Pharmaceuticals
GenScript ProBio and Neoletix signed a letter of intent on clinical and commercial production of recombinant human coagulation factor VIII
NANJING, China, June 1, 2021 /PRNewswire/ -- On June 1st 2021, GenScript ProBio and Neoletix (Beijing) Biotechnology Co., Ltd. (hereinafter referred to as Neoletix) signed a letter of intent on cooperation for clinical and commercial production of human coagulation factor VIII. GenScript ProBio s...
2021-06-01 21:00
1496
Positive FDA meetings enable Neuren to proceed with INDs for three Phase 2 trials
Highlights: * Clear and constructive guidance received from pre-IND meetings with the FDA Office of Neuroscience for Phase 2 clinical trials of NNZ-2591 in Phelan-McDermid, Angelman andPitt Hopkins syndromes * Positive outcome is an important milestone that enables Neuren to proceed with IND...
2021-06-01 18:00
1134
Samsung Biologics to add mRNA vaccine drug substance manufacturing suite to expand portfolio of services
* Samsung Biologics, a global leading CDMO, will add mRNA vaccine DS production capability to its existing facility by the first half of 2022 * The addition will enable Samsung Biologics to provide end-to-end mRNA vaccine manufacturing services from bulk drug substance to aseptic fill/finish ...
2021-05-31 19:00
2253
Dr. Seungpil Yu will hold a retirement ceremony and conclude his 46-year term as a pharmaceutical executive.
SEOUL, South Korea, May 28, 2021 /PRNewswire/ -- Dr. Seungpil Yu is a living witness to the long history of Yuyu Pharma, which celebrated its 80th anniversary this year, having laid the foundation for Yuyu Pharma to continue to thrive well into its 100th year. While in the United States, Dr. Yu r...
2021-05-28 21:00
3168
Samsung Biologics Adds Four Global ISO Certifications For BCMS, Energy, Health & Safety, and Environmental Management
* Expanding upon its existing ISO22301 certification, Samsung Biologics is now fully certified with Business Continuity Management System for Security and Resilience across all business areas * Samsung Biologics adds ISO50001, ISO45001, ISO14001 for Energy Management, Occupational Health and ...
2021-05-28 20:00
2740
AffaMed Therapeutics Announces Approval for the Phase IIb Clinical Study of AM006 in China for the Treatment of Parkinson's Disease
SHANGHAI, May 27, 2021 /PRNewswire/ -- AffaMed Therapeutics ("AffaMed"), a global clinical stage biopharmaceutical company dedicated to addressing critical unmet medical needs in ophthalmic, neurological and psychiatric disorders, today announced thatChina's National Medical Products Administrati...
2021-05-28 08:00
1586
Daewoong, first-in-class PRS-inhibitor for Idiopathic Pulmonary Fibrosis(IPF) shows promising result in early stage clinical test
* We confirmed the safety of 'DWN12088' and secured grounds for establishing treatment dosage * Confirming the potential as a treatment for IPF and planning to apply for Ph.2 within 2021 * 2nd ODD granted as treatment for systemic sclerosis from the US FDA SEOUL, South Korea, May 27, 2021...
2021-05-27 21:00
1497
Foresee Pharmaceuticals Announces FDA Approval of CAMCEVI® for the Treatment of Advanced Prostate Cancer; Accord BioPharma to Head the U.S. Commercialization
TAIPEI, May 26, 2021 /PRNewswire/ -- Foresee Pharmaceuticals (6576.TWO), ("Foresee") announced today that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for CAMCEVI® 42 mg, a ready-to-use 6-month subcutaneous depot formulation of leuprolide mesylate, as a ...
2021-05-27 11:33
2341
TransThera announces collaboration with Roche to evaluate TT-00420 as part of a novel combination to treat GI cancers in China
NANJING, China, May 26, 2021 /PRNewswire/ -- TransThera Biosciences Co. Ltd. ( "TransThera" ), a clinical stage biotechnology company dedicated to developing innovative therapeutics across oncology, cardiovascular, and inflammatory diseases with major unmet medical needs globally and inChina, to...
2021-05-26 21:00
1465
Gracell Biotechnologies Hosting Key Opinion Leader Webinar on High Risk Multiple Myeloma, Treatment Challenges and Dual-Targeting CAR-T with Overnight Manufacturing - a Novel Approach for Treatment of Multiple Myeloma
SUZHOU, China and PALO ALTO, Calif., May 26, 2021 /PRNewswire/ -- Gracell Biotechnologies Inc. (NASDAQ: GRCL) ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to discovering and developing highly efficacious and affordable cell therapies for the treatment of cancer, today ...
2021-05-26 21:00
10288
I Peace's cell manufacturing facility "Peace Engine Kyoto" receives third-party certification as US cGMP compliant: the facility now meets the standard for both the US and Japanese markets
PALO ALTO, Calif., May 25, 2021 /PRNewswire/ -- I Peace, Inc. (CEO: Koji Tanabe ), aPalo Alto-based biotech start-up focusing on Nobel Prize-winning technology "induced pluripotent stem cells (iPSCs)" received a third-party certification as US FDA cGMP compliant for its manufacturing facility "Pea...
2021-05-26 03:00
1363
Two Products of Zhaoke Ophthalmology (6622.HK) Passed The On-Site Inspection for Drug Registration of The National Medical Products Administration and The GMP Compliance Inspection of The Guangdong Medical Products Administration
HONG KONG, May 24, 2021 /PRNewswire/ -- Zhaoke Ophthalmology Limited ("Zhaoke Ophthalmology" or the "Company"; stock code: 6622), an ophthalmic pharmaceutical company dedicated to the research, development and commercialization of therapies that address significant unmet medical needs, announc...
2021-05-24 16:58
5256
A 'Game Changer' COVID-19 drug from Korea was introduced in a world class academic journal
SEOUL South Korea, May 23, 2021 /PRNewswire/ -- Hyundai Bioscience (KOSDAQ 048410) announced on the 24th that CNPharm, its major shareholding bio tech company, published an article containing the research results of CP-COV03, a Niclosamide-based oral treatment for COVID-19 based on its proprietar...
2021-05-24 08:16
1807
Moderna and Samsung Biologics Announce Agreement for Fill-Finish Manufacturing of Moderna's COVID-19 Vaccine
CAMBRIDGE, Mass. and INCHEON, South Korea, May 22, 2021 /PRNewswire/ -- Moderna (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, and Samsung Biologics (KRX: 207940.KS), a leading global CDMO providing a fully integrated end-to-end contract develop...
2021-05-23 00:00
8899
Kintor Announced (1) FDA Has Greenlighted Proxalutamide's Phase III Study for Hospitalized Male and Female COVID-19 Patients to Be Conducted; and (2) Inclusion of Female Outpatients in Proxalutamide's Phase III Study for Mild to Moderate COVID-19
SUZHOU, China, May 19, 2021 /PRNewswire/ -- On May 18, Kintor Pharmaceutical Limited (HKEX.9939), a clinical-stage biotechnology company developing innovative small molecule and biological therapeutics, announced that the U.S. Food and Drug Administration (FDA) has greenlighted proxalutamide's ph...
2021-05-20 09:47
9146
I-Mab Presents Phase 1 Data on Highly Differentiated CD73 Antibody Uliledlimab at ASCO 2021
* Uliledlimab is a highly differentiated CD73 antibody with a unique epitope that confers pharmacological advantages * Data from U.S. phase 1 dose escalation trial demonstrates favorable safety and tolerability with no dose-limiting toxicities; preliminary clinical activity of uliledlimab has...
2021-05-20 06:00
8326
Gracell Biotechnologies to Present Updated Results of GC012F FasTCAR-enabled BCMA/CD19 Dual-targeting CAR-T Cell Therapy for Relapsed/Refractory Multiple Myeloma at ASCO 2021 and EHA 2021
SUZHOU, China and PALO ALTO, Calif., May 19, 2021 /PRNewswire/ -- Gracell Biotechnologies Inc. (NASDAQ: GRCL) ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, is presenting updated ...
2021-05-20 05:15
8503
Luye Life Sciences Unveils Cutting-edge Advances in Gene and Cell Therapy at ASGCT 2021
BOSTON, May 13, 2021 /PRNewswire/ -- The Boston R&D Center and GeneLeap Biotech, two subsidiaries of Luye Life Sciences Group, took part in the 24th American Society of Gene & Cell Therapy (ASGCT) Annual Meeting, presenting the progress of four of the company's latest preclinical developments in ...
2021-05-14 11:58
2310
Final Results of Bioavailability Study of Phebra's Oral Arsenic Capsule for Acute Promyelocytic Leukaemia (APL) Confirm Bioequivalence of Oral and IV Formulations
SYDNEY, May 13, 2021 /PRNewswire/ -- Australian pharmaceutical group Phebra (' Company') congratulates the Australasian Leukaemia and Lymphoma Group (ALLG) on the release of their abstract EP433 at the virtual European Hematology Association (EHA) 2021 Conference. The abstract builds on the initi...
2021-05-14 10:33
1148
I-Mab Added to MSCI China Index
SHANGHAI and GAITHERSBURG, Md., May 13, 2021 /PRNewswire/ -- I-Mab (the "Company") (Nasdaq: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced that I-Mab has been selected for inclusion in the MSCI Ch...
2021-05-13 20:00
5114
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