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Sep 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
Sep 26, 2025, 22:45 ET The 2025 BPD Singapore Conference Has Concluded Successfully! Jointly Embarking on a New Journey for Global Development
to fully ensure the fulfillment of customer needs. Dr. Stuart Wang, Executive Director of US and EU CMC Management of WuXi XDC, shared insights on the CMC challenges and breakthrough strategies in the overseas expansion of China's ADC drugs. First, Dr. Stuart mentioned that the
More news about: WuXi XDC
Sep 26, 2025, 08:44 ET Sen-Jam Pharmaceutical and KVK Tech Complete Final CMC Deliverables for SJP-002C, Paving the Way for Late-Stage Clinical Development
Completion of submission batches and NDA-ready CMC package strengthens regulatory foundation for upcoming Phase 2b/3 trials and underscores Sen-Jam's leadership in immunoregulation and inflammaging. HUNTINGTON,
More news about: Sen-Jam Pharmaceutical
Sep 25, 2025, 09:00 ET YouthBio Therapeutics Announces Positive FDA INTERACT Feedback for YB002, Establishing Clear Path to Clinic for First-in-Class Alzheimer's Gene Therapy
bioactivity of YB002 and YouthBio's proposed first-in-human trial. This feedback represents a major de-risking event for YouthBio, which will now focus on CMC activities and a pilot toxicology study to support a Pre-IND meeting and finalize designs for IND-enabling studies. "We are thrilled with this
More news about: YouthBio Therapeutics Inc.
Sep 25, 2025, 08:00 ET Nobel Laureate Headlines Global Discussion in Cell & Gene Therapy in London
future trends of gene therapy and mRNA. Tackling CMC Challenges to Enable Broader Patient Access As promising as CGT may be, the journey from laboratory discovery to patient treatment is often slowed by manufacturing hurdles. CMC remains critical pain points for the sector, particularly
More news about: GenScript Biotech Corporation
Sep 25, 2025, 07:41 ET Respira Therapeutics Enters into Agreement with Gossamer Bio (Gossamer) Granting Gossamer Option to Acquire Respira from Samsara BioCapital
anticipated to continue for up to approximately two years, Gossamer will fund and Respira will undertake certain pre‑agreed development activities focused on CMC work necessary to position RT234 for successful subsequent clinical development. Respira is being advised by Sidley Austin LLP, Boston,
More news about: Respira Therapeutics, Inc.
Sep 24, 2025, 20:39 ET Savara Inc. Shareholders Who Lost Money in SVRA Should Contact Robbins LLP for Information About Leading the Class Action Lawsuit
[MOLBREEVI BLA] was not sufficiently complete to permit substantive review and requested additional data related to Chemistry, Manufacturing, and Controls (CMC)." On this news, Savara's stock price fell $0.90 per share, or 31.69%, to close at $1.94 per
More news about: Robbins LLP
Sep 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
Sep 22, 2025, 17:57 ET Claremont McKenna College to Dedicate Robert Day Sciences Center
Sept. 22, 2025 /PRNewswire/ -- Claremont McKenna College (CMC) unveils a stunning new home for its revolutionary approach to integrated science education, with a formal dedication of the Robert Day Sciences Center
More news about: Claremont McKenna College
Sep 22, 2025, 00:15 ET First-in-Class Potential! FDA Clears IND Application for LBL-047, an Anti-BDCA2/TACI Bispecific Fusion Protein Developed by Leads Biolabs
bispecific antibody portfolios. We have established integrated capabilities across early discovery, translational medicine, clinical development, CMC and business development. The innovative nature and competitive strengths of our drug candidates, coupled with our global perspectives, proactive strategy,
More news about: Leads Biolabs
Sep 19, 2025, 06:00 ET KuCoin Futures Implements Trading Upgrade for Improved Execution and Risk Management
platform metrics, underscoring the value of user-focused improvements. At the same time, KuCoin Futures is certified No. 4 globally by Coinglass, and its CMC derivatives ranking continues to trend upward. Going forward, KuCoin Futures will pursue combined offline engagement and online refinements in
More news about: KuCoin
Sep 19, 2025, 06:00 ET KuCoin Futures Implements Trading Upgrade for Improved Execution and Risk Management
platform metrics, underscoring the value of user-focused improvements. At the same time, KuCoin Futures is certified No. 4 globally by Coinglass, and its CMC derivatives ranking continues to trend upward. Going forward, KuCoin Futures will pursue combined offline engagement and online refinements in
More news about: KuCoin
Sep 18, 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
Sep 18, 2025, 06:45 ET CMC TO ACQUIRE CONCRETE PIPE & PRECAST, LLC
Texas, Sept. 18, 2025 /PRNewswire/ -- Commercial Metals Company (NYSE: CMC) ("CMC") today announced it has entered into a definitive agreement to acquire Concrete Pipe & Precast, LLC ("CP&P"), a leading supplier of precast
More news about: Commercial Metals Company
Sep 17, 2025, 12:08 ET Wheeler Bio and MindImmune Therapeutics Sign CDMO Partnership Agreement to Support MindImmune's Lead Alzheimer's Prevention Program, MITI-101
& CEO of Wheeler Bio. "MindImmune previously worked with Alloy Therapeutics in the discovery phase and their selection of Wheeler to support their CMC efforts will enable them to take advantage of the significant economic incentives provided by the Wheeler-Alloy partnership." "MITI-101 represents
More news about: Wheeler Bio, Inc.
Sep 17, 2025, 00:30 ET Geri Care hosts 3rd Geri Care Geriatric Conclave & 2nd Asian Geriatric Oncology Society (AGOS) Conference in Bengaluru
pioneer of Geriatric Oncology in India; Dr. Surekha V, President, Indian Association of Geriatrics and Professor, CMC, Vellore; Dr. Dominic G Benjamin, President, IAG Karnataka Chapter; Dr. Sundar Sankaran, Senior Nephrologist
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Sep 16, 2025, 20:52 ET Did You Lose Money in SVRA? Shareholders Who Lost Money in SVRA Should Contact Robbins LLP for Information About the Savara Inc. Securities Class Action Lawsuit
[MOLBREEVI BLA] was not sufficiently complete to permit substantive review and requested additional data related to Chemistry, Manufacturing, and Controls (CMC)." On this news, Savara's stock price fell $0.90 per share, or 31.69%, to close at $1.94 per
More news about: Robbins LLP
Sep 16, 2025, 16:15 ET CMC Announces Fourth Quarter and Full Year Fiscal 2025 Conference Call Webcast Details
www.cmc.com. About CMC CMC is an innovative solutions provider helping build a stronger, safer, and more sustainable world. Through an extensive manufacturing network
More news about: Commercial Metals Company
Sep 16, 2025, 08:29 ET EQT Life Sciences portfolio company VarmX partners with CSL in a strategic collaboration and option agreement worth up to USD 2.2 billion
"The collaboration with CSL represents a transformative step for VarmX. By securing full funding for the registrational trial, product development, CMC and pre-launch activities, we are well positioned to bring VMX-C001 to patients. We are proud to partner with CSL, whose expertise and global reach will
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Sep 15, 2025, 03:00 ET Mycenax and SPERA PHARMA Forge Strategic Alliance to Streamline ADC Drug Substance and Drug Product Manufacturing Services
Krisan Biotech and SPERA PHARMA's CMC expertise — particularly in high-potent fill-finish services for ADCs, the partnership delivers a one-stop solution tailored to the needs of global clients. Founded in 2017 as a spin-off from Takeda Pharmaceutical Company's CMC Research Division, SPERA PHARMA
More news about: Mycenax Biotech Inc.
Sep 15, 2025, 03:00 ET Mycenax und SPERA PHARMA schließen strategische Allianz zur Optimierung der Dienstleistungen im Bereich der Herstellung von ADC-Wirkstoffen und Arzneimitteln
Biologika und der CMC-Expertise von Krisan Biotech und SPERA PHARMA – insbesondere bei hochwirksamen Fill-Finish-Dienstleistungen für ADCs – bietet die Partnerschaft eine maßgeschneiderte Komplettlösung für die Anforderungen globaler Kunden. SPERA PHARMA wurde 2017 als Spin-off der CMC-Forschungsabteilung
More news about: Mycenax Biotech Inc.
Sep 15, 2025, 03:00 ET Mycenax y SPERA PHARMA forjan una alianza estratégica
experiencia en CMC de Krisan Biotech y SPERA PHARMA, especialmente en servicios de llenado y acabado de alta potencia para ADC, la alianza ofrece una solución integral adaptada a las necesidades de clientes globales. Fundada en 2017 como una filial de la División de Investigación CMC de Takeda Pharmaceutical
More news about: Mycenax Biotech Inc.
Sep 15, 2025, 03:00 ET Mycenax et SPERA PHARMA concluent une alliance stratégique pour rationaliser les services de fabrication de substances médicamenteuses et de produits pharmaceutiques CAM
stratégique avec SPERA PHARMA Inc., un expert basé au Japon dans le domaine de la chimie, de la fabrication et du contrôle des produits pharmaceutiques (CMC). Cette collaboration réunit les forces complémentaires des deux entreprises afin de fournir une solution complète pour les conjugués anticorps-médicaments
More news about: Mycenax Biotech Inc.