Pharmaceuticals

GMP cell CDMO I Peace, Inc. obtains accreditation as ISO 17025: 2017 compliant

Starts undertaking quality evaluation and characterization of iPSCs in accordance with ISO standards PALO ALTO, Calif. , Jan. 30, 2024 /PRNewswire/ -- Leading GMP cell CDMO I Peace, Inc. (https://www.ipeace.com ), specializing in induced pluripotent stem cells (iPSCs) an...

2024-01-31 05:46 2593

Endogenex Receives IDE Approval to Initiate Pivotal Clinical Study

A Prospective, Randomized, Multicenter Study Assessing the Safety and Efficacy of the ReCET™ System in Adult Patients with Type 2 Diabetes MINNEAPOLIS, Jan. 31, 2024 /PRNewswire/ -- Endogenex, Inc., a clinical stage medical device company dedicated to improving outcomes in patients with Type 2 D...

2024-01-30 22:00 2189

Results of the Phase III INSPIRE Study on Qilu Pharmaceutical's Iruplinalkib Published in the Journal of Thoracic Oncology

JINAN, China, Jan. 30, 2024 /PRNewswire/ -- The interim analysis results from the phase III INSPIRE study of iruplinalkib developed by Qilu Pharmaceutical, which focuses on the first-line treatment of locally advanced or metastatic anaplastic lymphoma kinase (ALK)-positive non-small cell lung can...

2024-01-30 16:45 1980

Inside information made public: Nanoform Announces Important Milestone with Promising Clinical Results for Patient-Centric Nanotechnology-Enhanced Enzalutamide

THIS PRESS RELEASE CONTAINS INFORMATION THAT NANOFORM IS OBLIGED TO MAKE PUBLIC PURSUANT TO THE EU MARKET ABUSE REGULATION. THE INFORMATION WAS SENT FOR PUBLICATION THROUGH THE AGENCY OF THE CONTACT PERSONS SET OUT BELOW, ONJANUARY 26, 2024, AT 11:20 FINNISH TIME / 10:20 SWEDISH TIME. HELSINKI, ...

2024-01-26 20:08 2225

AbbVie Expands Biologics Manufacturing Capacity with a $223 Million Investment in Singapore Manufacturing Site

* US$223 million expansion will add biologics capacity to AbbVie manufacturing network * Singapore manufacturing site to grow to more than 500 employees following expansion * Construction will commence immediately with facilities becoming operational in 2026 SINGAPORE, Jan. 26, 2024 /PRNews...

2024-01-26 08:30 6590

First International Shipment of HANSIZHUANG Launched

SHANGHAI, Jan. 25, 2024 /PRNewswire/ -- On January 25, a truck carrying anti-PD-1 mAb Zerpidio® (serplulimab, Chinese trade name: HANSIZHUANG) slowly left Henlius' Songjiang First Plant. These products, bearing Henlius' mission of benefiting patients worldwide with high-quality biopharmaceuticals...

2024-01-25 21:41 3484

First International Shipment of HANSIZHUANG

SHANGHAI, Jan. 25, 2024 /PRNewswire/ -- On January 25, a truck carrying HANSIZHUANG Zerpidio® (anti-PD-1 monoclonal antibody, Chinese trade name: HANSIZHUANG) slowly left Henlius' Songjiang First Plant. These products, bearing Henlius' mission of "benefiting patients worldwide with high-quality ...

2024-01-25 20:45 5508

Glenmark, Jiangsu Alphamab Biopharmaceuticals and 3D Medicines announce the signing of a License Agreement for KN035 (Envafolimab) for Multiple Geographies around the World

* Glenmark will be responsible for further developing, registering, and commercializing Envafolimab inIndia, Asia Pacific, Middle East and Africa, Russia, CIS, and Latin America. * Jiangsu Alphamab and 3D Medicines will receive a low double digit Million US Dollar amount up to launch, additio...

2024-01-25 18:38 2423

Alphamab Oncology and 3DMedicines Entered into a Licensing Agreement with Glenmark for KN035

SUZHOU, China, Jan. 25, 2024 /PRNewswire/ -- Alphamab Oncology (stock code: 9966.HK) and 3DMedicines (stock code: 1244.HK) ("Licensors") announced that we entered into a license agreement with Glenmark Specialty S.A. (GSSA), a subsidiary of Glenmark Pharmaceuticals Ltd. (BSE: 532296,NSE: GLENMARK...

2024-01-25 10:40 2689

PS128 Successfully Targets Behavioral and Emotional Challenges in Autism Spectrum Disorder (ASD): Completion of Pivotal Clinical Trial on Preschool Children with ASD

SAN DIEGO, Jan. 25, 2024 /PRNewswire/ -- A recent study published in the Research in Autism Spectrum Disorders unveils groundbreaking solutions for neurodevelopmental disorders. This is the first double-blinded, randomized, placebo-controlledtrial

2024-01-25 10:00 3320

FDA purchases digiM I2S software for the assessment of product quality attributes

Reviewers and regulatory researchers to use AI image analytics for process-quality correlation WOBURN, Mass., Jan. 24, 2024 /PRNewswire/ -- The U.S. Food and Drug Administration has placed a purchase order (75F40123P00369) committing to an annual subscription of digiM I2S, a fully integrated ima...

2024-01-24 23:37 1962

Seegene Announces Collaboration with Microsoft to Realize 'a World Free from All Diseases'

* Strategic collaboration to open a new chapter in the field of molecular diagnostics that aspires to 'a world free from all diseases and future pandemics' * Digitally enhance Seegene's automated diagnostic reagent development system with the integration of Microsoft Azure AI solutions * A ...

2024-01-24 20:00 3673

Sirnaomics Publishes Novel Mechanism of Action of RNAi Cancer Therapeutic STP707 for Solid Tumors

Study published in NAR Cancer, a leading peer-reviewed journal in the field of nucleic acid therapeutics HONG KONG, Germantown, Md. and SUZHOU, China, Jan. 24, 2024 /PRNewswire/ -- Sirnaomics Ltd. (the "Company", Stock Code: 2257, together with its subsidiaries, the "Group" or "Sirnaomics"), a l...

2024-01-24 17:49 2758

Sciwind Biosciences Announces Positive Results from Phase 1 Clinical Trial of XW004, an Oral Formulation of Long-acting GLP-1 Analog Ecnoglutide

* Oral ecnoglutide was safe and well tolerated with gastrointestinal side effects as the most commonly reported adverse events * Study participants receiving up to 30 mg oral ecnoglutide once-daily for 6 weeks achieved a mean body weight reduction of -6.8% from baseline, compared to -0.9% for...

2024-01-24 10:00 2677

INTREPID Alliance Releases Review of Antiviral Compounds in Clinical Development to Contribute to Collaborative Efforts in Pandemic Preparedness

Global landscape analysis identifies strengths and gaps in R&D pipeline  to inform international pandemic preparedness efforts ROME and CAMBRIDGE, Mass., Jan. 24, 2024 /PRNewswire/ -- The INTREPID Alliance, a consortium of innovative biopharmaceutical companies dedicated to accelerating the devel...

2024-01-24 08:22 1797

Caliway Received First Approval of CBL-514 Pivotal Phase 3 Study Application for Subcutaneous Fat Reduction

NEW TAIPEI CITY, Jan. 23, 2024 /PRNewswire/ -- Caliway Biopharmaceuticals (Caliway) announces that Australian Bellberry HREC has approved Caliway's application to initiate CBL-514's Pivotal Phase 3 study (CBL-0301) for subcutaneous fat reduction. "We are all delighted to see CBL-514 showing its ...

2024-01-23 21:12 2392

Gannex's Strategic Partner Sagimet Biosciences Announces Positive Topline Results from Phase 2b FASCINATE-2 Clinical Trial of Denifanstat in Biopsy-Confirmed F2/F3 NASH

Denifanstat achieved statistically significant results on primary and multiple secondary endpoints in a 52-week clinical trial of 168 NASH patients with stage 2 or 3 fibrosis -  Primary efficacy endpoints: * NASH resolution without worsening of fibrosis with ≥2-point reduction in NAS (NAFLD A...

2024-01-23 12:17 3308

Extensive R&D Capabilities:ICP DAS - BMP to Showcase a Broad Range of Medical-Grade TPU at MD&M West 2024, U.S.

HSINCHU, Jan. 23, 2024 /PRNewswire/ -- ICP DAS – BMP, Asia's first medical-grade thermoplastic polyurethane (TPU) supplier, will make its MD&M West debut inthe United States. Kicking off 2024, the company presents a comprehensive range of top-quality medical-grade TPU series to the foremost expe...

2024-01-23 10:06 3688

YS Biopharma Announces Unaudited Financial Results for the First Half of Fiscal Year 2024

GAITHERSBURG, Md., Jan. 23, 2024 /PRNewswire/ -- YS Biopharma Co., Ltd. (NASDAQ: YS) ("YS Biopharma") along with its subsidiaries ("YS Group" or the "Company"), a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and delivering new generations of vaccines and ...

2024-01-23 06:00 3322

Telix Highlights Presentations at Upcoming ASCO Genitourinary Cancers Symposium (ASCO GU 2024)

MELBOURNE, Australia, Jan. 22, 2024 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces presentations featuring the Company's theranostic programs at the upcoming American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU 2024) to be he...

2024-01-22 19:00 2242
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