Morning Briefing
Summaries of health policy coverage from major news organizations
Vending Machines Full Of Free Narcan Are Popping Up Across The Country
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 鈥
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)
Catalent received an FDA write-up for its syringe filling facility in Belgium, BioProcess International聽reports, adding that it is "allegedly" the culprit behind supply challenges for Novo Nordisk鈥檚 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)
The FDA blessed聽Idorsia's Quviviq (daridorexant), a sleeping pill for those with insomnia.聽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鈥攂y their estimate鈥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)
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 鈥渢argeted RNA degraders,鈥 this emerging technology will go after targets that traditional drug-development methods can鈥檛 reach. (Feuerstein, 1/11)
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 鈥
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)
After a 鈥榮kinny label鈥 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)
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)