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Johnson & Johnson Submits NDA for TAR-200 in High-Risk Bladder Cancer
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US-based Johnson & Johnson (J&J, NYSE: JNJ) has announced the initiation of the submission of a New Drug Application (NDA) filing with the US Food and Drug Administration (FDA) for TAR-200. The drug is intended for use in patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC) with carcinoma…
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Eli Lilly’s Omvoh Approved by FDA for Crohn’s Disease Treatment
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US major Eli Lilly and Company (NYSE: LLY) has announced receiving marketing approval from the US FDA for its Omvoh (mirikizumab-mrkz), an interleukin-23p19 (IL-23p19) antagonist, to treat moderately to severely active Crohn’s disease in adults. This approval follows the FDA’s nod for its use as a first-in-class treatment for moderately…
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IVIEW Therapeutics Secures Series A++ Funding for Ophthalmology Pipeline
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IVIEW Therapeutics Inc., an ophthalmology biotech operating out of the US and China, has reportedly raised an undisclosed amount of funds via a Series A++ financing round. The round was led by Chongqing Changsheng Shenghe Investment Fund, with contributions from Hangzhou Jiurun Investment, ehroh, and existing investors Proxima Ventures Fund…
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Boehringer Ingelheim’s Iclepertin Fails to Meet Phase III Study Endpoints
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German giant Boehringer Ingelheim has disclosed negative top-line results from the Phase III CONNEX study for its iclepertin, a treatment for cognitive impairment in adults with schizophrenia. The study failed to meet either primary or key secondary endpoints, indicating no statistically significant effects on cognition or functioning in patients treated…
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Telix Pharmaceuticals’ TLX591-CDx Approved in Europe via Decentralized Procedure
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Australia-based Telix Pharmaceuticals Ltd (ASX: TLX) has announced that the marketing filing in Europe via the Decentralized Procedure (DCP) for its TLX591-CDx (Illuccix, gallium Ga 68 PSMA-11), a radionuclide-drug conjugate (RDC) for the diagnosis of prostate cancer, has been approved by the regulatory body in the region. This approval marks…
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NMPA Implements Regulatory Reforms for Drug and Medical Device Industries
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The National Medical Products Administration (NMPA) has released a notification regarding the implementation of the “Decision of the State Council on Amending and Abolishing Some Administrative Regulations.” This move is part of a broader effort to streamline regulatory processes and enhance market vitality in the medical sector. Key Reforms and…
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Daiichi Sankyo Acquires Gatipotuzumab IP Rights for $132.5M
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Japan-based Daiichi Sankyo Company, Ltd (TYO: 4568) has announced an investment of USD 132.5 million to acquire the intellectual property (IP) rights of gatipotuzumab, an antitumor-associated mucin-1 (TA-MUC1) antibody, from Germany-headquartered Glycotope GmbH. This strategic acquisition strengthens Daiichi Sankyo’s portfolio in cancer therapy. Acquisition Details and BackgroundDaiichi Sankyo obtained global…
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NHSA Pushes for Real-Time Settlement Reform in Basic Medical Insurance
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The National Healthcare Security Administration (NHSA) has released a notification to promote the real-time settlement reform of the basic medical insurance (BMI) fund. The goal is to achieve real-time settlement in about 80% of the overall planning areas in China by 2025, with all areas expected to implement the reform…
