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AstraZeneca’s Soliris Gains Approval for Pediatric Generalized Myasthenia Gravis in Japan
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UK pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) announced last week that it has received an indication extension approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for its orphan drug Soliris (eculizumab). The drug is now approved as a treatment for generalized myasthenia gravis (gMG) in pediatric patients who…
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AstraZeneca and Daiichi Sankyo’s Enhertu Earns Two BTDs for HER2+ Malignancies
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The US Food and Drug Administration (FDA) has granted AstraZeneca (AZ; NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) two breakthrough therapy designations (BTDs) for their co-developed antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan). This recognition is for its potential as a therapy for HER2-positive malignancies, including unresectable or metastatic solid tumors…
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Bayer Funds Landmark Trials for Kerendia in Heart Failure Treatment Expansion
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Germany-based pharmaceutical company Bayer (ETR: BAYN) has announced funding for three investigator-sponsored collaborative studies aimed at expanding its late-stage clinical development program of the mineralocorticoid receptor antagonist (MRA) Kerendia (finerenone) for heart failure (HF). These new trials will broaden the patient pool to include those with reduced (HfrEF), mildly reduced…
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EMA and FDA Review AbbVie’s Skyrizi for Ulcerative Colitis Indication Extension
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The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have accepted for review indication extension filings for AbbVie’s (NYSE: ABBV) interleukin-23 (IL-23) inhibitor Skyrizi (risankizumab) for the treatment of moderately to severely active ulcerative colitis (UC). This development marks a further expansion of Skyrizi’s potential applications…
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Shandong Buchang Pharmaceuticals’ BC001 for mCRC Accepted for Review by NMPA
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Shandong Buchang Pharmaceuticals Co., Ltd (SHA: 603858), a China-based pharmaceutical company, has announced that the National Medical Products Administration (NMPA) has accepted a clinical trial filing for its investigational injectable product BC001. The product is intended for use in first and second-line metastatic colorectal cancer (mCRC) patients who have experienced…
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Sirnaomics’ STP707 siRNA Drug Shows Promising Results in Phase I Solid Tumor Study
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Sino-US siRNA therapy developer Sirnaomics Ltd (HKG: 2257) has revealed that all patients have been dosed in a Phase I clinical study for its siRNA drug candidate STP707, which targets multiple solid tumors. The study is designed to assess the safety, tolerability, and anti-tumor activity of STP707 in six dose…
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Servier Group’s Pancreatic Cancer Therapy Onivyde Launches in Major Chinese Cities
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France-based Servier has announced the first prescriptions for its pancreatic cancer therapy, Onivyde (irinotecan), in 10 hospitals across major cities in China, including Tianjin, Beijing, Shanghai, Nanjing, Fuzhou, and Guangzhou. The drug is used to treat metastatic pancreatic cancer after gemcitabine treatment, in combination with 5-fluorouracil (5-FU) plus leucovorin (LV).…
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Junshi Biosciences Reports H1 2023 Revenue Dip Amid Commercial Success and R&D Focus
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China’s Junshi Biosciences (HKG: 1877; SHA: 688180) has released its financial report for the first half of 2023, recording RMB 670 million (USD 91.9 million) in revenues, a 29.21% year-on-year (YOY) decrease, primarily due to decreased licensing income. Despite this, commercialized products generated RMB 625 million (USD 85.8 million), marking…
