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Pandemic disruptions severely hampered U.S. regulators’ ability to inspect drug and device makers’ manufacturing plants, delaying at least 68 applications for approval to market new products, according to a Food and Drug Administration review. Seven of the delayed applications were mission-critical, meaning they represented a medical advancement, the agency said Wednesday in its report, and six of those were for new drugs. The delayed applications were among 600 where the FDA required a factory inspection before approval decisions. (Edney, 5/5)

The controversial, but widely anticipated Biogen (BIIB) treatment for Alzheimer’s would only be cost-effective if it is priced between $2,500 and $8,300 a year due to “insufficient” evidence that the drug works, according to a preliminary analysis. The assessment, which is markedly below some Wall Street estimates of $50,000, reflects the debate over clinical trials that the company submitted to the Food and Drug Administration in hopes of winning approval for its medication. (Silverman, 5/5)

Biogen’s closely watched experimental medicine for Alzheimer’s disease has generated “insufficient” evidence to conclude that it would help patients, according to a withering assessment from an influential drug-pricing watchdog group that comes four weeks before regulators decide whether to approve it. Citing conflicting results from two late-stage clinical trials and indications that the medicine, called aducanumab, can cause worrisome side effects, the Boston-based group said in a draft report Wednesday that the Cambridge firm’s drug would deserve an annual price tag of $2,500 to $8,300 if approved, given its modest benefits. (Saltzman, 5/5)

A new medication for children with a rare and life-threatening cancer called neuroblastoma had a curious path to approval last November: With one exception, all U.S. patients in the clinical trials were treated at Memorial Sloan Kettering Cancer Center. For almost a decade, naxitamab — now one of the most expensive drugs on the market, at $733,248 for a six-month regimen — was available in the U.S. only at the prestigious New York cancer hospital. (Goldhill, 5/6)

Specialty drugs now account for more than half of pharmacy spend, a new report from CVS Health shows. CVS Caremark released its annual Drug Trend Report, which found that specialty medications accounted for 52% of drug spend in 2020. The pharmacy benefit manager also found a 98% increase in utilization related to conditions with new therapies or indications on the market. (Minemyer, 5/5)

Eventually, Cel-Sci will have to disclose the results of its Phase 3 cancer clinical trial. When that happens is anyone’s guess. Tuesday marked one year since the small biotech announced the completion of the study, which is investigating an immune-boosting drug called Multikine in patients with head and neck cancer. There is no set timeline for how long it takes to analyze and read out results from a clinical trial, but generally, six weeks to two months is a good rule; allowing three or four months to crunch the numbers is being generous. (Feuerstein, 5/5)

Roger Perlmutter, previously the head of research at Merck, said Wednesday he will become the CEO of a startup that is using Nobel Prize-winning microscope technology that can pinpoint the location of individual molecules within human cells as a way to invent new medicines. The company, Eikon Therapeutics of Hayward, Calif., also announced that it has raised $148 million from The Column Group and other investors including Foresite Capital, Innovation Endeavors, and Lux Capital. (Herper, 5/5)