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Conceptual image for brain cancer treatment

FDA issues CRL for Telix's glioma imaging agent, wants more data

April 29, 2025
By Tamra Sami
The U.S. FDA issued a complete response letter (CRL) to Telix Pharmaceuticals Ltd. for its NDA for glioma imaging agent, TLX-101-CDx (floretyrosine F18 or 18F-FET, Pixclara), citing the need for additional confirmatory clinical evidence.
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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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Green approved stamp

Akeso hot with FDA cancer win, nods in China, new data

April 29, 2025
By Randy Osborne
The intriguing VEGFxPD-1 bispecific antibody space gained oomph with phase III results disclosed April 23 by Akeso Pharmaceuticals Inc. related to Harmoni-6, testing ivonescimab in combination with platinum-based chemotherapy compared with Tevimbra (tislelizumab, Beigene Ltd.), a PD-1 inhibitor also paired with platinum-based chemo in patients with locally advanced or metastatic squamous non-small-cell lung cancer irrespective of PD-L1 expression. Those data were followed by a green light from the U.S. FDA April 24 for marketing the PD-1 monoclonal antibody penpulimab in combination with cisplatin or carboplatin and gemcitabine for the first-line treatment of adult recurrent or metastatic non-keratinizing nasopharyngeal carcinoma.
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China adds Ascentage's lisaftoclax, olverembatinib to guidelines

April 29, 2025
By Tamra Sami
Ascentage Pharma Group Corp. Ltd. said two of its novel candidates have been included in the 2025 Chinese Society of Clinical Oncology Guidelines, including its in-house developed Bcl-2 selective inhibitor, lisaftoclax (APG-2575), which is under review in China and could be the first domestically approved Bcl-2 inhibitor and the second global approval.
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Eye with bar chart, line graph

Street’s syringe whinges, sales dip dog Regeneron’s Eylea in AMD

April 29, 2025
By Randy Osborne
No Comments
Another complete response letter from the U.S. FDA for Regeneron Pharmaceuticals Inc.’s age-related macular degeneration (AMD) therapy Eylea (aflibercept) – along with disappointing sales of the VEGF inhibitor – dented shares (NASDAQ:REGN) by $41.95. They closed April 29 at $568.91, having traded as low as $542.44 during the day.
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PDUFA date miss another disappointing delay for Barth drug

April 29, 2025
By Mari Serebrov
No Comments
Stealth Biotherapeutics Inc., and, more importantly, patients with Barth syndrome, faced another disappointing delay April 29 when the U.S. FDA kicked its approval decision down the road for Stealth’s elamipretide.
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EO record among Day 100 Trump achievements

April 29, 2025
By Mari Serebrov
No Comments
With April 29 being Day 100 for U.S. President Donald Trump, his staff observed the day by touting the achievements of the administration’s first 100 days in office, especially new commitments made by the private sector to invest more than $5 trillion in U.S.-based manufacturing, R&D, infrastructure and technology.
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PerQseal Elite

Vivasure Perqseal vascular closure system lands CE mark

April 28, 2025
By Shani Alexander
Vivasure Medical Ltd. received CE mark approval for its Perqseal Elite vascular closure system which manages bleeding complications associated with large-bore arterial vessel closure. The sutureless, fully bioresorbable device has the potential to reduce problems associated with traditional closure methods in patients undergoing complex structural heart procedures.
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US flag, stock market chart, White House

100 days of uncertainty

April 28, 2025
The first 100 days of the Trump administration have been nothing short of chaotic, both in the U.S. and throughout the world. Shining a light through the uncertainty, BioWorld continues to cover the administration’s latest policy decisions and actions affecting the life sciences sector, as well as their impacts across the globe. It’s all right here at Trump administration impacts.
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IPO, coins, financial chart

China pharma migration: Hengrui greenlighted for Hong Kong IPO

April 28, 2025
By Marian (YoonJee) Chu
Jiangsu Hengrui Pharmaceuticals Co. Ltd. is the latest mainland China pharmaceutical company to seek a capital raise on the Hong Kong stock exchange, winning clearance April 28 from the China Securities Regulatory Commission to float new H-shares.
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