The Pharma Industry Speaks Out Against Abortion Drug Ruling

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On Friday, U.S. District Judge Matthew Kacsmaryk ruled that the FDA approval for Mifepristone, which is widely used for medication abortions, should be overturned. This measure was a preliminary injunction to stay the approval under litigation brought by pro-life groups against the regulatory body.

The FDA stood by its approval and has appealed the injunction, the effect of which is nationwide. The Biden Administration defended the agency and the Department of Justice filed an emergency stay of the injunction. Complicating the issue is another ruling in federal litigation on Friday that calls on the FDA to not revoke the drug’s approval. House Democrats also decried the ruling and have introduced legislation to nullify its effect. Top Republicans have mostly not offered any comment on the judge’s decision.

One potentially unintended consequence of Judge Kacsmaryk’s ruling is that Mifepristone is used for a variety of medical purposes, not just abortion. It’s used for gynecological uses, such as a treatment for uterine fibroids as well as a treatment for Cushing’s syndrome.

Health and Human Services Secretary Xavier Becarra warned that if this type of ruling is allowed to be made, it could upend the regulatory process for medical approvals on a wide variety of drugs. “You’re talking about our vaccines. You’re talking about insulin. You’re talking about the new Alzheimer’s drugs that may come on.”

This concern is shared by the pharmaceutical industry. Over 200 executives, scientists and other biotechnology experts have signed an open letter decrying the ruling. Signatories include Albert Bourla, CEO of Pfizer, Reshma Kewalramani, CEO of Vertex Pharmaceuticals, MIT Professor Robert Langer and many others. The letter highlights the fact that the industry relies on the FDA’s regulatory framework, and that “judicial activism” undermines it.

“Adding regulatory uncertainty to the already inherently risky work of discovering and developing new medicines will likely have the effect of reducing incentives for investment, endangering the innovation that characterizes our industry,” they wrote.

Pear Therapeutics Files For Bankruptcy

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Pear Therapeutics, which has three FDA-cleared prescription apps to help treat substance use disorder and insomnia, filed for bankruptcy last week, as the company struggled to get insurers to pay for its technology. While doctors were willing to prescribe digital therapeutics and patients were willing to use them, “that isn’t enough,” Pear’s CEO Corey McCann wrote in a LinkedIn post. “Payors have the ability to deny payment for therapies that are clinically necessary, effective, and cost-saving.” There were more than 45,000 prescriptions written for Pear’s products in 2022, but only around half were filled and the company was able to collect payment for only 41% of those. In 2022, Pear reported an operating loss of $123.4 million on $12.7 million in revenue.

Deals Of The Week

mRNA vaccines: This week, Moderna announced that it’s currently developing mRNA vaccines against tick-borne Lyme Disease and against noroviruses that cause stomach flu.

Cancer Treatment: Function Oncology has raised $28 million in Series A funding from investors, including a16z and Section 32, to develop its Crispr-based tool to better identify personalized cancer treatments based on patient tumors.

Healthtech: Availity is acquiring the health insurer-focused business unit of health AI startup Olive, which has developed software to automate prior authorization and other processes, for an undisclosed amount. Olive will now focus on automating revenue cycle functions for 200 healthcare provider customers.

Covid Treatment: German-based biotech company inflaRx received received an emergency use authorization from the FDA for a monoclonal antibody aimed at treating people with severe Covid.

The AI 50

Forbes

Now in its fifth year, Forbes’ annual list, produced in partnership with Sequoia and Meritech Capital, recognizes the most promising privately-held companies building businesses out of artificial intelligence.Many of the companies on this year’s list are utilizing AI for healthcare applications, including:

Insitro, the San Francisco-based startup from AI legend Daphne Koller that’s using machine learning for drug discovery.
Bayesian Health, whose software is used by hospital staff to help identify patients at high-risk of urgent conditions like sepsis and pressure injuries.
Viz.ai, which has algorithms to help spot disease and to coordinate care plans for patients. And there’s more impacts to healthcare beyond that.

Check out the whole list.

Other Healthcare News

The World Health Organization confirmed a woman in China has become the first person in the world to die from a strain of bird flu rarely found in humans.

Shares of Weight Watchers parent company WW International rallied 59% on Tuesday after it acquired a telehealth startup largely dedicated to helping patients get weight-loss drugs like Ozempic.

Walmart is launching a major mental health education and support effort for its employees led by Lyra Health.

FDA Commissioner Robert Califf says the spread of misinformation is contributing to lower than average life expectancy in the U.S.

Around one in five Americans report having a family member killed by gun violence, according to a survey by the Kaiser Family Foundation.