Wanting More Proof, FDA Delays Decision On Alzheimer’s Drug
The government had initially said it would decide by March 7 whether to approve aducanumab, but the agency has pushed it to June 7.
Stat:
FDA Delays Approval Decision For Biogen’s Alzheimer’s Treatment
The Food and Drug Administration is delaying its decision on Biogen’s closely watched Alzheimer’s 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)
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The FDA Delayed Its Decision On Biogen’s Alzheimer’s Drug. Now What?
The Food and Drug Administration’s decision to take three extra months to review Biogen’s controversial Alzheimer’s 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 —
The Hill:
McKinsey & Co Close To Deal With State AGs For Role In Opioid Crisis: Report
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’s deadly opioid epidemic. The Wall Street Journal reported the potential settlement Friday, citing people familiar with the matter. (Castronuovo, 1/29)
Stat:
Amgen’s KRAS-Blocking Drug Proves Effective For Lung Cancer Patients
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)
The New York Times:
How The Search For Covid-19 Treatments Faltered While Vaccines Sped Ahead
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 — remdesivir, monoclonal antibodies and the steroid dexamethasone — 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’re not for everyone, and efforts to repurpose other drugs, or discover new ones, have not had much success. (Zimmer, 1/30)
