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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

Could Cost Billions

NBC News reports that the new Alzheimer's disease drug from Biogen could cost Medicare in the US billions of dollars.

Not Quite Sent

The Biden Administration likely won't meet its goal of sending 80 million SARS-CoV-2 vaccine doses abroad by the end of the month, according to the Washington Post.

DTC Regulation Proposals

A new report calls on UK policymakers to review direct-to-consumer genetic testing regulations, the Independent reports.

PNAS Papers on Mosquito MicroRNAs, Acute Kidney Injury, Trichothiodystrophy

In PNAS this week: microRNAs involved in Aedes aegypti reproduction, proximal tubule cell response to kidney injury, and more.