Is there a cure for allergies?

Has the FDA become too flexible? And which drugs make you muscular? We cover all that and more this week on "The Readout LOUD," STAT's biotech podcast.

Recorded live from the STAT Breakthrough Summit East in New York City, we discuss some event highlights, including words from CRISPR pioneer Feng Zhang and Regeneron Pharmaceuticals head scientist George Yancopoulos. We also discuss the latest news in the life sciences, including a twist in the GLP-1 story, the cost of gene therapy, and, of course, pie.

Listen here.

M&A

EU adviser says Illumina merger was not problematic

Finally, a win for Illumina — for whom it's been doom and gloom for quite some time, after an $8 billion effort to acquire Grail was blocked by European regulators. Now, Nicholas Emiliou, advocate general of the Court of Justice of the EU, has said that decision was wrong and ought to be reversed, Financial Times writes. Although this isn't a legally binding decision, these options tend to be followed by the EU's highest court, which will likely rule on Illumina's case later this year.

The EU's 2022 decision to block Illumina's acquisition of Grail was considered controversial because Grail had no revenue or presence in Europe.

"Illumina agrees with the Advocate General that the European Commission's assertion of jurisdiction over this merger was improper," the company said in an email to Reuters.

drug pricing

Should orphan drugs be exempt from price caps?

Some drugmakers are lobbying for orphan drugs to be exempt from the price caps being set by state boards. Some lawmakers are backing these efforts, citing concern that patients might lose access to such drugs if pharmaceutical companies decide to stop selling or investing in them.

However, opponents argue that these exceptions could end up being used for blockbuster drugs that are also used to treat orphan diseases. Consumer advocates believe that price cap legislation would ultimately make it harder for patients to pay for their medication — ultimately preserving profits for drugmakers.

"I do know folks who have these rare diseases. They're scared. They're stressed. They're concerned if [the price of a drug] does get capped they may not get their medications," one state senator who used to work in large pharmaceutical companies told STAT. "I don't want to take that chance with this group of people. I don't know whether companies would pull out or not but is it worth taking that chance?"

xenotransplantation

Pig kidney transplanted into living human

Surgeons have transplanted the first kidney from a CRISPR gene-edited pig into a living human patient. Richard Slayman, a 62-year-old man who had previously received a human kidney transplant, underwent the landmark xenotransplantation procedure last Saturday at Massachusetts General Hospital. As of Thursday morning, he was up and walking.

The porcine kidney was engineered by eGenesis, a Massachusetts biotech that is creating a variety of human-compatible pig organs using CRISPR technology.

"We hope to learn if the durable transplant results that we observed in non-human primates, published in Nature in October, translate in to patients," eGenesis CEO Mike Curtis told STAT. "How well the patient and the graft do will be valuable information and inform the design of future studies."