The FDA has issued (PDF) a complete response letter to Mesoblast’s request for approval of allogeneic cell therapy remestemcel-L in children with steroid-resistant graft-versus-host disease. FDA officials want to see data from at least one additional clinical trial before granting full authorization, but Mesoblast is still hoping to snag an accelerated approval using its existing data.

Preclinical biotech Foghorn Therapeutics is aiming for a $100 million IPO, but don’t be surprised it if goes the way of many other biotech listings and shoots far north of that.

Through its COVID-19 diagnostic development initiative, the National Institutes of Health (NIH) announced it has awarded nearly $234 million to improve access to testing among underserved and vulnerable populations.

Synthetic Biologics and Cedars-Sinai Medical Center are pulling the plug on a phase 2b study in irritable bowel syndrome because it’s unlikely to hit its primary objective. Cedars-Sinai, the sponsor, will do a “comprehensive review” of the data and publish the findings.

The FDA has lifted the clinical hold on a phase 1/2 clinical trial of Solid Biosciences’ gene therapy treatment for Duchenne muscular dystrophy (DMD). Solid Bio secured clearance to resume dosing in the trial after making manufacturing changes to cut the number of viral particles given to patients.

Nearly two months after GlaxoSmithKline’s U.S. pharma and vaccine head left the Big Pharma in the middle of it making a pandemic shot, Jack Bailey has penned a deal to lead cancer biotech G1 Therapeutics.

As Corvidia CEO, Marc de Garidel saw the heart disease biotech through a $2.1 billion acquisition by Novo Nordisk. Barely two months later, he’s back in the saddle, this time at AZTherapies, a company working on treatments for Alzheimer’s and other neurodegenerative diseases.

After seven years running Merck’s R&D engine, much of which has revolved around cancer blockbuster Keytruda and, now, COVID-19 vaccines, Roger Perlmutter, M.D., Ph.D., is hitting the exit.

Last fall, Myovant’s prostate cancer drug outshone the standard of care at keeping patients’ testosterone levels down, a phase 3 showing that teed up an FDA filing. Now, as the agency ponders the case, the company is unveiling data for patients with metastatic disease—and they’re not so rosy.

When Takeda and Ovid Therapeutics joined forces in 2017, the duo got to work on midstage trials in a pair of rare epilepsies: Dravet syndrome and Lennox-Gastaut syndrome. They’ve since added two more conditions to their pact, and now they’re unveiling data on both.