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The Latest Breaking News from Clinical Trial

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

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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…

Benzinga

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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.

The Independent UK

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…

Benzinga

Merck, Athenex Join Forces To Evaluate Oraxol/Keytruda Combo In Lung Cancer

Athenex Inc (NASDAQ:ATNX) announced a clinical trial collaboration and supply agreement with Merck Co & Inc (NYSE:MRK). The agreement applies to the expansion phase of the Phase 1 clinical trial evaluating Athenex's oral paclitaxel combined with Merck's Keytruda (pembrolizumab) for certain NSCLC patients. The agreement will support the trial's expansion phase to investigate further the…

Benzinga

NanoViricides Starts Drug Development Program For Recent Cases Of Unexplained Pediatric Hepatitis

NanoViricides Inc (NYSE:NNVC) has initiated a program to screen its library of broad-spectrum antiviral nanoviricides against human Adenovirus 41 Type F (hAd41-F), believed to be strongly associated with the occurrence of severe hepatitis syndrome in some children. The company says its top priority remains to initiate human trials of its SARS-CoV-2 drug candidate…

Benzinga

C4 Therapeutics Doses First Patient in Phase 1/2 Trial of CFT8634 For SMARCB1-perturbed cancers

C4 Therapeutics, Inc. (C4T) (NASDAQ: CCCC) has dosed the first patient in the Phase 1/2 clinical trial of its drug candidate CFT8634, for the treatment of SMARCB1-perturbed cancers, including synovial sarcoma and SMARCB1-null tumors.

Benzinga

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Benzinga

Acutus Medical Completes Patient Enrolment In AcQForce Flutter IDE Trial

Acutus Medical (NASDAQ: AFIB) completed patient enrollment in the AcQForce Flutter Investigational Device Exemption (IDE) clinical trial. The trial was designed to evaluate the safety and efficacy of the AcQBlate FORCE sensing ablation catheter and system in the treatment of right atrial typical flutter.

Benzinga

MoonLake Immunotherapeutics Begins Sonelokimab Phase 2 trial In Hidradenitis Suppurativa (HS)

MoonLake Immunotherapeutics AG (NASDAQ: MLTX) dosed first patient in the Phase 2 clinical trial evaluating sonelokimab, for patients with moderate-to-severe hidradenitis suppurativa (HS).

Benzinga

Ecstasy Research Trial Completes Enrollment, Moves Closer To Approval To Treat PTSD

The non-profit Multidisciplinary Association for Psychedelics Studies (MAPS) and its subsidiary MAPS Public Benefit Corporation finished the enrollment stage for the second Phase 3 clinical trial on MDMA (MAPP2).

Benzinga

Psyched: Protesters At DEA HQ Demand Access To Psychedelics, Connecticut Approves Budget Bill With MDMA & Psilocybin Programs

Psychedelics policy action took center stage this week.

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Benzinga

The Daily Biotech Pulse: Pfizer Acquires Migraine Drugmaker For $11B, Biogen Files For Second Alzheimer's Drug Approval, Longeveron CEO Leaves

Here's a roundup of top developments in the biotech space over the last 24 hours:

Benzinga

Immatics Initiates Phase 1 Clinical Trial of IMA401 in Advanced Solid Tumors

Immatics N.V. (NASDAQ: IMTX) announced the initiation of a Phase 1 clinical trial of its drug candidate IMA401 for patients with recurrent and/or refractory solid tumors.

Benzinga

Eisai - Biogen Seek Accelerated Approval For Their Second Alzheimer's Drug

Eisai Co Ltd (OTC:ESALY) has completed the rolling submission of the FDA marketing application under the accelerated approval for lecanemab (BAN2401) for mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD. Eisai is collaborating with Biogen Inc (NASDAQ:BIIB) for drug development. Eisai has requested a Priority Review, while the lecanemab Phase 3…

Benzinga

Achilles Therapeutics Doses First Patient with Higher-dose cNeT in CHIRON Phase 1/2a Trial for Advanced NSCLC

Achilles Therapeutics plc (NASDAQ: ACHL) announced that the first patient has been dosed with personalized clonal neoantigen-reactive T cells, or cNeT, manufactured with the Company's higher-dose VELOS™ Process 2 in the ongoing Phase I/IIa CHIRON clinical trial for the treatment of advanced non-small cell lung can

The Philadelphia Inquirer

How COVID is helping us move away from white-centered clinical trials to reach more patients

PHILADELPHIA -- Rutgers researchers made a startling discovery when the pandemic curtailed routine medical visits: Going virtual to test cutting-edge therapies reached more diverse patients.

Benzinga

Arcturus Reports Three-Month Durability Results From ARCT-154 COVID-19 Booster Trial

Arcturus Therapeutics Holdings Inc (NASDAQ: ARCT) provided updated data from its Phase 1/2 booster clinical trial showing the durability of antibody response with ARCT-154 for at least three months after a low-dose (5 mcg) booster.

Benzinga

Tetra Bio-Pharma And Cannvalate Enter Into Partnership

Tetra Bio-Pharma Inc. (OTCQB: TBPMF) (TSX:TBP) (FRA:JAM1) has entered into a research and development agreement with Cannvalate Pty Ltd for the initiation of the REBORN, PLENITUDE and CAUMZ clinical trials in Australia, and a subscription agreement contempl

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