NIH crackdown disrupts global science collaboration

The NIH's abrupt move to block foreign subawards has meaningfully disrupted U.S. biomedical research, a STAT survey of nearly 1,000 NIH-supported scientists shows. About a quarter of scientists report they've felt a significant impact from these changes, and many have been forced to scrap, relocate, or dilute international collaborations that were often essential to their work.

One malaria researcher told STAT that his team was only able to continue an ongoing study in Africa because of an injection of bridge funding from his university and a philanthropic foundation.

"That was absolutely essential for us to keep our teams together for those eight or nine months," he said. "We were lucky. But I know of lots of cases where people haven't found non-NIH support and have had to pause or let people go."

Researchers describe losing access to critical patient populations, halting clinical trials, and being forced to rely on less compelling models. The new PF5 mechanism restores a pathway for global work, but adds overhead and fractures oversight, they say.

china

China's biotech boom is rewriting everything

The center of gravity in drug development is shifting fast toward China, according to two new JAMA letters, including one from erstwhile CDER chief Richard Pazdur. Early-stage pipelines have nearly doubled in a decade, but the real story is about a balance of power: China has gone from a marginal player to a near peer of the U.S.

Today, China now accounts for roughly a third of global drug development programs and is increasingly pursuing real innovation. The reason's fairly simple: Trials there are faster, cheaper, and embedded in a regulatory system that's built to move assets through the development pipeline. China's also developed a sort of talent loop that sends scientists abroad, and brings them back seasoned and sharper. For the first time, Americans may start getting access to breakthrough therapies after another country does.

"China's growing participation in global drug development is unlikely to reverse," Pazdur writes, along with BioCentury's Steve Usdin.

Deals

Novartis buys allergy startup

From my colleague Andrew Joseph: Novartis continued its recent buying spree this morning, saying that it was acquiring the privately held California biotech Excellergy in a deal worth up to $2 billion. The Swiss pharma company framed the deal as one that would help build on its expertise in allergic diseases, with the centerpiece molecule, called Exl-111, being tested in a Phase 1 trial as an experimental therapy for IgE-driven conditions.

"Excellergy adds a differentiated next-generation anti-IgE program that builds on biology Novartis knows well, supported by preclinical evidence and early clinical pharmacokinetic data," Fiona Marshall, Novartis' president of biomedical research, said in a statement. "Exl-111 is designed to go beyond conventional anti-IgE therapy, with the potential to deliver faster and deeper suppression of IgE signaling as well as improved symptom control."

The approach has promise in conditions including food allergies, chronic spontaneous urticaria, and allergic asthma, Novartis said. The company, with its partner Roche, has an approved medicine called Xolair targeting some of the same diseases, including food allergies, but the treatment is starting to face biosimilar competition.

podcast

Eli Lilly's deal man, Allogene's off-the-shelf CAR-T, and Merck's Terns buy

On this week's episode of "The Readout LOUD": Allison DeAngelis is still away, leaving Elaine Chen and Adam Feuerstein to mind the podcasting store. You've been warned.

Eli Lilly's deal man, Jake van Naarden, is very, very busy, so what does that mean for biotech and pharma? Speaking of deals, Merck is buying Terns for nearly $7 billion. Why are some people mad about it?

You might be surprised to hear this, but off-the-shelf CAR-T therapies for cancer are still a thing. We preview an interesting data readout coming soon from Allogene Therapeutics. And finally, someone forgot to tell Wave Life Sciences that weight loss drugs are supposed to help people lose weight.

Next week: Allison returns!

Listen here.

pharma

AstraZeneca drug shows benefit in lung disorder

From my colleague Andrew Joseph: AstraZeneca said this morning that an experimental drug for COPD, a progressive lung disorder, hit its target in a pair of Phase 3 trials, boosting the prospects for one of the medicines that the company is relying on to meet its 2030 revenue goals.

Company shares were up about 3% in morning trading in the U.K. AstraZeneca has forecasted that peak annual sales of the drug could reach $3 billion to $5 billion.

In the OBERON and TITANIA trials, the drug, called tozorakimab, led to reductions in COPD exacerbations versus placebo across different groups of paitents, including former and current smokers and those with varying levels of lung function. The trials focused on patients who were still having exacerbations despite being on standard treatments. The company described the drug as "generally well tolerated," while noting that full data would be presented at a future conference.

COPD is a major market, with 400 million people globally diagnosed with the condition. It's also become an increasingly competitive space, with GSK's Nucala and Sanofi and Regeneron's Dupixent picking up approvals in the disease in recent years.

obesity

Wave's stock drops 50% on disappointing high dose data

Wave Life Sciences yesterday lost more than half its value after early data on its obesity drug failed to impress. In a clinical trial, a higher 400 mg dose showed no clear advantage over a lower dose in reducing visceral fat, with body weight down just 1% after six months. And the topline numbers look awkward, Reuters notes: About 5% visceral fat loss at three months on the higher dose versus roughly 14% at six months on 240 mg, leaving investors wondering why more drug didn't translate into more effect.

The drug, WVE-007, is an siRNA-based candidate meant to silence a mRNA linked to metabolism.

The company's defense is that the higher-dose group started out "notably healthier," metabolically speaking, which muddies the comparison. It claims that the results will be more visible among the heavier patients in the next trial.

crime

Elizabeth Holmes gets a year cut from her prison sentence

A federal judge yesterday trimmed Elizabeth Holmes' prison sentence from 135 months to 123 months. This applies a newer sentencing guideline that gives certain first-time, nonviolent offenders a modest break — even in a case as notorious as Theranos.

The court found Holmes qualified for a sentence reduction despite the staggering $450 million investor fraud, largely because prosecutors couldn't show that any individual investor suffered the kind of personal financial devastation the rule requires.

"Instinctually, the $450 million in losses here would seem to meet that definition," the judge found. "But this gut reaction is a poor measure at best. Losing one million dollars may not even register as a loss for certain victims, whereas for others it could result in complete financial devastation."

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