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Thursday, Apr 30 2026 UPDATED 10:07 AM

Full Issue

High Court Hears 'Skinny Labeling' Case That Could Make Generic Rx Harder To Get

Skinny labeling, Stat explains, is when a generic drugmaker seeks approval to market a drug for a specific use other than those for which the brand-name medicine is prescribed as a way to avoid patent infringement lawsuits. The outcome of the hearing could affect access to generics.

After months of anticipation, Supreme Court justices heard arguments about a long-standing tactic used by generic companies to carve out a distinct market for a medicine, and did not appear inclined to alter legal standards for the maneuver. (Silverman, 4/29)

More on the high cost of prescriptions —

Healthcare conglomerates that dominate the pharmacy benefit manager market have gotten into the biosimilars business. Companies such as CVS Caremark owner CVS Health, Optum Rx owner UnitedHealth Group and Express Scripts owner Cigna seek to harness demand for lower-cost versions of biologic drugs and bolster their profits by establishing or repurposing overseas subsidiaries to produce private label biosimilars. (Tong, 4/29)

As federal regulators consider whether to implement a hotly contested 340B Drug Pricing Program rebate experiment, providers and drugmakers are speaking out on opposite sides of the debate. The 340B program requires drugmakers to sell outpatient medications to hospitals, community health centers and other safety-net providers for 25%-50% below list price as a condition of Medicaid covering their medicines. (Early, 4/29)

When it comes to prescription drugs, the Inflation Reduction Act may be best known for giving the federal government the authority to directly negotiate prices on behalf of people with Medicare. But a less-publicized measure written into the 2022 law could turn out to be more impactful. It’s the annual cap on out-of-pocket spending for medication, which went into effect in 2024. This change offers a much greater degree of protection to high-cost patients because it caps their annual spending at $2,100. At the same time, it has led to a substantial increase in spending by Medicare on prescription drugs. (Cohen, 4/29)

In other pharma and tech news —

Patients using recalled True Metrix blood glucose monitoring systems linked to one death and over 100 serious injuries should switch to an alternative testing method when possible, the FDA said on Tuesday. (Monaco, 4/29)

TB or not TB? That has been the question for nearly 150 years, when Dr. Robert Koch first identified the rod-shaped bacterium that causes tuberculosis. This serious respiratory illness is currently the world's deadliest infectious disease, killing more than a million people a year. The most common test to determine if someone has tuberculosis hasn't really changed since the late 1800s. The process relies on phlegm. (Daniel, 4/29)

A 10-year follow-up study has revealed that, compared to sham surgery, partial meniscectomy did not improve patients' symptoms or function. On the contrary, the 10-year follow-up of patients who had undergone partial meniscectomy found them to have more symptoms, more reduced function, increased progression of osteoarthritis and a higher probability of subsequent knee surgery when compared to sham surgery. (4/29)

A US company has tested a brain implant in a Chinese patient in Shanghai, a rare sign of cooperation as the two countries compete to develop the most advanced neurotechnology. The company, Axoft, also said on Wednesday it raised $55 million. It’s tested its device temporarily in 11 patients, including the one in Shanghai, Chief Executive Officer Paul Le Floch said. The company plans to study its device in more patients in China this year and is planning multiple clinical trials in the country, he said. (Swetlitz and Tong, 4/29)

J. Craig Venter, a scientist and entrepreneur who raced to decode the human genome, died on Wednesday in San Diego. He was 79. His death was announced by the J. Craig Venter Institute, a nonprofit research organization founded by Dr. Venter and based in San Diego and Rockville, Md. The institute said in a statement that Dr. Venter had been hospitalized recently for side effects from cancer treatment. (Wade, 4/30)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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