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Jiangsu Hengrui Pharmaceuticals Gets NMPA Approval for Phase Ib/III Study of Dalpiciclib in mHSPC
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a multi-center, randomized, double-blind Phase Ib/III clinical study. The study will assess the combination of dalpiciclib (SHR6390) with abiraterone plus prednisone in patients with metastatic hormone…
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Otsuka and Shape Therapeutics Partner on Ophthalmology Gene Therapies Development
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Japan drug maker Otsuka (OTCMKTS: OTSKY) and US firm Shape Therapeutics have announced a strategic partnership aimed at developing a range of ophthalmology gene therapies. The collaboration will leverage Shape’s machine learning-backed capsid discovery platform to create viral vectors with high target precision, enabling lower doses, and its transgene engineering…
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Roche and Alnylam’s Zilebesiran Achieves Primary Endpoint in Hypertension Phase II Trial
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Roche (SWX: ROG) and Alnylam (NASDAQ: ALNY) have announced that a Phase II trial for their RNAi therapeutic, zilebesiran, has successfully met its primary endpoint of significantly reducing 24-hour mean systolic blood pressure (SBP) at month three in patients with mild-to-moderate hypertension. The results also demonstrated reductions in SBP and…
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CDE Annual Report: Clinical Trials for Innovative Drugs in China Reach Record High
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The Center for Drug Evaluation (CDE) has released its annual report on clinical trials in support of innovative drugs in China for the year 2022. The report provides insights into the trends and developments in the clinical trial landscape for innovative drugs within the country. Record Number of Clinical Trial…
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Pfizer and Valneva’s Lyme Disease Vaccine VLA15 Shows Promise as Booster in Pediatric Trials
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Partners Pfizer (NYSE: PFE) and Valneva SE (NASDAQ: VALN) have revealed that their Lyme disease vaccine candidate, VLA15, has demonstrated immunogenicity and safety as a booster shot in individuals aged between 5 and 17 years. The primary scheme resulted in seroconversion rates of 94.6% to 95.3% for all serotypes of…
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European Commission Approves Pediatric Indication for MSD’s Ervebo Ebola Vaccine
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The European Commission (EC) has granted Merck, Sharp & Dohme (MSD; NYSE: MRK) approval for a pediatric indication for its vaccine Ervebo, expanding its use as an active immunization for individuals aged 1 year or older against Ebola virus disease (EVD) caused by Zaire ebolavirus. This life-threatening condition has been…
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Cutia Therapeutics’ CU-40102 Meets Primary Endpoint in Phase III Study for Androgenic Alopecia
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Dermatology therapy developer Cutia Therapeutics (HKG: 2487) has announced that its Phase III clinical study for CU-40102 (external einasteride spray) in androgenic alopecia in China has successfully reached its primary endpoint. Study Design and Patient EnrollmentThe multi-center, randomized, double-blind, placebo-controlled Phase III regulatory study was designed to assess the efficacy…
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AstraZeneca’s Ultomiris Faces FDA Rejection for NMOSD Indication Extension
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UK pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) has received a rejection from the US Food and Drug Administration (FDA) for an indication extension of its complement inhibitor Ultomiris (ravulizumab) to treat neuromyelitis optica spectrum disorder (NMOSD) in AQP4 antibody positive (Ab+) adults. The FDA has requested modifications to the drug’s…
