Drug Plant FDA Inspections Hit By Pandemic, Delaying Some New Drugs
At least 68 applications for approval to market new products were affected by inspections being delayed during the pandemic, according to the FDA, including seven that represented a medical advancement.
Bloomberg:
Pandemic Delayed Some FDA Plant Inspections, Product Approvals
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)
In other pharmaceutical and biotech industry news —
Stat:
Biogen's Alzheimer's Drug May Only Be Cost-Effective At $2,500 A Year
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)
The Boston Globe:
Drug Pricing Watchdog Says There’s ‘Insufficient’ Evidence That Biogen’s Alzheimer’s Medicine Would Help Patients
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)
Stat:
How A Cancer Center Promoted An Exclusive Drug To Draw Patients
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)
Fierce Healthcare:
CVS: Specialty Drugs Accounted For 52% Of Pharmacy Spend In 2020
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)
Stat:
The Long Wait For Cel-Sci To Finally Admit Its Cancer Drug Doesn't Work
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)
Stat:
Roger Perlmutter, Former Merck R&D Head, Becomes CEO Of Startup
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)
