- Reuters
Merck's Bridion faces generic threat from drugmaker Hikma
Merck has received a letter that Hikma Pharmaceuticals US unit has sought a pre-patent expiry approval from the US FDA to sell a generic version of its Bridion injection, the drugmaker said in filing on Monday. Merck said, on Feb. 5, it received the letter under the Hatch-Waxman Act, through which a company can seek FDA approval to market a copycat before the expiration of patents related to the brand-name drug. Merck said in the filing that it is currently considering its options.
- Reuters
High-dose opioid reversal spray no better than lower dose in field, US study finds
A high-dose version of the opioid reversal spray naloxone, made by Hikma Pharmaceuticals, did not result in an increased survival rate compared with lower-dose versions of the drug when administered in emergency situations by New York law enforcement, according to a U.S. study. The analysis also suggests that those given the higher 8 milligram strength spray were more than twice as likely to experience opioid withdrawal symptoms compared to other sprays such as Narcan that use a 4 mg dose. The Hikma version, sold under the brand name Kloxxado, was approved in 2021 after U.S. Food and Drug Administration advisers and National Institutes of Health reports suggested that a high-dose version was needed to respond to overdoses by more potent opioids such as fentanyl.
- Reuters
UPDATE 1-Ad firm Publicis, drugmaker Hikma settle US opioid cases for $500 million
A division of French advertising company Publicis Groupe SA and drug company Hikma Pharmaceuticals have reached separate settlements worth a collective $500 million to resolve claims that they helped fuel the deadly U.S. opioid epidemic. The settlements announced by U.S. state attorneys general on Thursday add to the more than $50 billion that drug manufacturers, distributors, pharmacy operators and consultants have agreed to pay to resolve lawsuits and investigations over their roles in the drug addiction crisis. Publicis Health, a subsidiary of Publicis Groupe, agreed to pay $350 million to resolve claims by all U.S. states and territories that it helped OxyContin maker Purdue Pharma devise marketing strategies to boost sales of its prescription opioid painkiller.
