July 16, 2025

The need-to-know this morning

Johnson & Johnson reported second-quarter earnings.

oncology

FDA questions safety of GSK's multiple myeloma drug

From my colleague Drew Joseph: Ahead of an advisory committee meeting Thursday focused on GSK's multiple myeloma drug Blenrep, the FDA pointed to concerns about the high rates of eye issues that have accompanied the use of the medicine and questioned the proposed dose.

In briefing documents released yesterday, the agency noted that some patients on a Blenrep combination suffered from blurred vision, corneal problems, and other eye issues, which led to dose interruptions and dose reductions in the two successful supporting trials. This "is a unique toxicity that is not seen with any currently available treatments for multiple myeloma," agency officials wrote.

Questions about the eye issues have long dogged Blenrep, and some analysts have said the side effects may limit uptake of the drug presuming it's approved. GSK has maintained that clinicians can adjust dosage plans should patients experience eye issues, though the FDA suggested that monitoring for eye problems and tweaking dosage schedules could be harder in routine care than it was during clinical trials.

In its own document, GSK said that Blenrep "provides a novel, highly effective, off-the-shelf, anti-BCMA option that is accessible in an outpatient setting without the need for hospitalization or specialized care." BCMA is Blenrep's molecular target.

The advisory committee meeting this week is seen as a step on Blenrep's comeback journey. The medicine, an antibody-drug conjugate, won accelerated approval in 2020 for use on its own, but was withdrawn from the market a few years later after a confirmatory study failed.

The more recent, successful trials, however, tested Blenrep in combination with other drugs in patients who had tried at least one other line of treatment. Japan and the U.K. have already approved the Blenrep combinations this year, and E.U. regulators have recommended it for approval.

The FDA is meant to rule on Blenrep by next Wednesday, though the agency has missed some target dates for approval decisions in recent months.

gene editing

Prime's scientific head leaves amid leadership shakeup

From my colleague Jason Mast: Prime Medicine, the beleaguered gene-editing startup, said yesterday that it parted ways with its chief scientific officer, Jeremy Duffield.

It's the latest shakeup at Prime's leadership ranks, following the replacement of its CEO, a layoff, and a strategic shift in May. The company did not issue a press release, disclosing the move only in an SEC filing. It said Duffield stepped down but noted he would receive severance benefits.

Duffield's departure may not come as a shock to those who have followed the company since its launch in 2019. The startup, seeded around a groundbreaking new tool to make virtually any small change to DNA, has been the victim of souring investor sentiment on gene-editing companies generally. But former employees previously told STAT the company was also mismanaged, as executives attempted to tackle too many diseases all at once and struggled to adapt to a changing market.

Prime is now trying to push forward in a slightly slimmed down form, although cash is still tight. Its stock has ticked up in recent weeks and company leadership is now trying to reprice employees' stock options to be more attainable in a depressed market.

Prime also announced Wednesday an expanded partnership with the Cystic Fibrosis Foundation to tackle the rare disease.

M&A

Sino Biopharm to buy Chinese cancer biotech

Chinese drugmaker Sino Biopharm said yesterday that it will acquire LaNova Medicines, which has licensed cancer drugs to Merck and AstraZeneca.

Sino will buy the roughly 95% stake it does not already hold in Shanghai-based LaNova for up to $951 million. Since LaNova holds around $450 million in cash, Sino will make a net payment of $501 million.

The deal comes as cancer drug development in China accelerates and pharma companies worldwide look to biotechs in the country to strike deals. Merck last year licensed a PD-1-VEGF bispecific antibody from LaNova for $588 million upfront and as much as $2.7 billion in future milestone payments.

Pfizer earlier this year paid another Chinese drugmaker, 3SBIO, $1.25 billion upfront plus another $4.8 billion in future contingency payouts for global rights to its PD-1-VEGF antibody.

manufacturing

Indian generic drugmaker fails another FDA inspection

Sun Pharma, the world's largest generic drugmaker, failed another FDA inspection of one of its facilities, after it's been repeatedly cited for serious quality control issues.

The problems cited at the plant involved a raft of practices that raised questions about the ability of the Indian drugmaker to properly ensure sterility, environmental conditions, and cleanliness, according to an FDA report.

The failed inspection comes amid rising anxiety over the viability of the supply of generic medicines from India. Manufacturers in the country supply about 40% of the generic medicines taken by Americans.