Angus Liu

Biopharma reporter @FiercePharma & @FierceBiotech. Medill MSJ 16

[Angus Liu @Angus_Fierce]

Thanks, Jacob. Means a lot coming from a fellow journalist whose work I admire.

[Jacob Plieth @JacobPlieth]

V nice story from @Angus_Fierce on trial design differences & changes for PD(L)1xVEGF bispecifics https://t.co/qDp3VbH0H2 $BNTX $PFE $BMY

[Angus Liu @Angus_Fierce]

#ASCO26: For Akeso's HARMONi-6, ivonescimab's 34% overall survival improvement versus PD-1 inhibitor in their chemo combos in first-line squamous NSCLC draws both hope and scrutiny at #ASCO2026 https://t.co/O3mz16uvNm

[FierceBiotech @FierceBiotech]

Merck's first PD-1xVEGF bispecific data are here: 55% unconfirmed ORR in a small group of first-line NSCLC patients #AACR26 https://t.co/DIGZWHUnCQ

[Angus Liu @Angus_Fierce]

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.

[Angus Liu @Angus_Fierce]

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.

[Stephen V Liu, MD @StephenVLiu]

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!

https://t.co/wPjv7KT8dA

[Angus Liu @Angus_Fierce]

@JacobPlieth @PearlF I think there's a difference between "can" and "should/must." FDA is not "requiring" MRD. The language is "MRD can be used as an endpoint to support accelerated approval in MM"

[Angus Liu @Angus_Fierce]

@JacobPlieth @PearlF @AuclairDan I think the focus is on earlier line given that FDA is already fully comfortable with late-line approvals based on ORR/CR. Even though earlier-line doesn't get singled out, the guidance makes it a possibility. But I agree, I'd be more comfortable if there were specific language

[Angus Liu @Angus_Fierce]

@DisneyAnimation @Disney @AMCHelps
@AMCTheatres I went to see Zootopia 2 in
@RealD3D at AMC Courthouse Plaza on 11/27 1110am based on AMC's ad promising a character keychain. But it was not available. CS refused a satisfactory resolution. False advertising is unacceptable @FTC

[Angus Liu @Angus_Fierce]

FDA unveils ‘plausible mechanism pathway,’ a new approach that could trigger a seismic shift in how bespoke gene editing therapies are developed and approved. https://t.co/fWBu3c9ckb

[Angus Liu @Angus_Fierce]

Was just wondering what Vivek's been up to.

[The Hill @thehill]

Vivek Ramaswamy set to launch Ohio governor bid on Feb. 24 https://t.co/cXGHsIE7lY

[Angus Liu @Angus_Fierce]

... Yunchan Lim ... Rach 2 ... 😭

[FiercePharma @FiercePharma]

Akeso, Summit's ivonescimab crushes Merck's Keytruda in China study, signaling potential new standard of care in lung cancer #WCLC24 https://t.co/oekcIuifJW

[FiercePharma @FiercePharma]

Before approving Amgen's breakthrough lung cancer med Imdelltra, FDA flagged 'a large number' of missing adverse events from a pivotal trial. https://t.co/Q6G3OMPgum

[FiercePharma @FiercePharma]

Eli Lilly invests additional $5.3B for production of diabetes, obesity drugs in Indiana https://t.co/qFyjYCcfGh

[FiercePharma @FiercePharma]

WuXi Biologics has quietly withdrawn from the BIO International Convention 2024 amid worsening geopolitical tensions https://t.co/2Ip15yhcwi

[Angus Liu @Angus_Fierce]

More background on the FDA's first-of-its-kind, confirmatory trial-related CRL for Regeneron. https://t.co/0NB8efZw55

[Angus Liu @Angus_Fierce]

Just imagine this: Every case of an important update being buried in an SEC filing is fed to an AI somewhere https://t.co/0nzItOn0Un

[FiercePharma @FiercePharma]

Special report: CAR-T hype faces infrastructure reality check https://t.co/FQga43mMi0

[FiercePharma @FiercePharma]

Novo Nordisk answers Eli Lilly's challenge in obesity treatment with its own head-to-head trial for a Wegovy combination against Zepbound. Details in story. https://t.co/MHQNxjwq1v

[FiercePharma @FiercePharma]

The FDA has approved Merck's Keytruda as part of a neoadjuvant-plus-adjuvant therapy for resectable non-small cell lung cancer. The label already includes overall survival data. https://t.co/oHL7u7k4oJ