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Ocugen, Inc. Announces Submission of Emergency Use Authorization Request to the US FDA for Investigational COVID-19 Vaccine COVAXIN™ (BBV152) for Children Ages 2-18 Years

11/10/2021

COVAXIN™ (BBV152) was recently awarded Emergency Use Listing by the World Health Organization Pediatric EUA submission based on immuno-bridging clinical trial in children, ages 2-18, demonstrating comparable neutralizing antibody response as seen in a large adult Phase 3 clinical trial conducted in India COVAXIN™ (BBV152) uses same Vero Cell manufacturing platform as other childhood vaccines,…

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Wave Life Sciences Highlights Therapeutic Potential for WVE-006 for Alpha-1 Antitrypsin Deficiency and Progress Bringing RNA Editing to the Clinic During Analyst and Investor Event

10/06/2022

WVE-006 is the most advanced candidate for AATD designed to restore functional wild-type AAT protein and reduce Z-AAT protein aggregation with potential for disease modification in both lung and liver phenotypes IND-enabling activities for WVE-006 are underway and Wave expects to submit clinical trial applications for WVE-006 in 2023 Wave is also pioneering new therapeutic…

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Bolt Biotherapeutics Initiates Phase 2 Clinical Studies of BDC-1001 in Patients With HER2-Positive Cancer

08/09/2023

Excerpt from the Press Release: REDWOOD CITY, Calif., Aug. 03, 2023 (GLOBE NEWSWIRE) — Bolt Biotherapeutics, Inc. (Nasdaq: BOLT), a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer, today announced that the first patients have been dosed in a Phase 2 dose-expansion clinical trial investigating BDC-1001, a HER2-targeting Boltbody™ Immune-Stimulating Antibody Conjugate…

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First detailed analysis of immune response to SARS-CoV-2 bodes well for COVID-19 vaccine development

06/03/2020

Excerpt from the article: “Newswise — LA JOLLA, CA—Scientists around the world are racing to develop a vaccine to protect against COVID-19 infection, and epidemiologists are trying to predict how the coronavirus pandemic will unfold until such a vaccine is available. Yet, both efforts are surrounded by unresolved uncertainty whether the immune system can mount…

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Streamline Trial Enrollment and Maximize Protocol Compliance with Fully Integrated eConsent

06/14/2023

TrialStat’s eConsent platform was designed and developed to solve the most pressing trial enrolment and protocol compliance problems. With a completely customizable workflow, content templates, multimedia capabilities, and multilingual options, Sponsors and CROs have the tools they need to create an immersive eConsent process for trial participants. Our eConsent module is fully integrated with our…

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Good Example of Integrating Wearable Devices (cameras) with Machine Learning Into Patient Care – The Potential For Use In Clinical Trials

08/31/2019

In a News Release on Eureka Alert, comes a fascinating example of how cameras were used in patient care combined with machine learning to better identify and improve lifestyle strategies for heart failure patients. The article titled “Tiny wearable cameras may improve quality of life in heart failure patients” and is an outstanding example of…

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Pardes Biosciences Announces FDA Clearance of IND Application for PBI-0451, an Oral Antiviral Drug Candidate for the Treatment and Prevention of SARS-CoV-2 Infections

02/10/2022

CARLSBAD, Calif., Feb. 03, 2022 (GLOBE NEWSWIRE) — Pardes Biosciences, Inc. (NASDAQ: PRDS), a clinical-stage biopharmaceutical company developing PBI-0451 as a potential novel direct-acting, oral antiviral drug candidate for the treatment and prevention of SARS-CoV-2 infections and associated diseases (i.e., COVID-19), today announced that its Investigational New Drug (IND) application for PBI-0451 has been cleared…

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ORIC Pharmaceuticals Announces Multiple Clinical Collaborations with Strategic Partners to Support Ongoing Trial Evaluating ORIC-944 in Combination with AR Inhibitors for the Treatment of Prostate Cancer

07/29/2024

ORIC-944, a potential best-in-class PRC2 inhibitor, is being evaluated in combination with darolutamide and in combination with apalutamide in patients with mCRPC ORIC entered into clinical trial collaboration and supply agreements with Bayerand Johnson & Johnson Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, Calif., July 16, 2024 (GLOBE NEWSWIRE) —…

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New Rapid Molecular Test For Tuberculosis Can Simultaneously Detect Resistance To First- And Second-Line Drugs

07/20/2020

Excerpt from the article: “GENEVA and SUNNYVALE, Calif., July 16, 2020 /PRNewswire/ — The Foundation for Innovative New Diagnostics (FIND) and Cepheid, Inc, announced today the launch of the new Xpert® MTB/XDR* test, which enables expanded drug-resistance tuberculosis (TB) profiling in less than 90 minutes. Xpert MTB/XDR can be used to empower clinicians to quickly prescribe…

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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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