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06/06/23 3:49 PM
Nasdaq : HLTH
covid-19
Cue Health Achieves Groundbreaking Milestone with FDA: First Company to Receive De Novo Authorization for a COVID-19 Home Use Test
Cue Health, a healthcare technology company, announces an industry breakthrough as the first company to receive De Novo authorization from the U.S. Food and Drug Administration for its Cue COVID-19 Molecular Test, designed for both home and point-of-care use. This sets a new standard as the first FDA De Novo authorization for a home use COVID-19 test and the...
RHEA-AI
neutral
06/05/23 4:18 PM
AMEX : OGEN
covid-19low float
Oragenics Project to Develop a Variant-Agnostic Protein Antigen for Use in its COVID-19 Intranasal Vaccine Receives Funding from CQDM
Oragenics, Inc., a biotechnology company dedicated to fighting infectious diseases, announces the award of a grant from CQDM, a Canadian bioresearch consortium, for the collaborative development of a variant-agnostic COVID-19 protein subunit vaccine candidate. The project, which aims to build upon Oragenics’ current lead intranasal vaccine candidate...
RHEA-AI
neutral
05/26/23 9:29 AM
Nasdaq : NVAX
covid-19high short
Novavax's Nuvaxovid™ Receives Positive CHMP Opinion for Full Marketing Authorization for the Prevention of COVID in the EU
Novavax, Inc., a global company advancing protein-based vaccines with its novel Matrix-M™ adjuvant, today announced that Nuvaxovid™ has been recommended for full Marketing Authorization for use as a primary series in individuals aged 12 and older and as a booster in individuals aged 18 and older for the prevention of...
RHEA-AI
neutral
05/26/23 2:30 AM
Nasdaq : BPTS
covid-19low float
Biophytis has Filed with the French National Authority for Health (HAS) an Application for Early Access Authorisation (EAA) for Sarconeos (BIO101) in the Treatment of Severe Forms of COVID-19
PARIS, FRANCE / CAMBRIDGE, MA / ACCESSWIRE / May 26, 2023 / Biophytis SA (NasdaqCM:BPTS)(Euronext Growth Paris:ALBPS) (the "Company" or "Biophytis"), a clinical-stage biotechnology company focused on the development of therapeutics that slow the degenerative processes associated
RHEA-AI
neutral
05/26/23 1:00 AM
Nasdaq : GILD
covid-19
CHMP Adopts Positive Opinion to Extend the Use of Veklury® (Remdesivir) to Treat COVID-19 in People With Severe Renal Impairment, Including Those on Dialysis
Gilead Sciences, Inc. today announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency granted a positive opinion for the use of Veklury ® in COVID-19 patients with severe renal impairment, including those on dialysis. The European Commission will review the CHMP recommendation and, if adopted, Veklury will become...
RHEA-AI
neutral
05/25/23 11:21 AM
NYSE : PFE
fda approvalcovid-19
Pfizer’s PAXLOVID™ Receives FDA Approval for Adult Patients at High Risk of Progression to Severe COVID-19
Pfizer Inc. announced today that the U.S. Food and Drug Administration approved PAXLOVID™ for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. PAXLOVID has been available in the U.S. since December 2021 under Emergency Use Authorization, and the overall...
RHEA-AI
neutral
05/22/23 8:01 AM
Nasdaq : AEMD
clinical trialcovid-19
Aethlon Medical Receives Ethics Board Approval to Add Second Site to its Ongoing Clinical Trial of its Hemopurifier® to Treat Severe COVID-19 in India
Aethlon Medical, Inc., a medical therapeutic company focused on developing products to diagnose and treat cancer and life threatening infectious diseases, today announced that it has received Ethics Review Board approval from the Maulana Azad Medical College, for a second site for its ongoing clinical trial of Aethlon's...
RHEA-AI
neutral
05/16/23 10:00 AM
NYSE : LRN
covid-19
After Exceeding Expectations During COVID, Alabama Virtual Academy Celebrates Class of 2023
The students of Alabama Virtual Academy, an online public school serving K-12 grade students throughout the state, will soon move forward to begin the rest of their lives. Collectively, the Class of 2023 reports having been awarded nearly $88,000 worth of college scholarships. H. Halgreen is ALVA’ s 2023 valedictorian and will be participating in a two-year...
RHEA-AI
neutral
05/16/23 4:00 AM
OTC, Nasdaq : WXXWY, IFRX
partnershipcovid-19
WuXi Biologics Announces Manufacturing Partnership with InflaRx to Advance Gohibic for the Treatment of Certain Critically Ill COVID-19 patients
WuXi Biologics, a leading global Contract Research, Development and Manufacturing Organization, announced the manufacturing partnership with InflaRx for its COVID-19 treatment Gohibic. InflaRx, a clinical-stage biopharmaceutical company headquartered in Jena, Germany developing anti-inflammatory therapeutics...
RHEA-AI
very positive
05/12/23 9:00 AM
Nasdaq : NVAX
covid-19high short
Access to Novavax's COVID Vaccine Grows with Extended Interim Authorization for Adolescents in Singapore
Extended interim authorization was based on data from the pediatric expansion of the Phase 3 PREVENT-19 trial of 1,799 adolescents aged 12 through 17 years in the U.S., to evaluate the safety and effectiveness of Nuvaxovid. In the trial, Nuvaxovid achieved its primary endpoint based on neutralising antibody response and demonstrated clinical efficacy...
RHEA-AI
neutral
05/09/23 6:28 AM
Nasdaq : NVAX
clinical trialcovid-19high short
Positive Phase 2 Topline Results Show Novavax's COVID-Influenza Combination, Stand-alone Influenza and High-dose COVID Vaccine Candidates Demonstrate Robust Immune Responses
This Phase 2 trial is evaluating three vaccine candidates: COVID-Influenza Combination, stand-alone influenza and high-dose COVID Preliminary topline immune responses for all three vaccine candidates were robust versus authorized comparators For the stand-alone influenza vaccine candidate, HAI responses were 31 to 56% higher for all four influenza...
RHEA-AI
neutral
05/08/23 4:01 PM
Nasdaq : ENTA
clinical trialcovid-19low float
Enanta Pharmaceuticals Reports Positive Topline Results from Phase 2 SPRINT Trial Evaluating EDP-235 in Standard Risk Patients with COVID-19
Enanta Pharmaceuticals, Inc., a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections, today announced topline data from SPRINT, a double-blind, placebo-controlled Phase 2 clinical trial of EDP-235, Enanta’ s oral, 3 CL protease inhibitor, in non-hospitalized, symptomatic adults with mild or moderate COVID-19...
RHEA-AI
neutral
05/04/23 8:30 AM
Nasdaq : VERU
clinical trialcovid-19
Veru Reaches Agreement with FDA on Confirmatory Phase 3 Clinical Trial for Sabizabulin Treatment of Hospitalized COVID-19 Adult Patients at High Risk for ARDS
Reached agreement with FDA on confirmatory Phase 3 clinical trial design in 408 subjects with primary endpoint of all-cause mortality at Day 60 Study to expand treatment population to include all WHO-4, WHO-5, and WHO-6 hospitalized adult COVID-19 patients at high risk for ARDS regardless of the
RHEA-AI
neutral
04/26/23 1:00 AM
OTC : RHHBY
covid-19
[Ad hoc announcement pursuant to Art. 53 LR] Roche reports strong sales growth in base business of both divisions in the first quarter; Group sales decline due to expected drop in demand for COVID-19 tests
Basel, 26 April 2023 As expected, significantly lower demand for COVID-19 tests leads to a decrease in G roup sale s (-3% 1 at constant exchange rates [CER] and -7% in Swiss francs); excluding this effect, Group sales grow 8% Pharmaceuticals Division sales up 9%; strong demand for newer medicines;
RHEA-AI
neutral
04/25/23 7:00 AM
Nasdaq : IVVD
clinical trialcovid-19
Invivyd Announces the FDA Has Cleared Its IND Application for VYD222, a Monoclonal Antibody Candidate for Prevention of COVID-19, and Provides Phase 1 VYD222 Clinical Trial Update
On track for initial readouts in Q2 2023 from ongoing Phase 1 VYD222 clinical trial being conducted in Australia, with cohort 1 dosing complete Discussions are underway with the FDA and global regulators regarding the company’s proposed VYD222 pivotal clinical trial design WALTHAM, Mass., April
RHEA-AI
neutral
04/20/23 9:00 AM
OTC : TSOI
clinical trialcovid-19
Therapeutic Solutions International Files to Initiate Phase III Clinical Trial for Acute Respiratory Distress Syndrome (ARDS) Leveraging Positive COVID-19 Data with JadiCell Stem Cell Therapy
Therapeutic Solutions International announced today filing of a new Phase III clinical trial application with the FDA for use of its JadiCell adult stem cells in treatment of acute respiratory distress syndrome. The decision of the Company to accelerate development of the ARDS programs came in part from a published decision from the U.S. Patent Trial and...
RHEA-AI
neutral
04/20/23 8:00 AM
Nasdaq : VTVT
clinical trialcovid-19
Cantex and Michigan Medicine Announce Initiation of a Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Clinical Study to Determine the Safety and Efficacy of Azeliragon in the Treatment of Patients Hospitalized for COVID-19
Cantex Pharmaceuticals, Inc., a clinical-stage pharmaceutical company focused on developing transformative therapies for cancer and other life-threatening medical conditions, and Michigan Medicine, a part of the University of
RHEA-AI
negative
04/20/23 5:45 AM
Nasdaq : BVXV
covid-19low float
United States Influenza Vaccines Market Analysis Report 2023: COVID-19/Influenza Combination Vaccines Gaining Momentum with GSK, CureVac and Novavax's Continued Advancements
The influenza vaccines market in the United States was valued at US$ 3,962 million in 2022 and is expected to reach US$ 8,347 million by 2031, registering a CAGR of 8.6% during the forecast period. This report on the influenza vaccines market in the United States is a comprehensive study and presentation of drivers, restraints, opportunities, demand, market size,...
RHEA-AI
neutral
04/17/23 7:00 AM
Nasdaq : ENTA
covid-19low float
Enanta Pharmaceuticals Presents Data for its COVID-19 and Respiratory Syncytial Virus Programs at the 33rd European Congress of Clinical Microbiology and Infectious Diseases
Enanta Pharmaceuticals, Inc., a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections, today announced the company will present two posters supporting the continued clinical development of EDP-235, its 3 CL protease inhibitor in development as an oral, once-daily treatment for SARS-CoV-2 infection, and...
RHEA-AI
very positive
04/04/23 8:30 AM
Nasdaq : VERU
clinical trialcovid-19
Veru Announces Preclinical Results from Expanded Sabizabulin Program into Influenza-Induced Severe Acute Respiratory Distress Syndrome and Provides Update on COVID-19 Program
In the final report, sabizabulin significantly reduced key cytokines involved in Acute Respiratory Distress Syndrome (ARDS) in H1N1 influenza pulmonary inflammation murine ARDS model Positive Phase 3 COVID-19 clinical study and preclinical influenza study further support the potential use of
RHEA-AI
neutral
03/27/23 6:00 AM
Nasdaq : YS
clinical trialcovid-19
YS Biopharma's PIKA Recombinant COVID-19 Vaccine Demonstrates Superior Antibody Neutralization Responses Compared to Inactivated COVID-19 Vaccine in Phase II Head-to-Head Clinical Study
The trial met its primary endpoint of superior immunogenicity of PIKA COVID-19 Vaccine vs inactivated COVID-19 vaccine, measured by GMT of neutralizing antibody against Omicron virus on Day 14, with statistical significance (95%CI: 2.1, 3.4, P<0.0001) based on interim data analysis The trial also
RHEA-AI
neutral