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BioWorld - Thursday, September 28, 2023
Home » Topics » Cancer, BioWorld Asia

Cancer, BioWorld Asia
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Postponed stamp on calendar

FDA pushes back PDUFA date for Daiichi Sankyo’s quizartinib

April 25, 2023
By Tamra Sami
No Comments
Daiichi Sankyo Co Ltd. has experienced yet another setback with its quizartinib NDA submission, as the U.S. FDA has now extended the review period by three months to July 24, 2023, to allow additional time to review requested updates to the proposed Risk Evaluation and Mitigation Strategies.
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3d illustration of ovarian cancer

Junshi Bioscience’s PARP inhibitor, senaparib, meets endpoint in phase III ovarian cancer trial

April 18, 2023
By Tamra Sami
No Comments
Junshi Biosciences Co. Ltd.’s PARP inhibitor, senaparib (JS-109/IMP4297), met the primary endpoint of progression-free survival in a phase III ovarian cancer study, according to a prespecified interim analysis.
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3D illustration demonstrating antibody-drug conjugate.

Pyramid in-licenses preclinical TROP2-targeted ADC from Genequantum in deal worth up to $1B

April 18, 2023
By Tamra Sami
No Comments
Pyramid Biosciences Inc. has in-licensed Genequantum Healthcare Co. Ltd.’s preclinical trophoblast cell surface antigen 2 (TROP2)-targeting antibody-drug conjugate (ADC), GQ-1010, in a deal worth up to $1 billion in potential milestones. Under the terms, Pyramid gains exclusive rights to develop and commercialize GQ-1010 globally, excluding greater China (mainland China, Hong Kong, Macau and Taiwan).  
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IPO stock market ticker

Cytomed squeaks out $9.6M in a near-frozen IPO market

April 18, 2023
By Karen Carey
No Comments
During what has become one of the slowest IPO years in recent memory, cancer immunotherapy company Cytomed Therapeutics Ltd. debuted on Nasdaq, raising $9.65 million, while inflammatory disease firm Acelyrin Inc. filed to list its stock for a potential $100 million. Up to this point, there were only six biopharma IPOs completed this year – the fewest since 2013. Cytomed, which priced 2.4 million shares at $4 apiece, is now the seventh for 2023, and the fifth on Nasdaq. Two other IPOs have closed on Chinese markets.
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Noxopharm quits development of Veyonda, reduces headcount as stock plummets nearly 40%

April 11, 2023
By Tamra Sami
No Comments
Noxopharm Pty Ltd.’s stock plummeted nearly 40% on the morning of April 6 after the company announced it was quitting development of its lead program, Veyonda (idronoxil/formerly OX-66), shuttering its DARRT-2 and CEP-2 oncology clinical trials and disbanding its clinical trial team to contain costs.
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Merck, Eisai stumble again in their cancer collaboration

April 11, 2023
By Lee Landenberger
No Comments
In the string of successes and frustrations generated by their five-year collaboration, Merck & Co. Inc. and Eisai Inc. can now add a few more frustrations. The companies are discontinuing the phase III LEAP-003 study of Keytruda (pembrolizumab) plus Lenvima (lenvatinib) for first-line treatment of unresectable or metastatic melanoma because it did not improve overall survival (OS) vs. Keytruda as a monotherapy. Also, the phase III LEAP-017 trial evaluating the combination in unresectable and metastatic colorectal cancer did not meet its primary endpoint of OS.
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Glass vials with radioactive label
Radioactive revolution

Radiopharma pipeline gathers atomic speed

April 11, 2023
By Tamra Sami
No Comments
The radiopharma field has garnered increasing attention in recent years due to big-ticket deals like Bayer AG's $2.9 billion acquisition of Algeta ASA and Novartis AG's nearly $6 billion spent on buying Advanced Accelerator Applications SA and Endocyte Inc. As a result, competition is ratcheting up and pipelines are exploding with new combinations of different drugs. The global radiopharmaceuticals market was estimated to be valued at $6.7 billion in 2020, a number expected to reach $11.5 billion by 2027, according to a 2022 William Blair report.
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Regulatory icons
Radioactive revolution

Keeping up with the technology a growing task for regulators

April 11, 2023
By Mari Serebrov
No Comments
The possibilities of cures for cancer and other tough-to-treat diseases and the ability to further personalize medicine are creating a lot of excitement about the future of radiopharmaceuticals as both therapy and diagnostics. To reach that future, industry and researchers will have to overcome a lot of challenges, not the least of which stem from the multiple government agencies involved in regulating the source material, development, distribution and use of radioactive drugs and devices.
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High Flux Reactor in the Netherlands
Radioactive revolution

Radiopharma industry grapples with supply challenges

April 11, 2023
By Tamra Sami
No Comments
Radiopharmaceuticals require sophisticated infrastructure, with just-in-time radioactives delivered to patients who must isolate while receiving the therapy. Quality control and numerous layers of regulation makes for a daunting space to enter.
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Radioactive revolution

How are radiopharma companies managing supply challenges?

April 11, 2023
By Tamra Sami
No Comments
Supply issues are a “major concern for the whole industry and for the medical community as well, because they see targeted radiotherapy as a very promising field with very interesting results in the clinic, but they are concerned that drugs may not be available for a large number of patients, and it is a legitimate concern,” Orano Med SAS CEO Julien Dodet said.
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