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FDA Issues Complete Response Letters to Six Novel Drugs in Q1 2023
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According to an analysis, the US FDA issued complete response letters (CRLs) to six novel drugs seeking first approval approvals during the first quarter of 2023. These CRLs highlight the stringent requirements for efficacy and safety data that the FDA demands before granting market access to new pharmaceuticals. Eli Lilly’s…
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Bioyond Robotics Secures $29 Million in Series A and A+ Financing Rounds
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Bioyond Robotics, a Shanghai-based intelligent automation company, has reportedly raised around RMB 200 million (USD 29 million) through Series A and A+ financing rounds. The Series A+ funding was co-led by BioTrack Capital and Lilly Asia Fund (LAV), with CICC Qide Fund, a subsidiary of CICC Capital, joining the round.…
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Henan Province Sees 53.6% Price Reduction in Neuro and Peripheral Intervention Consumables Tender
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The Henan Province Public Resources Trading Center has released a notification regarding the completion of price negotiations for neural intervention and peripheral intervention high-value consumable products as part of a consumables alliance procurement tender. The tender, which covered 2,323 specifications, resulted in an average price reduction of 53.6%. Led by…
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Jiangsu Hillgene Biopharma Secures Tens of Millions in Series A Financing for Cell Therapy R&D
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China-based cell therapy-focused Contract Development and Manufacturing Organization (CDMO) Jiangsu Hillgene Biopharma Co., Ltd has reportedly raised tens of millions of renminbi in a Series A financing round. The funding round was led by Jiarui Investment and Hesheng Venture Capital. The proceeds from this investment will be directed towards the…
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Forecyte Bio Expands with New Cell and Gene Therapy GMP Facility in Shanghai
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Maryland-based Contract Development and Manufacturing Organization (CDMO) Forecyte Biotechnologies has announced the opening of a new, state-of-the-art cell and gene therapy (CGT) GMP facility in Shanghai on March 31. This marks the company’s second facility, following the opening of a US-based facility in January. Investment and Global Impact of the…
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Yiling Pharmaceutical’s XY0206 Advances to Phase III Trial for FLT3-ITD AML
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China-based Yiling Pharmaceutical Co., Ltd (SHE: 002603) has announced its plans to initiate a Phase III clinical study for its Category 1 chemical drug XY0206, which targets recurrent/refractory acute myeloid leukemia (AML) patients with FLT3-ITD mutation (FMS-like tyrosine kinase 3 internal tandem duplication). XY0206: A Promising Multi-Target Tyrosine Kinase InhibitorXY0206…
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Jiangsu Yuyue Medical Secures NMPA Approval for Semi-Automatic External Defibrillator
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Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. (SHE: 002223), a China-based medical device company, has announced that it has received medical device marketing approval from the National Medical Products Administration (NMPA) for its semi-automatic external defibrillator (AED). Innovative Features of the AED ProductThe newly approved AED comes equipped with…
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MicuRx Pharmaceuticals Initiates Phase III Study for MRX-4 in Diabetic Foot Infection Treatment
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Sino-US firm MicuRx Pharmaceuticals Inc. has announced the initiation of a Phase III clinical study for its novel anti-microbial agent MRX-4, used in combination with contezolid (MRX-I), as a sequential treatment for diabetic foot infection in China. Global Multi-Center Phase III Study Design and ApprovalThe global multi-center, randomized, double-blind Phase…
