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The Latest Breaking News from Clinical Trial

Veru Seeks FDA Emergency Use Nod For Its COVID-19 Treatment

Veru Inc (NASDAQ:VERU) has submitted an emergency use authorization (EUA) for sabizabulin application to FDA for COVID-19 treatment. The application covers moderate to severe hospitalized COVID-19 patients at high risk for developing Acute Respiratory Distress Syndrome (ARDS). The EUA submission is based on the positive results from the Phase 3 COVID-19 clinical trial…

Benzinga

Experimental cancer drug 'cures' every patient in trial in 'really exciting' development

The drug dostarlimab appeared to cure practically every patient during a clinical trial at the Memorial Sloan Kettering Cancer Center (MSKCC) in New York

Irish Mirror

'Hunger-buster' diabetes jab helps obese lose 20% of their weight, trial finds

Obese volunteers who injected themselves with the highest dose of the 'game-changing' diabetes drug tirzepatide as part of a clinical trial lost 20% or more of their body weight

Daily Mirror

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Corbevax gets DCGI nod as COVID-19 booster after two doses of Covishield or Covaxin

Clinical trial data is reported to have shown that the Corbevax booster dose provided significant enhancement in immune response and a good safety profile.

The Hindu

US FDA Concerned over Potential Novavax Myocarditis Risk

The Food and Drug Administration voiced concern Friday about myocarditis being potentially linked to the Novavax Covid-19 vaccine, just as experts are to weigh its use in the United States. The Novavax vaccine is already authorized in other countries, particularly in Europe. In the United States, an independent committee convened…

Asharq Al-Awsat

Incannex Reveals Clinical Trial Results On Dronabinol-Based Drug For Obstructive Sleep Apnea

Incannex Healthcare Limited (NASDAQ: IXHL) (ASX:IHL), a clinical-stage pharmaceutical company developing medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for unmet medical needs, has completed an analysis of data from the Phase 2 proof-of-concept clinical trial invest

Benzinga

These 18 Clinical Trials Could Shape The Future Of The Psychedelics Industry

In the nascent industry of medical psychedelics, drug development is the name of the game. This subset of biotech, poised to become a $100 billion industry according to Canaccord Genuity, bases its success on the regulation and approval of scheduled psychoactive substances for mental health and other health indications.

Benzinga

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EPIX: Clinical Update on Phase 1 Monotherapy Trial of EPI-7386 Expected in 2Q22…

By David Bautz, PhD NASDAQ:EPIX READ THE FULL EPIX RESEARCH REPORT

Benzinga

Revive Therapeutics: Positive Comments From The FDA Regarding Primary Endpoint Change

The outlook for Revive Therapeutics Ltd. (OTC: RVVTF) Phase 3 clinical trial to evaluate the safety and efficacy of Bucillamine to treat COVID-19 got a little brighter on Thursday.

Benzinga

atai Life Sciences: Unparalleled Diversification With 10 Psychedelic Compounds Going Into Clinical Trials In 2022

In the speculative world of ‘psychedelic’ biotech, companies that are under-capitalized or lacking pipeline diversity face an uphill battle to reach the finish line.

Benzinga

Pfizer/BioNTech say 3 COVID shots elicit good response in children under 5

Drugmakers Pfizer Inc and BioNTech SE said on Monday that three doses of their COVID-19 vaccine generated a strong immune response in children under age 5 and was safe and well-tolerated in their clinical trial.

Reuters

Does turmeric’s reputation translate into real health benefits?

Clinical trials show that curcumin, present in the spice, may help fight osteoarthritis and other diseases, but there’s a catch – bioavailability, or how to get it into the blood

The Guardian - UK

The Trials And Tribulations Of Psychedelic Research

This article by Natasha Sumner was originally published on Microdose and appears here with permission.

Benzinga

Altamira's Drug-Free Nasal Spray Shows Benefit In House Dust Mite Study

Altamira Therapeutics Ltd (NASDAQ:CYTO) announced topline data from its clinical trial with Bentrio nasal spray in house dust mite (HDM) allergic rhinitis. The HDM challenge trial demonstrated a statistically significant reduction of nasal symptoms vs. untreated controls and good tolerability and safety. Bentrio is a drug-free nasal spray intended for personal protection against…

Benzinga

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Benzinga

Upcoming U.S. FDA Decision A Potentially Major De-Risk Event For Revive Therapeutics

It’s been a long and arduous road for Revive Therapeutics Ltd. (OTC: RVVTF) regarding their Phase 3 clinical trial to evaluate the safety and efficacy of Bucillamine to treat COVID-19.

Benzinga

Read Why Did Tricida Stop VALOR-CKD Renal Outcomes Trial Early

Tricida Inc (NASDAQ:TCDA) said that, as anticipated, it is stopping its VALOR-CKD renal outcomes trial early for administrative reasons under the existing study protocol to allow for six months of financial runway following topline results, currently anticipated in early Q4 2022. VALOR-CKD trial, initiated in 2018, was designed to evaluate veverimer's ability to…

Benzinga

Indaptus Shares Jump On FDA Nod For Early-Stage Solid Tumor Trial

The U.S. Food and Drug Administration (FDA) has announced clearance to Indaptus Therapeutics’ (NASDAQ: INDP) Investigational New Drug (IND) application for a Phase 1 clinical trial of its drug candidate Decoy20 in patients with advanced solid tumors where currently approved therapies have failed.

Benzinga

Aileron Treats First Patient With ALRN-6924 In Breast Cancer Setting

Aileron Therapeutics (NASDAQ: ALRN) enrolled the first patients in its Phase 1b clinical trial evaluating ALRN-6924 for bone marrow in patients patients with p53-mutated breast cancer who are being treated with doxorubicin plus cyclophosphamide and docetaxel (AC+D).

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Benzinga

Psychedelics Atai Life Sciences: Optimizing Drug Development By Avoiding Big Pharma's Past Missteps

In the early days of the psychedelics industry, financial reports mean very little. Unless a company wildly misses its operating spending budget and hemorrhages cash by more than expected, the report is basically a synopsis of a given company’s highlights and milestones over the previous quarter.

Benzinga

Avrobio's Pompe Disease Gene Therapy Shows Efficacy, Safety In Preclinical Study

Avrobio Inc (NASDAQ:AVRO) announced preclinical data demonstrating the efficacy and safety of AVR-RD-03 gene therapy in infantile-onset Pompe disease. Pompe disease is a lysosomal disorder caused by a mutation in the GAA gene. The lack of the enzyme encoded by GAA results in a toxic buildup of glycogen throughout the body and central nervous system.…

Benzinga

Keros Therapeutics Posts Preliminary Data Early-Stage KER-012 Trial

Keros Therapeutics Inc (NASDAQ:KROS) announced preliminary topline results from Part 1 of its Phase 1 trial evaluating single and multiple ascending doses of KER-012 in healthy postmenopausal volunteers. KER-012 was generally well tolerated in Part 1 at dose levels up to 5 mg/kg, the highest dose level tested when administered as a single…

Benzinga

Surrozen Commences Phase 1 Study of SZN-1326 In Ulcerative Colitis

Surrozen, Inc. (NASDAQ: SRZN) announced that the first patient has been dosed in the Phase 1 clinical trial to evaluate its drug candidate SZN-1326 for the potential treatment of moderate to severe ulcerative colitis.

Benzinga

University Of Nebraska Medical Center And ANANDA Scientific Get FDA Approval For Clinical Trial Of CBD-Based Drug For PTSD

The University of Nebraska Medical Center (UNMC) and ANANDA Scientific Inc. are collaborating on a new clinical trial investigating treatment for adults with post-traumatic stress disorder (PTSD).

Benzinga

IO Biotech Starts Dosing In Late-Stage IO102-IO103/Keytruda Combo Trial In Melanoma Patients

IO Biotech (NASDAQ: IOBT) dosed first patient in its phase 3 clinical trial of lead drug candidate, IO102-IO103, in combination with Merck's KEYTRUDA® (pembrolizumab) in patients with previously untreated, unresectable or metastatic (advanced) melanoma.

Benzinga

Adverum's Data at ASGCT Further Supports Phase 2 Development Plans For Wet-AMD Gene Therapy

Adverum Biotechnologies Inc (NASDAQ:ADVM) has shared new data from the ADVM-022 development program in wet age-related macular degeneration (wet AMD). The data were presented at the American Society of Gene and Cell Therapy (ASGCT) 2022 Annual Meeting. It exhibited results of the non-human primate (NHP) studies that provide support for the new 6…

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