Biopharma reporter @FiercePharma & @FierceBiotech. Medill MSJ 16

Joined November 2013
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Thanks, Jacob. Means a lot coming from a fellow journalist whose work I admire.
V nice story from @Angus_Fierce on trial design differences & changes for PD(L)1xVEGF bispecifics fiercebiotech.com/biotech/ne… $BNTX $PFE $BMY
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The FDA's press release says zongertinib's application was FILED on Jan. 13, 2026. But Boehringer told us that they actually completed the package under real-time oncology review on Nov. 14, 2025, and that it was ACCEPTED on Jan. 13.
A new first line standard of care for HER2 mutant NSCLC? Zongertinib receives accelerated approval as initial therapy based on Beamion LUNG-1 trial with 1L RR 76%. Part of the new FDA voucher program, approval granted 44 days after filing! fda.gov/news-events/press-an…
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In other words, FDA still took the full standard 60-day filing review period for a CNPV, even though this is an sNDA of an existing drug filed under RTOR, which means the review should have started before the entire submission package was completed.
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Was just wondering what Vivek's been up to.
17 Feb 2025
Vivek Ramaswamy set to launch Ohio governor bid on Feb. 24 trib.al/8DJ4C6p
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... Yunchan Lim ... Rach 2 ... 😭
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Angus Liu retweeted
In the Breakthroughs category, we’ll recognize organizations, clinicians, researchers and others whose work has pushed the boundaries of knowledge and improved the lives of countless individuals. fiercepharma.com/fierce-50/f… #Fierce50 #WeAreFierce
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