FDA Acknowledges National Shortage Of Adderall
Reports of supply shortages of Adderall have been circulating for weeks, but the FDA now admits there is a problem and said it would work to keep supply available for patients. Also: a Moderna skin cancer vaccine, racial bias in spirometry tests, and more.
After weeks of individual reports of frustration with getting Adderall prescriptions filled, the Food and Drug Administration confirmed Wednesday a nationwide shortage of the immediate release formulation of amphetamine mixed salts, commonly referred to by the brand name Adderall. (Pezenik, Salzman and Egan, 10/13)
Merck on Wednesday agreed to extend an ongoing collaboration with Moderna to develop a personalized vaccine for the treatment of patients with skin cancer. (Feuerstein, 10/12)
Japanese drugmaker Eisai Co. is 鈥渆xtremely confident鈥 of winning full US approval for its experimental Alzheimer鈥檚 drug, paving the way to broad coverage under Medicare insurance for elderly Americans, Chief Executive Officer Haruo Naito said. (Matsuyama and Huang, 10/12)
鈥淲e've decided in the United States that it's 鈥榥ormal鈥 for Black people to have lower lung function than white people,鈥 said Dr. Ravi Kalhan, deputy division chief of pulmonary and critical care at Northwestern University. 鈥淩ace-specific equations result in us not diagnosing lung disease in Black people 鈥 despite quite high prevalence." (Hassanein, 10/12)
Every two years since 1994, scientists have come together for an experiment 鈥 better described as a competition 鈥 where teams of computational biologists try to predict what proteins will look like in 3D given their amino acid sequence. (Tang, 10/13)
Ascidian Therapeutics, the latest entrant to the budding RNA editing field, emerged from stealth on Tuesday backed with $50 million to develop therapies that 鈥渞ewrite RNA.鈥 The Boston-based startup already has its sights set on developing an RNA-altering medicine for an inherited form of vision loss called Stargardt disease, for which there is no treatment. (Cross, 10/12)
Biotech companies developing cutting-edge cell and gene therapies often are tripped up by how much regulations around these drugs vary from country to country. On Wednesday, regulators from the United States, the European Union, and Japan came together to discuss the scale of the problem 鈥 and possible solutions. (Wosen, 10/12)
Also 鈥
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 reject a subpoena from Ms. Holmes as she seeks a new trial. Dr. Rosendorff emerged as a central witness for the prosecution in a monthslong trial of Ms. Holmes, who was convicted in January on four counts of wire fraud and conspiracy for misleading investors about the blood-testing startup鈥檚 technology. (Bobrowsky, 10/12)