Biotech startup Delix Therapeutics has unveiled promising interim phase 1 safety data for its lead neuroplasticity drug candidate DLX-001 at a leading neuroscience conference, marking the first clinical validation of its “psychoplastogen” pipeline. In essence, the company is developing psychedelic-inspired therapies that can prompt neuroplasticity without the hallucinogenic, psychotomimetic, or dissociative effects typical with traditional…
Zepbound helps people lose 25% of body weight on average 88 weeks, but weight regain is a concern
Lilly’s hot weight loss drug Zepbound (tirzepatide) may be one of the most effective drug therapies for weight loss. In an open-label 36-week study, participants lost an average of 20.9% of their body weight in 36 weeks. With an average weight of 107.3 kg (236.5 lbs), that equates to about 22.4 kg (49.4 lbs) on average.…
Pfizer hemophilia drug marstacimab accepted for FDA, EU review
U.S. and European regulators have accepted applications for Pfizer’s marstacimab, an investigational treatment for hemophilia A and B. The FDA set a decision date in late 2024 while the EMA set the stage for a possible approval in early 2025. The applications are based on positive data from the phase 3 BASIS trial, presented over…
EDC fading in prominence as AI and cloud gain ground
In a year or two, the clinical trial industry may move beyond electronic data capture (EDC), a technology that has been the cornerstone of clinical data management for decades, projects Raj Indupuri, CEO of eClinical Solutions. Given the potential of electronic medical records (EMR) to feed directly into data infrastructure, the need for EDC may…
At AWS re:Invent, Pfizer exec frames digital as a core business strategy
In the midst of a global pandemic, Pfizer, under the leadership of its chief digital and technology officer Lidia Fonseca, achieved what was once thought impossible. The company, with the partnership of BioNTech, developed a COVID-19 vaccine in only 269 days, a process that traditionally would have taken 8 to 10 years. While prior research…
Merck, Amgen back Culmination Bio’s quest to transform healthcare data analytics
In the same week that Merck and Amgen revealed expanded alliances with AWS, the bioinformatics startup Culmination Bio revealed that it has received $10 million in funding from the venture arms of those companies, Merck Global Health Innovation Fund and Amgen Ventures. Culmination Bio, a spinoff from Intermountain Health, has developed a vast data lake…
Can AI ‘move fast and cure things’ in healthcare?
The entry of AI into healthcare is starkly different from the accepted adage of “move fast and break things” in consumerism. In episode 1 of AI Meets Life Sci, Kayleen Brown, managing editor at DeviceTalks, and Brian Buntz, pharma and biotech editor, discuss the opportunities, limitations, and direct impact of Ai in healthcare fields including…
Evidence on GLP-1 drugs and muscle loss remains murky
[Updated on March 18, 2024] Do GLP-1 drugs lead to loss of muscle mass? The German expression “jein,” spanning both yes and no, captures researchers’ present understanding of the complexity of this issue. Yes, recent research on glucagon-like peptide-1 (GLP-1) drugs for weight loss indicates these medications may lead to significant reductions in lean body…
Tirzepatide beats semaglutide 3-to-1 for weight loss goals in real-world data
A new real-world study (pre-print) is the first to directly compare weight loss outcomes between the popular diabetes medications Lilly’s Mounjaro (tirzepatide) and Novo Nordisk’s Ozempic (semaglutide). The results show Mounjaro users are significantly more likely to achieve meaningful weight loss. Analyzing data from more than 40,000 patients from a large U.S. health database, the…
Organon reinforces commitment to women’s health beyond reproductive health
The fact that women’s health has long been underprioritized is common knowledge. Organon, with roots going back to 1923 and having sharpened its focus on women’s health post its 2021 spinoff from Merck & Co., aims to address significant gaps in treatment and care. “Our commitment to women’s health is not just a part of…
Nipocalimab shows promise in RA subgroups in phase 2a IRIS-RA study
Johnson & Johnson’s nipocalimab, which works by targeting the neonatal Fc receptor (FcRn), has the potential to treat an array of autoimmune conditions. But the antibody recently hit a snag in the first-ever clinical study of an FcRn inhibitor in rheumatoid arthritis (RA), missing its primary endpoint. The development has sparked debate within the rheumatology…
Vaccine mega-trials: Rare behemoths in the vaccine trial landscape
Abstract The vast majority of vaccines are prophylactic in nature. As a result, the demonstration of their efficacy paradoxically requires the infectious disease to occur among non-diseased study participants randomized between investigational vaccine and appropriate control groups. The statistics of vaccine efficacy (VE) calculation are nearly entirely and solely based on the number of observed…
Cybin sees near future for psychedelic therapy after promising interim phase 2 data
With promising interim phase 2 data in hand, Cybin believes psychedelic therapy will become a reality in the “not too distant future,” according to CEO Doug Drysdale. As recently as the 1990s, it would be difficult to imagine that a psychedelic drug would potentially be a clinical option for a mood disorder like depression. But…
Anticipating IND submission: Ensuring your drug is ready for preclinical toxicology studies
Drug development is often a vast and intricate journey. Each phase signifies an advancement in the process, always with an eye toward patient safety and efficacy. But before any therapeutic finds itself on the bedside tables of hopeful patients, it faces a formidable challenge: preclinical toxicology testing. As the gateway to clinical trials, this early…
Unlocking the secrets of cellular immunogenicity: A deep dive in ELISpot assays
Next generation therapies and vaccine research have recently dominated headlines and scientific discovery. This research and its ability to treat previously untreatable conditions has rightfully excited the scientific and medical communities worldwide. But the complexities involved require a nuanced approach to ensure the treatment is safe and effective. Integrating cell culture into cellular immunity testing…
Is the new $15,900 postpartum depression pill worth it?
Sage Therapeutics has pegged the wholesale acquisition price of the oral postpartum depression (PPD) drug Zurzuvae (zuranolone) at $15,900 for a 14-day course of the therapy. The drug, co-developed by Biogen, won the FDA green light in August. The companies plan on launching the drug in December. The DEA has classified zuranolone as Schedule IV,…
How a data lakehouse can give you a panoramic view of your AI-enabled clinical trials
In recent years, the term “data lakehouse” has entered the lexicon of data professionals. For AI-enabled clinical trials, the lakehouse architecture promises seamless integration of diverse data streams, spanning patient health records to real-time sensor data, all processed efficiently and queried in structured formats. The lakehouse architecture aims to provide a comprehensive overview of data,…
An overview of the RSV vaccine landscape: GSK aims to extend its approval of Arexvy?
GSK (NYSE:GSK) is aiming to expand the label for its respiratory syncytial virus (RSV) vaccine Arexvy, which was the first to win FDA approval. The firm is now eyeing an extension of the label to include adults aged 50 to 59, bolstered by encouraging preliminary data from a phase 3 study. The recent data from…
How the latest AI executive order might impact drug development in the U.S.
The White House has released an executive order that contains what it hails as “the most sweeping actions ever taken to protect Americans from the potential risks of AI systems.” Relevant to drug development, a fact sheet on the order describes its aim to help further “the responsible use of AI in healthcare and the…
Quantum leaps in drug discovery? NobleAI joins forces with Microsoft while King’s College London aligns with Kvantify
The word “revolutionize” gets thrown around a lot in describing the potential of emerging technologies. But quantum computing could make good on the promise to disrupt healthcare applications ranging from drug discovery to medical imaging. Theoretically, a quantum computer with 300 quantum bits (qubits) could crunch more calculations in an instant than there are atoms…
A year in review: AI’s evolving role in drug discovery and development in 2023
In the realm of drug discovery, AI is making waves, and 2023 could potentially be a pivotal year for this technology. As the technology enters the popular consciousness, pharma employees are wondering “why they can’t have similar AI-driven tools for their professional tasks,” said Diane Wuest, head of digital R&D at Sanofi, in a recent…
Insilico Medicine taps AI to nominate small molecule inhibitor ISM9274 as a preclinical cancer therapy
Clinical-stage AI company Insilico Medicine has nominated a novel small molecule inhibitor known as ISM9274 as a preclinical candidate for cancer treatment. The company used its PandaOmics AI platform to analyze genomic data from more than 90 tumor types and identified CDK12 as a promising target for multiple cancers including triple-negative breast cancer, lung cancer,…
NLP in drug discovery and the quest for the ‘right’ research elements
In drug discovery and development, data sources are as diverse as they are plentiful. There are comprehensive databases brimming with molecular targets, cellular processes, genomic sequences, proteomic profiles, and metabolite patterns that shed light on disease pathways. Data possibilities in the patient care realm are similarly vast, spanning electronic medical records, imaging datasets, and even…
Mirikizumab shows continued promise for ulcerative colitis after regulatory hiccup
Lilly has announced that its interleukin-23 blocker mirikizumab demonstrated promise in patients with moderately to severely active ulcerative colitis (UC) in the ongoing open-label LUCENT-3 extension study. The trial evaluated two-year efficacy and safety of the monoclonal antibody in patients who had previously undergone UC treatments, including biologics, that were ineffective, stopped working, or were…
Pfizer Ignite: Kathy Fernando’s vision for accelerating biotech innovation
Kathy Fernando, the senior vice president, head of Pfizer Ignite and Pfizer CentreOne, has had a professional trajectory marked by pivotal serendipities. One occurred when attending a seminar at the University of Pennsylvania, where she met Dr. Drew Weissman, a prominent immunologist and RNA vaccine researcher. Weissman, along with Katalin Karikó, recently received the Nobel…