Pharmaceuticals
Macrogen Approved for Export of its COVID-19 Test Kit
SEOUL, South Korea, May 20, 2020 /PRNewswire/ -- The Korean biotech company
Macrogen
2020-05-20 21:00
1915
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
7837
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
1861
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
1212
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
5348
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
2018
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
9722
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
1932
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
1680
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
11292
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
8633
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
1357
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
5380
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
1470
Clarity Pharmaceuticals Announces US FDA Grants 67Cu-SARTATE™ Orphan Drug Designation for Neuroblastoma
SYDNEY, April 21, 2020 /PRNewswire/ -- Clarity Pharmaceuticals, a radiopharmaceutical company focused on the treatment of serious disease, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for67Cu-SARTATE™, a therapy for the clinica...
2020-04-21 21:13
1179
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...
2020-04-20 23:00
1107
Fosun Pharma Receives FDA Emergency Use Authorization (EUA) For Its COVID-19 RT-PCR Detection Kit
SHANGHAI, April 19, 2020 According to the website of the U.S. Food and Drug Administration ("FDA"), Shanghai Fosun Pharmaceutical (Group) Co., Ltd ("Fosun Pharma"; Stock Code: 600196.SH, 02196.HK)has received emergency use authorization (EUA) from FDA for its COVID-19 RT-PCR detection kit. The t...
2020-04-19 20:00
4927
GC Pharma lights up to celebrate 'World Hemophilia Day'
YONGIN, South Korea, April 17, 2020 /PRNewswire/ -- GC Pharma (formerly known
as Green Cross Corporation), a South Korean biopharmaceutical company,
participate in campaign to celebrate World Hemophilia Day.
2020-04-17 21:00
2683
Mayne Pharma Submits New Drug Application for E4/DRSP to the FDA
ADELAIDE, Australia and LIEGE, Belgium, April 16, 2020 /PRNewswire/ -- Mayne Pharma Group Limited (ASX: MYX) and Mithra Pharmaceuticals, SA (Euronext Brussels: MITRA) today announced that Mayne Pharma has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA), seeking...
2020-04-16 12:30
5952
PharmaBlock Opens New Chemistry and Engineering Technology Center in Zhejiang
NANJING, China, April 13, 2020 /PRNewswire/ -- Early this April, PharmaBlock Sciences (Nanjing), Inc. announced the launch of a new Chemistry and Engineering Technology Center (CETC) located next to its GMP manufacturing site in Shangyu,Zhejiang Province. Addition of the CETC will further strengt...
2020-04-13 20:00
1304
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