Clinical functional proteomics of intercellular signalling in pancreatic cancer  Nature.com

Leading health researchers have urged Africans to embrace clinical trials, emphasising their vital role in addressing local health challenges and boosting economic opportunities. Ahead of the 2024 Impact Africa Summit in Lagos, the group of experts highlighted the need to create a robust and sustainable clinical trial ecosystem in Sub-Saharan Africa. They noted that this

Berlin-based x-cardiac GmbH is pleased to announce that Freiburg University Hospital has become the second pilot customer for its AI-based software "x-c-bleeding" for predicting severe bleeding complications after cardiac surgery. With the implementation of "x-c-bleeding", the University Hospital Freiburg takes another important step towards AI-based medicine.

Acousia Therapeutics GmbH, a Tübingen-based clinical stage biotech company focused on the enhancement and preservation of natural hearing, will be presenting the ACOU085 Phase 2 PROHEAR clinical study at the HansonWade 4th Inner Ear Disorders Therapeutics Summit in Boston (MA) from August 20–22, and at the 36th World Congress of Audiology from September 19–22, 2024.

Aachen, Germany, 22 October 2024 – Today, Grünenthal announced that the first participants have been enrolled in a first-in-human Phase I clinical trial for a nociceptin (NOP) receptor agonist. The trial will include 90 healthy volunteers and aims to demonstrate a favourable safety and tolerability profile and to confirm the pharmacokinetic characteristics of the compound after single and multiple ascending doses. The results of the trial are expected in Q3 2025.

- The Phase III trial AV001 aims to evaluate QUTENZA® in post-surgical neuropathic pain (PSNP), a debilitating complication of surgery occurring after approximately 10 percent of all surgical procedures[1], thus affecting more than 3 million people with surgical procedures per year in the U.S.[2]

(EMAILWIRE.COM, October 25, 2024 ) The global Clinical Microbiology Market growth in terms of revenue was estimated to be worth $5.0 billion in 2024 and is poised to reach $6.9 billion by 2029, growing at a CAGR of 6.5% from 2024 to 2029. The clinical microbiology market is driven by several key...

This year I (Fr. Anthony) decided to take a unit of "Clinical Pastoral Education" at a local hospital as part of my professional development. While the scheduling has been difficult, it has been well rewarded. In this episode I talk with my CPE supervisor, Mary Catherine Cole (M.Div. Candler School of Theology; Network Director of Pastoral Care and Library Services at St. Luke's University Health Network) about why CPE is so effective and how it can make help make all of us better at whatever we are called to do.

One story of a clinical depression sufferer's progress within the context of a welcoming community.

1. Management of opioid use disorder: 2024 update to the national clinical practice guideline  CMAJ
2. New set of guidelines set to combat opioid usage  CTV News Toronto

The post Antipsychotic Drugs: A Concise Review of History, Classification, Indications, Mechanism, Efficacy, Side Effects, Dosing, and Clinical Application was curated by information for practice.

Evaluation &the Health Professions, Ahead of Print. This systematic review provides an overview of the unique challenges allied health professions face in the translation and implementation of evidence into practice, which remain relatively under reported and uninformed by a theoretical basis of behaviour change. MEDLINE, EMBASE, CINAHL and Scopus databases from 2010 to 2022 were […]

The post Factors Influencing the Translation of Evidence Into Clinical Practice for Hospital Allied Health Professionals in Terms of the Domains of Behaviour Change Theory: A Systematic Review was curated by information for practice.

Journal of the American Psychiatric Nurses Association, Ahead of Print. Background:Using long-acting injectable (LAI) antipsychotic medications can improve the outcomes of patients with schizophrenia, such as reducing symptom severity and hospitalization risk. However, the outcomes of switching from oral to LAI antipsychotic medications are unclear.Aims:The purpose of this review is to provide a summary of […]

The post Clinical, Quality of Life, and Health Care Utilization Outcomes of Switching the Administration Route of Antipsychotic Medications Among People With Schizophrenia Spectrum Disorder: A Systematic Review and Meta-Analysis was curated by information for practice.

The post Improving Representation in Clinical Trials and Research: Building Research Equity for Women and Underrepresented Groups was curated by information for practice.

The post Notice of Special Interest (NOSI): Analysis of Existing Linked Datasets to Understand the Relationship between Housing Program Participation and Risk for Chronic Diseases and Other Conditions (R01-Clinical Trial Not Allowed) [First Available Due Date: Oct 07] was curated by information for practice.

The post Notice of Intent to Publish a Funding Opportunity Announcement for Advancing Health Equity through Interventions to Prevent and Address Housing Instability (R01 Clinical Trial Optional) [First Estimated Application Due Date: Dec 2024] was curated by information for practice.

The post Notice of Intent to Publish a Funding Opportunity Announcement for Tobacco, Alcohol, and Cannabis Policy Research for Health Equity (R01 Clinical Trial Optional) [First Estimated Application Due Date: Feb 5] was curated by information for practice.

The post Exploratory Studies to Investigate Mechanisms of HIV infection, Replication, Latency, and/or Pathogenesis in the Context of Substance Use Disorders (R01 Clinical Trial Not Allowed) [Letter of Intent Due Date: July 14] was curated by information for practice.

The post Notice of Special Interest (NOSI): Research on the Health of Women of Underrepresented, Underserved, and Underreported (U3) Populations (Admin Supp Clinical Trial Optional) was curated by information for practice.

The post Notice of Special Interest (NOSI): Analysis of Existing Linked Datasets to Understand the Relationship between Housing Program Participation and Risk for Chronic Diseases and Other Conditions (R01-Clinical Trial Not Allowed) was curated by information for practice.

The post Examining Clinical Research Participation for Substance Abuse Disorder Patient was curated by information for practice.

Source: Dr. Ram Selvaraju 10/18/2024

H.C. Wainwright & Co. analyst Dr. Ram Selvaraju, in a research report published on October 18, 2024, reiterated a Buy rating on Anavex Life Sciences Corp. (AVXL:NASDAQ) with a price target of US$40.00. The report follows Anavex's announcement of encouraging preliminary electroencephalography (EEG) biomarker results from Part A of the ongoing Phase 2 clinical study of ANAVEX3-71 for schizophrenia treatment.

Selvaraju highlighted the significance of these results, stating, "Preliminary results demonstrated a dose-dependent effect of ANAVEX3-71 on two key EEG biomarkers in patients with schizophrenia. Treatment with ANAVEX3-71 vs. placebo resulted in improvements in 40 Hz Auditory Steady-State Response (ASSR) Inter Trial Coherence (ITC) and Resting State Alpha Power."

The analyst viewed these developments positively, noting, "These results provide evidence of CNS target engagement and potential therapeutic effects of ANAVEX3-71 in schizophrenia. The observed changes reversed known EEG and ERP biomarker abnormalities associated with schizophrenia."

Regarding Anavex's lead candidate, blarcamesine, Selvaraju stated, "Anavex remains committed to completing the Marketing Authorization Application (MAA) submission to the European Medicines Agency (EMA) under the Centralized Procedure petitioning for approval of blarcamesine for treatment of Alzheimer's disease (AD) in 4Q24."

The report also highlighted Anavex's progress with other clinical programs, including a pivotal Phase 2b/3 trial in Parkinson's disease and potential trials in Rett syndrome and Fragile X Syndrome.

Selvaraju's valuation methodology for Anavex Life Sciences is based on a discounted cash flow (DCF) approach. He explained, "We utilize a discounted cash flow (DCF)-driven methodology, which ascribes a total value of roughly US$3.25B to blarcamesine alone without ascribing value to any other pipeline assets. We employ a 50% probability of approval in Rett syndrome; 60% in Parkinson's disease dementia (PDD); and 50% in AD."

The analyst added, "Further, we apply a 12% discount rate and 1% terminal growth rate. We derive a total firm value of ~US$3.4B, which yields a 12-month price objective of US$40 per share, assuming 84.8M shares outstanding as of end-F2Q25."

Selvaraju also outlined several risk factors, including potential negative clinical data, regulatory approval challenges, and commercialization difficulties.

In conclusion, H.C. Wainwright & Co.'s maintenance of a Buy rating and US$40 price target reflects a positive outlook on Anavex Life Sciences' clinical progress and potential in developing treatments for neurological disorders. The share price at the time of the report of US$5.51 represents a potential return of approximately 626% to the analyst's target price, highlighting the significant upside potential if the company's clinical development plans prove successful.

Important Disclosures:

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Disclosures for H.C. Wainwright & Co., Anavex Life Sciences Corp., October 18, 2024.

This material is confidential and intended for use by Institutional Accounts as defined in FINRA Rule 4512(c). It may also be privileged or otherwise protected by work product immunity or other legal rules. If you have received it by mistake, please let us know by e-mail reply to unsubscribe@hcwresearch.com and delete it from your system; you may not copy this message or disclose its contents to anyone. The integrity and security of this message cannot be guaranteed on the Internet. H.C. WAINWRIGHT & CO, LLC RATING SYSTEM: H.C. Wainwright employs a three tier rating system for evaluating both the potential return and risk associated with owning common equity shares of rated firms. The expected return of any given equity is measured on a RELATIVE basis of other companies in the same sector. The price objective is calculated to estimate the potential movements in price that a given equity could reach provided certain targets are met over a defined time horizon. Price objectives are subject to external factors including industry events and market volatility.

H.C. Wainwright & Co, LLC (the “Firm”) is a member of FINRA and SIPC and a registered U.S. Broker-Dealer. I, Raghuram Selvaraju, Ph.D. , certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies. None of the research analysts or the research analyst’s household has a financial interest in the securities of Anavex Life Sciences Corp. (including, without limitation, any option, right, warrant, future, long or short position). As of September 30, 2024 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Anavex Life Sciences Corp.. Neither the research analyst nor the Firm knows or has reason to know of any other material conflict of interest at the time of publication of this research report.

The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services. Mr. Selvaraju, who is [the][an] author of this report, is the Chairman of and receives compensation from Relief Therapeutics Holding SA, a Swiss, commercial-stage biopharmaceutical company identifying, developing and commercializing novel, patent protected products in selected specialty, rare and ultra-rare disease areas on a global basis ("Relief"). You should consider Mr. Selvaraju's position with Relief when reading this research report. The firm or its affiliates received compensation from Anavex Life Sciences Corp. for non-investment banking services in the previous 12 months. The Firm or its affiliates did not receive compensation from Anavex Life Sciences Corp. for investment banking services within twelve months before, but will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report. The Firm does not make a market in Anavex Life Sciences Corp. as of the date of this research report. The securities of the company discussed in this report may be unsuitable for investors depending on their specific investment objectives and financial position. Past performance is no guarantee of future results. This report is offered for informational purposes only, and does not constitute an offer or solicitation to buy or sell any securities discussed herein in any jurisdiction where such would be prohibited. This research report is not intended to provide tax advice or to be used to provide tax advice to any person. Electronic versions of H.C. Wainwright & Co., LLC research reports are made available to all clients simultaneously. No part of this report may be reproduced in any form without the expressed permission of H.C. Wainwright & Co., LLC. Additional information available upon request. H.C. Wainwright & Co., LLC does not provide individually tailored investment advice in research reports. This research report is not intended to provide personal investment advice and it does not take into account the specific investment objectives, financial situation and the particular needs of any specific person. Investors should seek financial advice regarding the appropriateness of investing in financial instruments and implementing investment strategies discussed or recommended in this research report. H.C. Wainwright & Co., LLC’s and its affiliates’ salespeople, traders, and other professionals may provide oral or written market commentary or trading strategies that reflect opinions that are contrary to the opinions expressed in this research report. H.C. Wainwright & Co., LLC and its affiliates, officers, directors, and employees, excluding its analysts, will from time to time have long or short positions in, act as principal in, and buy or sell, the securities or derivatives (including options and warrants) thereof of covered companies referred to in this research report. The information contained herein is based on sources which we believe to be reliable but is not guaranteed by us as being accurate and does not purport to be a complete statement or summary of the available data on the company, industry or security discussed in the report. All opinions and estimates included in this report constitute the analyst’s judgment as of the date of this report and are subject to change without notice. Securities and other financial instruments discussed in this research report: may lose value; are not insured by the Federal Deposit Insurance Corporation; and are subject to investment risks, including possible loss of the principal amount invested.

( Companies Mentioned: AVXL:NASDAQ, )

Marijuanas active components are potentially effective in treating pain, nausea, the anorexia of AIDS wasting, and other symptoms, and should be tested rigorously in clinical trials.

Conducting clinical investigations of mitochondrial replacement techniques (MRT) in humans is ethically permissible as long as significant conditions and principles are met, says a new report from the National Academies of Sciences, Engineering, and Medicine.

Mobilization of a rapid and robust clinical research program that explores whether investigational therapeutics and vaccines are safe and effective to combat the next infectious disease epidemic will depend on strengthening capacity in low-income countries for response and research, engaging people living in affected communities, and conducting safety trials before an epidemic hits, says a new report from the National Academies of Sciences, Engineering, and Medicine.

A commentary published in Nature calls for a moratorium on clinical uses of heritable human genome editing and the establishment of an international governance framework.

An international commission has been convened by the U.S. National Academy of Medicine, the U.S. National Academy of Sciences, and the Royal Society of the U.K., with the participation of science and medical academies around the world, to develop a framework for scientists, clinicians, and regulatory authorities to consider when assessing potential clinical applications of human germline genome editing.

The International Commission on the Clinical Use of Human Germline Genome Editing is tasked with identifying the scientific, medical, and ethical requirements to consider when assessing potential clinical applications of human germline genome editing — if society concludes that heritable human genome editing applications are acceptable.

Human embryos whose genomes have been edited should not be used to create a pregnancy until it is established that precise genomic changes can be made reliably without introducing undesired changes — a criterion that has not yet been met by any genome editing technology, says a new report by an international commission of the U.S. National Academy of Medicine, U.S. National Academy of Sciences, and the U.K.’s Royal Society.

Lack of representation in research is compounding disparities in health outcomes, with serious consequences for underrepresented groups and the nation as a whole. Urgent actions are needed by NIH, FDA, and others to boost representation of racial and ethnic minority groups and other underrepresented populations in clinical trials and research.

As health care delivery systems increasingly depend on technology, the expertise of clinical engineers in the use and management of this technology is critical for achieving best outcomes. In a new NAE Perspective, Thomas Judd and Yadin David discuss the indispensable role of clinical engineers in merging technology at the point of care.

Testing for exposure to PFAS — chemicals used in a broad range of consumer products for decades — should be offered to patients who are likely to have a history of elevated exposure. A new report provides advice to the CDC on how clinicians can interpret test results and deliver follow-up care.

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