Industry News

Spero Therapeutics Announces Positive Topline Results from its Phase 3 ADAPT-PO Clinical Trial of Oral Tebipenem HBr in Complicated Urinary Tract Infection and Acute Pyelonephritis

09/08/2020

Excerpt from the Press Release: CAMBRIDGE, Mass., Sept. 08, 2020 (GLOBE NEWSWIRE) — Spero Therapeutics, Inc. (Nasdaq: SPRO), a multi-asset clinical-stage biopharmaceutical company focused on identifying, developing and commercializing treatments in high unmet medical need areas involving multidrug-resistant (MDR) bacterial infections and rare diseases, today announced positive topline results from ADAPT-PO, the pivotal Phase 3 clinical…

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Prominent biotech leaders release Covid-19 guidelines calling for FDA independence, data transparency

09/07/2020

Excerpt from the Article: WASHINGTON — A group of prominent biotech CEOs are calling on their peers and the federal government to hold themselves to the highest standards when it comes to developing and reviewing Covid-19 treatments. Among their demands: That biotech companies don’t simply release clinical trial data in press releases, and that federal…

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Life Sciences Future – BioPharm September 30 – October 2, 2020

09/04/2020

Life Sciences Future – BioPharm will be held Wednesday, September 30 through Friday, October 2, 2020 using a robust web-based platform that includes both live and on-demand features. The conference will include the most popular event features and will focus on various topics within the biotechnology and pharmaceutical industries. To learn more about the event click…

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Translate Bio and Sanofi’s COVID-19 Vaccine Positive in Animal Studies

09/04/2020

Excerpt from the Article: In a regulatory filing with the U.S. Securities and Exchange Commission (SEC), Translate Bio indicated that the COVID-19 vaccine it is developing with Paris-based Sanofi induced an immune response in non-human studies. The companies expect to begin human clinical trials in November. On June 23, Sanofi Pasteur, the vaccines business unit…

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HiFiBiO Therapeutics Submits IND Application for Fully Human SARS-CoV-2 Neutralizing Antibody for the Treatment of COVID-19 Patients

09/03/2020

Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–HiFiBiO Therapeutics, a multinational biotherapeutics company focused on the development of novel antibodies for immunomodulation, announced today the submission of an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) for a novel SARS-CoV-2 neutralizing antibody for the treatment of COVID-19 patients. The highly…

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Sustaining the Legacy of the Massachusetts Life Sciences Cluster

09/02/2020

Excerpt from the Article: In June, MassBio released its State of Possible 2025 report, a five-year strategic plan for Massachusetts and MassBio to ensure the life sciences cluster’s long-term success. To learn more about how this report will serve as a roadmap for the next five years and beyond, we sat down with MassBio’s new…

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Health and life sciences companies focused on mental health and wellness invited to pitch at second Health Challenge Event

09/02/2020

Excerpt from the announcement: Health and life sciences companies in Atlantic Canada are being invited to present their innovative solutions for improving mental health and wellness of Nova Scotians during the second Health Challenge Pitch Event. Participants will vie for a $100,000 prize and an opportunity to launch their product in collaboration with Nova Scotia…

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CymaBay Therapeutics Presents Positive Final Results From 52-Week Phase 2 Study in Primary Biliary Cholangitis at The Digital International Liver Congress™ 2020

09/01/2020

Excerpt from the Press Release: NEWARK, Calif., Aug. 27, 2020 (GLOBE NEWSWIRE) — CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a biopharmaceutical company focused on developing and providing access to innovative therapies for patients with liver and other chronic diseases, today announced final results from a previously completed open-label Phase 2 study of seladelpar in patients with…

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Synchron’s Stentrode Brain-Computer Interface Receives Breakthrough Device Designation from FDA

08/31/2020

Excerpt from the Press Release: SAN FRANCISCO & NEW YORK & MELBOURNE, Australia–(BUSINESS WIRE)–Synchron, a neurovascular bioelectronics medicine company, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for Stentrode, a fully-implantable medical device that can translate brain activity or stimulate the nervous system from the inside of a…

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Sorrento Announces FDA IND Filing Today for COVI-GUARD Neutralizing and High Potency Antibody Against SARS-CoV-2

08/28/2020

Excerpt from the Press Release: SAN DIEGO, Aug. 19, 2020 (GLOBE NEWSWIRE) — Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) announced that it is filing an investigational new drug application (IND) for COVI-GUARD (STI-1499) for hospitalized COVID-19 patients today. Sorrento has previously received guidance from the FDA in response to a pre-IND meeting package and believes…

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