Earlier this week, stunning claims from Chinese scientist He Jiankui saying that the world’s first known, intentionally gene-edited babies had been born took the life sciences community by storm. Now, He is doubling down on the (still unverified) reported project, which has drawn criticism from a wide range of medical experts expressing ethical and practical concerns.

He has begun to offer some more details on the clinical trials, which involve modifying embryos via CRISPR gene editing technology in order to prevent HIV transmission in newborns, according to the BBC. For instance, He claims that the Southern University of Science and Technology in Shenzhen with which he is affiliated didn’t know about the project, which the researcher says is self-funded. (Another scientist, Rice University’s Michael Deem, is facing a probe into the matter by his own organization.)

He’s latest comments came during the Human Genome Editing Summit at the University of Hong Kong on Wednesday. While He apologized for the “unexpectedly” leaked materials, he also said that another possible gene edited pregnancy among his participants may be imminent.

It isn’t hyperbole to say these developments, if proved true, are a landmark advancement. (Whether or not that landmark is a good thing that’s been carried out responsibly… That’s a more complicated story.)

But amid the initial skepticism and outrage, it’s also important to recognize that scientific opinion is, for better or worse, subject to change. While prominent figures such as Feng Zhang, a CRISPR pioneer, and cardiologist/digital health expert Eric Topol, among others, have expressed deep concern over He’s claims and the ethical questions therein, scientific inertia has a way of pummeling forward—especially if it can be proven to do more good than harm.

The billion dollar question now is, how exactly do you assess that?

Read on for the day’s news.

DIGITAL HEALTH

Ketogenic diet? There's a gadget for that. The Keto craze has taken over the dietary industry in recent years. The low-carb diet has also been at the heart of multiple digital health ventures, including companies like Virta Health and others. Add one more to the list: The aptly named upstart Keyto, which has now raised $2.5 million in seed funding for a breath sensor and connected app which can, ostensibly, help measure the "ketosis" metabolic process at the heart of keto diets by a user's breath (rather than a blood or urine sample). (MobiHealthNews)

INDICATIONS

FDA approves the first Rituxan biosim. The Food and Drug Administration (FDA) has approved the first ever biosimilar copycat of a drug to treat adult patients with non-Hodgkin's lymphoma. This is now the agency's 15th biosimilar approval (the first one was only done in 2015). The product, Celltrion's Truxima, is a generic version of Genentech's blockbuster Rituxan. While Rituxan sales are expected to stay strong, the treatment has been steadily bleeding market share to biosimilar competitors in Europe, and is now slated to do so in the U.S. market, too.

Loxo, Bayer drug nabs a distinctive approval. The FDA has made big changes in its approach to drug approvals in recent years, including by shifting the very biological criteria that lead to a regulatory green light. The agency just took another step in that transformation by approving Bayer and biotech Loxo's Vitrakvi, the first treatment to be approved based on how it battles a specific genetic mutation rather than a type of cancer. The approach could prove lucrative for oncology companies since fighting a mutation could have widespread use across multiple cancers rather than just a single kind of tumor. Big changes come with big prices, too, though—Vitrakvi will reportedly come with a $394,000 annual list price.

THE BIG PICTURE

Early Obamacare signups lag. This is the first year in which the Affordable Care Act's individual insurance mandate will no longer apply. That provision's repeal was expected to lead to a drastic drop off in sign ups for individual insurance plans under Obamacare in the 2017 open enrollment period. Yet enrollment was still fairly strong, given the circumstances. Early indicators suggest the situation may be different this year—not because of the mandate repeal, but due to the Trump administration's continued cuts to the outreach programs that help Americans sign up for health plans. The administration has allocated just $10 million in "navigator" funding this year, or less than a third of the 2017 figure, leading to a sharp initial drop in enrollments. It's possible, though, that the trend could reverse itself, as signups regularly surge later in the open enrollment period. (NPR)

REQUIRED READING

Artificial Intelligence Is Giving Rise to Fake Fingerprints, by Jonathan Vanian

Sheryl Sandberg's Fall from Grace and What It Can Teach Working Women, by Kristen Bellstrom

Innovation With Chinese Characteristics, by Clay Chandler

raceAhead: Facebook's Black People Problem, by Ellen McGirt