It seems billionaire business mogul Mark Cuban had a heads up.

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The latest effort involves tripling the annual supply of the drug, a long-acting medication known as cabotegravir, in hopes of making more than 2 million doses available during 2025 and 2026. The company — which is largely owned by GSK, while Pfizer and Shionogi hold minority stakes — explained this will roughly triple the availability this year in those countries.

ViiV also maintained that the rollout for the drug, which is available at a not-for-profit price of about $30 a vial, is progressing at a “record pace” in sub-Saharan Africa and poorer countries. So far, half of all regulatory approvals are in sub-Saharan African and 79% are in lower and middle-income countries. By the end of this year, ViiV will have supplied the drug to a total of 14 countries.

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Harris has followed in President Biden’s footsteps by calling to expand Medicare’s new drug price negotiation to include more drugs and make drugs qualify for negotiation with less time on the market. 

The drug industry’s fear when lawmakers first allowed Medicare to negotiate drug prices was that once the firewall prohibiting Medicare from interfering with drug prices was broken, Congress would find expanding the program to pay for other policies irresistible. If Harris has her way, those fears could become reality.

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The law, which was enacted in 2019, was designed to ensure that pharmacy benefit managers maintain access to a large number of pharmacies and do not steer patients to favored outlets, among other things. The move came amid increased concern that opaque business practices were raising prescription drug costs for consumers and health plans, often by squeezing independently owned pharmacies.

But the Pharmaceutical Care Management Association, a trade group for pharmacy benefit managers, sued to block the law and objected to Oklahoma’s attempt to “interfere” with efforts to administer health plans that promote “affordable choices” for patients. Specifically, the group argued the law was preempted under the Employee Retirement Income Security Act and the Medicare Part D program.

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Physics Nobel goes to pioneers of machine learning

John Hopfield of Princeton University and Geoffrey Hinton of the University of Toronto, two researchers behind the development of machine learning, won the Nobel Prize in physics on Tuesday. The Nobel committee cited their “foundational discoveries and inventions that enable machine learning with artificial neural networks.”

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The lawsuits stem from a national investigation into TikTok, which was launched in March 2022 by a bipartisan coalition of attorneys general from many states, including California, Kentucky, and New Jersey. All of the complaints were filed in state courts.

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Otsuka and Amalgam partner on Alzheimer’s care tech

Precision health company Otsuka — which, you may remember, decided to price its depression digital therapeutic lower to make it more accessible even if it’ll lose money on it — is now partnering with Amalgam on an app for the caregivers of Alzheimer’s patients. The app, called Elevmi, is based on a large language model trained on information from the National Institute on Aging and an online mental health site, PsychU.

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A trade group representing large compounding pharmacies has sued the U.S. Food and Drug Administration for a “reckless and arbitrary” decision to remove a widely prescribed Eli Lilly drug for combating diabetes and obesity from an official shortages list, STAT tells us. The Outsourcing Facilities Association argued that a shortage of the drug, known as tirzepatide, still exists and the agency action was a coup for the company that came at the expense of the public. Moreover, the trade group maintained the FDA move was “unlawful,” because it failed to follow so-called rule-making procedures and provide proper notice of its plans. The lawsuits follow an FDA announcement last week that Lilly determined its manufacturing capacity can meet “present and projected” national demand after a sustained shortage of the drug. The trade group, however, insisted the FDA “acted to benefit special interests, raise drug prices and deprive much of the public of access to a needed medicine.”

A U.S. appeals court ruled 2-1 that Merck is immune from an antitrust lawsuit accusing it of misleading regulators about the effectiveness of its mumps vaccine in order to ward off competition, Reuters says. The court found Merck is protected by a legal doctrine known as Noerr-Pennington immunity, which states that parties cannot face antitrust claims for petitioning the government even if they are advocating for government action that would reduce competition. A group of doctors and medical practices claimed they overpaid for the vaccine, which was the only mumps shot in the U.S. from 1967 until 2022. It is sold as part of a combined vaccine against mumps, measles, and rubella, known as MMR-II, and another product called ProQuad that additionally protects against varicella, also known as chickenpox. In the late 1990s, the FDA raised concerns the vaccine lost potency toward the end of its 24-month shelf life. Merck responded by boosting the initial potency in hopes of addressing the problem.

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Good morning. Lots of great stories from my colleagues today so we’ll jump straight into it.

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The Outsourcing Facilities Association argued that a shortage of the drug, known as tirzepatide, actually still exists and the agency action was a coup for the company that came at the expense of the public. Moreover, the trade group maintained the FDA move was “unlawful,” because it failed to follow so-called rule-making procedures and provide proper notice of its plans.

The lawsuit follows an FDA announcement last week that Lilly determined its manufacturing capacity can meet “present and projected” national demand after a sustained shortage of the drug, which Lilly sells under the brand name Mounjaro for treating diabetes and as Zepbound for weight loss. The FDA noted, though, that a rival drug from Novo Nordisk called Wegovy remains on the shortages list.

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His new venture, City Therapeutics, launched Tuesday with $135 million from ARCH Venture Partners, Fidelity, Invus, Rock Springs Capital, Regeneron Ventures, and others, he told STAT exclusively. Maraganore is a venture partner at ARCH, and also holds various positions at Atlas Venture, Blackstone Life Sciences, and RTW Investments.  

City Therapeutics, based in Cambridge, Mass., is developing new medicines that use RNA interference, or RNAi, to silence genes and halt the production of harmful proteins. That’s a familiar enough story in biotech: Alnylam won regulatory approval of the first RNAi treatment in 2018, and several other such therapies have followed. But City’s next step is delivering treatments to hard-to-reach tissues by using new delivery vehicles and smaller versions of RNA molecules called cleavage inducing tiny RNAs, or “cityRNAs” — hence, the startup’s name. 

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The award went to John Hopfield, 91, of Princeton University and Geoffrey Hinton, 76, of the University of Toronto, “for foundational discoveries and inventions that enable machine learning with artificial neural networks,” the Nobel committee announced. 

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He rose to international infamy in 2018, when it came to light that he had performed a series of secretive, ethically fraught, scientifically sloppy genetic experiments that resulted in the birth of three CRISPR’d children. The ensuing uproar earned him a 3-year prison sentence for “illegal medical practices” and made him a pariah among the global scientific community. But in certain tech circles, He’s transgressions have found fans.

“The world needs more brave scientists like yourself who are willing to challenge conventional wisdom and take calculated risks to help humanity cure disease,” Ryan Shea, founder and CEO of the crypto firm Opus, wrote He in that June message.

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Under the deal, Talkiatry, which recently raised $130 million and employs over 350 psychiatrists, created a new landing page on its website with information about postpartum depression. From there, visitors can take an intake assessment that funnels them into Talkiatry’s care programs. The Zurzuvae website will include a link to the landing page. The terms of the deal were not disclosed.

According to the CDC, 1 in 8 people experience postpartum depression after giving birth, with symptoms that may include sadness or guilt or a desire to harm oneself. Many do not receive adequate care, with potential long-term impacts on the health of parents and newborns.

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As the former director of the Biomedical Advanced Research and Development Authority (BARDA), I know just how absurd that statement is.

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The studies investigate ableism towards several different populations, including people with low vision trying to access services and maternal health outcomes among Medicaid beneficiaries with intellectual and developmental disabilities.

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In late September, Hurricane Helene shut down a Baxter plant in Marion, N. C., which manufactures approximately 60% of the IV solutions for the U.S. Both Baxter and “all other suppliers” of IV solutions have restricted how much their customers can order and have stopped taking new customers, AHA president Rick Pollack wrote in the organization’s letter to Biden. As a result, hospitals have declared internal shortages and restricted IV use. 

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The Golden State has the country’s largest concentration of dairy farms, roughly 1,100 herds. The concern has been if the virus got into California, the prospects for spread would be huge and containment a challenge.

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The morning of the announcement, STAT sat down with Ruvkun, a professor of genetics at Harvard Medical School and investigator at MGH, to discuss the future of microRNA and how researchers are credited with awards. The conversation has been edited for length and clarity. 

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Why do bad menstrual cramps happen to good people? A study answering that question would get the Gaffney Prize (from me). Until that happens, we’ve got the Nobels. STAT’s Drew Joseph has more below on the first announcement of the week, in physiology or medicine.

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