-
Oramed Pharmaceuticals and Hefei Tianhui Biotech to Form Joint Venture for Oral Insulin Product
•
Israel-based drug developer Oramed Pharmaceuticals Inc., (NASDAQ: ORMP) has revealed that a deal has been signed with its existing China-based partner, Hefei Tianhui Biotech Co., Ltd (HTIT), to establish a joint venture (JV). The non-binding term sheet signed by both parties outlines that the JV will focus on the development…
-
Astellas Pharma’s Izervay Receives FDA Approval for Geographic Atrophy Treatment
•
Japan-based Astellas Pharma Inc., (TYO: 4503) has announced that it has received new market approval from the US FDA for its drug Izervay (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). This approval reinforces the rationale behind Astellas’ July 2023 acquisition…
-
Regeneron Pharmaceuticals Halts Enrollment in REGN5678 Clinical Trial After Patient Deaths
•
US-based Regeneron Pharmaceuticals Inc., (NASDAQ: REGN) has reported in its Q2 2023 financial results the suspension of enrollment in a clinical trial for the experimental bispecific antibody (BsAb) drug, REGN5678. This drug, which targets PSMA and CD28, is under Phase I assessment for treating prostate cancer, both as a monotherapy…
-
Ascentage Pharma’s Lisaftoclax (APG-2575) Gets FDA Green Light for Phase III Study
•
China-based Ascentage Pharma (HKG: 6855) has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a regulatory Phase III clinical study for its novel Bcl-2 inhibitor, lisaftoclax (APG-2575). The study will evaluate the efficacy of lisaftoclax in combination with a Bruton’s tyrosine kinase…
-
Jenscare Scientific and Lifetech Scientific Achieve Milestone with First Compassionate Use of LuX-Valve Plus
•
Partners Jenscare Scientific Co., Ltd. (HKG: 9877), a leading structural heart disease device manufacturer based in Ningbo, and Lifetech Scientific Corporation (HKG: 1302) have successfully accomplished the first compassionate use case utilizing Jenscare’s transjugular tricuspid valve replacement product, LuX-Valve Plus, in Hong Kong. Understanding Compassionate UseCompassionate use, also referred to…
-
GuangDong Pharmaceutical Association Releases Updated Off-Label Drug List for 2023
•
The GuangDong Pharmaceutical Association has released the 2023 version of its off-label drug list, marking the 9th edition since its inception in 2015. The list serves as a reference tool rather than a recommendation guide. Contributors to this comprehensive list include Class 3A hospitals from various provinces across China, including…
-
Venus Medtech Receives FDA IDE Approval for VenusP-Valve, a Milestone for Chinese Heart Valve Technology
•
Venus Medtech (Hangzhou) Inc. (HKG: 2500) has announced obtaining Investigational Device Exemption (IDE) approval from the US FDA for its VenusP-Valve, marking a significant step as the first China-developed heart valvular system to be approved by the FDA for clinical trial. IDE approval is a critical exemption that allows medical…
-
MicroPort CardioFlow Announces Positive Results for Transcatheter Mitral Valve Replacement System
•
China-based MicroPort Scientific Corp’s spin-off, MicroPort CardioFlow Medtech Co., Ltd (HKG: 2160), has announced positive follow-up results for its in-house developed transcatheter mitral valve replacement system. The system has successfully treated multiple severe cases of mitral regurgitation, a condition characterized by the leakage of the mitral valve. One-Year Follow-Up and…
