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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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
5847
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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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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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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SunHo Announces First Patient Dosed in Phase 1/2 Clinical Trial of Two First-in-class Immunocytokines: IAP0971 and IAE0972
NANJING, China, July 7, 2022 /PRNewswire/ -- SunHo BioPharmaceutical Co., Ltd. ("SunHo"), a clinical-stage leading biopharma in immunocytokines with full-set of capabilities from discovery to commercialization, announced that IAP0971 (PD1-IL15 immunocytokine) and IAE0972 (EGFR-IL10 immunocytokine...
2022-07-07 20:00
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Alterity Therapeutics Doses First Patient in ATH434 Phase 2 Clinical Trial in Multiple System Atrophy
MELBOURNE, Australia and SAN FRANCISCO, July 6, 2022 /PRNewswire/ -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) ("Alterity" or "the Company"), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today announced the first patient has bee...
2022-07-06 23:00
3226
I-Mab to Host 2022 R&D Day
GAITHERSBURG, MD. and SHANGHAI, July 6, 2022 /PRNewswire/ -- I-Mab ("I-Mab" or the "Company") (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development, and commercialization of novel biologics, today announced that it will host its 2022 Research and Devel...
2022-07-06 20:00
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US FDA AWARDS RARE PEDIATRIC DISEASE DESIGNATION (RPDD) TO PAXALISIB FOR AT/RT, A RARE FORM OF CHILDHOOD BRAIN CANCER
SYDNEY, July 6, 2022 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA; ASX: KZA), an oncology-focused drug development company, is pleased to announce that the United States Food and Drug Administration (FDA) has awarded Rare Pediatric Disease Designation (RPDD) to Kazia's paxalisib for t...
2022-07-06 19:00
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Inmagene and HUTCHMED Announce First Participants in Global Phase I Trial of IMG-007
SAN DIEGO and HONG KONG and SYDNEY, July 6, 2022 /PRNewswire/ -- Inmagene
Biopharmaceuticals ("Inmagene
2022-07-06 12:00
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EditForce and Mitsubishi Tanabe Pharma Enter into License Agreement
FUKUOKA, Japan, July 5, 2022 /PRNewswire/ -- EditForce, Inc. (Headquarters: Fukuoka, President and CEO: Takashi Ono; hereinafter "EditForce") has entered into a License Agreement (hereinafter "Agreement") with Mitsubishi Tanabe Pharma Corporation (Headquarters:Osaka, Representative Director: Hiro...
2022-07-05 15:00
2642
ClinChoice Raises $150 mm Series E Round Financing, Further Strengthening its Global Services Capabilities
PHILADELPHIA, July 4, 2022 /PRNewswire/ -- Recently, ClinChoice announced the successful completion of its $150 mm Series E round financing. The investment was led by Legend Capital, and co-invested by Taikang Life Insurance, Sherpa Healthcare Partners and existing shareholders, including Lilly A...
2022-07-05 09:20
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