Angus Liu
Verified- Deputy Editor, Fierce Biotech
- Deputy Editor, Fierce Pharma
- Deputy Editor, Questex Media Group
Washington, D.C.
Biopharma reporter @FiercePharma & @FierceBiotech. Medill MSJ 16
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Articles by Angus Liu
BioNTech to close 3 sites in Germany after failed buyer search
BioNTech is set to shutter multiple sites in Germany, impacting about 1,800 jobs, after efforts to find buyers fell through. BioNTech announced plans to exit three German sites in May, as the mRNA pioneer adjusts production capacity in response to a sharp drop in global COVID-19 vaccine demand while pivoting to its developing oncology pipeline. At the time, the German company said it was exploring potential divestment options, including a partial or total sale, for the manufacturing sites.
With FDA approval, Lilly’s BTK drug Jaypirca enters first-line CLL
Eli Lilly’s Jaypirca, the first noncovalent BTK inhibitor, has won FDA approval for the first-line treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). Friday’s approval follows Jaypirca’s FDA approval in 2023 as a third-line therapy for CLL/SLL and a follow-on go-ahead in the second-line setting, making it the fourth BTK inhibitor cleared for previously untreated CLL/SLL.
Fierce Pharma Asia—AZ’s $2B bet on ivonescimab; Novo buys Hengrui GLP-1; Merck doubles down on KRAS
In three deals each worth $2 billion or more, AstraZeneca is investing in Summit Therapeutics with a focus on ivonescimab and Novo bought a preclinical GLP-1/GIP drug from Hengrui Pharma, while Merck & Co. got a preclinical RAS(ON) inhibitor from China's SciBrunch. And more. 1. AstraZeneca scales Summit’s PD-1xVEGF strategy with $2B investment to fuel ADC combos AstraZeneca is investing $2 billion in Summit Therapeutics to bankroll the development of Akeso’s PD-1xVEGF bispecific ivonescimab.
BioMarin lays off 117 California workers to consolidate footprint
Just months after trimming jobs in New Jersey following an acquisition, BioMarin is laying off 117 employees in California as part of a consolidation of its footprint. Effective Dec. 4, BioMarin plans to cut 117 jobs at its Novato, California, site, according to a California WARN notice. The move follows BioMarin’s decision to consolidate its footprint in the California city into “a smaller, more focused site,” a company spokesperson said in a statement to Fierce.
Hansoh’s Tagrisso rival loses EU approval after AstraZeneca legal challenge
The European Commission has revoked the EU marketing authorization for Hansoh Pharma’s lung cancer drug Aumseqa (aumolertinib) following a legal challenge from rival AstraZeneca. The EC made the decision after the European Medicines Agency concluded that Hansoh partner SFL Pharma’s application from 2022 violated data protection rules by referencing AstraZeneca’s clinical data for Tagrisso, according to a Sept.
US details rules for 0% specialty pharmaceutical tariff exemptions
Before broad 100% tariffs on imported pharmaceuticals take full effect today, the Trump administration has detailed rules that allow certain specialty drugs, including orphan treatments, nuclear medicines, cell and gene therapies, and antibody-drug conjugates, to enter the U.S. duty-free. The Trump administration announced the 100% Section 232 tariffs on patented pharmaceutical products and ingredients in April.
BioNTech to close 3 sites in Germany after failed buyer search
BioNTech is set to shutter multiple sites in Germany, impacting about 1,800 jobs, after efforts to find buyers fell through. BioNTech announced plans to exit three German sites in May, as the mRNA pioneer adjusts production capacity in response to a sharp drop in global COVID-19 vaccine demand while pivoting to its developing oncology pipeline. At the time, the German company said it was exploring potential divestment options, including a partial or total sale, for the manufacturing sites.
Merck, Eisai’s Welireg-Lenvima combo lands FDA nod to jump the kidney cancer queue
Merck & Co. has scored an FDA approval for its blockbuster-to-be Welireg to move into second-line treatment of kidney cancer. Originally approved as a third-line option, Welireg has now won the FDA’s blessing to be used alongside Merck’s Eisai-partnered Lenvima in second-line renal cell carcinoma with a clear cell component (ccRCC) following a PD-(L)1 inhibitor.
Fierce Pharma Asia—Lilly’s $3.35B InnoCare deal; Korea’s breakthrough; China’s 5-year biotech plan
Eli Lilly and InnoCare Pharma inked a multi-target deal potentially worth $3.35 billion. The FDA has doled out the first approval for a novel cancer drug from a Korean company. China's new pharmaceuticals five-year plan includes some ambitious goals. And more. 1.
Pioneer of China NewCo model sued in US over trade secret misuse, double-dealing
A legal feud unfolding in New York is putting a spotlight on the work of a business development veteran who is credited for pioneering one of biopharma’s hottest dealmaking mechanism: the China “NewCo” model.
Elevar wins FDA nod for bile duct cancer drug Lyrfigtu, a first for a Korean firm
The FDA came to Elevar Therapeutics bearing gift ahead of the mid-autumn festival. The U.S. agency has approved the company’s Lyrfigtu (lirafugratinib) for patients with previously treated bile duct cancer harboring an FGFR2 gene fusion or other rearrangement. As Jin Yang-gon, chairman of HLB Group, Elevar’s parent company, noted in a YouTube announcement, Lyrfigtu marks the first novel cancer drug from a Korean company to secure FDA approval.
Kyverna ‘resetting conversation’ with 1-year miv-cel data as autoimmune CAR-T peers hit safety snags
As two Big Pharma players in the autoimmune CAR-T space face unexpected safety setbacks, Kyverna Therapeutics is reporting long-term clinical data that showcase sustained efficacy alongside an unblemished safety profile for its potential first-in-class candidate, miv-cel.
Eli Lilly CEO touts 70% share as Medicare GLP-1 program reaches 700K seniors
Sign-ups for Medicare’s GLP-1 coverage plan keep expanding, and Eli Lilly is dominating the market with 70% share, the company’s CEO David Ricks said. Since its rollout on July 1, the Medicare GLP-1 Bridge has attracted about 700,000 seniors who’ve started treatment, Ricks said in an interview with CNBC. The demonstration program seems to be expanding rapidly. In an Aug.
Bristol Myers cuts another 265 jobs tied to New Jersey headquarters
Bristol Myers Squibb plans another major round of job cuts in New Jersey, bringing the number of total layoffs the company has announced this year in the Garden State to more than 700. In a WARN notice (PDF) filed with New Jersey's labor and workforce development department, BMS said it plans to lay off 265 employees tied to its corporate headquarters in Princeton. The reductions are expected to be implemented between December 2026 and May 2027, according to the notice.
Travere CEO Eric Dube to step down after transforming the rare disease biotech
Eric Dube, Ph.D., the CEO who rebranded Travere Therapeutics and oversaw the launch of its rare kidney disease drug Filspari, will step down. Bradley Campbell, who led Amicus Therapeutics until its recent $4.8 billion acquisition by BioMarin, will become Travere’s new CEO on Dec. 1, 2026. Dube will continue to serve as executive advisor through Feb. 15, 2027, to support an orderly transition, Travere said Monday.
Bayer offloads cancer drug Stivarga to Grünenthal for up to $431M as new competition looms
Bayer has decided to offload its aging cancer drug Stivarga to German compatriot Grünenthal as competition mounts. Grünenthal announced Monday that it will pay up to 375 million euros ($431 million) to acquire Stivarga, an oral multikinase inhibitor. According to Grünenthal, patent protection for Stivarga is expected to last until 2029 in the European Union and by 2030 in the U.S. But loss of exclusivity in China has already taken a toll on sales.
Eli Lilly escalates oral SERD battle with FDA approval for Inluriyo, Verzenio combo
Eli Lilly is sharpening its competitive edge in the crowded oral SERD arena as the FDA has approved a combination of its Inluriyo with its CDK4/6 inhibitor Verzenio. The label expansion builds on Inluriyo’s existing monotherapy indication, approved nearly a year ago for the treatment of ER-positive, HER2-negative breast cancer that carries ESR1 mutations in previously treated patients.
Fierce Pharma Asia—China deals safe from COINS?; Key WCLC data; Legend’s new CEO
Most drug licensing deals with China will be safe from rules being drafted by the U.S. Treasury Department, Reuters reports. Akeso and Summit Therapeutics' ivonescimab, B7-H3 antibody-drug conjugates and a surprise negative overall survival trend from Enhertu headlined WCLC26. Plus more. 1.
FDA approves Ultragenyx’s gene therapy Fayuvi for rare neurodegenerative disorder
Ultragenyx scored a belated regulatory win with the FDA approval of a first-in-disease gene therapy, giving the company a boost after a previous regulatory rejection and a recent late-stage setback. The FDA has approved Ultragenyx’s Fayuvi as the first treatment for children with mucopolysaccharidosis type IIIA (MPS IIIA), also known as Sanfilippo syndrome type A, a rare genetic disorder. MPS III is a neurodegenerative disorder, with MPS IIIA as the most common form.
Roche’s Lunsumio delivers positive confirmatory trial readout in follicular lymphoma
Roche’s T-cell engager portfolio has notched another milestone, as a phase 3 trial of the company’s Lunsumio met its primary endpoint in earlier-line follicular lymphoma. Without sharing any specific data, Roche and its subsidiary Genentech said Lunsumio’s combination with lenalidomide (Revlimid) demonstrated a statistically and clinically meaningful improvement in progression-free survival against rituximab (Rituxan) plus lenalidomide, known as R2, in the phase 3 Celestimo study.
Vera’s strong phase 3 IgAN data for Trutakna intensify kidney disease rivalry
New phase 3 data show Vera Therapeutics’ Trutakna successfully stabilizes kidney function in IgA nephropathy patients, mirroring an earlier clinical success from Otsuka’s Voyxact and heating up competition in a rapidly evolving market race.
Legend Biotech names Novartis veteran Ingrid Zhang as new CEO
Legend Biotech has found its permanent CEO, poaching Novartis veteran Ingrid Zhang as the CAR-T specialist eyes its next phase of growth. Zhang officially took the Legend CEO title on Sept. 15, assuming the post from interim chief Alan Bash, who has now returned to his role as president of Carvykti. Bash temporarily filled the position after then-CEO Ying Huang, Ph.D., abruptly resigned in July before quickly re-emerging as the CEO of a startup called K2 Therapeutics.
FDA approves first radioligand equivalent, Curium’s copycat of Novartis’ Lutathera
The FDA has approved the industry’s very first generic radioligand therapy, known as a radioligand equivalent. Curium’s lutetium Lu 177 dotatate injection, Bexlutry, won that title by referencing Novartis’ Lutathera for gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
GSK prepares frontline FDA bid for Jideytro, its first lung cancer drug
GSK is advancing its inaugural lung cancer asset, Jideytro, toward a landmark first-line FDA approval, aided by an unprecedented complete response rate. In a quick return for GSK’s $10.6 billion acquisition of Nuvalent, an early FDA nod in July has made Jideytro GSK’s first commercial lung cancer drug, with a label covering advanced ROS1-positive non-small cell lung cancer following treatment with a prior ROS1 tyrosine kinase inhibitor (TKI).
Increased deaths shadow AstraZeneca, Daiichi’s Enhertu first-line lung cancer data
A higher death risk in a phase 3 trial threatens to thwart AstraZeneca and Daiichi Sankyo’s bid to establish their star antibody-drug conjugate Enhertu as a first-line treatment for patients with HER2-mutant non-small cell lung cancer. Treatment with Enhertu showed a preliminary 15% increased risk of death compared with Keytruda plus chemotherapy in the phase 3 Destiny-Lung04 study, according to results shared at the 2026 World Conference on Lung Cancer.
Merck, Gilead’s failed Trodelvy lung cancer trial shows better China results
The fact that Gilead Sciences’ Trodelvy failed as a first-line treatment for non-small cell lung cancer was not new. Yet newly revealed global phase 3 data could reignite the question around translating Chinese data to the West.
Akeso, Summit’s ivonescimab tops Keytruda in lung cancer survival, with strong data in PD-L1-high patients
Akeso and Summit Therapeutics’ ivonescimab reduced the risk of death by 27% compared with Keytruda in patients with treatment-naïve, PD-L1-positive advanced non-small cell lung cancer in the phase 3 Harmoni-2 trial conducted in China.
AstraZeneca’s Etcamah flunks first-line breast cancer trial, adding to oral SERDs’ failure record
The ink was barely dry on the FDA approval letter for AstraZeneca’s Etcamah before the oral SERD suffered a key clinical setback. Etcamah failed to significantly improve patients’ time before tumor progression or death compared with the aromatase inhibitor anastrozole for the first-line treatment of ER-positive, HER2-negative breast cancer, AZ said Friday. The readout comes from the Serena-4 phase 3 trial, in which all patients also received Pfizer’s CDK4/6 inhibitor Ibrance.
Fierce Pharma Asia—Takeda’s R&D leadership change; Daiichi’s $1.3B court win; New Samsung Bio contract
Takeda's long-time R&D chief Andy Plump will retire. Daiichi Sankyo beat back a $1.3 billion damage claim in a lawsuit. Samsung Biologics signed a $262 million contract with an unnamed client. And more. 1. Takeda’s long-serving R&D chief Andy Plump to retire in wake of pipeline successes Takeda’s R&D chief, Andy Plump, M.D., Ph.D., will retire from the company in June 2027.
In first interview as FDA oncology chief, Angelo de Claro vows to ‘continue the innovation’ behind OCE legacy Original
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 continued regulatory modernization.
Novartis shareholder calls for board overhaul following costly deal setbacks: Reuters Original
Novartis’ recent dual clinical setbacks have prompted questions from a major shareholder about the board’s oversight of dealmaking. The call for a board shake-up came from David Samra, managing director at Artisan Partners, an asset management firm and a top 20 investor in Novartis, according to Reuters. In an interview with Reuters, Samra reportedly urged Novartis Chairman Giovanni Caforio to tighten the leash on how the Swiss pharma strikes deals.
Amgen’s DLL3-targeted Imdelltra scores overall survival win in first-line small cell lung cancer
In further validation of the DLL3 target pioneered by Amgen’s Imdelltra, the T-cell engager has delivered an overall survival win in first-line small cell lung cancer (SCLC). Imdelltra, used together with AstraZeneca’s Imfinzi, led to a “statistically significant and clinically meaningful” improvement in overall survival (OS) compared with Imfinzi alone as a first-line maintenance treatment for extensive stage SCLC, Amgen announced Tuesday.
FDA approves AstraZeneca’s Etcamah, opening ctDNA-guided treatment paradigm in breast cancer Original
In a rare divergence from its own expert panel, the FDA has granted accelerated approval to AstraZeneca’s camizestrant, turning a contentious regulatory review into a landmark win that opens a new treatment paradigm for molecular-guided cancer care.
Fierce Pharma Asia—Roche, GSK, Novartis billion-dollar deals; More MFN sign-ups; Akeso’s OS win
GSK, Roche and Novartis continued Big Pharma's dealmaking spree with Asian companies. Three midsized Asian biopharmas reached “most favored nation” deals with the White House. Akeso and Summit Therapeutics' ivonescimab delivered a head-to-head overall survival win against Keytruda. And more. 1.
Akeso, Summit’s ivonescimab extends lives in Keytruda head-to-head trial. What now?
About two years ago, a head-to-head progression-free survival win made Akeso and Summit Therapeutics’ ivonescimab—and the PD-1xVEGF class—the most promising agent to replace Keytruda as the new cancer immunotherapy king. Now, that same trial has met its overall survival endpoint, but to a far more measured reception.
Novartis telegraphs 130 job cuts amid biologics rethink in Switzerland Original
Novartis could cut around 130 jobs in Switzerland as it rethinks its biologics technical development and production footprint in Basel. Wednesday, Novartis said it plans to discontinue small-volume biologics production at its Kleinbasel site by the end of 2027. The decision could eliminate approximately 130 jobs, subject to proper process, the Swiss pharma said (German).
Trump GLP-1 update teases blockbuster annual sales for Lilly from Medicare program: analyst
As part of the “most favored nation” (MFN) drug pricing deal the Trump administration signed with obesity giants Eli Lilly and Novo Nordisk, Medicare recently launched a “bridge” model, offering weight loss drugs to eligible seniors at $50 per month. Now, we know the initial uptake from the program. Since the launch of the Medicare GLP-1 Bridge on July 1, over 500,000 seniors have utilized the program and together saved $216 million on those medicines, the White House said on Aug.
Novartis claims MS win as Rhapsido clears phase 3 with ‘no liver safety signal’
Novartis appears to have broken the curse of the BTK inhibitor class. The Swiss pharma announced Tuesday that two phase 3 trials for Rhapsido in relapsing multiple sclerosis hit their goals without any liver safety flags. The phase 3 Remodel-1 and -2 trials showed that Rhapsido (remibrutinib) beat Sanofi’s older drug Aubagio (teriflunomide) at reducing annualized relapse rate in relapsing MS, the studies’ primary endpoint, according to Novartis.
Jazz’s Ziihera secures 2nd survival win to solidify its HER2-positive stomach cancer status
Jazz Pharmaceuticals has added a second overall survival win to Ziihera’s cap, bolstering the bispecific’s claim as the new HER2 agent of choice in stomach cancer. On the heels of a broad FDA approval in first-line HER2-positive gastroesophageal adenocarcinoma (GEA), the phase 3 trial supporting Ziihera’s recent nod reported meeting overall survival on another comparison.
Takeda bolsters blood cancer portfolio with FDA nod for Mimrylo in polycythemia vera
The FDA has approved Takeda’s Mimrylo (rusfertide) for polycythemia vera, introducing a new mechanism of action to the nonmalignant rare blood cancer and handing CEO Julie Kim another major regulatory win since taking the helm. A form of myeloproliferative neoplasm, polycythemia vera (PV) causes the bone marrow to make too many red blood cells, which can result in life-threatening cardiovascular events, such as stroke and heart attack.
Fierce Pharma Asia—Roche’s $2.5B obesity deal; Akeso CEO’s defense; Lawmaker’s reflection on China
With a potential $2.5 billion deal with Hanmi, Roche is taking a less-trodden path in obesity. Akeso's CEO countered concerns over shrinking lung cancer data for ivonescimab as the PD-1xVEGF drug delivered its first phase 3 win outside lung cancer. A U.S. congressman says China is "beating us on our ground game" in biotech. And more. 1.
Amgen, AZ’s Tezspire lands phase 3 eosinophilic esophagitis win, turning up heat on Dupixent
Amgen and AstraZeneca’s inflammatory disease drug Tezspire has clinched a phase 3 win in eosinophilic esophagitis (EoE) as the partners eye another challenge to Sanofi and Regeneron’s incumbent Dupixent. A phase 3 EoE trial for Tezspire has hit all primary and key secondary endpoints, Amgen and AZ announced Thursday.
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 continues to defend the drug’s data against skepticism. In a China phase 3 trial, ivonescimab plus chemotherapy prolonged patients’ lives compared with the standard combination of AstraZeneca’s Imfinzi and chemo for the first-line treatment of advanced biliary tract cancer, Akeso announced Tuesday.
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 continues to defend the drug’s data against skepticism. In a China phase 3 trial, ivonescimab plus chemotherapy prolonged patients’ lives compared with the standard combination of AstraZeneca’s Imfinzi and chemo for the first-line treatment of advanced biliary tract cancer, Akeso announced Tuesday.
Jazz's HER2 bispecific Ziihera gains FDA approval to change practice in stomach cancer
Jazz Pharmaceuticals’ bispecific antibody Ziihera has gained an FDA approval for first-line HER2-positive stomach cancer, unlocking another market as the company builds toward a $2 billion-plus peak sales target. The latest green light allows Ziihera to be used in addition to chemotherapy, with or without BeOne Medicines’ Tevimbra, in previously untreated, HER2-positive advanced gastroesophageal adenocarcinoma (GEA).
Biokin bispecific ADC iza-bren hits goal in lung cancer trial, boosting case for BMS’ global test
Biokin Pharma’s iza-bren, a first-in-class antibody-drug conjugate partnered with Bristol Myers Squibb, has posted another positive phase 3 readout. The Panku-Lung01 lung cancer trial met its primary endpoint at an interim analysis, showing a significant progression-free survival benefit for iza-bren, Biokin said Tuesday in a securities filing (Chinese, PDF).
Biokin bispecific ADC iza-bren hits goal in lung cancer trial, boosting case for BMS’ global test
Biokin Pharma’s iza-bren, a first-in-class antibody-drug conjugate partnered with Bristol Myers Squibb, has posted another positive phase 3 readout. The Panku-Lung01 lung cancer trial met its primary endpoint at an interim analysis, showing a significant progression-free survival benefit for iza-bren, Biokin said Tuesday in a securities filing (Chinese, PDF).
Sanofi to lay off 229 Blueprint Medicines staffers, close Cambridge offices following acquisition
In the first major workforce reduction disclosed under new CEO Belén Garijo, Sanofi is laying off 229 employees from legacy Blueprint Medicines in Massachusetts as part of a post-acquisition integration. The cuts, detailed in a state Worker Adjustment and Retraining Notification (WARN) notice, comes roughly a year after the French pharma giant closed its $9.1 billion buyout of Blueprint to bag the rare immunology drug Ayvakit and other KIT inhibitor pipeline candidates.
AstraZeneca touts Enhertu, Orpathys dual lung cancer wins amid bispecific failure
AstraZeneca reported positive results from two non-small cell lung cancer trials for Enhertu and an Orpathys-Tagrisso combination, although the dual wins provided little cover for the company amid the failure of a PD-1/CTLA-4 bispecific antibody.
AstraZeneca touts Enhertu, Orpathys dual lung cancer wins amid bispecific failure
AstraZeneca reported positive results from two non-small cell lung cancer trials for Enhertu and an Orpathys-Tagrisso combination, although the dual wins provided little cover for the company amid the failure of a PD-1/CTLA-4 bispecific antibody.
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