Formulation Development
Rilzabrutinib Granted Orphan Drug Designation in the US for Sickle Cell Disease
The US FDA has granted orphan drug designation to rilzabrutinib, a novel, advanced, oral, reversible Bruton's tyrosine kinase (BTK) inhibitor that works via multi-immune modulation,…
Symeres & Yoneda Labs Use AI to Optimize Cross-Coupling Reactions
Yoneda Labs, a leader in computational tools for reaction optimization, has successfully collaborated with Symeres, a leading transatlantic, small molecule contract research and manufacturing organization.…
Coya Therapeutics Announces Issuance of New Patent Protecting Methods of Producing Recombinant Human Interleukin-2 Liquid Formulations
Coya Therapeutics, Inc. recently announced the issuance of a US patent relevant to its investigational ready-to-use (RTU) liquid formulation of IL-2. In particular, the US…
EXECUTIVE INTERVIEW - Sanner Group: Building a Suite of World-Leading Services for its Customers
Chris Gilmor, Vice President of Sales, Sanner of America, explains how Sanner’s Advance with Agility™ program helps its partners achieve faster development times and reduce time to market, and how the company embeds sustainable practices into its global business.
DRUG ADMINISTRATION - Protecting Patient Data in Cell & Gene Therapy: The Role of Tech Platforms
Matthew Lakelin, PhD, explores the unique data challenges in CGT, emphasizing the need for robust technology platforms to ensure patient privacy and security.
Fujifilm Rebrands Life Sciences Companies to Strengthen Position as Strategic Partners for Life, Offering End-to-End Solutions
FUJIFILM Corporation's Life Sciences Group companies, a portfolio of businesses offering products, services and comprehensive solutions that span all stages of therapeutic development from discovery…
Kymera Therapeutics Announces Positive First-in-Human Results From Phase 1 Trial of a First-in-Class, Oral STAT6 Degrader
Kymera Therapeutics, Inc. recently announced positive clinical results from the Phase 1 healthy volunteer study of KT-621, its first-in-class, oral STAT6 degrader medicine. “Our primary objective…
Curevo Enrolls First Participants in Phase 2 Extension Trial
Curevo Vaccine recently announced the enrollment of the first patients in a Phase 2 extension trial of its investigational shingles vaccine, amezosvatein. “I’m so proud…
BioNTech & Bristol Myers Squibb Announce Global Strategic Partnership to Co-Develop & Co-Commercialize Next-Generation Bispecific Antibody Candidate Broadly for Multiple Solid Tumor Types
BioNTech SE and Bristol Myers Squibb recently announced they have entered into an agreement for the global co-development and co-commercialization of BioNTech’s investigational bispecific antibody…
CERo Therapeutics Doses First Patient With CER-1236 in Phase 1 Clinical Trial for Acute Myeloid Leukemia and is Advancing Through Protocol-Defined Evaluations
CERo Therapeutics Holdings, Inc. recently announced it has dosed the first patient in its Phase 1 clinical trial of CER-1236. The patient was dosed at…
Cellares & Mitsui Fudosan Announce the First IDMO Smart Factory for Commercial-Scale Cell Therapy Manufacturing in Japan
Cellares, in collaboration with Mitsui Fudosan, recently announced the establishment of Japan’s first next-gen commercial production site for CAR-T cell therapies. The facility is under…
Sibeprenlimab's Priority Review Highlights Potential to Differentiate in IgAN Space
Otsuka Pharmaceutical recently announced that the FDA has accepted for review the Biologics License Application (BLA) for sibeprenlimab, which acts as A Proliferation Inducing Ligand…
Cartesian Therapeutics Announces First Participant Enrolled in the Phase 3 Trial of Descartes-08 in Patients With Myasthenia Gravis
Cartesian Therapeutics, Inc. recently announced the first participant has been enrolled in its Phase 3 AURORA trial of Descartes-08 in patients with myasthenia gravis (MG).…
Bora Adds Automated Fill/Finish Line in Baltimore
Bora Pharmaceuticals Co., Ltd. recently announced that due to continued growth in demand for its drug product services, it plans to add further sterile fill/finish…
Nuclera & Cytiva Collaborate to Accelerate Characterization of Proteins for Drug Development
Nuclera recently announced a collaboration with Cytiva focused on accelerating the production, purification, and characterization of proteins required for drug research and development, enabled through…
Alvotech & Advanz Pharma Extend Strategic Partnership to Commercialize Three Additional Biosimilars in Europe
Alvotech and Advanz Pharma recently announced they have entered an agreement to expand their commercial partnership to cover three additional biosimilar candidates. The new agreement…
Candel Therapeutics Receives FDA Regenerative Medicine Advanced Therapy Designation for CAN-2409 for the Treatment of Prostate Cancer
Candel Therapeutics, Inc. recently announced the US FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to CAN-2409 (aglatimagene besadenovec), the company’s biological immunotherapy lead…
Monarch Therapeutics & SNAP Biosciences Enter Licensing Agreement to Bolster Cell Therapy in Oncology
SNAP Biosciences, Inc., a majority-owned subsidiary of Coeptis Therapeutics Holdings Inc., and Monarch Therapeutics Inc. recently announced a licensing agreement to enable the development and…
ProMed Pharma Secures DEA Registration for Schedule III Controlled Substances
ProMed Pharma recently announced it has successfully secured registration from the U.S. Drug Enforcement Administration (DEA) to handle Schedule III controlled substances. This regulatory milestone…
WHITEPAPER - Container Selection for a Highly Sensitive Drug Product: A Success Story
When Stevanato Group is involved from the early stages, before the container is even chosen, we can support the client with a comprehensive data-driven analysis so the client can make an informed choice and select the optimal solution for their drug product.
