Novo Nordisk Files Patent Suit Against Hims & Hers Over Ozempic, Wegovy
The Wall Street Journal reports that what's at issue is sales of custom-made, or compounded, versions of weight loss drugs. Also: The FDA issued a warning letter to a compounding pharmacy owned by Hims & Hers over inspection issues, as well as warned Novo Nordisk that its Wegovy pill ad included “false or misleading” claims.
The Wall Street Journal:
Novo Nordisk Escalates Fight Against Hims & Hers
A lawsuit that drugmaker Novo Nordisk filed on Monday against telehealth firm Hims & Hers shows how fierce the maneuvering over the booming obesity-drug market has become. In the lawsuit filed in a federal court in Delaware, Novo Nordisk accused Hims & Hers of violating the patents covering its Ozempic and Wegovy drugs used for weight loss by trying to sell custom-made versions of those medicines. (Loftus, 2/9)
Stat:
Hims & Hers Compounder Received FDA Warning Letter
The Food and Drug Administration late last year issued a warning letter to MedisourceRx, a compounding pharmacy owned by Hims & Hers, six months after a facility was cited for troubling problems during an inspection. (Silverman, 2/9)
CNBC:
FDA Says Novo Nordisk's Obesity Pill TV Ad Includes Misleading Claims
The Food and Drug Administration said Novo Nordisk’s TV advertisement for its newly launched Wegovy pill for obesity included “false or misleading” claims about the medicine’s abilities and benefits to patients. (Constantino, 2/9)
More pharmaceutical developments —
Stat:
FDA Rejects Regenxbio’s MPS II Rare-Disease Gene Therapy
The Food and Drug Administration has rejected a rare-disease gene therapy from Regenxbio, the company said Monday. The one-time treatment, called RGX-121, is designed to replace a malfunctioning gene that causes mucopolysaccharidosis type II, also known as Hunter syndrome, an ultra-rare disorder that causes physical and cognitive impairments. (Feuerstein, 2/9)
MedPage Today:
Statin Adverse Event Labels May Be Overcautious, Analysis Suggests
Many adverse events listed on statin product labels don't have good evidence that they are actually caused by the drug, a pooled analysis of the clinical trial evidence showed. In individual participant-level data from double-blind randomized controlled trials, only four of 66 assessed side effects attributed to statins on product labels rose above the level of likely false discovery due to multiple comparisons, the Cholesterol Treatment Trialists' (CTT) Collaboration reported in The Lancet. (Phend, 2/9)
KFF Health News:
US Cancer Institute Studying Ivermectin’s ‘Ability To Kill Cancer Cells’
The National Cancer Institute, the federal research agency charged with leading the war against the nation’s second-largest killer, is studying ivermectin as a potential cancer treatment, according to its top official. “There are enough reports of it, enough interest in it, that we actually did — ivermectin, in particular — did engage in sort of a better preclinical study of its properties and its ability to kill cancer cells,” said Anthony Letai, a physician the Trump administration appointed as NCI director in September. (Pradhan, 2/10)
CIDRAP:
Most US Women Favor In-Clinic To At-Home Cervical Cancer Testing; Less Screening May Benefit Norwegian Women
Two analyses detail preferred cervical cancer (CC) screening strategies, with one concluding that most US women would choose in-clinic testing over at-home sample collection, and the other suggesting that the cost-effectiveness and risk-benefit tradeoffs of adapting CC screening strategies by age at human papillomavirus (HPV) vaccination favor less-frequent screening and longer intervals between tests rather than the current five-year recommendations in Norway. (Van Beusekom, 2/9)
