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.
ABC News:
FDA Confirms Adderall Shortage In The US
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)
Stat:
Merck Pays $250M To License A Moderna Skin-Cancer Vaccine Candidate
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)
Bloomberg:
Eisai ‘Extremely Confident’ Of Winning US Approval For Alzheimer’s Drug
Japanese drugmaker Eisai Co. is “extremely confident” of winning full US approval for its experimental Alzheimer’s drug, paving the way to broad coverage under Medicare insurance for elderly Americans, Chief Executive Officer Haruo Naito said. (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 Black people to have lower lung function than white people,” said Dr. Ravi Kalhan, deputy division chief of pulmonary and critical care at Northwestern University. “Race-specific equations result in us not diagnosing lung disease in Black people – despite quite high prevalence." (Hassanein, 10/12)
Stat:
Can Alphabet's AlphaFold AI Really Speed Up Drug Discovery?
Every two years since 1994, scientists have come together for an experiment — better 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:
Boston Startup Ascidian Therapeutics Charts Vision For Therapies That ‘Rewrite RNA’
Ascidian Therapeutics, the latest entrant to the budding RNA editing field, emerged from stealth on Tuesday backed with $50 million to develop therapies that “rewrite RNA.” 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)
Stat:
Nations' Varied Rules Keep Some Advanced Therapies From Patients
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 — and possible solutions. (Wosen, 10/12)
Also —
The Wall Street Journal:
Elizabeth Holmes’s Ex-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 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’s technology. (Bobrowsky, 10/12)
