@Angus_Fierce

Biopharma reporter @FiercePharma & @FierceBiotech. Medill MSJ 16

Joined November 2013
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Amgen’s Imdelltra drives massive survival benefit in ‘watershed moment’ for small cell lung cancer. #ESMO26 fiercepharma.com/pharma/amge…

ESMO: Amgen’s Imdelltra drives massive survival benefit in ‘watershed moment’ for small cell lung...

Fresh off the excitement of Rasonque’s big splash in pancreatic cancer, the oncology community has another impressive clinical win to celebrate. | Amgen’s T-cell engager Imdelltra has posted a...

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In his first interview as FDA's oncology chief, Dr. Angelo de Claro vows to "continue the innovation that the OCE is known for." fiercepharma.com/pharma/firs…

In first interview as FDA oncology chief, Angelo de Claro vows to ‘continue the innovation’ behind...

In his first interview after taking the reins of the FDA’s Oncology Center of Excellence (OCE), Angelo de Claro, M.D., is outlining a regulatory agenda that prioritizes organizational strength and |...

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Akeso CEO agrees that $SMMT needs a Big Pharma partner to back ivonescimab. FYI, $MRK just pubbed the first global trial for its PD-1xVEGF on registry: a solid tumor ph.2 with sac-TMT fiercepharma.com/pharma/akes…

Akeso CEO looks beyond lung cancer with biliary tract win, counters ivonescimab debate

Fresh off a phase 3 win in biliary tract cancer, Akeso CEO Michelle Xia, Ph.D., is touting the PD-1xVEGF bispecific antibody ivonescimab’s ability beyond non-small cell lung cancer, even as she con |...

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Merck briefly posted—and then rapidly deleted—a new trial listing testing its PD-1xVEGF bispecific (MK-2010) combined with its TROP2 ADC (sac-TMT). fiercebiotech.com/biotech/me…

Merck posts—then pulls—trial plan for PD-1xVEGF and TROP2 ADC combination

After keeping tight-lipped for nearly two years, Merck & Co. | After keeping tight-lipped for nearly two years, Merck & Co. briefly dropped the first concrete hint as to where it intends to take its...

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89% PFS, 62% OS improvements from J&J's MonumenTAL-6 trial for bispecific doublet Tecvayli and Talvey in 2L+ multiple myeloma. fiercepharma.com/pharma/jj-b…

J&J’s bispecific combo slashes myeloma progression risk by 89% in phase 3 trial

Johnson & Johnson has unveiled massive phase 3 survival data for its dual bispecific combination in earlier-line multiple myeloma, delivering another catalyst that could add a new twist in the |...

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After a 4-month investigation, Nature has decided to retract viral PD-1 study that tied lung cancer survival to treatment timing fiercepharma.com/pharma/natu…

Nature retracts provocative PD-1 study that tied lung cancer survival to treatment timing

A Nature Medicine paper landed on Feb. | After a four-month investigation, Nature Medicine has decided to pull a viral study that linked early-day PD-1/chemo treatment to a massive survival benefit...

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Thanks, Jacob. Means a lot coming from a fellow journalist whose work I admire.
Jacob Plieth@JacobPliethMay 31
V nice story from @Angus_Fierce on trial design differences & changes for PD(L)1xVEGF bispecifics fiercebiotech.com/biotech/ne… $BNTX $PFE $BMY

ASCO: In next-gen IO race, BioNTech/BMS and Pfizer are divided on overall survival approach

In the race to forge the next Keytruda from PD-(L)1xVEGF bispecific antibodies, Pfizer and the BioNTech-Bristol Myers Squibb alliance are split on how to position overall survival—the gold-standard |...

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#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 fiercepharma.com/pharma/asco…

ASCO: Akeso’s ivonescimab bests PD-1 inhibitor in lung cancer chemo combos, slashing death risk by...

It’s the moment of truth for Akeso’s ivonescimab, and to many, a high-stakes test for China’s booming biotech industry. | Although the first-in-class PD-1xVEGF bispecific didn’t disappoint on its...

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Merck's first PD-1xVEGF bispecific data are here: 55% unconfirmed ORR in a small group of first-line NSCLC patients #AACR26 fiercebiotech.com/biotech/me…

AACR: Merck unveils PD-1xVEGF bispecific data in NSCLC, remains tight-lipped on phase 3 plans

More than a year after licensing its PD-1xVEGF bispecific, Merck & Co. | More than a year after licensing its PD-1xVEGF bispecific, Merck & Co. has finally unveiled the first clinical data from the...

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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.
Stephen V Liu, MD
@StephenVLiuFeb 26
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…

FDA Grants Second Approval under the National Priority Voucher Pilot Program

The U.S. Food and Drug Administration today issued an approval for the lung cancer drug Hernexeos (zongertinib) as a part of the new Commissioner's National Priority Voucher (CNPV) pilot program.

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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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FDA unveils ‘plausible mechanism pathway,’ a new approach that could trigger a seismic shift in how bespoke gene editing therapies are developed and approved. fiercebiotech.com/biotech/fd…

UPDATED: Prasad, Makary unveil new FDA path for accelerating custom gene editing therapies

In a highly anticipated article, FDA officials Vinay Prasad, M.D., and Martin Makary, M.D., outlined a novel regulatory pathway that could trigger a seismic shift in how bespoke gene editing therap |...

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Was just wondering what Vivek's been up to.
The Hill
@thehill17 Feb 2025
Vivek Ramaswamy set to launch Ohio governor bid on Feb. 24 trib.al/8DJ4C6p

Ramaswamy set to launch Ohio governor bid on Feb. 24

Former GOP presidential candidate Vivek Ramaswamy is set to launch his expected 2026 run for Ohio governor next Monday, The Hill has learned. After weeks of hints at the move, Ramaswamy is on track…

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... Yunchan Lim ... Rach 2 ... 😭
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Akeso, Summit's ivonescimab crushes Merck's Keytruda in China study, signaling potential new standard of care in lung cancer #WCLC24 fiercepharma.com/pharma/akes…

Akeso, Summit's PD-1 bispecific crushes Merck's Keytruda in study, signaling potential new standard...

The Keytruda-beating data from Akeso and Summit’s ivonescimab that oncology industry watchers had been awaiting are here. | The Keytruda-beating data from Akeso and Summit’s ivonescimab that oncology...

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Before approving Amgen's breakthrough lung cancer med Imdelltra, FDA flagged 'a large number' of missing adverse events from a pivotal trial. fiercepharma.com/pharma/appr…

To approve Amgen's lung cancer med Imdelltra, FDA saw past 'large number' of missing adverse events

When the FDA approved Amgen’s Imdelltra in May, the T-cell engager was hailed as a breakthrough for the treatment of small cell lung cancer (SCLC) and as the first DLL3-targeting therapy of potenti |...

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Eli Lilly invests additional $5.3B for production of diabetes, obesity drugs in Indiana fiercepharma.com/manufacturi…

Eli Lilly invests additional $5.3B for production of diabetes, obesity drugs in Indiana

Since scoring approval two years ago for its next-generation diabetes treatment Mounjaro (tirzepatide), Eli Lilly has been playing catch up with market leader Novo Nordisk. | Eli Lilly will invest an...

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WuXi Biologics has quietly withdrawn from the BIO International Convention 2024 amid worsening geopolitical tensions fiercepharma.com/pharma/wuxi…

WuXi Biologics withdraws from 2024 BIO convention amid worsening geopolitical tensions

Amid a U.S. | WuXi Biologics has quietly pulled out of the 2024 BIO International Convention in June. The company's withdrawal from the convention comes at a point of heightened tension between...

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More background on the FDA's first-of-its-kind, confirmatory trial-related CRL for Regeneron. fiercebiotech.com/biotech/wh…

What does it mean for a confirmatory trial to be 'well underway'? Regeneron wants to know

Days after Regeneron received a complete response letter (CRL) for the blood cancer medicine odronextamab, hematology executive Andres Sirulnik, M.D., Ph.D., says the trial is enrolling just fine—i |...

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Just imagine this: Every case of an important update being buried in an SEC filing is fed to an AI somewhere fiercebiotech.com/biotech/mo…

Moderna won't advance US-backed Zika vaccine without more outside funding

Moderna does not plan to advance a midstage Zika vaccine without additional outside cash, despite receiving U.S. funding thus far, according to a regulatory disclosure.  | Moderna does not plan to...

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