Cerebral CEO Ousted, Over One Million Covid Deaths and Liquid Biopsy For Pregnancy

InnovationRx is your weekly digest of healthcare news. To get it in your inbox, subscribe here.

Kyle Robertson, the cofounder of mental health startup Cerebral, was ousted by the board this week, as the company faces a Department of Justice investigation over its prescribing practices for controlled substances, including ADHD medications. Cerebral said Wednesday Robertson left “effective immediately” and chief medical officer David Mou would step into the top role. The Wall Street Journal first reported on Robertson’s ouster last night.

It appears Robertson, who founded the company in January 2020 alongside physician Ho Anh (who left the company in early 2021), is going to put up a fight. According to a transcript of remarks Robertson made at the board meeting obtained by Bloomberg, he called the move illegal: “I plan to pursue all avenues, legal and otherwise, to defend myself and highlight the nefarious actions that the Board of Directors will take today and I expect will take in the future.”

Cerebral has not been accused of violating any law but has acknowledged it received a subpoena from the U.S. Attorney’s Office for the Eastern District of New York related to “possible violations of the Controlled Substances Act,” a federal law regulates the prescribing of medications that have potential for abuse and dependence, like Adderall and Xanax. Former Cerebral vice president Matthew Truebe filed a lawsuit in April alleging he was fired in retaliation for speaking up about unethical business practices, including the overprescribing of ADHD medications, which he alleged was directed by both Robertson and Mou. A Cerebral spokesperson has said the allegations are “not true, and the Company denies them in all respects.” As this continues to play out, there’s sure to be a lot of finger-pointing, and the central question is who is ultimately responsible for the company’s strategy around controlled substance prescribing: Robertson, Mou, investors, or some combination of them.

Mirvie Raises $60 Million For Blood Test To Predict Pregnancy Complications

This year, more than 3.6 million women will give birth in the U.S. Around 4% of them will have a potentially fatal high blood pressure condition known as preeclampsia. It will be three times more likely to kill Black mothers than white ones. And the main tools to identify who’s at risk haven’t changed in decades: a checklist of risk factors and a blood pressure cuff. Maneesh Jain and Stephen Quake are hoping to change that. The cofounders of South San Francisco-based Mirvie are developing non-invasive diagnostic tools to help predict the risk of conditions like preeclampsia and premature birth from a vial of blood. Up until now, this technology, known as liquid biopsy, has mainly been used for early cancer detection. Read more here.

Deals Of The Week

Exclusive Cancer Drug: Drug engineering platform company BridgeBio announced that it has entered into an exclusive license agreement with Bristol Myers Squibb to develop and commercialize the company’s SHP2-inhibitor cancer drug, BBP-398. The deal could net BridgeBio up to $905 million and includes an upfront payment of $90 million.

Natural Language Collaboration: Lilly has entered into an agreement with AI software company Yseop to create a collaboration aimed at using Yseop’s natural language generation software to accelerate its regulatory submissions process, which Lilly hopes can be used to accelerate the drug approval process.

Free Services For Formula Shortage: Telehealth platform SimpliFed, which helps connect parents with baby feeding services, announced today that it will be offering free services to parents to help them navigate the current baby formula shortage.

Noteworthy

“Pharma bro” Martin Shkreli, the former hedge fund manager who raised the price of an anti-parasitic drug by 5,000%, was released early from his seven-year prison sentence for securities fraud.

Kintsugi is building artificial intelligence software that analyzes the human voice to detect depression and anxiety but clinical studies are needed to validate outcomes.

Dental artificial intelligence startup Overjet received its second FDA clearance for detecting and outlining cavities in patients’ X-rays.

UNICEF warns Russia’s invasion of Ukraine is fueling a “catastrophic” wave of malnutrition among young children.

New study finds pollution was responsible for more than 9 million deaths around the world in 2019.

Coronavirus Updates

According to official estimates from the CDC, as well as estimates from Johns Hopkins University and other organizations that collect public health data, the United States has now seen over one million deaths from Covid-19. To put that in perspective, seasonal flu only caused 360,000 deaths from 2010 and 2020, and that’s more deaths than the country has seen from HIV. The number comprised about 16% of Covid deaths worldwide, even though the U.S. comprises only about 4% of the global population. The states with the highest death rates from Covid are Mississippi, Arizona, Oklahoma, Alabama and Tennessee. In 2020 and 2021, Covid was the third leading cause of death in the United States after heart disease and cancer. And with cases on the rise again and a large projected toll of cases in the winter, the disease will continue to take its toll in 2022.

Getting Vaccinated After Infection Could Slash Risk Of Long Covid, Study Finds

Getting vaccinated after a coronavirus infection could slash the risk of developing long Covid, according to a new study published in the British Medical Journal, a possible glimmer of hope for developing future treatments for the millions of people still suffering symptoms months or even years after contracting the virus. Read more here.

Other Coronavirus News

Shanghai on Tuesday achieved a key milestone in its reopening plan: three consecutive days with no new Covid-19 cases outside designated quarantine zones.

The FDA authorized a booster dose of Pfizer-BioNTech’s Covid-19 vaccine for children ages 5-11, expanding access to boosters to the youngest age group yet after the agency allowed children ages 12-15 to get a booster earlier this year.

On Wednesday, North Korea claimed its Covid-19 outbreak was taking a “favorable turn” while still reporting more than 200,000 new suspected cases, but the World Health Organization expressed concerns about the lack of proper data from the country and the risk of unchecked spread.

Rising Covid-19 cases across the country so far aren’t resulting in local mask mandates coming back, as officials in multiple Democratic-leaning cities said in recent days they have no plans to bring back Covid-19 restrictions even as they recommend people voluntarily mask up.

Across Forbes

Dow Falls 800 Points, Stock Market Selloff Continues As Major Retailers Warn Of Rising Cost Pressures

The 50 Highest-Paid Athletes Made Nearly $3 Billion; Here’s A Breakdown Of The Numbers

‘Alarming’ Climate Records In 2021 Prompt UN Call To Triple Renewable Energy Investment To $4 Trillion

What Else We are Reading

What COVID Hospitalization Numbers Are Missing (The Atlantic)

Pfizer’s Tight Paxlovid Rein Stymies Drug Combination Research (Bloomberg)

Mozambique declares polio outbreak linked to Pakistan (AP)