Intensive care medicine

Cerecor Announces CERC-002 Significantly Reduced Respiratory Failure and Mortality in Phase 2 Clinical Trial in Patients Hospitalized with COVID-19 ARDS

Tuesday, March 2, 2021 - 12:00pm

All patients in this trial were hospitalized with COVID-19 associated pneumonia and mild-to-moderate acute respiratory distress syndrome (ARDS).

Key Points: 
  • All patients in this trial were hospitalized with COVID-19 associated pneumonia and mild-to-moderate acute respiratory distress syndrome (ARDS).
  • Due to the protocol allowing patients to receive high flow oxygen prior to randomization, 62 patients were included in the intention-to-treat (ITT) analysis of the primary endpoint.
  • At both the 28-day and the 60-day final timepoints, an approximately 50% trend in mortality reduction (22.5% vs 10.8%) was observed.
  • No drug-related serious adverse effects (SAEs) were reported in the trial, and there was no increase in infections in CERC-002 treated patients.

Traumatic Brain Injury Epidemiology Forecasts 2018-2020 & 2021-2030 - ResearchAndMarkets.com

Tuesday, March 2, 2021 - 10:14am

This 'Traumatic Brain Injury (TBI)-Epidemiology Forecast - 2030' report delivers an in-depth understanding of the Traumatic Brain Injury (TBI), historical and forecasted epidemiology in the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom) and Japan.

Key Points: 
  • This 'Traumatic Brain Injury (TBI)-Epidemiology Forecast - 2030' report delivers an in-depth understanding of the Traumatic Brain Injury (TBI), historical and forecasted epidemiology in the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom) and Japan.
  • The Traumatic Brain Injury (TBI) epidemiology division provides insights about the historical and current patient pool along with the forecasted trend for every seven major countries.
  • The epidemiology segment also provides the Traumatic Brain Injury (TBI) epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.
  • What are the disease risk, burden, and unmet needs of Traumatic Brain Injury (TBI)?

CorMedix Receives Complete Response Letter From FDA for DefenCath™ Catheter Lock Solution

Monday, March 1, 2021 - 1:30pm

FDA noted concerns at the third-party manufacturing facility after a review of records requested by FDA and provided by the manufacturing facility.

Key Points: 
  • FDA noted concerns at the third-party manufacturing facility after a review of records requested by FDA and provided by the manufacturing facility.
  • FDA did not specify the issues and CorMedix intends to work with the manufacturing facility to develop a plan for resolution when FDA informs the facility of the specific concerns.
  • Satisfactory resolution of these issues is required for approval of the DefenCath NDA by a pre-approval inspection and/or adequate manufacturing facility responses addressing these concerns.
  • CorMedix also intends to develop DefenCath as a catheter lock solution for use in oncology and total parenteral nutrition patients.

Veru Receives FDA Agreement to Advance VERU-111 into Phase 3 Study in Hospitalized COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome (ARDS)

Monday, March 1, 2021 - 1:30pm

We have the resources to conduct a Phase 3 trial without impacting our cancer drugs clinical development.

Key Points: 
  • We have the resources to conduct a Phase 3 trial without impacting our cancer drugs clinical development.
  • The Company has enough clinical drug supply on hand to complete the Phase 3 clinical study.
  • Patients hospitalized with documented evidence of COVID-19 infection and at high risk for ARDS were enrolled.
  • VERU-111 is also being advanced into Phase 3 for the treatment of hospitalized patients with COVID-19 who are at high risk for acute respiratory distress syndrome.

BioXcel Therapeutics Announces Initiation of Phase 2 PLACIDITY Trial of BXCL501 for the Treatment of Delirium Related Agitation

Thursday, February 25, 2021 - 12:00pm

The initiation of PLACIDITY marks an important milestone in our efforts to showcase BXCL501s ability to calm patients struggling with delirium related agitation, our fifth potential indication for this candidate, commented Vimal Mehta, Chief Executive Officer of BioXcel.

Key Points: 
  • The initiation of PLACIDITY marks an important milestone in our efforts to showcase BXCL501s ability to calm patients struggling with delirium related agitation, our fifth potential indication for this candidate, commented Vimal Mehta, Chief Executive Officer of BioXcel.
  • The PLACIDITY trial is a multicenter, randomized, double-blind, placebo-controlled, ascending dose-finding, adaptive Phase 2 study designed to evaluate the safety, efficacy, and pharmacokinetics of BXCL501 in intensive care unit adult patients experiencing delirium related agitation, including COVID-19 patients.
  • The primary endpoint is the reduction in agitation measured by at least a 2-point drop in the Richmond Agitation Sedation Scale (RASS) at two hours post BXCL501 administration.
  • BXCL501 has been studied in two Phase 3 trials (SERENITY I and II) for the acute treatment of schizophrenia related agitation and bipolar disorder related agitation, respectively, and in a Phase 1b/2 trial (TRANQUILITY) for the acute treatment of dementia related agitation.

Longeveron Announces Successful Completion of Phase 1 Clinical Study of Lomecel-B Intramyocardial Injection in Hypoplastic Left Heart Syndrome Patients

Wednesday, February 24, 2021 - 1:30pm

Lomecel-B is an allogeneic, bone marrow-derived medicinal signaling cell product manufactured under cGMP in Longeverons cell processing facility in Miami.

Key Points: 
  • Lomecel-B is an allogeneic, bone marrow-derived medicinal signaling cell product manufactured under cGMP in Longeverons cell processing facility in Miami.
  • HLHS is a rare congenital heart defect that effects approximately 1,000 babies per year in the U.S.
  • Babies with HLHS are born with an underdeveloped left ventricle, which impairs the hearts ability to pump adequate amounts of blood throughout the body.
  • Longeveron is currently sponsoring Phase 1 and 2 clinical trials in the following indications: Aging Frailty, Alzheimers disease, the Metabolic Syndrome, Acute Respiratory Distress Syndrome (ARDS), and hypoplastic left heart syndrome (HLHS).

ICU Medical, Inc. to Present at the Raymond James 42nd Annual Institutional Investors Conference

Wednesday, February 24, 2021 - 1:30pm

SAN CLEMENTE, Calif., Feb. 24, 2021 (GLOBE NEWSWIRE) -- ICU Medical, Inc. (Nasdaq:ICUI), a leader in the development, manufacture and sale of innovative medical products used in infusion therapy and critical care applications, today announced that Company management will present at the Raymond James 42nd Annual Institutional Investors Conference, held virtually March 1-3, 2021.

Key Points: 
  • SAN CLEMENTE, Calif., Feb. 24, 2021 (GLOBE NEWSWIRE) -- ICU Medical, Inc. (Nasdaq:ICUI), a leader in the development, manufacture and sale of innovative medical products used in infusion therapy and critical care applications, today announced that Company management will present at the Raymond James 42nd Annual Institutional Investors Conference, held virtually March 1-3, 2021.
  • ICU Medicals presentation will be on Monday, March 1, 2021 at 1:40 p.m. PST (4:40 p.m. EST).
  • The presentation will be webcast live and can be accessed by going to the Companys website at http://www.icumed.com , clicking on the Investors tab and clicking on the Event Calendar tab.
  • ICU Medical, Inc. (Nasdaq:ICUI) develops, manufactures and sells innovative medical products used in infusion therapy and critical care applications.

NeuroRx Announces that ZYESAMI™ (Aviptadil) has Successfully Demonstrated 10-Day Accelerated Recovery from Respiratory Failure in Critically Ill Patients with Covid-19 Treated with High Flow Nasal Oxygen at 28-Day Interim Endpoint

Tuesday, February 23, 2021 - 6:11pm

At 28 days, patients treated with ZYESAMI demonstrate 35% higher likelihood of recovery from respiratory failure with continued survival compared to patients treated with placebo (Hazard Ratio 1.53; P=.08).

Key Points: 
  • At 28 days, patients treated with ZYESAMI demonstrate 35% higher likelihood of recovery from respiratory failure with continued survival compared to patients treated with placebo (Hazard Ratio 1.53; P=.08).
  • Should the above trends continue through day 60, NeuroRx anticipates filing a request for Emergency Use Authorization in this population of critically ill patients (i.e.
  • those on High Flow Nasal Oxygen) who have exhausted all currently approved treatments.
  • We look forward to working with the sponsor to secure emergency use authorization for ZYESAMI in this population of patients."

Petriage Awarded First-Ever Patent For Online AI-Driven Pet Symptom Checker, A 99%-Plus Accurate Teletriage Tool For Assessing Urgency Of Seeking Care

Tuesday, February 23, 2021 - 5:44pm

Driven by artificial intelligence, the vet-validated teletriage Pet Symptom Analysis tool informs pet owners with over 97%-plus accuracy of the urgency for seeking care for their ailing dog or cat, based on information about their pet's symptoms inputted by the owner.

Key Points: 
  • Driven by artificial intelligence, the vet-validated teletriage Pet Symptom Analysis tool informs pet owners with over 97%-plus accuracy of the urgency for seeking care for their ailing dog or cat, based on information about their pet's symptoms inputted by the owner.
  • Petriage, a B2B pet health tech co., was granted an industry-first patent for its unique online pet symptom checker.
  • 10,930,401, entitled "Pet Evaluation and Triage System," protecting Petriage's innovative technology and investments for 20 years from its priority date.
  • Pet-owner clients get free 24/7 access to the pet symptom checker, which uses a sophisticated algorithm to identify pet ailments with increasing levels of urgency.

Florica Therapeutics, Inc. Awarded Competitive Grant from the National Science Foundation to Study Brain-Immune Axis in COVID-19

Tuesday, February 23, 2021 - 2:00pm

Florica Therapeutics, Inc. has been awarded a National Science Foundation (NSF) Small Business Innovation Research (SBIR) grant for $255,678 to work on the Hypothalamus Stem Cell Exosomes for Treatment of COVID-19 project.

Key Points: 
  • Florica Therapeutics, Inc. has been awarded a National Science Foundation (NSF) Small Business Innovation Research (SBIR) grant for $255,678 to work on the Hypothalamus Stem Cell Exosomes for Treatment of COVID-19 project.
  • This Phase I grant will develop drugs that can modulate the immune response to prevent escalation of COVID-19 to acute respiratory distress syndrome (ARDS).
  • The hypothalamus is crucial to secretion of cortisol and other immune-modulators that dampen the immune response following immune activation.
  • Christine Ichim, founder and CEO of Florica Therapeutics continued, Florica Therapeutics is a labor of love dedicated to my mother Florica Ichim.