Capricor sues partner over Duchenne therapy launch

Capricor Therapeutics is suing its Japanese partner Nippon Shinyaku and subsidiary NS Pharma, arguing the companies botched launch preparations for deramiocel, the biotech’s closely watched Duchenne muscular dystrophy cell therapy. Capricor says the companies also created a pricing structure that could make the treatment financially inaccessible for many patients.

The lawsuit claims the distribution agreement contains a “fundamental pricing flaw” tied to Medicare reimbursement rules that would eventually force providers to administer the therapy at a loss.

“I have spent nearly two decades building Capricor with one goal in mind: making Deramiocel available to treat these boys,” Capricor CEO Linda Marbán said in a statement. “I know what every additional month of delay costs them, because I know what is happening inside their muscles when they cannot be treated. There is no version of this case in which I am willing to watch NS Pharma’s inaction take that away from them.”

In a statement, Nippon Shinyaku said it had not been served with the complaint yet. It added, however, "We are confident that both Nippon Shinyaku and NS Pharma have responded appropriately and sincerely to ensure treatment reaches DMD patients after approval. While we recognize that Capricor’s claims lack merit, we remain open to discussions with Capricor to maximize the value of" deramiocel.

research

Scientists grow less disruptive as they age

It’s not just Einstein: A sweeping new Science paper tracking 12.5 million researchers found that scientists tend to do their most disruptive work early in their careers, STAT’s Anil Oza writes. From there, they tend to gradually shift toward more incremental research that builds on older ideas.

The study adds workforce aging to a growing list of explanations for why scientific breakthroughs appear to be slowing. Other issues, of course, are that scientists are getting hyper-specialized, team sizes are increasing, and funding incentives are narrowing.

Also, interestingly, older scientists consistently cited older literature, while younger scientists — and countries with younger scientific workforces like China and India — produced more disruptive work.

video

Why we left the FDA: Six former officials share stories

From STAT’s Alex Hogan: A year after U.S. DOGE Service cuts shook up the federal government, STAT FDA reporter Lizzy Lawrence has been speaking with former officials about their time at the agency. Two weeks ago, I hit the road with Lizzy to interview six of them about what drew them to the agency, the important work they did during their career there, and, ultimately, why they decided to leave during the second Trump administration.

In a special road-trip addition of STATus Report, Lizzy and I travel around the leafy suburbs of Washington to bring you first-person testimonies, including from the former director of the FDA’s Center for Drug Evaluation and Research, Richard Pazdur; Sheryl Lard-Whiteford, a leader in the FDA’s biologics center; and Julie Tierney, who worked on Operation Warp Speed.

Watch here.

podcast

Seaport's IPO adventure, obesity pill battles, and Makary's troubles

On this week’s episode of "The Readout LOUD," we chat with Seaport Therapeutics CEO Daphne Zohar, fresh off the biotech’s successful IPO. Plus, Elaine, Allison, and Adam chat about this week’s notable news, including the obesity pill battle between Eli Lilly and Novo Nordisk, a Phase 3 study win for Cytokinetics, and FDA Commissioner Marty Makary’s White House troubles.

Oh, by the way, this is the 400th episode of your favorite biotech podcast.

Listen here.

fashion break

The biotechs wear Prada

From my colleague Elaine Chen: Longtime newsletter subscribers may recall that when early May rolls around, we have an annual tradition: Met Gala outfits as biopharma logos. (See the previous years' editions here and here.)

This year's Met Gala dress code was “Fashion is Art.” I do believe that all fashion is art, and I'm sure the marketing teams at biotech companies would argue that corporate logos are art, too.

Credit goes to my colleagues Brittany Trang and Allison DeAngelis for finding these pairings!

Naomi Osaka as Gilead