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Well, this wraps up one of the most eventful weeks of the biotech year — ASCO, followed by BIO. Anyone else as zonked as I am? Today, we discuss the impact that the BIOSECURE Act is already having on the industry, preview what FDA reviewers want to know about donanemab, and more.
The need-to-know this morning
- The FDA approved Geron‘s drug imetelstat for certain patients with myelodysplastic syndromes, a type of slow-moving blood cancer. Marketed as Rytelo, it’s the first drug to emerge from the once-ballyhooed company since its founding in 1990.
BIOSECURE shaking up partnerships at BIO
Although it isn’t yet a law, the BIOSECURE Act is already making waves in the biotech industry — as evidenced by some notable shifts at this week’s BIO International Convention in San Diego. STAT’s Jonathan Wosen and I were on site, and found that, with the possible blacklisting of certain Chinese suppliers looming, biotechs are scrambling to find alternatives to manufacturers like WuXi. Meantime, an executive at one U.S.-based CDMO said “month to month, new business has gone through the roof.”
The convention this year, despite billing itself as an international gathering, focused heavily on the importance of national security in biotech.
“Our customers are mainly small biotechs, and they’re very worried about whether they’ll be able to afford the U.S. CDMOs,” one China-based CDMO employee said. “They’re worried about backlogs, since the U.S. companies are suddenly so busy. My customers are telling me they’re already waiting in line to get a slot, in case we are put on the BIOSECURE list next.”
What FDA reviewers want to know about donanemab
On Monday, an FDA advisory committee will discuss the merits of donanemab, an experimental Alzheimer’s drug from Eli Lilly. Ahead of the meeting, FDA reviewers have posed some questions: Should the drug only be given to patients who are given PET scans to confirm the presence of tau proteins? That could reduce access to the drug substantially. And, of course, they ask, do the benefits outweigh the risks?
STAT’s Matthew Harper and Elaine Chen dive into what regulators seek to learn in the upcoming ad comm. It was a bit of a surprise that the meeting was called at all — the expectation was that donanemab would have a relatively simple FDA review process, given that Leqembi, a similar drug and a rival, has already been approved.
Psychedelics at the FDA, ASCO recap, & Morphosys
How did advisers react to the first psychedelic therapy to go before the Food and Drug Administration? And did the American Society of Clinical Oncology meeting surpass expectations? We discuss that and more in this week’s episode of “The Readout LOUD.”
Yours truly joined the podcast to dissect Lykos Therapeutics’ meeting with an FDA advisory committee. Adam and Allison also discussed the latest news in the health and life sciences, including stories from major biotech conferences.
Vanda Pharmaceuticals has another suitor
A public bidding war is underway: Cycle Pharmaceuticals has offered $466 million — or $8 per share — to acquire Vanda Pharmaceuticals. Just a month back, the CDMO FuturePak offered $7.25 per share for the company, and then raised it to $7.75. Shares in Vanda rose 27% on news of its being courted again.
After not making a deal with the board behind closed doors, Cycle Pharma is attempting to force Vanda’s hand in a public arena: “While we would have preferred to reach an agreement privately, Cycle is publicly disclosing our proposal for the benefit of Vanda shareholders,” it said in a statement.
More reads
- Italy opens antitrust case against Novartis, Roche and others, claiming collusion to delay biosimilar launch, FiercePharma
- Nine years and four generics later, the HIV drug at the center of the Shkreli controversy still has a high price, Endpoints
- Moderna’s mRNA candidate joins FDA’s accelerator program for rare diseases, BioSpace