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Neumora Races Toward Phase III with New Driver in the Hot Seat

Pictured: A silhouette of a woman sitting on the floor with her head in her hands/iStock, simpson33 Neumora Therapeutics is making big moves this week. On Tuesday the young biotech announced the initiation of a Phase III program for its potential depression treatment along with a new CEO to lead the way. The nearly two-year-old startup posted statistically significant results for treating moderate-to-severe major depressive disorder (MDD) in its Phase II trial of navacaprant, a kappa opioid receptor (KOR) antagonist. Initiated by BlackThorn Therapeutics prior to its acquisition by Neumora, the trial was amended to include those more serious MDD patients, the population in which it appears to be most effective. In moderate-to-severe patients, navacaprant had statistically significant results in lowering patients’ 17-item Hamilton Rating Scale for Depression score by 3 points at week 4 and 2.8 points by week 8. Across all patients, which included mildly depressed patients, navacaprant did not achieve ...
- Source: drugdu
- 115
- July 20, 2023
An AI System to Figure Out When to Trust AI-based Medical Diagnoses

Performance of CoDoC in breast cancer prediction compared to that of a standalone predictive AI system and clinical readers. Credit: Nature Medicine (2023). DOI: 10.1038/s41591-023-02437-x A team of AI and medical specialists working with or for Google Research and Google DeepMind, has developed an AI based system designed to judge the confidence level of existing AI systems used for analyzing medical scans as a means of improving analysis of diagnostic tools, such as mammograms or chest X-rays. In their paper, published in the journal Nature Medicine, the group describes how they built the system and how well it worked when tested. Fiona Gilbert, with the University of Cambridge’s Clinical School of Medicine, has published a News & Views piece in the same journal issue outlining the work done by the team on this new effort. Over the past several years, as AI applications have become more refined, the medical establishment has embraced the ...
- Source: drugdu
- 117
- July 20, 2023
Pfizer, Flagship Team Up in $100M R&D Pact — 10 New Drugs for Unmet Needs

Pfizer and Flagship Pioneering are partnering in a drug research alliance leveraging the capabilities of the more than 40 biotech startups in the venture capital firm’s portfolio. The new partners aim to develop drugs for unmet needs, including those in broad patient populations. Pharmaceutical companies frequently strike deals with smaller biotech companies as a way to build up their drug pipelines, and Pfizer is no exception. But in a twist to this strategy, the pharma giant is now turning to Flagship Pioneering, the venture capital firm whose highest profile creation might be the messenger RNA company Moderna. The alliance announced Tuesday calls for Flagship and Pfizer to each invest $50 million up front. The cash will go toward the R&D of 10 single-asset programs. Flagship does not create single-asset companies. The startups that spring from its labs are all formed around platform technologies, each with the capability of yielding ...
- Source: drugdu
- 132
- July 20, 2023
Pukang Biotechnology Completes Phase IV Clinical Trial of Hepatitis A Vaccine

Recently, Zhejiang Pukang Biotechnology Co., Ltd. has completed the Phase IV clinical trial titled “Single-Arm, Multi-Center Evaluation of the Safety and Immunogenicity of Freeze-Dried Live Attenuated Hepatitis A Vaccine in Chinese Children Aged 18-24 Months” and received the final report. This Phase IV clinical study, involving a large sample size of 10,000 cases across multiple centers, aimed to observe the safety and immunogenicity of the freeze-dried live attenuated Hepatitis A vaccine in the real world. The study results show that after a single dose of the vaccine, the AEFI incidence rate in the 18-24 month-old children was 0.34%, with no serious AEFI reported, and an antibody seroconversion rate of 98.91%. This confirms the vaccine’s good safety and immunogenicity profile, providing richer data support for its widespread application. The freeze-dried live attenuated Hepatitis A vaccine (H2 strain), developed and produced by Zhejiang Pukang Biotechnology Co., Ltd., simulates ...
- Source: drugdu
- 146
- July 20, 2023
Black Patients with ICDs Have Higher Rate of Post-Implant Cardiac Events and Risk of Death

Black patients with implantable cardioverter defibrillators (ICDs) have a significantly higher burden of disease than white patients with the same device, according to a new study from University of Rochester Medical Center (URMC) cardiology researchers. Analyzing data from clinical trials conducted over a 20-year period by the Clinical Cardiovascular Research Center (CCRC) at URMC, investigators concluded that not only did Black patients with ICDs tend to be significantly younger than white patients, but they also had a higher rate of post-implant cardiac events and risk of death. When a patient is at risk for cardiac arrest, an ICD helps to monitor their heart rhythm, and if an abnormality is detected, the device delivers a shock of electricity to reset the heartbeat to a normal rhythm. The study, published in Circulation, examines the rate of events that a patient experiences after their ICD is implanted. After three years of ...
- Source: drugdu
- 131
- July 19, 2023
DNA Origami Could Be Used to Create Customized Virus-Like Particles

Bioengineers have found a way to program the size and shape of virus particles by combining viral protein building blocks and templates made from DNA. The resulting nanostructures could have applications in vaccine development and transporting drugs inside the body. Virus capsid proteins-;the proteins that shield the genome of a virus-;can be used to build precisely structured protein assemblies. Their shapes and geometry, however, depend largely on the virus strain. Reprogramming these assemblies, no matter the original viral blueprint, is an intriguing possibility for drug delivery and vaccine development. Scientists tackled the challenge by generating a “structured genome” template on which capsid proteins can assemble. To avoid deforming the flexible genome and creating unintended shapes, they used rigid DNA origami structures. These structures are only tens to hundreds of nanometres in length, but entirely made of DNA, which is folded accurately into the desired template shape. ...
- Source: drugdu
- 169
- July 19, 2023
Experts Flag Eye Inflammation Reports Tied to Apellis’ Geographic Atrophy Med Syfovre

Apellis Pharmaceuticals’ Syfovre, after achieving the first FDA approval for advanced eye disease geographic atrophy, has been associated with rare but severe side effects, according to the American Society of Retinal Specialists (ASRS).The group issued a letter to doctors Saturday flagging cases of eye inflammation and six reports of occlusive retinal vasculitis in patients who took the drug, BioPharma Dive reported. The condition is a type of inflammation that blocks blood flow to the retina and could potentially cause blindness.ASRS didn’t tie the safety issues to a specific batch of product but noted that the side effects began one to two weeks after a patient’s first Syfovre injection. The organization urged vigilance and close follow-up after administration, according to the news outlet. The news caused Apellis’ stock price to sink nearly 32% to $52.62 by Monday afternoon. The company puts the Syfovre-associated retinal vasculitis rates at 0.01% per ...
- Source: drugdu
- 142
- July 19, 2023
Fighting AMR with a Value and Subscription Model

Antimicrobial resistance (AMR) happens when microbes such as bacteria, viruses and fungi change over time and stop responding to medicine. Their failure to respond makes it harder to treat infections, potentially resulting in spread, serious illness or death. In today’s AMR drug discovery sector, pharmaceutical companies find it challenging to profit from new innovative drugs because, rightfully, hospitals reserve these drugs for only advanced cases. As a result, the current approach reduces the financial incentive to make these drugs, contributing to global concern about AMR infections and their impact. Legal guidance on AMR returns On 27 April, the Pasteur Act, which deals with AMR and is sold as a bipartisan legislation to combat superbugs, was reintroduced into the US Senate. A core focus, this time around, is to jumpstart antibiotic development with a new payment model for novel treatments alongside improving how existing antibiotics are prescribed. ...
- Source: drugdu
- 147
- July 19, 2023
Acumen Shares Positive Results for Investigational Alzheimer’s Disease Therapy at AAIC

Acumen Pharmaceuticals has presented positive topline results from an early-stage study of its investigational Alzheimer’s disease therapy at this year’s Alzheimer’s Association International Conference (AAIC). The drug, ACU193, works by targeting and binding to amyloid beta oligomers, a toxic and soluble version of the amyloid protein that forms brain plaques associated with Alzheimer’s disease. Results from the phase 1 randomised, placebo-controlled INTERCEPT-AD study of 62 patients with early Alzheimer’s disease showed the candidate was generally well tolerated throughout both single-ascending and multiple-ascending dose cohorts. Patients who received higher doses of the drug also showed a reduction in amyloid plaque after six to 12 weeks, the company said, adding that the study suggests the drug can be given as a monthly intravenous infusion. Commenting on the positive results, Acumen’s president and chief executive officer, Daniel O’Connell, said: “ACU193’s observed dose-related central target engagement, rapid reduction of ...
- Source: drugdu
- 125
- July 19, 2023
Gilead’s COVID-19 Treatment Approved by FDA for Patients with Severe Renal Impairment

Gilead Sciences has announced that its COVID-19 treatment, Veklury (remdesivir), has been approved by the US Food and Drug Administration (FDA) to treat patients with severe renal impairment, including those on dialysis. The drug is already approved in the US to treat COVID-19 in adults and paediatric patients who are hospitalised or have mild-to-moderate COVID-19 and are at high risk for progression to severe illness. However, its use has previously been limited among patients with severe renal impairment due to insufficient data. The FDA’s latest decision makes Veklury the first and only approved antiviral COVID-19 treatment that can be used across all stages of renal disease. Gilead’s supplemental new drug application was supported by positive results from a phase 1 study as well as data from the phase 3 REDPINE trial that demonstrated the efficacy and safety profile of Veklury among patients with moderately and severely ...
- Source: drugdu
- 121
- July 19, 2023

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