STAT+: Pharmalittle: FTC suit over Amgen spotlights ‘bundling’ deals with insurers; FDA staff says Pfizer RSV vaccine is effective
The FTC's suit to block Amgen from acquiring Horizon Therapeutics cast a spotlight on a practice known as bundling.
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In seeking to block Amgen from acquiring Horizon Therapeutics over concerns about monopolies, the U.S. Federal Trade Commission cast a spotlight on a practice known as bundling, STAT explains. Simply put, this occurs when a drug company combines two or more medicines in a package deal for health plans and pharmacy benefit managers, which determine lists of medicines that are covered by insurance. The maneuver has previously sparked concerns that a drug company will unfairly offer higher rebates for bundles in order to win favorable formulary placements. By doing so, the regulatory agency is concerned this can drive up consumer costs.
U.S. Food and Drug Administration staffers reported that an experimental RSV vaccine developed by Pfizer to protect infants — by vaccinating pregnant women — was effective in preventing severe lower respiratory tract disease, STAT writes. The agency analysis, which was released ahead of an advisory panel meeting on Thursday, also revealed a slightly higher proportion of preterm births of babies whose moms got the experimental vaccine compared with those given a placebo. A Pfizer trial found the shot was 82% effective at preventing severe disease from RSV in newborns during the first 90 days of life. The FDA is slated to make a decision on whether to clear the shot in August.
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