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...

2021-01-06 15:11 2729

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") ...

2021-01-05 20:30 11913

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...

2021-01-05 09:00 2649

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...

2021-01-05 08:32 3069

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...

2021-01-05 08:00 3861

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 ...

2021-01-04 22:30 4036

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...

2021-01-04 08:00 4559

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 ...

2020-12-31 22:38 8747

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...

2020-12-28 08:30 4365

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...

2020-12-28 08:00 8942

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...

2020-12-24 23:12 7963

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 ) is launching LycovaryTM Daily, a new generation of food supplement for ovarian health in the family of oxygenation products. It provides clinically validated and...

2020-12-24 08:00 5215

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...

2020-12-23 08:00 4347

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...

2020-12-22 20:38 5034

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...

2020-12-22 18:29 2861

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...

2020-12-21 23:00 3257

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...

2020-12-21 22:08 2460

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...

2020-12-21 21:02 3034

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 ...

2020-12-21 07:00 2411

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...

2020-12-18 21:29 4799