Lilly’s Foundayo Nod Launches New Battle With Novo, M&A Mania Continues, Tariffs Hit Pharma

Eli Lilly won FDA approval last week for orforglipron—now Foundayo— officially launching what promises to be a heated battle between Lilly and chief rival Novo Nordisk.  Elsewhere, the M&A space keeps chugging along, with Gilead Sciences gobbling up partner Tubulis for up to $5 billion and Neurocrine Biosciences nabbing Soleno Therapeutics for $2.9 billion. The industry will be on high alert for more deals, as analysts say Amgen, AbbVie and Bristol Myers Squibb all have more money to spend. At the White House, President Donald Trump levied his long-promised tariffs on the pharma industry, but myriad carveouts mean many companies will be safe from the 100% tax, at least for now. And Trump’s Most Favored National pricing scheme is endangering access to new drugs in Europe as companies forgo launches  in countries that could pull down U.S. prices. Meanwhile, the Trump administration came out with its proposed 2027 budget on Friday, with several requests for the FDA and Department of Health and Human Services overall. In line with the administration’s efforts to accelerate development of therapies for rare diseases, the FDA proposes is seeking to permanently authorize the rare pediatric disease priority review voucher program. Other proposals include a new clinical trial notification pathway and expanded authority to regulate post approval manufacturing changes. These requests come during a time when the agency is, as always, walking the precarious tightrope of rigor vs. unmet need—with rare disease leaders calling for clarity around topics like externally controlled trials.