China’s CDE Releases Guidelines for CGT Clinical Trials Communication
The Center for Drug Evaluation (CDE) in China has released the “Technical Guiding Principles for...
Cell-therapy
Gilead’s Kite Receives FDA Nod to Add Overall Survival Data to Yescarta for Large B-Cell Lymphoma
Gilead Sciences Inc. (NASDAQ: GILD) subsidiary Kite has received approval from the U.S. Food and...
Simcere Affiliate Shanghai Simnova Biotech Gets China Nod for CAR-T Therapy SNC109
Shanghai Simnova Biotech Co., Ltd, known as Simnova outside of China and an affiliate of...
AstraZeneca to Acquire China’s Gracell Biotechnologies in $1.2 Billion Deal
Pharmaceutical giant AstraZeneca (AZ, NASDAQ: AZN) has announced its intention to fully acquire Gracell Biotechnologies...
Legend Biotech’s Carvykti Therapy to Include Myeloid Neoplasms Warning in Label Update
GenScript Biotech Corporation (HKG: 1548), a China-based Contract Research Organization (CRO), has announced that its...
AbelZeta Pharma Expands Janssen Partnership to Include Commercial Rights in China
AbelZeta Pharma Inc., a Sino-US biotechnology company with operations in Rockville, Maryland, and Shanghai, China,...
J&J’s Carvykti Demonstrates Extended Time to Symptom Worsening in Multiple Myeloma Patients
Johnson & Johnson (J&J; NYSE: JNJ) has released data from a Phase III study showing...
CARsgen Therapeutics Halts Clinical Studies for Three CAR-T Therapies in the US Following FDA Request
China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171) has announced that the US Food and Drug...
Chinese Biotech Precision Biotechnology Gets NMPA Green Light for Advanced Cancer Therapies
Chongqing Precision Biotechnology Co., Ltd, a Chinese biopharmaceutical company, has received approval from the National...
Taiwan Bio and TRACT Therapeutics Forge Partnership to Combat Organ Rejection
Taiwan Bio Therapeutics Co., Ltd. has entered into a strategic partnership with U.S.-based TRACT Therapeutics,...
Stem-Cell Startup Xellsmart Earns FDA Orphan Drug Designation for ALS Therapy
Xellsmart, a stem-cell startup headquartered in Suzhou, has announced that it has received orphan drug...
CARsgen Therapeutics Secures U.S. FDA Approval for CT071 Clinical Trials in Multiple Myeloma
CARsgen Therapeutics Holdings Ltd (HKG: 2171), based in China, has announced that it has received...
China’s State Council Unveils Comprehensive Plan to Boost Beijing’s Healthcare Sector
The State Council has unveiled a comprehensive “Work Plan” aimed at enhancing Beijing’s service industry...
JW Therapeutics Secures Priority Review for Carteyva in Relapsed/Refractory Mantle Cell Lymphoma
JW Therapeutics (HKG: 2126), based in China, has announced that its CAR-T cell therapy, Carteyva...
Gracell Biotechnologies Gets FDA Green Light for FasTCAR-T Therapy in Systemic Lupus Erythematosus
Gracell Biotechnologies Inc., a Suzhou-based biotech company (NASDAQ: GRCL), has received approval from the US...
AstraZeneca to Open R&D Center in Hong Kong, Focusing on Cell and Gene Therapies
UK pharmaceutical giant AstraZeneca (AZ; NASDAQ: AZN) has concluded a roughly 12-month discussion period with...
SCG Cell Therapy’s SCG101 Receives Tacit Approval for Cholangiocarcinoma Clinical Trial in China
China’s Center for Drug Evaluation (CDE) website has indicated that SCG Cell Therapy Pte. Ltd’s...
BMS and 2seventy Bio’s Abecma Faces FDA Review Extension
The US Food and Drug Administration (FDA) has postponed the target action date for Bristol...
Suzhou Porton Biologics Partners with Asclepius Technology for NK Cell Project
China-based Contract Development and Manufacturing Organization (CDMO) Suzhou Porton Biologics Ltd has entered into a...
Gilead’s Kite Expands Partnership with Arcellx for Innovative Cell Therapies
Gilead (NASDAQ: GILD), a leading biopharmaceutical company, has announced an expansion of its 2022 partnership...