A fixation on China is causing a rupture in biotech

America’s biotech industry is fracturing over its growing dependence on Chinese drug development, STAT’s Damian Garde reports. Executives and investors are battling over whether partnering with Chinese firms means smart capitalism — or whether the deals amount to a long-term existential threat to the ability of U.S. biotech staying ahead.

Molecules invented in China now make up more than 40% of the global drug pipeline, up from just 8% a decade ago, while American companies are increasingly licensing cheaper, faster-to-develop drugs from China rather than building them domestically. There’s concern that the U.S. is making the same strategic mistakes it made with rare earths and electric vehicles, potentially handing China leverage over future access to lifesaving medicines.

The debate has become increasingly public thanks to Ginkgo Bioworks CEO Jason Kelly, who is among a cadre of executives pushing for the U.S. government to block biotech deals with China. Damian also explains why Kelly's own future, and Gingko's, may ride on what happens next.

WASHINGTON

FDA leadership shakeup widens

The FDA’s leadership shakeup widened Friday after acting drug center director Tracy Beth Høeg was ousted from office.

Høeg's departure came just days after Marty Makary resigned as commissioner under intense pressure, and was accompanied by a series of other moves in the FDA's top ranks.

Michael Davis, who had been serving as deputy director of CDER, has taken over as acting director. Katherine Szarama, who had served as the acting director of CBER for a very short period, is leaving her role but will stay at the agency to assist with product issues. Szarama has been be replaced by Karim Mikhail, who joined the FDA in 2025 as a senior adviser in the office of the commissioner.

Read about these changes and some others here.

And don't miss a new First Opinion essay from Joshua Sharfstein, a former principal deputy commissioner at the FDA, on what he thinks Makary fundamentally misunderstood about the agency.

chronic disease

AZ picks up FDA approval for hypertension drug

AstraZeneca's hypertension drug Baxfendy has won FDA approval, the company said this morning, giving the U.K. firm a boost for its goal to hit $80 billion in revenue by 2030.

The drug, also known as baxdrostat, was approved as an add-on therapy for patients who struggle to control their blood pressure on other medications. Known as an aldosterone synthase inhibitor, or ASI, it has a different mechanism than existing hypertension drugs.

The approval gives AZ a new asset for its cardiovascular, renal, and metabolism diseases group, an important step as its cornerstone Farxiga is losing patent protection. AZ has forecast peak annual sales of $5 billion for Baxfendy.

Still, it could face competition soon. Mineralys Therapeutics has filed its own ASI, called lorundrostat, with the FDA, with a decision expected in December.

drug pricing

U.K. drug deal sparks legal threat from advocates

Two advocacy groups are threatening legal action against the U.K. government over a new drug trade agreement with the U.S. They’re arguing that the deal could undermine the independence of the country’s drug-pricing watchdog and dramatically increase NHS spending on medicines.

The agreement, finalized last month, gives the U.K. tariff-free access to the U.S. pharmaceutical market in exchange for a series of industry-friendly concessions, STAT’s Ed Silverman writes. This includes higher NHS drug spending targets, a 25% increase in medicine prices paid by the health system, and changes to how the National Institute for Health and Care Excellence evaluates cost-effectiveness.

“The government caved in to threats from Donald Trump and the pharmaceutical industry and signed a deal that experts say could cost the lives of over 300,000 NHS patients,” one advocacy group leader said. "But we believe the process they have followed is unlawful, and we are ready to take them to court to defend NHS patients and our democracy.”

rare disease

20 deaths linked to Amgen's Tavneos in Japan

Alarm is growing around Amgen’s rare disease drug Tavneos after partner Kissei Pharmaceutical disclosed roughly 20 deaths linked to serious liver dysfunction in Japan, the Wall Street Journal writes.

The company told doctors to stop prescribing the drug to new patients and reevaluate those already taking it, warning that many severe liver injuries showed up within three months of treatment. Some cases involved a devastating condition that destroys bile ducts.

About 8,500 patients in Japan have received Tavneos since its 2022 launch. The drug treats ANCA-associated vasculitis, a rare autoimmune disease that inflames blood vessels. Earlier this year, the FDA asked Amgen to voluntarily pull the drug from the U.S. market over liver safety concerns. Amgen refused, arguing the drug still has a favorable benefit-risk profile.

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