FDA Acknowledges Nationwide Adderall Shortage

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Reports of Adderall supply shortages have been circulating for weeks, but the FDA now admits there is a problem and said it would work to keep the supply available for patients. Plus: a Moderna skin cancer vaccine, racial bias in spirometry tests, and more.

ABC News: FDA Confirms Adderall Shortage in the US

After weeks of individual reports of frustration with obtaining Adderall prescriptions, the Food and Drug Administration on Wednesday confirmed a nationwide shortage of the mixed salts of amphetamine immediate-release formulation, commonly known by the brand name Adderall. (Pezenik, Salzman, and Egan, 10/13)

Stats: Merck pays $250 million to license skin cancer vaccine candidate from Moderna

Merck agreed on Wednesday to extend an ongoing collaboration with Moderna to develop a personalized vaccine to treat skin cancer patients. (Feuerstein, 10/12)

Bloomberg: Eisai ‘extremely confident’ of getting US approval for Alzheimer’s drug

Japanese drugmaker Eisai Co. is “extremely confident” of gaining full US approval for its experimental Alzheimer’s drug, paving the way for broad coverage under Medicare insurance for older Americans, it said. CEO Haruo Naito. (Matsuyama and Huang, 10/12)

USA Today: Lung Disease Test Spirometry Fails Black Patients, Studies Show

“We’ve decided in the United States that it’s ‘normal’ for blacks to have lower lung function than whites,” said Dr. Ravi Kalhan, deputy director of Northwestern University’s division of pulmonary and critical care. “Race-specific equations result in us underdiagnosing lung disease in black people, despite a fairly high prevalence.” (Hassanein, 12/10)

Stat: Can Alphabet’s AlphaFold AI Really Accelerate Drug Discovery?

Every two years since 1994, scientists have come together for an experiment, best described as a competition, where teams of computational biologists try to predict what proteins will look like in 3D given their amino acid sequence. (Tang, 10/13)

The Boston Globe: Ascidian Therapeutics, a Boston Startup, Outlines Vision for Therapies That “Rewrite RNA”

Ascidian Therapeutics, the latest entrant in the fledgling RNA editing field, came out of hiding Tuesday with $50 million backing to develop therapies that “rewrite RNA.” The Boston-based startup already has its sights set on developing an RNA-altering drug for an inherited form of vision loss called Stargardt disease, for which there is no treatment. (Cross, 10/12)

Statistic: Varying Nation Rules Prevent Patients From Receiving Some Advanced Therapies

Biotech companies developing cutting-edge cell and gene therapies are often surprised by the number of regulations on these drugs that vary from country to country. On Wednesday, regulators from the United States, the European Union and Japan met to discuss the scale of the problem and possible solutions. (Item, 10/12)

Also –

The Wall Street Journal: Elizabeth Holmes’ Former Colleague Disputes Account in Her Bid for New Trial

Lawyers for Adam Rosendorff, the former Theranos Inc. lab director who testified against founder Elizabeth Holmes in her criminal fraud trial, asked a judge Wednesday to dismiss a subpoena from Holmes as he seeks a new trial. Dr. Rosendorff emerged as a central witness for the prosecution in a months-long trial against Ms. Holmes, who was convicted in January on four counts of wire fraud and conspiracy to mislead investors about the new data analysis company’s technology. blood. (Bobrowsky, 10/12)

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

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