Medical/Pharmaceuticals
Daewoong Pharmaceutical Gets First Korean US FDA Fast-Track for New Idiopathic Pulmonary Fibrosis Drug
* US Food and Drug Administration (FDA) fast-tracks idiopathic pulmonary fibrosis treatment DWN12088 * First-in-class new drug to quickly take on the pulmonary fibrosis market, predicted to reach$6.1 billion globally by 2030 SEOUL, South Korea, July 20, 2022 /PRNewswire/ -- As many Korean p...
2022-07-20 21:00
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Ascentage Pharma and Innovent Announce the China NMPA Accepted and Granted Priority Review Designation to a New Drug Application for Olverembatinib for the Treatment of Drug-Resistant CML
SUZHOU, China, ROCKVILLE, Md. and SAN FRANCISCO, July 19, 2022 /PRNewswire/ -- Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, and Innovent Biologics, Inc. ("Innovent") (HKEX: 01...
2022-07-20 00:15
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Gracell Biotechnologies Appoints Veteran BioPharma Executive Dr. Samuel Zhang as Chief Business Officer
SAN DIEGO, Calif. and SUZHOU and SHANGHAI, China, July 19, 2022 /PRNewswire/ -- Gracell Biotechnologies Inc. ("Gracell" or the "Company", NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of ...
2022-07-19 20:00
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China Pharma Announced the Submission of a Plan of Compliance to NYSE American
HAIKOU, China, July 18, 2022 /PRNewswire/ -- China Pharma Holdings, Inc. (NYSE American: CPHI) ("China Pharma," the "Company" or "We"), a specialty pharmaceutical company, today announced that onJuly 15, 2022, the Company submitted a plan of compliance to NYSE American LLC ("NYSE American" or the...
2022-07-18 20:00
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OliPass Moves Forward to Second Stage of Phase 2a Trial for Pain Killer OLP-1002
SEOUL, South Korea, July 18, 2022 /PRNewswire/ -- OliPass Corporation, a South Korea based biotech specialized in the development of RNA therapeutics, announced to move forward to the second stage of the Phase 2a trial inAustralia in osteoarthritis (OA) patients for pain killer OLP-1002, an SCN9A...
2022-07-18 20:00
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Samsung Biologics to purchase land for its second Bio Campus
* Acquires additional land, sized 357,366㎡ valued at KRW 426 billion, for Bio Campus 2 * Plans to build Multi-Modal Plant, Open Innovation, and expanded manufacturing capacities INCHEON, South Korea, July 18, 2022 /PRNewswire/ -- Samsung Biologics (KRX: 207940.KS), the world's leading contrac...
2022-07-18 19:00
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Everest Medicines Announces European Commission Grants Approval of Kinpeygo® for Adults with Primary IgA Nephropathy to our Partner Calliditas Therapeutics
Kinpeygo® (developed under the name NEFECON) is the first and only EMA- approved treatment for IgAN Everest Medicines has exclusive rights to develop and commercialize NEFECON in Greater China, Singapore and South Korea SHANGHAI, July 17, 2022 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Ev...
2022-07-18 08:00
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China CDE Grants Breakthrough Therapy Designation (BTD) to Neurophth's NR082 in LHON
WUHAN, China and SAN DIEGO, July 15, 2022 /PRNewswire/ -- Neurophth Therapeutics, Inc., ("Neurophth") today announced thatthe Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) has granted a Breakthrough Therapy Designation (BTD) to the Company's leading gen...
2022-07-15 21:00
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Pulnovo Medical Concludes Successfully First Pre-Sub Meeting with FDA for PADN Global Clinical Trial
SHANGHAI, July 15, 2022 /PRNewswire/ -- Pulnovo Medical Limited, a globally recognized device pioneer in the treatment for cardiopulmonary diseases, today announced that it has successfully concluded the first Pre-Sub meeting with the U.S. Food and Drug Administration ("FDA") for its Pulmonary Ar...
2022-07-15 20:30
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Lunit to be Listed on KOSDAQ next week
* Initial Public Offering of 1,215,800 shares of its common stock at KRW 30,000 * To be listed on the KOSDAQ market on July 21, 2022 SEOUL, South Korea, July 14, 2022 /PRNewswire/ -- Lunit, a global provider of AI-based cancer solutions, announced that it priced its initial public offering (I...
2022-07-14 21:00
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Health2Sync and AstraZeneca Taiwan to Kick off Digital Patient Management Programs for Chronic Kidney Diseases
TAIPEI, July 13, 2022 /PRNewswire/ -- Health2Sync, Asia's leading digital chronic disease management platform, announced today that it is signing a Memorandum of Understanding (MOU) with AstraZeneca Taiwan to provide its first digital solution for chronic kidney disease (CKD) patients inTaiwan. T...
2022-07-13 12:47
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Bridge Biotherapeutics to Present Interim Clinical Data from Ongoing Phase 1 Study of BBT-176 at the World Conference of Lung Cancer
* The abstract suggests that BBT-176 has shown its capability of inducing clinical tumor responses in EGFR triple mutation-containing patients * Further exploration of the drug efficacy and safety profiles at RP2D is planned * The abstract is now available on the IASLC 2022 WCLC website SEON...
2022-07-13 06:30
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Flat Medical Enters the Vascular Access Medtech Domain with its Newly Acquired MDR Certification and New Medical Advisor
TAIPEI, July 12, 2022 /PRNewswire/ -- Flat Medical Co., Ltd., a MedTech company specializing in safety solutions for anesthesia and critical care procedures, announced that it has received Medical Device Regulation (MDR) certification from its Notified Body, the British Standards Institution (BSI...
2022-07-12 21:08
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KAZIA LAUNCHES NEW SCIENTIFIC ADVISORY BOARD COMPRISED OF WORLD-LEADING EXPERTS IN BRAIN CANCER
SYDNEY, July 12, 2022 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA; ASX: KZA), an oncology-focused drug development company, is pleased to announce the launch of its Scientific Advisory Board (SAB). The new SAB consists of four distinguished clinicians and scientists with expertise in...
2022-07-12 20:15
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WuXi Vaccines Received First GMP Certificate of QC Potency Lab from Ireland Health Products Regulatory Authority
- The first GMP certificate that WuXi Vaccines has received from the regulatory agency - A critical step for WuXi Vaccines to enable the manufacturing of commercial vaccine products in its Dundalk facility and supplying the global market for a top-10 pharmaceutical company DUNDALK, Ireland, Jul...
2022-07-12 16:00
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iNtRON Confirms Efficacy of CDL200 Against CDI Clinical Isolates
* Shows potent and rapid antibacterial activity against clinical isolates in Europe and Korea both * CDL200, a novel endolysin pipeline for the treatment of Clostridioides difficile Infection (CDI) * The world's first endolysin in capsule formulation to be administered orally BOSTON and SEO...
2022-07-12 10:06
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'Sustainable CDMO' Samsung Biologics releases 2022 ESG Report
* Aims to build an eco-friendly business environment and achieve net zero GHG emissions in its operations, moving towards 100% renewable energy. * Details new social contribution activities that strives to support the health of its local communities. * Requires commitment to the Supplier Cod...
2022-07-11 19:00
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Biotech Startup Noul Releases 2021 Sustainability Report
* Disclose achievement and improvement on economic, social, and environmental commitments * Contain corporate will to take sustainability as its management philosophy since its foundation * Write based on the GRI standards and self-disclose to the DART electronic disclosure system YONGIN, S...
2022-07-08 15:00
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NEW EARLY BREAST CANCER DRUG TO REDUCE RISK OF RECURRENCE OR DEATH NOW AVAILABLE IN THE PHILIPPINES
* NERLYNX® (neratinib) is approved by the Food and Drug Administration of the Philippines * Leading regional breast cancer oncologists say the availability of NERLYNX is a 'great step forward' for women inthe Philippines who have been diagnosed with HER2+ early-stage breast cancer * Five-y...
2022-07-08 09:28
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WuXi XDC and AbTis Sign Memorandum of Understanding for Development and Manufacturing of Antibody Drug Conjugates
SHANGHAI and SEOUL, South Korea, July 7, 2022 /PRNewswire/ -- WuXi XDC, a global leading CRDMO (Contract Research, Development and Manufacturing Organization) dedicated to end-to-end bioconjugates services, and AbTis, a Korean biotechnology company dedicated to the development of antibody drug c...
2022-07-08 09:27
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