News & Updates
Excerpt from the article: “Although much has changed in the landscape of clinical trials because of COVID-19, the framework of inspection readiness planning and activities remains the same. It is however crucial to understand how the impacts of COVID-19 play a role in our preparation activities. Our recent Halloran Speaker Series, “Inspection Readiness Framework and…Read More
Excerpt from the article: “This week’s DeviceTalks Weekly podcast episode talks with industry leaders about improving worker diversity and developing new ways to treat COVID-19 patients. Kevin Lobo, chairman and CEO of Stryker, explains how his company — and the industry group AdvaMed — has been working to increase diversity of its workforce, particularly in…Read More
Excerpt from the article: “Gilead Sciences Inc. is prepping to launch clinical trials of an inhaled form of its Covid-19-fighting drug remdesivir, a version that could expand access to the treatment and keep less-severe patients out of hospitals. Remdesivir is the only drug granted emergency use authorization from the Food and Drug Administration against the…Read More
Excerpt from the article: “Last year, MIT engineers developed a double-sided adhesive that could quickly and firmly stick to wet surfaces such as biological tissues. They showed that the tape could be used to seal up rips and tears in lungs and intestines within seconds, or to affix implants and other medical devices to the…Read More
Excerpt from the press release: “PHILADELPHIA – June 24, 2020 – PRLog — SFA Therapeutics, Inc. is pleased to announce receipt of a “Save Our Start-ups” (SOS) grant to study SFA005 in the treatment of cytokine storm linked to Acute Respiratory Distress Syndrome (ARDS), which has been experienced by patients infected with COVID-19. This grant…Read More
Fulcrum Therapeutics Announces Initiation of Multi-Center Phase 3 (LOSVID) Trial with Losmapimod for Hospitalized COVID-19 Patients
Excerpt from the press release: “CAMBRIDGE, Mass., June 24, 2020 (GLOBE NEWSWIRE) — Fulcrum Therapeutics, Inc. (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases, today announced that it received early notification from the U.S. Food and Drug Administration (FDA) that the company may proceed with initiating…Read More
NeuroRx and Relief Therapeutics Announce Fast Track Designation Granted by the FDA to RLF-100 (Aviptadil) for the Treatment of Respiratory Distress in COVID-19
Excerpt from the press release: “RADNOR, Pa. and GENEVA, June 24, 2020 (GLOBE NEWSWIRE) — NeuroRx, Inc., in partnership with RELIEF THERAPEUTICS Holding AG (SIX:RLF) “Relief” today announced that the U.S. Food and Drug Administration (FDA) awarded Fast Track Designation to NeuroRx for the investigation of RLF-100 (Aviptadil) for the treatment of acute lung injury/acute…Read More
Excerpt from the press release: “CARLSBAD, Calif., May 15, 2020 (GLOBE NEWSWIRE) — Leading BioSciences, Inc. (LBS), a drug development company focused on improving human health through therapeutic protection of the intestinal mucosal barrier, today announced the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for a phase…Read More
Excerpt from the article: “More than a dozen drug firms in Massachusetts are urgently searching for a medicine to treat COVID-19, but the most potent therapy may not end up being a single medication. Instead, medical experts say, the most effective way to battle the disease will likely be a combination of drugs taken together.…Read More
First detailed analysis of immune response to SARS-CoV-2 bodes well for COVID-19 vaccine development
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…Read More
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