animal models. By making breakthroughs in multi-functional innovative molecular configurations in R&D and improving the manufacturing process in CMC, HanchorBio develops transformative medicines to address unmet medical needs. For more information, please visit:
More news about: HanchorBio Inc.
Oct 23, 2025, 04:00 ET $1.8 Billion Orion Critical Mineral Consortium formed to strengthen U.S. economic competitiveness and national security
investment firm specializing in metals and materials, today announces the formation of the Orion Critical Mineral Consortium ("Orion CMC" or the "Consortium"). Orion CMC is a new, mission-driven consortium designed to support the United States and its allied and partner nations to develop secure, responsible,
More news about: Orion Resource Partners LP
Oct 23, 2025, 04:00 ET $1.8 Billion Orion Critical Mineral Consortium formed to strengthen U.S. economic competitiveness and national security
investment firm specializing in metals and materials, today announces the formation of the Orion Critical Mineral Consortium ("Orion CMC" or the "Consortium"). Orion CMC is a new, mission-driven consortium designed to support the United States and its allied and partner nations to develop secure, responsible,
More news about: Orion Resource Partners LP
Oct 21, 2025, 09:00 ET Brixton Biosciences Announces Scientific Advisory Board Leadership
guide the company as it advances its mission to deliver safe, long-lasting pain relief to patients with osteoarthritis of the knee, lateral hip pain, CMC (thumb joint) pain and beyond.
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Oct 21, 2025, 08:30 ET CMC Development Strategies to Prevent Rework and Delays, Upcoming Webinar Hosted by Xtalks
decision-making throughout the CMC lifecycle. TORONTO, Oct. 21, 2025 /PRNewswire/ -- Inefficiencies and errors in Chemistry, Manufacturing and Controls (CMC) development are a
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Oct 21, 2025, 08:23 ET Hoth Therapeutics Reports FDA Orphan Drug Designation and Strong Preclinical Data for HT-KIT in Rare c-KIT-Driven Cancers
Steps (Near-Term): Complete GLP toxicology and CMC packages; submit IND. Initiate Phase 1/2 dose-escalation/expansion
More news about: Hoth Therapeutics, Inc.
Oct 21, 2025, 08:03 ET What Will Define the Future of Pharma? Five Trends on Solvias' Radar Ahead of CPHI Frankfurt 2025
Characterization CMC Development as a Critical Pathway "CPHI always highlights the pressure to accelerate drug development, and we see CMC as increasingly central to that challenge. With rising product complexity
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Oct 21, 2025, 07:00 ET HanchorBio Secures US Patent for Innovative SIRPα/CD47 Fusion Protein HCB101
animal models. By making breakthroughs in multi-functional innovative molecular configurations in R&D and improving the manufacturing process in CMC, HanchorBio develops transformative medicines to address unmet medical needs. For more information, please visit:
More news about: HanchorBio Inc.
Oct 20, 2025, 07:43 ET Exploring the Next Era of Cell & Gene Therapy with Nobel Laureate in London
3rd panel: From Lab to Patient: Overcoming CMC Barriers in Cell and Gene Therapy Manufacturing Despite its promise, CGT faces manufacturing challenges, with CMC hurdles impacting reproducibility, scalability, and regulatory compliance.
More news about: GenScript Biotech Corporation