Pharmaceuticals

Nippon Express (UK) Receives WDA and GDP Certification for Company Warehouse near London Heathrow Airport

TOKYO, May 22, 2020 /PRNewswire/ -- Nippon Express (UK) Co., Ltd. (hereinafter, "NEUK"), a local subsidiary of Nippon Express Co., Ltd. based inTokyo, has been officially granted Wholesale Distribution Authorisation (WDA) and Good Distribution Practice (GDP) certification for its warehouse near L...

2020-05-22 13:00 1530

GSK partners with Samsung Biologics to secure additional manufacturing capacity for innovative biopharmaceutical portfolio

LONDON and SONGDO, South Korea, May 21, 2020 /PRNewswire/ -- GlaxoSmithKline plc (LSE/NYSE: GSK) and Samsung Biologics (207940.KS) have entered into a partnership to provide GSK with additional capacity to manufacture and supply GSK's innovative biopharmaceutical therapies. Under the terms of th...

2020-05-22 07:11 6501

I-Mab and Genexine Announce China NMPA Clearance for Phase 2 Clinical Trial of TJ107/HyLeukin-7™ in Glioblastoma Multiforme

SHANGHAI, GAITHERSBURG, Md. and SEOUL, South Korea, May 21, 2020 /PRNewswire/ -- I-Mab (NASDAQ: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development and commercialization of novel or highly differentiated biologics to treat diseases with significant unmet medi...

2020-05-21 20:00 5906

Alterity Therapeutics presents data on ATH434 to the American Academy of Neurology

MELBOURNE, Austrilia and SAN FRANCISCO, May 21, 2020 /PRNewswire/ -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) ("Alterity" or "the Company") has presented data on ATH434 (formerly PBT434) for the treatment of Multiple System Atrophy at the American Academy of Neurology (AAN) virtual meeting....

2020-05-21 08:58 6223

China Biologic Comments on the Xinjiang Deyuan and Shuanglin Transaction

BEIJING, May 20, 2020 /PRNewswire/ -- China Biologic Products Holdings, Inc. (NASDAQ: CBPO, "China Biologic" or the "Company"), a leading fully integrated plasma-based biopharmaceutical company inChina, today declared that Xinjiang Deyuan Bioengineering Co., Ltd. ("Xinjiang Deyuan"), China Biolog...

2020-05-21 04:45 11556

China Biologic Reports Financial Results for the First Quarter of 2020

BEIJING, May 20, 2020 /PRNewswire/ -- China Biologic Products Holdings, Inc. (NASDAQ: CBPO, "China Biologic" or the "Company"), a leading fully integrated plasma-based biopharmaceutical company inChina, today announced its unaudited financial results for the first quarter of 2020. First Quarter ...

2020-05-21 04:30 10707

Macrogen Approved for Export of its COVID-19 Test Kit

SEOUL, South Korea, May 20, 2020 /PRNewswire/ -- The Korean biotech company Macrogen (CEO Sukang Lee) (KOSDAQ: 038290), announced that it obtained export approval for COVID-19 test kit 'AxenTM COVID-19 RT' from the Ministry of Food and Drug Safety (MFDS) on the 18th. ...

2020-05-20 21:00 1964

I-Mab Expands Global Presence with New Hong Kong Office

SHANGHAI and ROCKVILLE, Md., May 20, 2020 /PRNewswire/ -- I-Mab (NASDAQ:IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel or highly differentiated biologics to treat diseases with significant unmet medical needs, particularly ...

2020-05-20 16:00 7884

Samsung Biologics Expands Business Continuity Excellence with Additional ISO22301 Certification

SONGDO, South Korea, May 19, 2020 /PRNewswire/ -- Samsung Biologics (207940.KS) announced it has attained ISO22301 certification for additional business operations, demonstrating its unsurpassed commitment to ensuring client satisfaction and operational excellence through its world-class business...

2020-05-20 07:11 1911

SciMount announces FDA approval of SMP-100's IND application for the treatment of Irritable Bowel Syndrome

CHENGDU, China, May 13, 2020 /PRNewswire/ -- SciMount Pharmatech, Co. Ltd., a wholly-owned subsidiary ofXiling Lab, announces today that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for SMP-100 for the treatment of Irritable Bowel Synd...

2020-05-14 18:00 1244

First Patient Dosed with I-Mab's CD73 Antibody TJD5 in Phase 1/2 Clinical Trial in China for Advanced Solid Tumors

SHANGHAI and ROCKVILLE, Md., May 13, 2020 /PRNewswire/ -- I-Mab (NASDAQ: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel or highly differentiated biologics to treat diseases with significant unmet medical needs, today announ...

2020-05-13 20:00 5389

ChemPartner Assists the Mount Sinai Health System in Producing Reagent for COVID-19 Research

SHANGHAI, May 12, 2020 /PRNewswire/ -- Shanghai ChemPartner announced they have entered into a non-exclusive agreement with the Mount Sinai Health System ( Mount Sinai) to assist in a trial production run of a component of the Mount Sinai COVID-19 serological assay that recently received Emergency...

2020-05-12 23:03 2071

China Biologic Products to Report First Quarter 2020 Financial Results

BEIJING, China, May 12, 2020 /PRNewswire/ -- China Biologic Products Holdings, Inc. (NASDAQ: CBPO) ("China Biologic" or the "Company"), a leading fully integrated plasma-based biopharmaceutical company inChina, today announced that the Company plans to release its first quarter 2020 financial res...

2020-05-12 20:30 9833

HJB and Mabspace Biosciences' Development and Manufacturing Agreement for Novel Humanized Claudin18.2 Monoclonal Antibody Accomplished FDA and NMPA IND Clearance

HANGZHOU, China, May 8, 2020 /PRNewswire/ -- HJB, a biologics CDMO committed to quality, reliability and speed for each and every CMCpackage delivered to its partners, today announces that its partner Mabspace Biosciences has received Investigational New Drug (IND) clearance from both the U.S. Fo...

2020-05-08 23:00 1978

Bridge Biotherapeutics Announces the IND Clearance of BBT-176, an EGFR TKI for NSCLC, in South Korea

* Following the US FDA's IND clearance, South Korea's MFDS cleared the IND application of BBT-176, submitted inDecember 2019 * BBT-176 will be the company's first drug candidate to launch clinical studies inSouth Korea * In the second half of this year, the company is expected to initiate a ...

2020-05-08 07:30 1715

Alterity Therapeutics Limited Releases Its Appendix 4C - Q3 FY20 Quarterly Cash Flow Report

Highlights: * European Commission designated Orphan Drug status for ATH434's treatment of Multiple System Atrophy in the European Union * Phase 2 preparatory work continues * Cash balance of $10.4M MELBOURNE, Australia and SAN FRANCISCO, April 30, 2020 /PRNewswire/ -- Alterity Therapeutics ...

2020-04-30 16:35 11369

Fosun Pharma Invites Chinese and Foreign Experts to Jointly Discuss Prevention and Control Measures of COVID-19 Epidemic in Africa

SHANGHAI, April 29, 2020 /PRNewswire/ -- In order to support African medical institutions in their response to the COVID-19 pandemic, Fosun Pharma(Stock Code: 600196.SH, 02196.HK), partnering with Shanghai Fosun Foundation, Fosun Medical and Tridem Pharma, People's Daily Health platform and the H...

2020-04-30 00:50 8686

Gracell Reports Data of First-in-human Clinical Trial for Universal TruUCAR™ GC027 in Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia at the AACR Virtual Annual Meeting

SUZHOU, China and SHANGHAI, April 28, 2020 /PRNewswire/ -- Gracell Biotechnologies Co., Ltd. ("Gracell"), a clinical-stage immune cell and gene therapy company, has announced data of its first-in-human clinical trial for UniversalTruUCAR™ GC027 in relapsed or refractory (R/R) T-cell acute lympho...

2020-04-29 04:00 1387

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...

2020-04-27 18:00 5523

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 ...

2020-04-23 08:00 1507