biopharma R&D Archives - Medical Design Sourcing

Delix’s psychedelic-inspired DLX-001 poses no safety or hallucinogenic risks in early testing

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 psychedelic compounds.

According to Delix’s chief medical officer Dr. Aaron Koenig, DLX-001 is safe and well-tolerated. With neuroplasticity emerging as a key factor in rapid-acting antidepressant mechanisms, the company is optimistic about this early human proof-of-concept, which could pave the way for larger efficacy studies and offer an alternative approach in the field where psychedelic medicines have shown limitations, particularly in terms of side effects and potential cardiac liability.

The interim data fro…

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 our corporate strategy; it’s at the core of who we are as a company,” said Dr. Juan Camilo Arjona Ferreira, chief medical officer at the company, in a recent interview.

Organon sees women’s health as encompassing more than just reproductive issues. “It’s a continuum that spans a woman’s entire life,” said Arjona, a gynecologist by training. “There’s plenty of opportunities across the board because women’s health has been understudied and underappreciated.”

Organon’s approach to women’s health challenges

Dr. Juan Camilo Arjo…

Nvidia-Genentech AI drug discovery alliance unites computing brawn with biological brains

NVIDIA BioNeMo AI molecular modeling software can uncover complex biochemical interactions through AI-driven molecular modeling techniques. [Image courtesy of NVIDIA]

Technically, graphics processing and AI hardware powerhouse Nvidia is also a drug discovery company. It may not discover drugs in-house, but it has developed BioNeMo, a comprehensive generative AI platform for drug discovery and Clara, a collection of healthcare frameworks, applications, and tools, including for biopharma. Nvidia partners include Amgen, AstraZeneca, GSK and Insilico Medicine.

Similarly, biotech pioneer and Roche subsidiary Genentech is also an AI company. It has experience in applying machine learning to an array of disease areas, and has extensive biological and molecular datasets and research capabilities. Its initiatives include alliance with firms such as Recursion Pharmaceuticals and Reverie Labs that focus on using AI for nov…

Is the new $15,900 postpartum depression pill worth it?

Zuranolone molecule image from PubChem

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, which mostly includes benzodiazepines. That status could influence prescriber and patient perceptions concerning the drug’s safety profile and potential for abuse. The formulary review process for Zurzuvae, critical for insurance coverage, will occur throughout 2024.

Sage had initially aimed to price Zurzuvae under $10,000, but its failure to win approval earlier this year for zuranolone for major depressive disorder altered its pricing strategy.

Zurzuvae postpartum depression cost in context

The wholesale acquisiti…

How a data lakehouse can give you a panoramic view of your AI-enabled clinical trials

[Outlier Artifacts/Adobe Stock]

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, ensuring both vast storage and real-time processing capabilities. In other words, the lakehouse offers the “best of both worlds” when it comes to data warehouses and data lakes, according to Venu Mallarapu, vice president of global strategy and operations at eClinical Solutions.

AI and ML move from buzzwords to practical tools in clinical trial management

As the use of AI and ML in clinical trials becomes more prevalent in patient recruitment, real-time data monitoring and beyond, …