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CDE Lists Five Drugs and One Companion Diagnostic for Priority Review Status
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The Center for Drug Evaluation (CDE) has indicated on its website that five investigational drugs and one companion diagnostic (CDx) are on track to receive priority review status. The drugs include: Novartis’ Fabhalta (iptacopan) for C3 glomerulopathy (C3G), a best-in-class specific complement factor B oral inhibitor that comprehensively controls intravascular…
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Hainan Province Approves Heart-Lung Walking Test Analysis Software as Category II Device
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The Hainan Medical Products Administration has granted marketing approval to a heart-lung walking test data analysis software following a priority review process. This digital therapy product, classified as a Category II medical device, is designed to assist healthcare professionals in evaluating patients’ exercise cardiopulmonary function, excluding automatic diagnosis. The approval…
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Frontera Therapeutics Receives FDA Approval for Phase II Study of First Chinese rAAV Gene Therapy
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Frontera Therapeutics, Inc., a Sino-US biopharmaceutical company, has announced that it has received approval from the US Food and Drug Administration (FDA) to proceed with a Phase II clinical study for its investigational gene therapy, FT-002. This recombinant adeno-associated virus (rAAV) gene therapy candidate marks a significant milestone as the…
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Suzhou’s LongBio Secures RMB 100 Million in Series B2 Financing to Advance Clinical Programs
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LongBio, a biopharmaceutical company specializing in biomacromolecule drug development and based in Suzhou, China, has reportedly secured nearly RMB 100 million in a Series B2 financing round. The round was led by Qiming Venture Partners, with the funds earmarked to accelerate the clinical trials of its core programs in China,…
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Yunnan Province Increases Pediatric Medical Service Prices for Children Under 6
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The Yunnan Provincial Healthcare Security Administration and the Health Commission of Yunnan Province have issued a notification to implement a policy that allows for increased pricing on certain pediatric medical services for children under the age of 6 in public medical institutions, effective from October 10, 2024. This policy aims…
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Sihuan Pharmaceutical Sees Aesthetics and Biopharma Growth Amid Overall Revenue Dip
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Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460), a leading pharmaceutical company in China, has released its financial report for the first half of 2024, highlighting a strategic pivot towards medical aesthetics and biopharmaceuticals. The company’s “medical aesthetics + innovative drug” dual-driven strategy has been instrumental in this transformation. For the…
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Global Researchers Call for the Revival of the Human Genome Project to Advance Precision Medicine
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A consortium of international researchers, spearheaded by a team from China’s gene sequencing giant BGI, has issued a call to action for the revival of the Human Genome Project (HGP) in a new iteration dubbed HGP2. The initiative aims to address the burgeoning challenges facing the advancement of precision medicine…
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Sanofi’s Sarclisa Secures FDA Approval for First-Line Multiple Myeloma Treatment
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Sanofi (EPA: SAN; NASDAQ: SNY) has announced that the US Food and Drug Administration (FDA) has granted a third indication for its CD38 antibody Sarclisa (isatuximab) for the treatment of multiple myeloma (MM). The new approval allows for the first-line use of Sarclisa in combination with standard-of-care treatments, specifically bortezomib,…
