Business Wire

1. China's Center For Drug Evaluation Accepts Merck KGaA, Darmstadt, Germany's Application For Marketing Authorization Of Pimicotinib For Treatment Of Tenosynovial Giant Cell Tumor 6/10/2025

   Merck KGaA, Darmstadt, Germany, a leading science and technology company, today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) officially accepted the company’s application for marketing authorization of pimicotinib as a Class 1 innovative drug for adult patients with tenosynovial giant cell tumors (TGCT) requiring systemic treatment.

2. Emulate Launches AVA Emulation System To Accelerate Drug Development With First-Of-Its-Kind High-Throughput Organ-Chip Platform 6/10/2025

   Emulate, Inc., the world leader in Organ-on-a-Chip technology, today announced the commercial launch of the AVA Emulation System, a self-contained instrument that cultures, incubates, and images up to 96 independent Organ-Chip samples in a single run.

3. CN Bio Introduces Cross-Species DILI Services To Enhance In Vitro To In Vivo Extrapolation During Preclinical Drug Development 6/10/2025

   CN Bio, a leading provider of Organ-on-a-chip (OOC) systems and solutions that accelerate drug discovery and development workflows, has introduced two new animal microphysiological system (MPS) models that enhance translatability in preclinical drug safety and toxicology assessments to its Contract Research Services (CRS).

4. IonQ Speeds Quantum-Accelerated Drug Development Application With AstraZeneca, AWS, And NVIDIA 6/9/2025

   IonQ, a leading commercial quantum computing and networking company, announced results of a collaborative research program between IonQ, AstraZeneca, Amazon Web Services (AWS), and NVIDIA to develop and demonstrate a quantum-accelerated computational chemistry workflow which has the potential to power world-changing innovation in healthcare, life sciences, chemistry, and more.

5. Mission Bio Unveils Industry-First Single-Cell Genotype And Targeted Gene Expression Solution Aimed At Derisking Cancer Drug Clinical Development 6/5/2025

   Mission Bio, a leader in single-cell multi-omics solutions for precision medicine, today announced the launch of its Single-Cell Genotype and Targeted Gene Expression assay, expanding the capabilities of its Tapestri Platform to become the only commercial solution that delivers simultaneous genotype and targeted gene expression profiling from over 10,000 single cells.

6. Tenpoint Therapeutics Ltd. Announces FDA Acceptance Of New Drug Application For BRIMOCHOL PF For The Treatment Of Presbyopia 6/3/2025

   Tenpoint Therapeutics, Ltd. (“Tenpoint”), a global, clinical-stage biotechnology company focused on developing groundbreaking treatments to rejuvenate vision in the aging eye, today announces that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for BRIMOCHOL PF for the treatment of presbyopia.

7. Orbis Medicines Accelerates Next-Generation Oral Macrocycle Platform With Enhanced Artificial Intelligence Capabilities Of Gefion Supercomputer 6/3/2025

   Orbis Medicines, a leader in oral macrocycle drug discovery, and the Danish Center for AI Innovation (DCAI) today announced that Orbis has begun using Denmark’s first AI supercomputer, Gefion, which is owned and operated by DCAI.

8. Kivu Bioscience Selects Sterling Pharma Solutions For cGMP Manufacturing Of Lead Oncology Antibody-Drug Conjugate KIVU-107 6/2/2025

   Kivu Bioscience, a biotech company developing next-generation antibody-drug conjugates, announced today a manufacturing partnership with Sterling Pharma Solutions, a global contract development and manufacturing organisation, to produce cGMP-quality material for Phase 1 clinical trials of its lead oncology antibody-drug conjugate (ADC) candidate, KIVU-107.

9. BioNTech And Bristol Myers Squibb Announce Global Strategic Partnership To Co-Develop And Co-Commercialize Next-Generation Bispecific Antibody Candidate BNT327 Broadly For Multiple Solid Tumor Types 6/2/2025

   BioNTech SE and Bristol Myers Squibb today announced that the companies have entered into an agreement for the global co-development and co-commercialization of BioNTech’s investigational bispecific antibody BNT327 across numerous solid tumor types. Under the agreement, BioNTech and BMS will work jointly to broaden and accelerate the development of this clinical candidate.

10. ImmunAbs Announces FDA Phase 2 IND Approval Of IM-101, A Novel Complement C5 Inhibitor, For Treatment Of Myasthenia Gravis 6/2/2025

    ImmunAbs Inc., a clinical-stage biotech specializing in developing antibody therapeutics, today announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug (IND) application to initiate a Phase 2 clinical trial evaluating the safety and efficacy of IM-101, a novel complement C5 inhibitor, for the treatment of Myasthenia Gravis.