China Biotech BeiGene Wins FDA Approval for Rare Blood Cancer Drug

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The Food and Drug Administration (FDA) on Thursday approved BeiGene’s Brukinsa, a treatment for the rare blood cancer mantle cell lymphoma (MCL). The immunotherapy drug is approved for adult patients who have been treated with at least one other medicine.

From a business perspective, it’s big news for BeiGene—the China-based biotech that’s one of the pioneers in that country’s biopharma Renaissance. New stock exchange rules in Hong Kong have helped fledgling biotechs in China raise capital; BeiGene, for its part, had a nearly $160 million U.S. public offering in 2016 and then a $903 million secondary Hong Kong IPO in 2018.

American companies have taken notice. In October, Amgen took a 20.5% stake in BeiGene. It may be feeling good about that bet right about now.

Read on for the day’s news.

Sy Mukherjee
sayak.mukherjee@fortune.com
@the_sy_guy

DIGITAL HEALTH

A whistleblower's account of the Google-Ascension partnership. We'll be delving into this issue in far greater detail in the coming weeks and months—but it's worth noting, for now at least, the striking piece published in the Guardian from an individual who claims to be a whistleblower on Google's efforts to collect personal health data in conjunction with a major U.S. medical provider (dubbed "Project Nightingale". ) (The Guardian)

Apple will allow users to enroll in three health studies. On a related note in the medical data collection industry... Apple launched a new app in conjunction with the Harvard T.H. Chan School of Public Health and the NIH’s National Institute of Environmental Health Sciences that will allow Apple Watch and iPhone users to participate in three separate public health studies. The organizations say that users will be able to control what data is shared, but the available options would include the Apple Women’s Health Study, Apple Heart and Movement Study, and the Apple Hearing Study. (Reuters)

INDICATIONS

Amarin snags a critical FDA committee recommendation for its fish oil drug. An expert advisory panel to the Food and Drug Administration (FDA) on Thursday unanimously recommended expanding the label for Amarin's fish oil-based treatment Vascepa—and the recommendation, if ratified by the broader agency, could prove a massive financial boon to Amarin. The FDA panel is, in essence, ratifying Amarin's phase 3 clinical trial data showing 25% relative reductions in major cardiovascular events like stroke and heart attack in at-risk patients. (BioPharma Dive)