Eric Sagonowsky

5 days ago | fiercepharma.com | Eric Sagonowsky

Despite uncertainties arising from new FDA policies around COVID-19 vaccines, Moderna has cleared the agency's desk with its next-gen shot, mNEXSPIKE. The FDA has signed off on the company's new COVID-19 vaccine for use in all adults 65 and older, as well as in individuals ages 12 to 64 who have one or more underlying risk factor for severe COVID, such as asthma, diabetes or COPD, Moderna said in a Saturday, May 31 press release.

1 week ago | fiercepharma.com | Ayla Ellison |Eric Sagonowsky |Kevin Dunleavy |Gabrielle Masson

Despite the long holiday weekend, news in biopharma never slows down. In this week’s episode of "The Top Line," the Fierce team breaks down some of the biggest stories from the past week. On the pharma side, Eric Sagonowsky and Kevin Dunleavy examine Big Pharma’s first-quarter 2025 performance. While most of the top 25 companies are still delivering strong sales growth despite emerging uncertainties in Washington, D.C., a few major players are starting to see a slowdown.

1 week ago | fiercepharma.com | Eric Sagonowsky

China's anti-graft watchdog is investigating Bi Jingquan, the former head of the China Food and Drug Administration. Daiichi Sankyo, along with partner Merck & Co., has pulled an FDA approval filing for an antibody-drug conjugate (ADC) cancer prospect. Novartis expanded a commercial collaboration with Shanghai Pharma. Plus more. 1.

1 week ago | fiercebiotech.com | Eric Sagonowsky

When Merck & Co. and Daiichi Sankyo last year received an FDA complete response letter for their HER3-directed antibody-drug conjugate (ADC) patritumab deruxtecan, the companies hoped to address manufacturing concerns flagged by the agency and quickly return to the regulator's desk. But now they're navigating another setback for the drug.

2 weeks ago | fiercepharma.com | Eric Sagonowsky

President Donald Trump put the biopharma industry on its back foot earlier this month with his executive order on international reference prices. While many unknowns remained at the time of the May 12 signing ceremony, his administration is now filling in some details about the initiative—and they're sure to make pharma recoil. In a May 20 press release, the Department of Health and Human Services (HHS) laid out expectations for how drugmakers can cooperate with the Trump order.