Announcements

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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IASO Biotherapeutics’ World’s First Fully Human CD19/CD22 Dual-Targeted CAR-T Drug Receives Two IND Clearances, Enters Clinical Trials

08/07/2021

Excerpt from the Press Release: PLEASANTON, Calif. & NANJING, China & SHANGHAI–(BUSINESS WIRE)–IASO Biotherapeutics (IASO Bio), a clinical-stage biopharmaceutical company advancing the development of novel cell therapies for cancer, today announced the clearance from China’s National Medical Products Administration (NMPA) of two Initial New Drug (IND) applications for CT120, the company’s in-house developed fully human CD19/CD22…

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Seres Therapeutics Announces Topline Results for SER-287 Phase 2b Study in Mild-to-Moderate Ulcerative Colitis

08/06/2021

Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, today announced topline results from the Phase 2b ECO-RESET study evaluating SER-287 in patients with mild-to-moderate ulcerative colitis (UC). The study did not meet its primary endpoint of improving clinical remission rates compared to placebo. Both dosing regimens of…

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NIH Advances ACTIV-5/BET-B Trial Evaluating Lenzilumab from a Phase 2 Exploratory Study to a Phase 2/3 Study for the Treatment of COVID-19

08/06/2021

Excerpt from the Press Release: BURLINGAME, Calif.–(BUSINESS WIRE)–Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), a clinical-stage biopharmaceutical company developing a first-in-class GM-CSF neutralizing antibody to prevent and treat an immune hyper-response called ‘cytokine storm’ across multiple therapeutic indications, has announced that the NIH has advanced the ACTIV-5/BET-B study to a Phase 2/3 study and modified the primary…

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EUREKA THERAPEUTICS ANNOUNCES INITIATION OF PHASE I/II ARYA-3 CLINICAL TRIAL OF GPC3 TARGETING ARTEMIS® T CELL THERAPY IN LIVER CANCER

08/06/2021

Excerpt from the Press Release: Emeryville, California, July 21, 2021 — Eureka Therapeutics, Inc., a clinical-stage biotechnology company developing novel T cell therapies to treat solid tumors, today announced the initiation of a Phase I/II clinical trial of ECT204, a GPC3 targeting ARTEMIS® T-cell therapy for the treatment of hepatocellular carcinoma (HCC), the predominant type of…

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FDA Clears Vaxart’s IND Application for S-Only Oral Tablet COVID-19 Vaccine Candidate

08/06/2021

Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., Aug. 2, 2021 /PRNewswire/ — Vaxart, Inc., (NASDAQ: VXRT), a clinical-stage biotechnology company developing oral vaccines administered by tablet, announced today that the U.S. Food and Drug Administration has cleared Vaxart’s Investigational New Drug application for an S-only oral tablet SARS-CoV-2 vaccine candidate. “This is great news because it allows us to move forward…

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Sorrento Announces Dosing of COVID-19 Patients in Phase 2 Clinical Trial for COVIDROPS, a Highly Potent Neutralizing Antibody Against SARS-CoV-2 Including Delta and Alpha Variants of Concern, in an At-Home Outpatient Setting in United Kingdom

08/06/2021

Excerpt from the Press Release: SAN DIEGO, July 21, 2021 (GLOBE NEWSWIRE) — Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) today announced that COVID-19 patients have been dosed in its Phase 2 efficacy trial. Approximately 350 outpatients with COVID-19 who are asymptomatic or have mild symptoms will be enrolled in this large double-blind, randomized clinical trial evaluating COVIDROPS doses of…

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