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Allurion’s Non-Invasive Weight-Loss Balloon Debuts at Ruijin Hospital’s Hainan Subsidiary
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US-based Allurion’s (NYSE: ALUR) weight-loss intragastric balloon has been first applied in Shanghai Ruijin Hospital’s Hainan subsidiary, offering a non-invasive weight loss solution for obese patients with a body mass index (BMI) greater than 27. This innovative device provides an alternative approach to weight management in a hospital setting. Clinically…
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Janssen Submits Rybrevant for FDA Review as First-Line NSCLC Treatment
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Johnson & Johnson (J&J; NYSE: JNJ) subsidiary Janssen has submitted an additional indication for review with the US Food and Drug Administration (FDA) for its bispecific antibody (BsAb) Rybrevant (amivantamab). The submission seeks approval for Rybrevant in combination with carboplatin and pemetrexed as a first-line treatment for locally advanced or…
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AstraZeneca Challenges US Government’s Drug Price Negotiation Plan for Medicare
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UK-based pharmaceutical giant AstraZeneca (AZ, NASDAQ: AZN) has filed a legal claim against the US government’s plan to negotiate the price of selected drugs for the 2026 period onwards through the elderly health insurance program, Medicare. This move makes AstraZeneca the fourth company to contest the initiative this year, following…
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MSD Initiates Phase III Trial for PCSK9 Inhibitor MK-0616 in LDL Cholesterol Reduction
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has commenced Phase III development for its experimental proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, MK-0616, focusing on low-density lipoprotein (LDL) cholesterol reduction in adults with and without heterozygous familial hypercholesterolemia (HeFH). This marks a significant milestone as MK-0616 becomes the first oral…
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Henlius Biotech Expands Licensing Agreement with KGbio for PD-1 Inhibitor
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Shanghai Henlius Biotech Co., Ltd (HKG: 2696) has announced an update to the licensing agreement initially struck with PT Kalbe Genexine Biologics (KGbio) in September 2019 regarding Henlius’s programmed death-1 (PD-1) inhibitor, HanSiZhuang (serplulimab). The Indonesian firm was initially granted rights to develop and commercialize the drug in certain Southeast…
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Sandoz Receives FDA Clearance for First Biosimilar to Biogen’s Tysabri
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The Sandoz unit of Switzerland-based Novartis (NYSE: NVS) has received regulatory clearance from the US Food and Drug Administration (FDA) for Tyruko (natalizumab), marking it as the first biosimilar version referencing Biogen’s (NASDAQ: BIIB) blockbuster biologic Tysabri. Both monoclonal antibodies (mAbs) are indicated for treating Crohn’s disease and relapsing forms…
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CDE Seeks Public Feedback on Biological Product Changes During Clinical Trials
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The Center for Drug Evaluation (CDE) is once again seeking public feedback on two key documents: the “Guiding Principles for Pharmaceutical Changes and Research Technologies of Biological Products during Clinical Trials” and the “Guiding Principles for Research Technologies of Pharmaceutical Changes in Marketed Vaccines”. These documents are open for public…
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Chinese Pharma Consortium Eyes Poland’s Neuca in Strategic European Market Acquisition
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A consortium of China-based pharmaceutical companies, potentially including the state-owned giant Sinopharm (HKG: 1099), is reportedly considering the acquisition of Poland-based drug wholesaler Neuca. According to sources, the potential sale was discussed during a recent consultation between Neuca and Poland’s Competition and Consumer Office UOKIK. However, no specifics regarding the…
