Biotechnology
JOYSBIO's COVID-19 antigen test kit is capable of detecting the new SARS-COV-2 strain found in the United Kingdom and the United States
BINHAI, Tianjin, Jan. 6, 2021 /PRNewswire/ -- As the world watches a concerning new strain of SARS-COV-2 first identified in theUnited Kingdom, one global biotech company has announced that their antigen test kit can detect the variant. JOYSBIO Biotechnology Co.'s SARS-CoV-2 Antigen Rapid Test K...
Global Cord Blood Announces NHC Policy Update
HONG KONG, Jan. 5, 2021 /PRNewswire/ -- Global Cord Blood Corporation (NYSE: CO) (the "Company"),China's leading provider of cord blood collection, laboratory testing, hematopoietic stem cell processing and stem cell storage services, today reported thatChina's National Health Commission ("NHC") ...
Y-Biologics signed License Agreement with 3D Medicines for T cell bispecific engager in Greater China territory
DAEJEON, South Korea and SHANGHAI, Jan. 5, 2021 /PRNewswire/ -- The South Korean biotech company Y-Biologics and theChina-based biopharmaceutical company 3D Medicines have entered into a License Agreement granting exclusive rights to develop, manufacture, and commercialize YBL-013, a T cell bi-sp...
Ascentage Pharma Announces its 9th Orphan Drug Designation from the US FDA in 2020, Setting a Record for Chinese Biopharmaceutical Companies
SUZHOU, China and ROCKVILLE, Md., Jan. 5, 2021 /PRNewswire/ -- Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, today announced that the US Food and Drug Adm...
Antengene Announces Submission of IND Application in China for a Global Phase 3 Trial of ATG-010 (Selinexor) in Advanced or Recurrent Endometrial Cancer
SHANGHAI and HONG KONG, Jan. 5, 2021 /PRNewswire/ -- Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in class therapeutics in hematology and oncolo...
AGC Biologics Confirms Cell and Gene Therapy Commercial Expertise as Manufacturer of Orchard Therapeutics' Newly Approved Libmeldy(TM)
SEATTLE, Jan. 4, 2021 /PRNewswire/ -- AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), is the first manufacturer of Orchard Therapeutics' Libmeldy™, which was recently approved by the European Commission (EC) as a one-time therapy for ...
Antengene Submits NDA for ATG-010 (Selinexor) in South Korea for rrMM and rrDLBCL
SHANGHAI and HONG KONG, Jan. 4, 2021 /PRNewswire/ -- Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in class therapeutics in hematology and oncolo...
RedHill Biopharma Announces Positive Top-Line Safety and Efficacy Data from Phase 2 COVID-19 Study of Opaganib
Preliminary data from the non-powered U.S. Phase 2 study of 40 hospitalized patients shows that orally-administered opaganib was safe, with no material safety differences between opaganib and control arms Consistent trends demonstrate greater improvement in reducing oxygen requirement by end of ...
First Subject Dosed with Gannex's FXR Agonist ASC42 in a U.S. Phase I Trial
SHANGHAI, Dec. 28, 2020 /PRNewswire/ -- Gannex, a wholly owned company of Ascletis Pharma Inc. (HKEX: 1672) and fully dedicated to the R&D and commercialization of new drugs in the field of NASH, announces today dosing of first subject with its NASH drug candidate ASC42, a Farnesoid X Receptor (F...
Innovent Announces the NMPA Granted New Indication Approval for BYVASDA® (Bevacizumab Biosimilar) for the Treatment of Adult Recurrent Glioblastoma
SAN FRANCISCO and SUZHOU, China, Dec. 28, 2020 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseas...
INOVIO Announces Publication of Phase 1 Data from its COVID-19 DNA Vaccine Candidate, INO-4800 in The Lancet's EClinicalMedicine
Peer-reviewed Phase 1 data shows INO-4800 to be immunogenic in 100% of subjects, inducing neutralizing antibody and/or T cell responses INO-4800 demonstrates favorable safety and tolerability, with no serious adverse events reported Offers best-in-class thermostability, including a five-year pro...
LycovaryTM Daily provides anti-ageing oxygenation of the ovaries to help women with PMS, painful periods and comfortable menopause transition
CAMBRIDGE, England, Dec. 24, 2020 /PRNewswire/ -- Cambridge Diagnostic Imaging,
CaDi, (cadifamily.com
Transcenta Closes $105 Million in Crossover Financing
HONG KONG and SUZHOU, China, and HANGZHOU, China, Dec. 23, 2020 /PRNewswire/ -- Transcenta Holding Limited ("Transcenta"), a global biotherapeutics company with fully-integrated capabilities in discovery, development and manufacturing of antibody-based therapeutics, announces today the complet...
RedHill's Phase 2/3 COVID-19 Study of Opaganib Passes Second DSMB with Unanimous Recommendation to Continue
Independent DSMB unanimously recommends continuation of the global Phase 2/3 study of orally-administered opaganib in severe COVID-19 based on review of unblinded safety data from 155 treated patients Top-line data from the 270-patient global Phase 2/3 COVID-19 study expected Q1/2021 Top-line d...
Ascentage Pharma's Licensee UNITY Biotechnology Announces Milestone Reached in Clinical Development of Treatments for Age-Related Disease, Leading to Milestone Payment
SUZHOU, China and ROCKVILLE, Md., Dec. 22, 2020 /PRNewswire/ -- Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, today announced that its licensee, UNITY Bi...
Pierre Fabre Selects AGC Biologics as CDMO to manufacture the orphan drug ER-004
SEATTLE, Dec. 21, 2020 /PRNewswire/ -- AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), announced its partnership with Laboratoire Pierre Fabre to manufacture ER-004 – an intra-amniotic drug that will pioneer the treatment of a rare and...
LT1001 (Naldebain(R)), an Extended-Release Analgesic Injection, Received Its Second Approval from Singapore's HSA
TAIPEI, Dec. 21, 2020 /PRNewswire/ -- Lumosa Therapeutics is pleased to announce the market approval of LT1001 (Naldebain®), an extended-release analgesic injection, fromSingapore's Health Science Agency (HSA). HSA is regarded as one of the regulatory reference countries in the world. The approv...
WuXi Biologics to Acquire Drug Substance Facility in Wuppertal, Germany from Bayer
* The DS facility (MFG19) with 3x1000L perfusion and 6x2000L fed-batch capacity for vaccines and biologics is expected to be GMP ready in late 2021 * Complements WuXi Biologics' existing DP capacity in Germany * Capacity expansion allows WuXi Biologics to meet growing client demand worldwide...
Thermo Scientific Tundra Cryo-TEM Democratizes Cryo-Electron Microscopy, Extends to Users of Any Experience Level
New instrument overcomes cryo-EM barriers, implements artificial intelligence to deliver unparalleled ease-of-use at an affordable price HILLSBORO, Ore., Dec. 21, 2020 /PRNewswire/ -- Thermo Fisher Scientific, the world leader in serving science, today announced the new Thermo Scientific Tundra ...
Occlutech's Atrial Flow Regulator (AFR) Receives U.S. FDA Breakthrough Device Designation
SCHAFFHAUSEN, Switzerland, Dec. 18, 2020 /PRNewswire/ -- Occlutech, a privately-held company, announced today that the US Food and Drug Administration (FDA) has granted the company a Breakthrough Device designation for its first-in-class, implantable Atrial Flow Regulator (AFR) for Pulmonary Art...
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