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AstraZeneca’s Tagrisso Combination Therapy Shows Improved Efficacy in EGFR-mutated NSCLC
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UK-headquartered AstraZeneca (AZ; NASDAQ: AZN) has announced interim Phase III data demonstrating that the addition of pemetrexed plus cisplatin/carboplatin chemotherapy to tyrosine kinase inhibitor (TKI) Tagrisso (osimertinib) improves therapeutic effects in patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC). The combination therapy reduced the risk of…
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Jiangsu Recbio and Yikang Biological Partner to Develop RSV Preventative Vaccine
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Jiangsu Recbio Technology Co., Ltd, a China-based biotechnology company, has entered into a product development cooperation agreement with Yikang Biological (Suzhou) Co., Ltd to develop a recombinant respiratory syncytial virus (RSV) vaccine aimed at preventing RSV-induced respiratory diseases. Under the terms of the agreement, Yikang will contribute its self-designed RSV…
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Janssen Reports Positive Results from Phase Ib/II Study of Rybrevant Combo in EGFR-mutated NSCLC
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Johnson & Johnson (J&J; NYSE: JNJ) subsidiary Janssen has provided an update on an ongoing Phase Ib/II study cohort assessing the safety and pharmacokinetics of the bispecific antibody (BsAb) Rybrevant (amivantamab) in combination with tyrosine kinase inhibitor (TKI) lazertinib and chemotherapy for the treatment of relapsed/refractory EGFR-mutated non-small cell lung…
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AstraZeneca’s Enhertu Shows Promising Results in Phase II HER2-mutant NSCLC Trial
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AstraZeneca (AZ; NASDAQ: AZN) has released early data from a Phase II trial investigating the antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) in patients with HER2-mutant unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC). The trial assessed the efficacy and safety of different dosages of Enhertu, revealing that while a…
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Innovent Biologics Plans Share Placement to Raise HKD 2.36 Billion for Global Expansion
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China-based biotech Innovent Biologics Inc., (HKG: 1801) has issued a notice stating its intention to release 68 million shares priced at HKD 38.30 (USD 4.90), offering an 8.8% discount to the September 11, 2023, closing price. Morgan Stanley is acting as the agent for the placement, responsible for securing purchasers…
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NMPA Pilots Priority Review for Rare Disease Formula Foods, Aims to Reduce Approval Time
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The National Medical Products Administration (NMPA) has initiated a pilot program to implement “Priority review and approval procedures applied to formula foods for rare diseases and special medical purposes that are urgently needed in clinical practice.” According to the People’s Daily, these procedures are expected to be incorporated into the…
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Huadong Medicine’s Subsidiary Viora Ltd’s V20 Accepted for NMPA Review
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that the National Medical Products Administration (NMPA) has accepted a Category III market filing for its wholly owned subsidiary Viora Ltd’s V20 optical radiofrequency therapy instrument. This development marks a significant step forward for the company’s entry into the Chinese medical…
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Gan & Lee Pharmaceuticals Initiates Phase II Clinical Study for Weekly Insulin GZR4
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Gan & Lee Pharmaceuticals (SHA: 603087), a China-based pharmaceutical company, has announced the dosing of the first patient in a Phase II clinical study for its Category 1 therapeutic biologic product, GZR4. GZR4 is an investigational ultra-long-acting insulin designed for once-per-week subcutaneous injection to treat diabetes. Design and Objectives of…