| | | |   | Hello, all. Damian here. If you're curious about what the future holds for CRISPR, join STAT later this month for an open-ended conversation with the CEO of Intellia Therapeutics. You can register to participate here. | | | Why the FDA changed its tone on Chinese cancer drugs Last week, the FDA’s top cancer drug reviewer changed his tune on the subject of cancer medicines developed entirely in China, casting doubt on a class of drugs he previously welcomed. Speaking to STAT in the aftermath, FDA oncology leader Richard Pazdur was unapologetic about the shift and said it should serve as a message to the drug industry.
“Do I have a right to change my mind? Yeah,” Pazdur told STAT’s Adam Feuerstein. “There are forces that came into play which makes it reasonable for me to change my mind.” Among them: Data derived entirely from a single foreign country — China, most often — is a “step back” from efforts increase the racial and ethnic diversity in clinical trials, he said. Chinese data are not “generalisable” to American cancer patients, according to Pazdur, and “do not fulfill an unmet medical need” in the U.S.
Pazdur’s about-face will have an immediate, deleterious effect on Eli Lilly and its Chinese partner Innovent, whose cancer immunotherapy is now under FDA review. It might derail the plans of companies including EQRx and Coherus Biosciences, which hope to market Chinese-developed cancer drugs in the U.S. at lower prices.
Read more. | Amgen sees growth in its future How much? Well, the biotech giant was a bit coy. Speaking to investors and analysts yesterday, Amgen CEO Bob Bradway said Amgen expects “mid-single-digit” revenue growth through 2030. That’s off an expected $26 billion in revenue for 2022.
But Amgen decided against offering any specific revenue numbers, letting analysts do the math themselves. Which they did, coming up with a revenue forecast of approximately $35 billion in 2030 — well above the consensus estimate of approximately $25 billion.
Similarly, Amgen’s implied earnings growth through 2030 also greatly exceeds Wall Street’s current expectations.
Amgen’s growth forecast is “doable,” Evercore ISI analyst Umer Raffat told clients, “given Amgen’s track record at delivering on numbers.” For now, investors are believers. Amgen share rose nearly 8% in trading yesterday, adding $9.5 billion in market value. | The #1 cloud financial management for biotech and life sciences companies Sage Intacct cloud accounting is ideal for the needs of Biotech, Pharmaceutical, and Life Sciences companies at every stage of growth: from two scientists and a molecule to large, public companies. Get rid of spreadsheets, automate your processes, handle complex consolidations, and get real-time analytics, so you are always on top of your research. Sage Intacct is the only accounting solution endorsed by the AICPA. | Pfizer lost $10 billion for making $81 billion Yesterday, Pfizer said it made $81 billion in revenue last year and forecast a record-setting $100 billion in sales for 2022. The company was rewarded with a roughly 4% decline in its stock price that cut $10 billion from its valuation.
The issue is that Pfizer’s projections aren’t record-setting enough for Wall Street’s liking. The company’s 2022 guidance — $98 billion to $102 billion in revenue and earnings per share of $6.35 to $6.55 — were about 3% below analysts’ estimates.
But as Evercore ISI analyst Umer Raffat pointed out in a note to clients, Pfizer’s math will likely prove to be conservative. The company expects $22 billion from Paxlovid, its oral treatment for Covid-19, but that number reflects only Pfizer’s existing sales contracts. If Paxlovid proves to be more popular, as an oral treatment for Covid-19 is likely to be, Pfizer’s full-year revenue might prove more record-setting than it seems. | One mother’s quest to make ‘N of 1’ drugs available to families in need Julia Vitarello knows the effect individualized medicines can have on families. Four years ago, her daughter, Mila, was given a drug created just for her. It was called milasen, and it halted her rapidly progressing condition and later improved her quality of life. Mila’s disease eventually overcame the drug’s effects, and she died last year at age 10.
Now, working from Mila’s bedroom, Vitarello is on a mission to speed up the development of so-called “N of 1” drugs, which has meant mobilizing an academic consortium focused on the creation of custom medicines.
“Creating Mila’s drug was like climbing Everest without oxygen or guides,” Vitarello said. “But we need a clear path and to lower Everest.”
Read more. | More reads - Amazon Care announces nationwide expansion of health clinics. STAT+
- Novavax underdelivers on Covid-19 vaccine promises. Reuters
- U.S. adds China’s Wuxi Biologics to ‘unverified list’; shares dive. Wall Street Journal
- How PDUFA VII can catalyze ‘lightspeed’ vaccine and drug development. STAT+
| Thanks for reading! Until tomorrow,  | | | |
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