BioSpace News Archive

An exclusive, invite-only event designed for senior scientists and executives at the forefront of AI-driven innovation in pharma and biotech. This highly interactive forum explores critical challenges in data quality, target identification, lead optimization, drug response prediction, and molecular design. Attendees will engage in expert-led roundtables, spotlight presentations, and pre-arranged 1:1 meetings to share insights, explore real-world applications, and build strategic collaborations. With contributions from leading voices at Amgen, Gilead, Digital Science, and more, the event offers a unique opportunity to accelerate the integration of AI across the drug discovery pipeline.

An exclusive, invite-only forum designed for senior leaders driving innovation in cell and gene therapies. This highly interactive event focuses on solving key challenges in vector engineering, CMC strategy, cell therapy development, and scalable manufacturing. Through expert-led roundtables, spotlight presentations, and 1:1 networking, participants will gain actionable insights, share best practices, and forge strategic collaborations to accelerate the development and commercialization of advanced therapies.

An exclusive, invite-only forum designed for senior executives and scientists working at the intersection of medical devices and therapeutic innovation. This highly interactive event focuses on overcoming key challenges in regulatory strategy, clinical validation, product development, scalable manufacturing, and supply chain optimization. Through expert-led roundtable discussions, spotlight presentations, and 1:1 networking, participants will gain actionable insights and forge strategic collaborations to accelerate MedTech innovation.

Capricor Therapeutics met with the FDA last week for a type A meeting, during which CEO Linda Marbán aimed to explain to the regulator that it got it wrong. Capricor plans to resubmit the application based on deramiocel’s existing dataset.

The Trump administration’s ever-changing tariffs and Most Favored Nation drug pricing are part of a blizzard of unclear, potentially illegal tactics that leave observers throwing their hands in the air.

A draft copy of an upcoming MAHA report reveals a strategy in lockstep with recent HHS actions such as reviving the Task Force on Safer Childhood Vaccines; Viking Therapeutics reports robust efficacy from mid-stage oral obesity candidate but is tripped up by tolerability concerns; Novo Nordisk wins approval for Wegovy in MASH; and Lilly takes a pricing stand.

The CDC no longer recommends COVID-19 vaccines for healthy children and healthy pregnant women, a position that has been opposed by leading medical societies.

Regulations aiming to lower the cost of vital medicines will instead end up restricting access and disincentivizing R&D.

With its structural changes, CSL expects to generate $500 to $550 million in annualized savings over the next three years.

The platform strategy of using one molecule to target an underlying biological pathway to address many different diseases can be a goldmine for smaller companies. But it also has a unique set of challenges.