The latest stories from healthcare and the life sciences in the US. The FDA names Stanford’s George Tidmarsh as the new head of CDER; AstraZeneca commits USD 50 billion to new US manufacturing and R&D projects; Moderna cancels its planned mRNA facility in Japan; Sarepta refuses to halt Elevidys shipments despite FDA concerns; and a spike in US measles cases prompts new therapeutic R&D.
FDA’s CDER Gets New Chief in Biopharma Veteran George Tidmarsh (Biospace)
George Tidmarsh, an adjunct professor of pediatrics and neonatology at Stanford University’s School of Medicine with a long history in the biopharma and biotechnology industries, will be the FDA’s next head of the Center for Drug Evaluation and Research.
Tidmarsh is replacing Jacqueline Corrigan-Curay, the current acting head of CDER. Corrigan-Curay announced in June that she would be departing in July. She herself had only been in the job since January when Patricia Cavazzoni left the position two days before President Donald Trump began his second term.
“Dr. Tidmarsh is an accomplished physician-scientist and leader whose experience spans the full arc of drug development—from bench to bedside,” said FDA Commissioner Marty Makary, M.D., M.P.H. “His appointment to lead CDER brings exceptional scientific, regulatory, and operational expertise to the agency. I look forward to working with him to strengthen our drug review programs, foster innovation, and advance cross-agency initiatives that improve health outcomes for the American public.”
AstraZeneca Commits USD 50B More to US Manufacturing, R&D Projects (GEN)
AstraZeneca has increased its investment in US operations more than 14-fold, committing USD 50 billion to a range of manufacturing and R&D projects planned over the next five years.
The cornerstone of AstraZeneca’s latest USD 50 billion commitment, on top of USD 3.5 billion announced last November, will be the largest-ever facility the company has ever built to date—a “multi-million-dollar” manufacturing facility to arise in an as-yet undetermined site in Virginia.
“Today’s announcement underpins our belief in America’s innovation in biopharmaceuticals and our commitment to the millions of patients who need our medicines in America and globally,” AstraZeneca CEO Pascal Soriot said in a statement.
Moderna cancels plans to build Japan plant on poor business environment (Reuters)
Moderna said on Friday it will not proceed with plans to build a messenger RNA manufacturing plant in Japan due to “changes in the business environment” around the world and in Japan.
The company has been battered by declining revenue from its COVID-19 shots and less-than-expected uptake of its respiratory syncytial virus vaccine, and has been banking on revenue from newer mRNA shots to make up for weak revenue.
Moderna had begun development of the plant in Japan in 2023 at the Shonan Health Innovation Park in Kanagawa Prefecture. Moderna said it would reconsider the development of mRNA drug manufacturing facilities in Japan when the business environment improves.
Sarepta says it won’t comply with FDA request to stop shipping gene therapy Elevidys (Reuters)
US regulators asked Sarepta Therapeutics opens new tab on Friday to voluntarily halt shipments of its Elevidys gene therapy after a muscular dystrophy patient who received a different, experimental treatment died, but the company said it would not do so.
Sarepta said it made the decision “based on our comprehensive scientific interpretation of the data, which shows no new or changed safety signals in the ambulant patient population.”
While the 51-year-old man with limb girdle muscular dystrophy who died most recently was not taking Elevidys, his experimental therapy and Elevidys are based on similar gene technology, the FDA said.
The FDA said it was putting clinical trials for limb girdle muscular dystrophy on hold due to safety concerns.
Early measles drug R&D kicks into gear as US records record outbreak (Pharmavoice)
Decades after fading into obscurity in the US, the measles virus is surging once again.
The CDC has logged 1,288 cases and 27 outbreaks across the country so far this year, putting the spread on track to potentially surpass the last one-year high of 2,126 cases in 1992.
Now, Americans who haven’t gotten the jab are suffering the most from the current outbreak. According to the CDC, 92 percent of measles cases this year had an “unvaccinated or unknown” status.
Invivyd announced in May a new discovery program for a monoclonal antibody that could potentially treat measles or provide post-exposure protection against the virus.
