Medical/Pharmaceuticals
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
5827
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
5385
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
2725
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
2725
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
2787
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
2815
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
3622
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
2504
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
2380
'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
2845
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
3027
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
2665
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
5321
United Imaging To Feature Leaders of Choice Program, Innovative Purchasing Models, and World's-First Equipment at AHRA in Phoenix
Leaders of Choice is the educational program United Imaging and AHRA Announced Jointly in May. HOUSTON, July 7, 2022 /PRNewswire/ -- United Imaging confirmed that its Houston-based U.S. leadership team will be on hand in Phoenix for the AHRA (Association for Medical Imaging Management) Annual Me...
2022-07-07 20:18
2455
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
2342
Zhiyi Biotech Raised $45 Million in Series B Funding Round to Accelerate the Clinical Development of LBPs Pipelines
GUANGZHOU, China, July 7, 2022 /PRNewswire/ -- Recently, Zhiyi Biotech announced that it has raised$15 million in its B++ funding round. The funds will be used to boost the clinical development of the company's live biotherapeutic products (LBPs) pipelines. It's worth mentioning thatZhiyi has su...
2022-07-07 17:45
1927
WuXi STA Opens New Large-scale Oligonucleotide and Peptide Manufacturing Facility
Site Enhances New Modality CRDMO Platform Capacity for Customers SHANGHAI , July 6, 2022 /PRNewswire/ -- WuXi STA, a subsidiary of WuXi AppTec, today announced the opening of a new large-scale oligonucleotide and peptide manufacturing facility at itsChangzhou campus. The new facility underscores...
2022-07-07 08:00
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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
3182
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
2323
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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