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The National Institutes of Health (NIH) on Thursday announced a potential oral antiviral treatment to lessen the severity of COVID-19 disease, ahead of clinical studies assessing efficacy in patients. Researchers said the experimental drug, TEMPOL, showed promise in cell cultures by impacting the virus’ ability to replicate, or impairing an enzyme called RNA replicase. Findings were published in the journal Science. "We urgently need additional effective, accessible treatments for COVID-19," Dr. Diana W. Bianchi, National Institute of Child Health and Human Development (NICHD) director, said in a statement posted Thursday. "An oral drug that prevents SARS-CoV-2 from replicating would be an important tool for reducing the severity of the disease." (Rivas, 6/3)

Come Monday, we should learn whether the Food and Drug Administration will approve the first new drug since 2003 to help slow the relentless cognitive decline caused by Alzheimer’s disease. While there is much uncertainty swirling over whether the drug will be approved, how effective it is, how much it should cost, and how it could be administered given the shortage of memory specialists and brain imaging machines required to identify eligible patients, one thing is abundantly clear: Approval of Biogen’s aducanumab, or other similar medications rising through the drug development pipeline, is likely to only increase massive racial inequities in the treatment of the more than 6 million Americans with Alzheimer’s. (McFarling, 6/4)

The FDA will soon decide the fate of Biogen's experimental Alzheimer's drug. But there is one glaring issue — there is no conclusive evidence the drug effectively treats the crippling neurological disease. This will be one of the FDA's most important decisions in years. The outcome will show whether the federal agency sides with the overwhelming scientific consensus that the drug isn't proven to work, or with an industry and a patient population desperate for anything to be approved. (Herman, 6/4)

KHN: FDA Weighs Approval Of A Lucrative Alzheimer’s Drug But Benefits Are Iffy 

The Food and Drug Administration’s decision next week whether to approve the first treatment for Alzheimer’s disease highlights a deep division over the drug’s benefits as well as criticism about the integrity of the FDA approval process. The agency said it will decide by June 7 the fate of Biogen’s drug aducanumab, despite a near-unanimous rejection of the product by an FDA advisory committee of outside experts in November. Doubts were raised when, in 2019, Biogen halted two large clinical trials of the drug after determining it wouldn’t reach its targets for efficacy. But the drugmaker later revised that assessment, stating that one trial showed the drug reduced the decline in patients’ cognitive and functional ability by 22%. (Meyer, 6/4)

In an unexpected move, Canada’s Federal Court quashed the approval of a rare disease drug after the manufacturer of a rival medicine claimed that Health Canada had originally issued an “incorrect and unreasonable” endorsement. In a 63-page ruling, Justice Martine St-Louis set aside the approval issued by the regulator last year. As a result, the government will now have to review the marketing file submitted by Jacobus Pharmaceuticals, a small, family-run company that sells a drug to treat people with a rare neuromuscular disorder called Lambert-Eaton myasthenic syndrome, or LEMS. (Silverman, 6/3)

A lymphoma drug that was approved later than expected by regulators is at the center of a lawsuit accusing Bristol Myers Squibb (BMY) of deliberately delaying production and development of the medicine in order to save $6.4 billion in payments to investors. At issue is a provision in the 2019 agreement in which Bristol Myers paid $80.3 billion for Celgene. As part of the deal, Bristol Myers agreed to pay Celgene shareholders $9 in cash, or contingent value rights, for each share they held. But there was a stipulation — the company had to win Food and Drug Administration approval for a treatment for Non-Hodgkin’s lymphoma by Dec. 31, 2020. (Silverman, 6/3)

Martin Shkreli’s drug company has a lot of problems. Revenue was cut in half last year. Losses are mounting. There’s a pile of ongoing civil lawsuits, and the federal government is trying to shut the whole thing down. But the biggest problem might be Shkreli himself, who has been running the firm from federal prison and using it as a financial lifeline for himself and his associates. (Garde and Feuerstein, 6/4)

A federal judge rejected Theranos Inc. founder Elizabeth Holmes’s request to keep her emails with law firm Boies Schiller Flexner LLP out of her coming criminal fraud trial. Ms. Holmes, who faces wire fraud charges for allegedly deceiving investors and patients about her blood-testing company, had argued that 13 documents showing communications she exchanged with Boies Schiller lawyers were protected by attorney-client privilege. (Randazzo, 6/3)

Dozens of organizations, including the American Heart Association, the Arthritis Foundation and Mental Health America, have urged passage of federal legislation. Even so, supporters admit they are not hopeful that any measure can emerge from a gridlocked Congress, especially in the face of well-financed opposition. “We don’t have a place at the table when it comes to issues like this,” said Louis Tharp, executive director of the Global Healthy Living Foundation and co-author of the journal article. “The reality is patients are not as powerful as lobbyists.” (Ollove, 6/3)

Two years ago, scientists in Britain swapped out the DNA of the bacteria Escerichia coli for a genetic coding program that was entirely human-made. At the time, it was the largest and most complex synthetic genome ever created. On Thursday, that same group of researchers at the Medical Research Council Laboratory of Molecular Biology reported in Science that with continued tinkering, they’ve made their artificial life form virtually invincible to viral infection. Other adjustments to the bacteria’s designer genome endowed the bug with the ability to string together non-natural amino acids to produce proteins never before seen inside a living cell. (Molteni, 6/3)