June 7, 2023

The need-to-know this morning

The European Commission approved GSK's RSV vaccine, bringing to the market the first such tool that can protect older adults from the common respiratory bug.
Johnson & Johnson and Legend Biotech filed a supplemental application with the FDA, seeking to expand the use of Carvykti, their patient-specific CAR-T treatment, to include patients with earlier-stage multiple myeloma.
Fibrogen said its experimental drug pamrevlumab did not improve muscle function in people with non-ambulatory Duchenne muscular dystrophy, failing to achieve the goal of a late-stage clinical trial. Results from a second study in people with ambulatory Duchenne are expected later this year.
The FDA is convening on Friday a panel of outside experts to consider full approval for Leqembi, the Alzheimer's treatment from Eisai and Biogen that received conditional approval in January. Briefing documents for the meeting will be posted here later this morning.

litigation

Merck is suing the government for 'extortion'

Merck sued the federal government yesterday for allowing Medicare to negotiate drug prices as part of the Inflation Reduction Act. It calls the negotiation "a sham," and characterizes the legislation as unconstitutional. Merck says the law lets the government force drugmakers to sell their property without "just compensation," which it claims is a violation of the Fifth Amendment.

Merck also says the government would be "taking" its drugs — saying that companies have no choice, lest they face excessive penalties if they do not participate in negotiations. The company estimates that a single day resisting negotiations for just one drug would translate into "tens of millions of dollars." The law, Merck writes, "is tantamount to extortion."

The only way drugmakers might avoid the negotiation programs would be to withdraw all their medications from both Medicare and Medicaid. "No rational manufacturer could simply withdraw from half of the U.S. prescription drug market, leaving tens of millions of patients without their medicines," Merck writes.

trade secrets

Biotech spying isn't cloak-and-dagger, it's collaborative

The intellectual property that underlies early stage treatments, diagnostics, and devices is under growing threat from foreign influences, according to panelists speaking at BIO this week. And these trade secret leaks can happen in seemingly innocuous ways.

"It's really easy to wake up one morning and realize that you might actually be an industrial spy for a foreign government," one security expert said. "Despite what you see in the movies, it is not somebody walking in and saying, 'Do you want to spy for me?' It is, 'let's start a company together.'"

For example, one researcher at a top university set up a lab at a foreign institution — but ended up conducting National Science Foundation-funded work in a country where the agency has no oversight. But the researcher never disclosed that to the NSF, or to his home university, one NSF security leader said on the panel. This phenomenon is becoming increasingly common, as scientists are being offered large sums for such collaborations — but in the process, intellectual property spills out.

succession

Biogen CEO likes his new board

Chris Vierbacher, Biogen's new CEO, seems to have inherited a more agreeable board than his predecessor's. The company brought on Caroline Dorsa, former CFO of Gilead Sciences, as its new board chair — and Viehbacher told an audience at this week's BIO conference that he has "alignment" with the current board.

Michel Vounatsos, Biogen's former chief executive, would often put together business proposals that were scuttled by dueling factions on the board, which was led by biotech "godfather" Stelios Papadopoulos. Viehbacher told the crowd that Dorsa had a "much different background than Stelios, as chair," adding that "as a CEO, never, ever ignore your board."

Vierbacher has a busy agenda ahead of him, attempting to cut costs substantially while growing the company through partnerships and acquisitions. His goal for the first three years of his tenure is to return Biogen to sustainable growth, and build up the company's talent pool once more.

ASCO

A new ASCO president

As ASCO wrapped up this week, a new president took her place: Lynn Schuchter, chief of the hematology-oncology division at the University of Pennsylvania, began her one-year term heading up the sprawling organization. Schuchter's work has centered on developing new treatments for melanoma. Now, she wants to use her leverage at ASCO to advance palliative and support care for cancer, and also help improve clinician well-being.

Schuchter told STAT that she was particularly impressed with the results that came out of this year's meeting — some were "truly practice-changing for many different types of cancer," she said. Of particular import were results in glioma, in rectal cancer, and in lung cancer.

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