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BioWorld - Tuesday, August 4, 2026
Home » Keywords » CMC

Items Tagged with 'CMC'

ARTICLES

Liver tumor treatment conceptual illustration

HLB, Hengrui receive third US FDA rejection on liver cancer combo

July 14, 2026
By Marian (YoonJee) Chu
No Comments
The U.S. FDA declined to approve, for a third time, an investigational liver cancer drug regimen comprising HLB Co. Ltd.’s rivoceranib and Jiangsu Hengrui Pharmaceutical Co. Ltd.’s camrelizumab, reportedly citing issues from a drug manufacturing facility inspection.
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Liver tumor treatment conceptual illustration

HLB, Hengrui receive third US FDA rejection on liver cancer combo

July 10, 2026
By Marian (YoonJee) Chu
No Comments
The U.S. FDA declined to approve, for a third time, an investigational liver cancer drug regimen comprising HLB Co. Ltd.’s rivoceranib and Jiangsu Hengrui Pharmaceutical Co. Ltd.’s camrelizumab, reportedly citing issues from a drug manufacturing facility inspection.
Read More
Kim Dong-gun (DG), CEO, Elevar

Elevar gets new CEO, files NDAs for lirafugratinib, rivoceranib

Feb. 3, 2026
By Marian (YoonJee) Chu
No Comments
Elevar Therapeutics Inc. appointed Kim Dong-gun (DG) as CEO Jan. 29, as the company focuses on post-NDA strategies for lirafugratinib in bile duct cancer, and the twice-rejected rivoceranib-camrelizumab combination for liver cancer.
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Kim Dong-gun (DG), CEO, Elevar

Elevar gets new CEO, files NDAs for lirafugratinib, rivoceranib

Jan. 30, 2026
By Marian (YoonJee) Chu
No Comments
Elevar Therapeutics Inc. appointed Kim Dong-gun (DG) as CEO Jan. 29, as the company focuses on post-NDA strategies for lirafugratinib in bile duct cancer, and the twice-rejected rivoceranib-camrelizumab combination for liver cancer.
Read More
Jorge A. Goldstein at Bio Korea 2025
Bio Korea 2025

US legal issues to track in pharma, biotech

May 13, 2025
By Marian (YoonJee) Chu
No Comments
Ongoing policy issues in the U.S., including the Inflation Reduction Act and recent proposals under President Donald Trump’s administration, have wide ranging implications for the global biopharmaceutical industry, speakers at Bio Korea 2025 said May 8, including a heightened need for all biotechs to draft regulatory strategies.
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Jorge A. Goldstein at Bio Korea 2025

US legal issues to track in pharma, biotech: Bio Korea 2025

May 8, 2025
By Marian (YoonJee) Chu
No Comments
Ongoing policy issues in the U.S., including the Inflation Reduction Act and recent proposals under President Donald Trump’s administration, have wide ranging implications for the global biopharmaceutical industry, speakers at Bio Korea 2025 said May 8, including a heightened need for all biotechs to draft regulatory strategies.
Read More
Handshake with digital globe overlay

Chinabio 2025: Europe-China pharma deals rise as US markets shut

April 29, 2025
By Marian (YoonJee) Chu
Europe was a bigger counterpart to China in pharmaceutical dealmaking than the U.S. last year, speakers at Chinabio Partnering Forum said April 23, and the trend is likely to continue in 2025 with the shuttering of U.S. capital and volatility ailing global markets.
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Handshake with digital globe overlay

Chinabio 2025: Europe-China pharma deals rise as US markets shut

April 23, 2025
By Marian (YoonJee) Chu
Europe was a bigger counterpart to China in pharmaceutical dealmaking than the U.S. last year, speakers at Chinabio Partnering Forum said April 23, and the trend is likely to continue in 2025 with the shuttering of U.S. capital and volatility ailing global markets.
Read More

Myst it again: Milestone gets a CRL for its heart spray

March 28, 2025
By Lee Landenberger
Milestone Pharmaceuticals Inc.’s heart rhythm-restoring calcium channel blocker for paroxysmal supraventricular tachycardia (PSVT) has yet another obstacle in its way. 
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Microbiome illustration
Bio-Europe 2020

Seventure leads think-in on microbiome dealmaking

March 26, 2020
By Cormac Sheridan
DUBLIN – Bio-Europe Spring’s virtual panel on the partnering dynamic between big pharma and microbiome-focused biotech firms was essentially an in-house webinar hosted by Seventure Partners, a Paris-based venture capital fund that has led the way in investing in microbiome-related therapeutics, diagnostics and other products.
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