Biotech winter freezes jobs, but not hope in SoCal

San Diego's once-sizzling biotech scene is now in a cold snap. It's left some workers desperate after months of fruitless job hunting for vanishing opportunities, STAT's Jonathan Wosen writes, while vacancy rates for lab space have surged from 1% to over 22% as companies slash costs.

But the picture of the area's economic health is nuanced. San Diego-area biotechs outperformed national peers in 2024, venture returns outstrip Boston and the Bay Area, and pharma giants like Novartis are doubling down with billion-dollar bets on the region's future.

"We continue to see very differentiated, very powerful companies, technologies, products, platforms, emerging out of San Diego," Josh Schimmer, a market analyst for Cantor Fitzgerald, told STAT.

regulation

Replimune drug was derailed after contentious debate

FDA oncology chief Richard Pazdur intervened during the late-stage review of a skin cancer drug called RP1 from Replimune Group — contributing to the treatment's rejection, STAT's Adam Feuerstein reports. The decision, made amid agency turmoil and after months of positive signals from the FDA's biologics division, stunned the company and external melanoma experts, who praised RP1's trial results.

Notably, recently ousted CBER head Vinay Prasad played relatively little role in the outcome. Instead, Pazdur and his team were concerned that the tumor-killing effects of RP1 couldn't be distinguished from the efficacy of Opdivo, which was used in combination with the Replimune drug in a trial.

"I was surprised by the FDA's rejection of the RP1 application and judging by the texts, emails, and posts from melanoma-focused colleagues around the world, I am not alone," one melanoma expert told STAT. "I hope the FDA will meet with melanoma experts to better understand how striking and impressive we find the results of this clinical trial."

hiv prevention

Trump administration is sued over Gilead PrEP deal

A patient advocacy group is suing the Trump administration for withholding details of its secretive settlement with Gilead Sciences over patent rights to HIV prevention drugs. The group, PrEP4All, alleged that the deal undermines public accountability and efforts to combat price gouging.

The dispute stems from a related legal battle in which the Centers for Disease Control and Prevention claimed it funded critical research behind Gilead antivirals Truvada and Descovy — only for the drugmaker to charge extremely high prices for them. The litigation, STAT's Ed Silverman writes, marked the first time the U.S. government has filed a patent infringement lawsuit against a pharmaceutical company.

"With the recent launch of a six-month injectable version of PrEP — priced at $28,000 per year — Gilead remains the dominant PrEP manufacturer in America," PrEP4All's executive director told STAT. "For advocates calling for equitable access to PrEP through a National PrEP Program, we need to see the terms of this settlement to understand what options we still have in mitigating Gilead's price gouging and market manipulations."

drug pricing

Drug price reports obscure more than reveal

Drugmakers like Johnson & Johnson continue to release yearly price transparency reports, but they omit crucial data on specific drug costs, experts tell STAT's Bob Herman writes. These reports, which average price changes across entire portfolios and exclude product-level list prices, net prices, and rebates, are not particularly useful in terms of offering clarity on why drugs are costly.

Instead, they "are essentially part of a larger strategy by the industry to blame high drug prices on pharmacy benefit managers and hospitals and avoid any role that they play in setting high drug prices," one Harvard pricing researcher and primary care doctor told STAT.

Now, with the Trump administration weighing new rules to force disclosure of actual drug prices, drugmakers are seemingly lobbying to preserve their ability to keep pricing strategy occluded — all while pushing for stricter reporting from insurers and PBMs instead.

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