Morning Briefing
Summaries of health policy coverage from major news organizations
Wanting More Proof, FDA Delays Decision On Alzheimer's Drug
The Food and Drug Administration is delaying its decision on Biogen鈥檚 closely watched Alzheimer鈥檚 drug aducanumab, requesting more evidence that the treatment can slow the cognitive decline associated with the disease, the company said Friday. The FDA had promised to render a decision on the approval of aducanumab by March 7. The process is now being extended by three months to June 7, the company said. (Feuerstein and Garde, 1/29)
The Food and Drug Administration鈥檚 decision to take three extra months to review Biogen鈥檚 controversial Alzheimer鈥檚 drug has brought more questions than answers, further complicating the future of what would be the first new treatment for the disease in nearly 20 years. (Garde and Feuerstein, 2/1)
In other pharmaceutical industry news 鈥�
Management consulting firm McKinsey & Co. is reportedly nearing a settlement with state attorneys general following the release of court filings indicating that it made recommendations to Purdue Pharma and other manufacturers accused of playing a role in the nation鈥檚 deadly opioid epidemic.聽The Wall Street Journal reported the potential settlement Friday, citing people familiar with the matter. (Castronuovo, 1/29)
A drug from Amgen designed to block the cancer protein known as KRAS shrank tumors in 37% of patients with advanced lung cancer and delayed tumor progression by just under seven months, according to results from a clinical trial announced Thursday. (Feuerstein, 1/28)
Nearly a year into the coronavirus pandemic, as thousands of patients are dying every day in the United States and widespread vaccination is still months away, doctors have precious few drugs to fight the virus. A handful of therapies 鈥� remdesivir, monoclonal antibodies and the steroid dexamethasone 鈥� have improved the care of Covid patients, putting doctors in a better position than they were when the virus surged last spring. But these drugs are not cure-alls and they鈥檙e not for everyone, and efforts to repurpose other drugs, or discover new ones, have not had much success. (Zimmer, 1/30)