Biotechnology
CARsgen Therapeutics Receives Positive EMA Opinion on Orphan Drug Designation for Fully Human Anti-BCMA CAR-T Cells (CT053) for the Treatment of Multiple Myeloma
SHANGHAI, April 27, 2020 /PRNewswire/ -- CARsgen Therapeutics Co., Ltd., a clinical-stage biopharmaceutical company, today announced the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) adopted a positive opinion on CARsgen's application for orphan designation of its...
Volition Files Patent for Nu.Q(TM) COVID-19 Triage Test and Commences Proof of Concept Studies
AUSTIN, Texas, April 23, 2020 /PRNewswire/ -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") today announced that it is actively developing a COVID-19 triage test aiming to predict the likelihood that an individual who is COVID-19 positive will develop complications and severe disease, usi...
Samsung Biologics and ImmuneOncia Therapeutics Inc. Development and Manufacturing Agreement Accomplishes IND Clearance of IMC-002 (anti-CD47 antibody)
SONGDO, South Korea, April 22, 2020 /PRNewswire/ -- Samsung Biologics (207940.KS) and ImmuneOncia Therapeutics Inc. announced the successful FDA IND approval of IMC-002 under a development and manufacturing agreement with Samsung Biologics since 2018. As a result, ImmuneOncia will begin Phase 1 ...
Samsung Biologics Earnings to Beat Consensus Again, Continues to Sign New Projects with Enhanced Virtual Support
SONGDO, South Korea, April 22, 2020 /PRNewswire/ -- Samsung Biologics (KRX: 207940.KS) announced Q1 earnings results onMonday, April 20th. The company posted consolidated sales of207.2 billion Korean Won, operating profit of 62.6 billion Korean Won, and net income of 39.1 billion Korean Won. The ...
Transcenta Received IND Clearance from FDA for Initiating Clinical Trials for its Novel Humanized Claudin 18.2 Monoclonal Antibody TST001
SUZHOU and HANGZHOU, China, April 20, 2020 /PRNewswire/ -- Transcenta Holding Limited. ("Transcenta"), a global biotherapeutics company that fully integrates antibody-based biotherapeutics discovery, R&D and manufacturing, today announced that its subsidiary Mabspace Biosciences (Suzhou) Co., Lim...
Innovent Biologics Announces FDA Approval of Pemazyre™ (Pemigatinib) as First Targeted Treatment for Adults with Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma
SUZHOU, China, April 19, 2020 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent" or "the Company") (HKEX: 1801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, autoimmune, metabolic and other major dis...
Nucleus Network's 10 Step Guide to conducting Clinical Trials during a time of uncertainty
MELBOURNE, Australia, April 14, 2020 /PRNewswire/ -- A new white paper,
Undertaking Phase I Clinical Trials inAustralia During a Time of Uncertainty
WuXi Biologics (Suzhou) Successfully Passed First EMA GMP Inspection
SUZHOU, China, April 13, 2020 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.HK), a global company with leading open-access biologics technology platform, announced that WuXi Biologics (Suzhou) Co., Ltd. has successfully passed its first GMP inspection by the European Medicines Agency (EMA), wi...
Gracell to Present the First-in-human, Universal TruUCAR™ GC027 Therapy for Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia at the AACR Annual Meeting
SUZHOU, China and SHANGHAI, April 13, 2020 /PRNewswire/ -- Gracell Biotechnologies Co., Ltd. ("Gracell"), a clinical-stage immune cell and gene therapy company, is pleased to announce that their first-in-human phase I data of UniversalTruUCAR™ GC027 in relapsed or refractory (R/R) T-cell acute l...
Samsung Biologics and Vir Biotechnology Enter into Agreement for Large Scale Manufacture of SARS-COV-2 Antibodies for Potential COVID-19 Treatment
SONGDO, South Korea and SAN FRANCISCO, April 9, 2020 /PRNewswire/ -- Samsung Biologics (207940.KS) and Vir Biotechnology, Inc. (Nasdaq: VIR) today announced a manufacturing agreement under which Samsung Biologics will perform large scale manufacturing services for Vir's SARS-CoV-2 monoclonal anti...
Bridge Biotherapeutics Discloses Interim Results from the First Cohort of Phase 2a Study of BBT-401, an Experimental Drug for Ulcerative Colitis
* The Interim data showed that 3 out of 9 evaluable patients on BBT-401 responded with more than 30% reduction in Total Mayo Score or 25% reduction in Partial Mayo Score * Safety and tolerability profiles remain consistent with results from Phase I trial in healthy volunteers SEONGNAM, South ...
Samsung Biologics named Champion in 2020 CMO Leadership Awards
SONGDO, South Korea, April 8, 2020 /PRNewswire/ -- Samsung Biologics (207940.KS) announced that it has been awarded the 2020 CMO Leadership Awards for its excellence in the Capabilities, Compatibility, Quality, Reliability, and Service categories across Big Pharma and Overall (combined Big and Sm...
THE.WAVE.TALK raises US$2M
SEOUL, South Korea, April 7, 2020 /PRNewswire/ -- THE.WAVE.TALK, a member company of theBorn2Global Centre, successfully attracted a funding of USD 2 million in early February from Yellowdog and Silicon Valley-based Big Basin Capital, bringing its accumulated total to approximately USD 6 million ...
Samsung Biologics enters into a development and manufacturing partnership with PharmAbcine for oncology and neovascular treatment
SONGDO, South Korea, April 5, 2020 /PRNewswire/ -- Samsung Biologics (207940.KS) entered into a strategic partnership with PharmAbcine for the development and manufacturing of PMC-402 pipeline, a next generation therapeutic antibody candidate to treat oncology and neovascular disorders. Under th...
Gracell Announces China NMPA Acceptance of Investigational New Drug Application for GC007g Cell Therapy for CD19 Positive Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia
SHANGHAI and SUZHOU, China, April 3, 2020 /PRNewswire/ -- Gracell Biotechnologies Co., Ltd. ("Gracell"), a clinical-stage immune cell & gene therapy company, is pleased to announce that China National Medical Products Administration (NMPA) has accepted Gracell's Investigational New Drug (IND) ...
ImmuneMed's 'hzVSF,' Used for Treatment of COVID-19 Pneumonia Patients
CHUNCHEON, South Korea, March 30, 2020 /PRNewswire/ -- 'hzVSF v13 (humanized Virus Suppressing Factor; VSF)', a treatment that can be used for a wide range of viral diseases developed by ImmuneMed, was administered onMarch 28th at Yonsei University Hospital to treat COVID-19 pneumonia patients...
Samsung Biologics expands leadership for CDO business
SONGDO, South Korea, March 30, 2020 /PRNewswire/ -- Samsung Biologics
(207940.KS) has appointedEun Young Yang as vice president of business
development for the company's expanded CDO (contract development organization)
business.
WuXi Biologics Achieved Remarkable Results in 2019
57.2% Revenue Growth to RMB3,983.7 Million 63.0% Gross Profit Growth to RMB1,658.8 Million Adjusted Net Profit Up 60.3% to RMB1,205.0 Million Diluted EPS of RMB0.76 and Adjusted Diluted EPS of RMB0.91, Increasing 58.3% and 59.6% Backlog Increased 40.2% to US$5.1 Billion Milestone Payments Surg...
WuXi AppTec Reports Strong 2019 Annual Results
Revenue Growth Accelerated 33.9% Year-Over-Year to RMB12,872 Million Adjusted Non-IFRS Net Profit Attributable to Owners of the Company Up 38.2% Year-Over-Year toRMB2,407 Million Adjusted Diluted Non-IFRS EPS Up by 19.7% to RMB1.46[1] SHANGHAI, March 24, 2020 /PRNewswire/ -- WuXi AppTec Co., Ltd. ...
Novogene unveils intelligent Next Generation Sequencing delivery platform - Falcon
BEIJING, March 24, 2020 /PRNewswire/ -- Novogene recently announced Falcon, the first intelligent delivery platform for high-throughput Next Generation Sequencing (NGS). This platform represents a breakthrough in traditional NGS and will shape NGS industry standards and drive the future developme...
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