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China’s CDE Issues Guidelines for Pediatric Drug Labeling Updates
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China’s Center for Drug Evaluation (CDE) has issued a notice outlining the “Detailed Rules for Adding Pediatric Medication Information to the Labeling of Listed Drugs.” The notice provides clarity on the procedural steps for updating pediatric labeling information on drugs. Under the new guidelines, originator companies are permitted to directly…
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GSK’s Shingrix Vaccine Maintains High Efficacy for Over a Decade, Phase III Data Show
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GlaxoSmithKline (GSK, LON: GSK, NYSE: GSK), the UK-based pharmaceutical giant, has this week released long-term data from a follow-up Phase III trial of its recombinant herpes zoster vaccine, Shingrix. The vaccine demonstrated robust efficacy in adults aged 50 and above, with a 79.7% efficacy rate sustained from year 6 to…
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AbbVie’s Rinvoq Meets Main Goal in Late-Stage Giant Cell Arteritis Trial
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AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, has announced that a late-stage clinical trial for its JAK inhibitor Rinvoq (upadacitinib) in combination with corticosteroids has successfully met the primary endpoint in patients with giant cell arteritis (GCA). The study demonstrated sustained remission from week 12 through week 52. The…
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Chia Tai Tianqing’s Rovadicitinib Meets Main Goal in Myelofibrosis Trial, Eyes Market Filing
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Chia Tai Tianqing, a renowned pharmaceutical company based in China, has declared that it has successfully met the primary endpoint in a pivotal study for its Category 1 drug, rovadicitinib, for the treatment of medium-to-high-risk myelofibrosis (MF). The company is advancing towards filing for market approval in China, following consultations…
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Shanghai Escugen and Anke Bio Partner to Develop ADC Products with EZWi-Fit Platform
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Shanghai Escugen, a biopharmaceutical company based in China, has entered into a licensing and cooperation agreement with Anhui Anke Biotechnology (Group) Co., Ltd (SHE: 300009). Under the terms of the agreement, Escugen will grant Anke Bio the rights to its antibody-drug conjugate (ADC) technology platform, EZWi-Fit, for the development of…
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China’s CNIPA and USPTO Pledge to Deepen Intellectual Property Cooperation
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Shen Changyu, Director of the China National Intellectual Property Administration (CNIPA), met with Kathi Vidal, Director of the United States Patent and Trademark Office (USPTO), in Beijing this week for high-level discussions. The meeting focused on exchanging updates on intellectual property (IP) protection efforts in both countries and resulted in…
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Novartis’s Kesimpta Shows Sustained Efficacy in 6-Year Relapsing MS Study
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has this week unveiled six-year efficacy data for its anti-CD20 drug Kesimpta (ofatumumab) in the treatment of recently diagnosed relapsing multiple sclerosis (MS) in treatment-naive patients. The data shows that first-line continuous Kesimpta treatment, as compared to a teriflunomide regimen switched to Kesimpta, resulted…
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Abbott Reports Q1 2024 Organic Sales Growth of 4.7%, Led by Pharmaceuticals and Devices
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Abbott (NYSE: ABT), a global healthcare giant, has this week announced its financial results for the first quarter of 2024. The company reported a 4.7% year-on-year (YOY) increase in global sales on an organic basis, reaching USD 10.0 billion. Excluding the impact of reduced demand for SARS-CoV-2 tests, the growth…
