New FDA Chief | Vaccines May Prevent Long Covid | Losses At Oscar

Plus: Americans are working from home because they want to, not because of Covid

Robert Califf, 71, was confirmed as the new Food and Drug Administration Commissioner this week by a Senate vote of 50 to 46. It’s been more than a year since the agency, which is responsible for protecting public health by ensuring the safety of drugs and medical devices, has had a permanent director. Acting commissioner Janet Woodcock tweeted that she would be transitioning to the role of principal deputy. 

This is Califf’s second time in the role having previously served during the Obama administration. Leaving the FDA in January 2017, the cardiologist became a senior advisor at Verily, the life sciences arm of Alphabet, where he earned more than $2.7 million in salary, according to financial disclosures first reported by POLITICO. He served on the boards of Centessa Pharmaceuticals and Cytokinetics and consulted for Merck, Biogen and Eli Lilly, which led several Democrats to oppose his nomination, including Sen. Bernie Sanders of Vermont, who cited Califf’s “close relationship [with] Big Pharma.”

One of the biggest challenges for the FDA will be navigating the road ahead from its controversial decision to approve Biogen’s Alzheimer’s drug Aduhelm. What is the line the FDA should draw when presented with lackluster data? After all, the agency’s mission is not just to ensure the safety but also the efficacy of the drugs it approves. Will Califf take a tougher stance on approvals or will he bow to industry pressure? 

And of course there’s the ongoing pandemic and the looming authorization of Pfizer’s vaccine for young children ages 6 months to under 5 years old. Just as the FDA gets a new permanent director, the National Institutes of Health is losing John Mascola, the head of its vaccine research center and Operation Warp Speed lead, who is retiring at the end of March, according to Endpoints News.

Health insurer Oscar Health’s fourth quarter revenue more than doubled to $496 million compared to $158 million in the fourth quarter of last year as premium revenue increased from new members. But Oscar’s total expenses also more than doubled to $692 million in the fourth quarter from $344 million in the fourth quarter of 2020.  

Deals Of The Week

Eating Disorder Treatment: Equip, the eating disorder treatment startup cofounded by Forbes Under 30 alum Kristina Saffran, has raised a $58 million Series B led by The Chernin Group, along with new investors Tiger Global and General Catalyst. Katie Couric is joining the company as an investor and advisor. 

Ro Raises Again: Less than a year after raising $500 million at a $5 billion valuation, digital health startup Ro has raised another $150 million from existing investors led by ShawSpring Partners. The company also announced the launch of an online skincare clinic called Ro Derm. 

Backend Software: PriorAuthNow has raised $25 million led by Insight Partners to help streamline – well, you probably guessed it – prior authorization, that pesky process of patients needing approval from health insurance companies before doctors can perform certain procedures. 

Nine Figures For Hives: Cambridge-based company Third Harmonic Bio came out of stealth Wednesday, and announced its $105 million series B round at the same time. The company, which has raised $155 million in venture capital to date, is working on treatments for severe allergies and inflammatory conditions. It’s first drug, aimed to treat a chronic form of hives, is currently in phase 1 clinical trials.

Morgan Takes Zephyr’s Reins: AI drug discovery company ZephyrAI, which was cofounded by Rally Health founder Grant Verstandig, announced Wednesday that it has a new CEO: David L. Morgan. Morgan previously served as president of Eurofins Transplant Diagnostics US and Senior VP of Eurofins Scientific Group. Verstandig will remain as executive chairman of the company. 

Noteworthy

Billionaire Jared Isaacman will be returning to space after his previous Inspiration4 flight helped raise over $240 million for St. Jude’s Children’s Research Hospital. The new series of missions he’ll conduct with SpaceX will involve doing health-related research in space. 

Big Tech has consistently underestimated four factors related to the American healthcare system. 

Study suggests women experience more side effects than men from cancer treatments including immunotherapies.

Arizona, and West Virginia lawmakers have approved 15-week abortion bans — and Florida may be next.

Coronavirus Updates

Unlike the flu and other respiratory infections, significant numbers of people with Covid-19 go on to have lingering symptoms for weeks, months or potentially longer. While scientists are still trying to determine exactly what causes “long Covid” and what might treat it, one thing that’s become clear over the past few months is that vaccination helps. That’s underlined by a new review of studies by the U.K. Health Security Agency, which found that people who have been vaccinated against Covid-19 are less likely to suffer from long Covid if they get an infection than those who haven’t. Some of the studies reviewed suggest vaccines may also be therapeutic, finding that unvaccinated patients who get long Covid report improvements to their symptoms after getting vaccinated. 

In other coronavirus news:

As states and cities across the country lift mask mandates and other Covid restrictions, a new poll suggests many voters aren’t ready to get rid of the measures yet.

NBA Commissioner Adam Silver questioned a New York City Covid-19 vaccine requirement Wednesday that bars Brooklyn Nets star Kyrie Irving from playing in home games but allows unvaccinated visiting players to play.

The CDC has eased its warning about Covid-19 risk on cruise ships, citing lower cases, but urges passengers to get their booster shots before traveling. 

Switzerland will lift most coronavirus restrictions starting Thursday, becoming the latest country to end pandemic measures amid relatively low hospitalization rates, despite warnings from public health officials.

Massive blockades across Canada protesting Covid mandates inspired similar demonstrations across the world, but the protests appear to be fading as governments enact anti-protest measures and choose to drop Covid restrictions.

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What Else We Are Reading

• Their Bionic Eyes Are Now Obsolete And Unsupported (IEEE Spectrum)

• In two years, this mainline denomination has paid off $100 million in medical debt (Religion News)

• By altering the blood type of lungs, researchers raise the possibility of universal organs for transplants (Stat)