Month: August 2021

Personalis, Inc. Publishes New Data Demonstrating a Novel Composite Biomarker NEOPS™ for Predicting Response to Cancer Immunotherapy in Late-Stage Melanoma Patients

08/11/2021

Excerpt from the Press Release: MENLO PARK, Calif.–(BUSINESS WIRE)–Personalis, Inc. (Nasdaq: PSNL), a leader in advanced translational genomics and diagnostics for cancer, today announced the publication of its study “Prediction of immunotherapy response in melanoma through combined modeling of neoantigen burden and immune-related resistance mechanisms,”(1) in Clinical Cancer Research, a journal published by the American Association for…

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Ambrx Announces First Patient Dosed in a Phase 1 Trial for ARX517, an ADC in Development to Treat PSMA Expressing Tumors

08/11/2021

Excerpt from the Press Release: SAN DIEGO–(BUSINESS WIRE)–Ambrx (NYSE: AMAM), a clinical stage biopharmaceutical company using an expanded genetic code technology platform to create Engineered Precision Biologics, today announced the first patient has been dosed in a Phase 1, multicenter, open-label, dose-escalation, and dose expansion study to evaluate the safety, pharmacokinetics (PK), and anti-tumor activity…

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Ambrx Announces First Patient Dosed in a Phase 1 Trial for ARX517, an ADC in Development to Treat PSMA Expressing Tumors

08/10/2021

Excerpt from the Press Release: SAN DIEGO–(BUSINESS WIRE)–Ambrx (NYSE: AMAM), a clinical stage biopharmaceutical company using an expanded genetic code technology platform to create Engineered Precision Biologics, today announced the first patient has been dosed in a Phase 1, multicenter, open-label, dose-escalation, and dose expansion study to evaluate the safety, pharmacokinetics (PK), and anti-tumor activity…

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Arcturus Announces Approval of Singapore Clinical Trial Application to Advance ARCT-154 and ARCT-165, Next Generation STARR™ mRNA Vaccines Targeting SARS-CoV-2 Variants of Concern, in a Phase 1/2 Study

08/10/2021

Excerpt from the Press Release: SAN DIEGO–(BUSINESS WIRE)–Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a leading clinical-stage messenger RNA medicines company focused on the development of infectious disease vaccines and significant opportunities within liver and respiratory rare diseases, announced today that the Company has received approval for a Clinical Trial Application (CTA) from…

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Carrick Therapeutics Announces Collaboration with Roche to Evaluate Novel Samuraciclib Combination to Treat HR+ Breast Cancer

08/10/2021

Excerpt from the Press Release: DUBLIN, Ireland and BOSTON, Aug. 02, 2021 (GLOBE NEWSWIRE) — Carrick Therapeutics, an oncology-focused biopharmaceutical company discovering and developing highly differentiated therapies, today announced a clinical collaboration with Roche to evaluate a novel combination of Carrick’s samuraciclib and Roche’s giredestrant in CDK4/6i resistant HR+, HER2- metastatic breast cancer. The collaboration…

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Rhythm Pharmaceuticals Announces Comprehensive Expansion of Clinical Development Program with Five New Phase 2 and 3 Trials Planned to Evaluate Setmelanotide in Rare Genetic Diseases of Obesity

08/09/2021

Excerpt from the Press Release: CAMBRIDGE, Mass., Aug. 03, 2021 (GLOBE NEWSWIRE) — Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic diseases of obesity, today announced a significant expansion of its clinical development program for setmelanotide with five new planned Phase 2 and 3…

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NAMSA Acquires Leading Clinical Research Organization Clinlogix to Enhance Therapeutic Expertise and Global Footprint

08/09/2021

Excerpt from the Press Release: TOLEDO, Ohio & PHILADELPHIA–(BUSINESS WIRE)–NAMSA, the world’s only 100% medical device-focused Contract Research Organization (CRO) providing full continuum development solutions, announced today its acquisition of Clinlogix, a leading, Philadelphia-based global clinical research organization. Third in an advancing series, this acquisition follows NAMSA’s purchase announcements of Syntactx and American Preclinical Services (APS) in early…

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Children’s Hospital of Philadelphia Researchers Identify Approach for Potential Nontypeable Haemophilus Influenzae Vaccine

08/09/2021

Excerpt from the Press Release: PHILADELPHIA, Aug. 2, 2021 /PRNewswire/ — Scientists at Children’s Hospital of Philadelphia (CHOP) have identified two proteins that could be used for a potential vaccine against nontypeable Haemophilus influenzae (NTHi). Working in a mouse model, the investigators found that administering two bacterial adhesive proteins that play a key role in helping the bacteria to latch on…

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Marinus Pharmaceuticals Submits New Drug Application (NDA) to FDA for Ganaxolone for the Treatment of Seizures Associated with CDKL5 Deficiency Disorder and Provides Pipeline Update

08/07/2021

Excerpt from the Press Release: RADNOR, Pa.–(BUSINESS WIRE)–Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the use of its lead product candidate ganaxolone, to treat seizures…

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Vaxart stock soars after FDA approves IND application for oral COVID-19 vaccine tablet

08/07/2021

Excerpt from the Press Release: Vaxart (NSDQ:VXRT) announced today that the FDA cleared the investigational new drug (IND) application for its oral COVID-19 vaccine. Upon news of the IND application approval for the S-only protein construct-based vaccine candidate, shares of VXRT were up 16.1% at $8.35 in early-morning trading today. Click the button below to read…

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