FDA Surprises By Not Approving Nasal Spray Alternative To EpiPens
The medication would have been the first needle-free alternative to epinephrine autoinjectors. The FDA's decision advises drugmaker ARS Pharmaceuticals that it needed to conduct another study on its "Neffy" spray. In May, an FDA committee had recommended approval.
NBC News:
FDA Rejects First Needle-Free Alternative To EpiPens, Calling For Additional Research
The Food and Drug Administration did not approve an epinephrine nasal spray that would have been the first needle-free alternative to epinephrine autoinjectors, including EpiPens. The agency told drugmaker ARS Pharmaceuticals that it needed to conduct another study on the drug, called Neffy, to support approval, the company said in a statement late Tuesday night. The move came as a surprise: In May, an FDA advisory committee voted to recommend approval of the drug for children and adults. (Lovelace Jr. and Miller, 9/20)
On weight-loss drugs —
CNBC:
Eli Lilly Sues Clinics Allegedly Selling Knockoff Versions Of Mounjaro
Eli Lilly on Tuesday sued 10 medical spas, wellness clinics and compounding pharmacies across the U.S. for allegedly selling cheaper, unauthorized versions of the company’s diabetes drug Mounjaro. (Constantino, 9/19)
The Washington Post:
Inside The Gold Rush To Sell Cheaper Imitations Of Ozempic
The popularity of Ozempic for weight loss has fueled a cottage industry selling off-brand versions, taking advantage of a regulation allowing pharmacies to copy drugs in shortage. (Gilbert, 9/19)
In other pharmaceutical developments —
The Wall Street Journal:
Marlboro Maker Hits Reset On $2 Billion Bet On Medicine
Philip Morris International’s push into healthcare is faltering, prompting the tobacco giant to consider options such as selling a stake in its biggest pharmaceuticals unit. In 2021, the tobacco giant agreed to acquire three pharmaceutical companies for a total of more than $2 billion as part of a plan to pivot away from cigarette sales. The deals inserted the Marlboro maker into the market for inhalers and other treatments for respiratory diseases that are linked to cigarette smoking. (Dummett and Maloney, 9/19)
The Boston Globe:
Lab Space Demand Is Dropping In Boston
A report released Tuesday by Chicago-based commercial real estate giant JLL depicted an overbuilt market that is forcing building owners, who only recently commanded top dollar for premium lab space, to reduce rents and scramble for tenants. The rising vacancies are the result of a slowdown in the biopharma, medical technology, and biomanufacturing sectors after a building boom that started before the arrival of COVID and accelerated in the first two years of the pandemic. (Weisman, 9/19)
