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Laekna and Eli Lilly & Co. Enter Clinical Cooperation to Advance Obesity Treatment LAE102
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Sino-US biotech company Laekna, Inc. (HKG: 2105) has announced a significant clinical cooperation agreement with US pharmaceutical major Eli Lilly & Co., (NYSE: LLY), aimed at accelerating the global clinical development of Laekna’s obesity treatment candidate, LAE102. Under the terms of the agreement, Lilly will take on the responsibility for…
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GSK’s Linerixibat Demonstrates Efficacy in Phase III GLISTEN Study for Cholestatic Pruritus
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UK-based pharmaceutical giant GlaxoSmithKline (GSK; NYSE: GSK) has announced positive headline results from the Phase III GLISTEN study, which assessed the efficacy of its ileal bile acid transporter (IBAT) inhibitor, linerixibat, in treating cholestatic pruritus (relentless itch) associated with primary biliary cholangitis (PBC). Study Design and Primary Endpoint AchievementThe GLISTEN…
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Astellas Pharma’s Izervay sNDA for Geographic Atrophy Receives FDA Complete Response Letter
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Japan-based Astellas Pharma Inc. (TYO: 4568) has announced that its supplemental New Drug Application (sNDA) for Izervay (avacincaptad pegol), indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD), has received a Complete Response Letter (CRL) from the US FDA. The CRL addresses a statistical matter…
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Bayer AG Secures Exclusive Rights to Cytokinetics’ Aficamten in Japan
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Germany-based Bayer AG (ETR: BAYN) has announced a significant collaboration and license agreement with US-based Cytokinetics, Incorporated (NASDAQ: CYTK), acquiring exclusive development and commercialization rights to aficamten in Japan. The agreement is subject to certain reserved development rights of Cytokinetics. Phase III Study and Global Trial ExpansionUnder the terms of…
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MSD Announces Positive Topline Results from Phase III Subcutaneous Keytruda Trial
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US-based Merck, Sharp & Dohme Inc., (MSD, NYSE: MRK) has released positive topline results from the pivotal Phase III MK-3475A-D77 trial. The study aimed to assess the noninferiority of subcutaneous administration of PD-1 inhibitor Keytruda (pembrolizumab) combined with berahyaluronidase alfa, a hyaluronidase variant developed by Alteogen Inc., in comparison to…
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Servier and Dana-Farber Launch SHINEDoc Program, Enroll First PhD Student
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French pharmaceutical company Servier and the US-based Dana-Farber Cancer Institute have announced the start of the Servier-funded SHINEDoc program in the United States, with the enrollment of the first PhD student from Dana-Farber. The program, which is set to begin this month, marks a significant step in fostering innovation in…
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New Horizon Health Registers Three Medical Devices in Hong Kong’s Department of Health
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Hangzhou-based New Horizon Health Ltd (HKG: 6606) has announced the successful registration of three of its medical products with the Department of Health in the Hong Kong Special Administrative Region, facilitated through the Medical Device Administrative Control System (MDACS). This development marks a significant expansion of the company’s reach and…
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NMPA Launches ‘Medical Service Price Items’ Column with Comprehensive Sub-Sections
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The National Medical Products Administration (NMPA) has taken a significant step towards enhancing transparency in the medical sector by launching a new “Medical Service Price Items” column on its official website. This initiative is designed to provide a centralized resource for stakeholders, including patients, healthcare providers, and policymakers, and is…
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