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MYSTERIOUS: 17 - What They Never Told You

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

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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

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).

Benzinga

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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.

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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…

The Independent UK

Parents of Pret allergy death teenager set up clinical trial to find treatment

Natasha Ednan-Laperouse, 15, died in 2016 after she suffered a severe allergic reaction to sesame in a Pret baguette.

Benzinga

Numinus Granted Canada's Special Access Program For Magic Mushrooms To Treat Life-Threatening Conditions

Numinus Wellness Inc (OTCQB: NUMIF) has been approved to use psilocybin-assisted therapy through Health Canada’s Special Access Program (SAP), marking the first instance in which Numinus will provide this treatment outside of a clinical trial.

Benzinga

Inhibrx's INBRX-101 Shows Favorable Safety Profile In An Inherited Disorder

Inhibrx Inc (NASDAQ:INBX) announced topline results from a Phase 1 clinical trial of INBRX-101, an optimized recombinant human AAT-Fc fusion protein, in patients with alpha-1 antitrypsin deficiency (AATD). AATD is an inherited condition that raises lung and liver disease risks. AAT is a protein that protects the lungs, and the liver makes it. …

Benzinga

Inventiva Raises €50M Debt Financing To Fund Its Lead Program In NASH Patients

Inventiva (NASDAQ:IVA) has signed a €50 million bullet credit facility agreement with the European Investment Bank. The company plans to use the facility for its preclinical and clinical pipeline, including to help fund a portion of its Phase 3 clinical trial of lanifibranor in patients with non-alcoholic steatohepatitis (NASH). Related: Inventiva Posts Results of…

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