News
Novo Nordisk has brought on other cardiometabolic collaborators this year, including United Laboratories International and Deep Apple Therapeutics.
FEATURED STORIES
After a slow 2024, the biotech shell company Concentra Biosciences is back, offering to buy four biotechs in the past month and seven so far this year.
Sarepta’s troubles had nothing to do with Arrowhead’s assets, and yet both companies have seen their stock prices decline this past month. BioSpace caught up with Arrowhead’s Chris Anzalone to talk about the biotech’s role as an RNAi pipeline savior.
Leaders at Eli Lilly believe heavy investment in the company’s manufacturing footprint “sets a high standard that newcomers may find challenging to match.” At least one of those newcomers disagrees.
Job Trends
In another delay for the psychedelic treatment space, Compass Pathways announced adjusted timelines for two Phase III trials of its psilocybin to address treatment-resistant depression.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Project 2025, a blueprint for a potential second Trump term that highlights the IRA as a potential target, took a starring role in this week’s Democratic National Convention.
THE LATEST
The FDA recommends that companies use overall survival as a primary endpoint for clinical trials where feasible. The new guidance follows the surprising return of CBER Head Vinay Prasad, who has previously argued for prioritizing OS.
With its structural changes, CSL expects to generate $500 to $550 million in annualized savings over the next three years.
Regulations aiming to lower the cost of vital medicines will instead end up restricting access and disincentivizing R&D.
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.
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.
Media coverage can help biopharma executives connect with, inform and inspire the public. In this column, Kaye/Bassman’s Michael Pietrack and three communications experts share how to make the most of these opportunities.
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.
Drugs are being invented and manufactured right here in the U.S. by Americans, for Americans. So why doesn’t the industry hold the same respect as steelworkers or other all-American pursuits?
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.