Skip to main content
Premium Trial:

Request an Annual Quote

Stopped in their Tracks

That FDA has apparently been issuing more refusal to file decisions, particularly to big pharma, is "yet another possible indication that [the agency] is getting still tougher with its approval process," Pharmalot's Ed Silverman says. "Among big drug-makers receiving an RTF [refusal to file notice] in the last two years were Pfizer, Novartis, Roche and Merck, as well as Gilead Sciences, one of the largest biotechs," Silverman adds. Howard Liang, managing director of biotechnology at investment firm Leerink Swann, tells Pharmalot that these RTFs could "be related to the recent FDA implementation of good review practices in an initiative … under which reviewers are expected to frontload the review and identify showstoppers early." In reviewing 28 RTFs issued to pharma, Liang tells Silverman he found three common problem-areas that may have led to FDA's refusal to file — "deficiencies" in clinical data; problems with chemistry, manufacturing, and controls; and electronic file errors.

The Scan

Alzheimer's Risk Gene Among Women

CNN reports that researchers have found that variants in MGMT contribute to Alzheimer's disease risk among women but not men.

Still Hanging Around

The Guardian writes that persistent pockets of SARS-CoV-2 in the body could contribute to long COVID.

Through a Little Spit

Enteric viruses like norovirus may also be transmitted through saliva, not just the fecal-oral route, according to New Scientist.

Nature Papers Present Method to Detect Full Transcriptome, Viruses Infecting Asgard Archaea, More

In Nature this week: VASA-seq approach to detect full transcriptome, analysis of viruses infecting Asgard archaea, and more.