Are generalist investors good or bad for biotech?
by Meghana Keshavan · STATWant to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox.
Good morning! Today, we see Ginkgo pivot into AI, becoming yet another contender in a crowded market. Also, we see more documents destroyed at an Indian drug manufacturing plant, and offer up a fabulous podcast.
The need-to-know this morning
- Apellis Pharmaceuticals said its eye drug Syfovre was rejected for a second time by advisers to the European Medicines Agency.
Under pressure, Ginkgo Bioworks bets on AI
Ginkgo Bioworks is pivoting: Once a synthetic biology darling, the flailing company has now turned to AI-driven protein modeling and data generation amid layoffs and a plummeting stock price. Ginkgo will offer customers a new AI model to use for biological research, and a data service with vast datasets to help customers train their own models.
The company’s shares rose 21% on the news, but its trajectory in a crowded market may still be iffy, STAT’s Brittany Trang and Jason Mast write. Though it has proprietary data, Ginkgo’s AI model performs comparably to existing open-source models — which is causing many to question its competitive edge.
Are generalist investors good or bad for biotech?
How did Elaine and Adam’s trip to New York go? And how long has George Church owned that brown corduroy blazer?
We cover all that and more on the latest episode of “The Readout Loud.” Mizuho analyst Jared Holz joins us to discuss what the Federal Reserve’s long-awaited decision to lower interest rates means for biotech stocks and startups. Elaine, Adam, and Allison also discuss the latest news in life sciences, including the use of cannabinoid receptor drugs in weight loss and the Lasker Awards, a.k.a. “America’s Nobel.”
Document destruction at an Indian generic plant
Generic drugmakers in India have been found destroying key documents on multiple occassions. Now, a “large number of torn pieces” of documents were found among three truckloads of “scrap materials” from a site run by the drugmaker Granules in Telangana, India. When confronted by FDA inspectors, STAT’s Ed Silverman writes, plant management acknowledge the papers should not have been destroyed.
Other companies in India, like Cipla, Intas, and Strides Pharma have all been found to have destroyed or attempted to destroy critical records needed to ensure drug safety and compliance. The incidents raise concerns among regulators, as Indian manufacturers are responsible for about 90% of U.S. generic prescriptions.
Sen. Cassidy’s bid to protect small biotechs
A top Republican senator has introduced a bill, obtained by STAT, that’s meant to help small biotechs avoid Medicare price negotiations. Specifically, the legislation from Sen. Bill Cassidy of Louisiana would allow “research and development-intensive small biotech manufacturers” to extend their exemption from haggling with the government over prices past 2028. It also creates a new way to determine what qualifies as a small biotech.
With President Biden in the White House and Democrats controlling the Senate, STAT’s John Wilkerson writes, the bill has no chance of passing. But depending on election results, it could signal what Republicans have in store for biopharma and drug pricing next year.
More reads
- Novo Nordisk’s Wegovy gets EU backing to treat obesity-related heart failure, WSJ
- How I fought Big Pharma on insulin prices — and won, STAT
- Corbus shares will soar or dive soon. Here’s why, STAT
- Aligos’ MASH prospect slashes liver fat in phase 2, but stock drops anyway, Fierce Biotech