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Taiwan FDA Reviews Nefecon New Drug Application from Everest Medicines
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China-based Everest Medicines (HKG: 1952) has announced that the New Drug Application (NDA) for Nefecon (sustained-release budesonide) has been accepted for review by the Taiwan Food and Drug Administration (TFDA). The application seeks approval for the treatment of primary immunoglobulin A nephropathy (IgAN) in adult patients. Nefecon is a patented…
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J&J’s Janssen Secures Exclusive Global Rights to Develop LCB84 ADC from LegoChem Biosciences
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Johnson & Johnson’s (J&J; NYSE: JNJ) pharmaceutical subsidiary, Janssen, has entered into an exclusive global agreement with South Korean-based LegoChem Biosciences (LCB; KOSDAQ: 141080) to develop and commercialize the antibody drug conjugate (ADC) LCB84. Under the terms of the agreement, LCB is set to receive $100 million in upfront payments…
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BMS Expands Oncology Portfolio with $4.1 Billion RayzeBio Acquisition
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Bristol Myers Squibb (BMS; NYSE: BMY) has announced the acquisition of RayzeBio (NASDAQ: RYZB), a clinical-stage developer of actinium-based radiopharmaceutical therapeutics (RPT), bolstering its oncology portfolio. BMS will purchase all outstanding shares of RayzeBio for an estimated $4.1 billion, with the transaction anticipated to close in the first half of…
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Amgen’s Lumakras Faces Full Approval Delay as FDA Requests New Study
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The US Food and Drug Administration (FDA) has declined to grant full approval for Amgen’s (NASDAQ: AMGN) Lumakras (sotorasib), a first-in-class KRASG12C inhibitor, for the treatment of locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer (NSCLC). The regulator has requested an additional confirmatory study, which Amgen intends to…
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China’s NMPA Proposes Enhanced IT and Visualization Requirements for Blood Product GMP
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The National Medical Products Administration (NMPA) of China is currently soliciting public feedback on the revised draft proposal for the annex amendment of the Good Manufacturing Practice (GMP) standards for blood products. This updated version introduces new requirements focusing on information technology and visualization in the manufacturing and testing processes…
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Fresenius Medical Care Expands Dialysis Solutions in China with 6008 CARESystem Launch
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Fresenius Medical Care AG has announced the official launch of its 6008 CARESystem hemodialysis filtration system in China, marking a significant advancement in the treatment options for patients with renal failure in the country. The 6008 CARESystem is comprised of a 6008 blood dialysis device and a complementary 6008 CARESet…
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China Charts Course for Advanced Disease Prevention and Control System by 2030
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China’s State Council has issued the “Guiding Opinions on Promoting the High Quality Development of Disease Prevention and Control,” outlining a comprehensive plan to enhance the country’s public health infrastructure. By 2030, the nation aims to refine its multi-departmental, cross-regional, and military-civilian joint prevention and control mechanism. The strategy involves…
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Innovent Biologics Partners with Sanegene Bio USA to Develop Hypertension Drug
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China-based Innovent Biologics (HKG: 1801) has entered into a partnership with Sanegene Bio USA Inc. to co-develop the small interfering RNA (siRNA) candidate drug SGB-3908 for the treatment of hypertension. Innovent Biologics has secured the exclusive option to license global development, manufacturing, and commercialization rights for the drug. Upon the…
