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BioWorld - Tuesday, December 9, 2025
Home » Topics » Regulatory » Fast track

Fast track
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Antibodies attacking cancer cell

Innovent rings up $11.4B deal with Takeda for three I-O/ADC assets

Oct. 22, 2025
By Marian (YoonJee) Chu
No Comments
Takeda Pharmaceutical Co. Ltd. agreed to codevelop and commercialize up to three of Innovent Biologics Co. Ltd.’s immuno-oncology (I-O) and antibody-drug conjugate (ADC) candidates with the signing of a $11.4 billion deal, including $1.2 billion paid up front.
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Cochlear Nuclea Nexa system

FDA green lights Cochlear’s smart cochlear implant

July 11, 2025
By Tamra Sami
Cochlear Ltd. heard good news from the U.S. FDA, as the agency approved its next-generation cochlear implant, the Nucleus Nexa System, the first smart cochlear implant system. Cochlear expects to launch the new products in the U.S. in the next few months, Brendan Murray, vice president for Cochlear Implant products portfolio and strategy told BioWorld.
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CSPC headquarters

CSPC hints at three upcoming deals worth $5B for EGFR ADC, others

June 3, 2025
By Marian (YoonJee) Chu
No Comments
CSPC Pharmaceutical Group Ltd. on May 30 disclosed that the company was engaged in ongoing negotiations with unnamed, independent third parties regarding three license deals and collaborations that could total up to $5 billion combined.
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CSPC headquarters

CSPC hints at three upcoming deals worth $5B for EGFR ADC, others

May 30, 2025
By Marian (YoonJee) Chu
No Comments
CSPC Pharmaceutical Group Ltd. on May 30 disclosed that the company was engaged in ongoing negotiations with unnamed, independent third parties regarding three license deals and collaborations that could total up to $5 billion combined.
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Coronavirus, lungs

Healios posts more upbeat data on Multistem cell therapy for ARDS

March 18, 2025
By Marian (YoonJee) Chu
Latest findings on Healios K.K.’s stem cell therapy to treat acute respiratory distress syndrome (ARDS), coined Multistem (invimestrocel; HLCM-051), found the regenerative medicine effective in reducing the number of patient days on ventilator treatment, as well as mortality benefits.
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Coronavirus, lungs

Healios posts more upbeat data on Multistem cell therapy for ARDS

March 14, 2025
By Marian (YoonJee) Chu
Latest findings on Healios K.K.’s stem cell therapy to treat acute respiratory distress syndrome (ARDS), coined Multistem (invimestrocel; HLCM-051), found the regenerative medicine effective in reducing the number of patient days on ventilator treatment, as well as mortality benefits.
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US FDA grants fast track to Moebius-Sun’s knee OA pain injection

Sep. 10, 2024
By Marian (YoonJee) Chu
The U.S. FDA on Sept. 6 granted fast track designation to MM-II – a novel, non-opioid injectable candidate for knee osteoarthritis (OA) co-developed by Sun Pharmaceutical Industries Ltd. and Moebius Medical Ltd. Mumbai, India-based Sun and Tel Aviv, Israel-based Moebius agreed, under undisclosed terms, to co-develop the novel liposomal non-opioid pain therapy in an exclusive global licensing deal in 2016.
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US FDA grants fast track to Moebius-Sun’s knee OA pain injection

Sep. 9, 2024
By Marian (YoonJee) Chu
The U.S. FDA on Sept. 6 granted fast track designation to MM-II – a novel, non-opioid injectable candidate for knee osteoarthritis (OA) co-developed by Sun Pharmaceutical Industries Ltd. and Moebius Medical Ltd. Mumbai, India-based Sun and Tel Aviv, Israel-based Moebius agreed, under undisclosed terms, to co-develop the novel liposomal non-opioid pain therapy in an exclusive global licensing deal in 2016.
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Mabwell joins ADC breast cancer race as China clears phase II

July 16, 2024
By Marian (YoonJee) Chu
Mabwell Bioscience Co. gained clearance in China to start a phase II study of its novel Nectin4-targeting antibody drug conjugate (ADC), 9MW-2821, for metastatic triple-negative breast cancer.
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Vials of SNB-101

SN Bioscience nabs FDA fast track for lung cancer drug

May 14, 2024
By Marian (YoonJee) Chu
SN Bioscience Co. Ltd., headquartered in Seongnam-si, Gyeonggi-do’s second Pangyo Valley, gained U.S. FDA fast track designation for SNB-101 (SN-38), its new polymer nanoparticle cancer drug candidate for small-cell lung cancer.
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