Morning Briefing
Summaries of health policy coverage from major news organizations
Vending Machines Full Of Free Narcan Are Popping Up Across The Country
Axios: Narcan Vending Machines Target Opioid Overdose Crisis
Free vending machines are popping up around the country to dispense doses of Narcan, or naloxone, a drug that can quickly reverse the effects of an opioid overdose. New York City plans to install 10 public health vending machines that would dispense free Narcan and other "harm reduction" supplies in neighborhoods that have been hit hard by drug overdoses, according to the Times. (Muller, 1/11)
In other pharmaceutical news —
Becker's Hospital Review: Pfizer To Produce 120M Courses Of Paxlovid In 2022
Pfizer expects to produce at least 120 million courses of Paxlovid, its COVID-19 antiviral pill, in 2022, the drugmaker's CEO, Albert Bourla, PhD, said during a J.P. Morgan Healthcare Conference session Jan. 10. Dr. Bourla said the drugmaker will produce 30 million courses by the end of the second quarter, with 6 million to 7 million being produced by the end of the first quarter, according to a tweet from Rebecca Robbins, a reporter for The New York Times. Dr. Bourla said Pfizer will produce approximately 45 million courses for both the third and fourth quarters. (Adams, 1/11)
FiercePharma: Catalent's FDA Write-Up Spurred Novo Nordisk's Wegovy Supply Woes
Catalent received an FDA write-up for its syringe filling facility in Belgium, BioProcess International reports, adding that it is "allegedly" the culprit behind supply challenges for Novo Nordisk’s obesity med Wegovy. An FDA inspection of the CDMO's filling site in Brussels yielded a Form 483, the publication said, calling it a "recent" inspection. (Kansteiner, 1/7)
FiercePharma: Idorsia Scores FDA Go-Ahead For Insomnia Drug Quviviq
The FDA blessed Idorsia's Quviviq (daridorexant), a sleeping pill for those with insomnia. Because the FDA has recommended Idorsia to register Quviviq as a controlled substance, the treatment will not reach the market until May, the company said. After more than two decades of trial and error and experiments with—by their estimate—25,000 compounds, the husband and wife team of executives at Idorsia, Jean-Paul and Martine Clozel, said they have finally reached the finish line with a drug they believe can be a game-changer. (Dunleavy, 1/10)
Stat: Amgen, Arrakis Partner To Develop Drugs That Eliminate Troublesome RNA
Amgen and the biotech startup Arrakis Therapeutics announced a research collaboration Tuesday to discover and develop a new class of oral drugs that selectively destroy RNA molecules that turn genetic instructions into disease-causing proteins. Called “targeted RNA degraders,” this emerging technology will go after targets that traditional drug-development methods can’t reach. (Feuerstein, 1/11)
CIDRAP: Review Finds Too Few Innovative Drugs In Antibiotic Development Pipeline
A new review of the antibiotic development pipeline finds that there are relatively few clinically differentiated products in late-stage clinical development, especially against critical, multidrug-resistant pathogens, an international team of researchers reported yesterday in Antimicrobial Agents and Chemotherapy. (1/11)
In news about drug costs —
The (Cleveland) Plain Dealer: Feds Pledge Review Of Fees Ohio Pharmacists Say Boost Drug Costs And Are Driving Them Out Of Business
The Centers for Medicare and Medicaid Services has told U.S. Sen. Sherrod Brown that it is considering a crackdown on a controversial pharmacy benefit management practice that Ohio pharmacies say is putting the squeeze on them and driving up drug costs for Medicare Part D beneficiaries. Brown, an Ohio Democrat, joined legislators from both political parties last year in asking CMS to address the problem of direct and indirect remuneration (DIR) fees that pharmacy benefit management companies charge pharmacists. (Eaton, 1/5)
Stat: 'Skinny Label' For Generic Of Pricey Cancer Drug Cut Costs For Consumers
After a ‘skinny label’ was used to market a generic version of a pricey brand-name medicine, more consumers gained access to the lower-cost copycat drug and saved on out-of-pockets cost, a new study finds. In this instance, a generic version of the Gleevec cancer drug became available in 2016. But while the product label noted it could be used to treat a form of leukemia known as CML and other cancers, the generic labeling deliberately excluded language saying it could be used to treat uncommon tumors in the gastrointestinal tract, a condition called GIST. (Silverman, 1/11)
Stat: More Clinical Trial Protocols Are Experiencing Costly Changes
Over the past several years, the number of deviations and substantial amendments made to clinical trial protocols has increased notably, contributing to delays in drug development and rising costs for completing studies, a new analysis finds. (Silverman, 1/10)
