Pharmaceuticals
AFTER FIVE YEARS OF SUCCESSFUL EXPERIENCE INTERNATIONALLY, BIOCON BIOLOGICS' HULIO® BIOSIMILAR TO HUMIRA®, NOW AVAILABLE IN THE UNITED STATES
BRIDGEWATER, N.J. and BENGALURU, India, July 3, 2023 /PRNewswire/ -- Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd, today announced that HULIO® (adalimumab-fkjp) injection, a biosimilar to Humira® (adalimumab), is now available to patients inthe United States after five years of experien...
2023-07-04 01:22
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Skyline Therapeutics Receives FDA Clearance of IND for SKG0106, a Novel Intravitreally Delivered AAV Gene Therapy Candidate for Neovascular Age-related Macular Degeneration
SHANGHAI and BOSTON, July 3, 2023 /PRNewswire/ -- Skyline Therapeutics, an innovation-driven gene therapy company committed to developing unique and novel solutions for rare and severe diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New D...
2023-07-03 19:00
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Henlius Forecasts Profit in 1H 2023
Spurring a Seamless R&D, Manufacturing, and Commercialisation Positive Cycle SHANGHAI, July 3, 2023 /PRNewswire/ -- Henlius (2696.HK) released a positive profit forecast. Based on the preliminary assessment of the unaudited comprehensive management accounts for the six months endedJune 30, 2023, ...
2023-07-03 18:59
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Henlius Forecasts Profit in 1H 2023
Spurring a Seamless R&D, Manufacturing, and Commercialisation Positive Cycle SHANGHAI, July 3, 2023 /PRNewswire/ -- Henlius (2696.HK) released a positive profit forecast. Based on the preliminary assessment of the unaudited comprehensive management accounts for the six months endedJune 30, 2023, ...
2023-07-03 17:49
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SHL Medical acquires 100% of the shares in Swiss company LCA Automation
SHL Medical announces the acquisition of LCA Automation AG, a Swiss innovative automation solutions provider. The acquisition is SHL Medical's response to the growing market demand for drug delivery solutions and will support its manufacturing operations globally, especially the upcomingSwiss man...
2023-07-03 17:00
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Zymedi announced their collaboration with the National Heart, Lung, and Blood Institute through a CTA CRADA to develop ZMA001 mAb, a potential treatment for Pulmonary Arterial Hypertension (PAH), a rare, female predominant disease
SEOUL, South Korea, July 2, 2023 /PRNewswire/ -- Today Zymedi, a Korean biotech venture-backed company, announced the signing of a clinical Cooperative Research and Development Agreement (CRADA) with the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health ...
2023-07-03 08:00
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Innovent and IASO Bio Announce the NMPA Approval of FUCASO®, the First Fully-human BCMA CAR-T Therapy, for the Treatment of Relapsed or Refractory Multiple Myeloma
ROCKVILLE, Md. and SUZHOU, China, July 3, 2023 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, metabolic, ophthalmology and...
2023-07-03 08:00
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Lifera and CENTOGENE, Enter Strategic Collaboration - Forming Saudi Arabian Joint Venture to Increase Access to Leading Data-Driven Multiomic Testing
* Joint Venture (JV) combines CENTOGENE's global leadership in multiomics with local insight of Lifera, a biopharmaceutical company wholly owned by the Public Investment Fund (PIF) based inRiyadh. * JV focuses on providing state-of-the-art multiomic testing services to patients, health system...
2023-07-02 14:00
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Chime Biologics Announces Strategic Cooperation with Leads Biolabs and BeiGene to Advance LBL-007 mAb Development and Manufacturing Globally
* Leads Biolabs and Chime Biologics initiate strategic cooperation to accelerate IND application and provide clinical trial materials inChina. * BeiGene and Chime Biologics establish strategic cooperation to facilitate IND applications overseas and clinical trial materials supply. SHANGHAI, Ju...
2023-06-30 20:15
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Transcenta Presented PFS Data by CLDN18.2 Expression Level from Phase I/II Study of Osemitamab (TST001) plus CAPOX as the First-Line Treatment of Advanced G/GEJ Cancer at ESMO GI Annual Congress 2023
* 64 patients with CLDN18.2 positive G/GEJ cancer were enrolled in TranStar102 (TST001-1002). CLDN18.2 positivity is defined as ≥10% tumor cells with ≥1+ intensity. These patients represent approximately 55% of all G/GEJ adenocarcinomas. The overall median PFS was 9.5 months with no differences...
2023-06-30 17:33
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Harbour BioMed Announces Biologics License Application Acceptance of Batoclimab for Treatment of Generalized Myasthenia Gravis by NMPA
CAMBRIDGE, Mass., ROTTERDAM, Netherlands and SUZHOU, China, June 29, 2023 /PRNewswire/ -- Harbour BioMed (the "Company"; HKEX: 02142), a global biopharmaceutical company committed to the discovery, development, and commercialization of novel antibody therapeutics focusing on oncology and immunol...
2023-06-29 21:26
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HaemaLogiX Announces Positive Final Results from KappaMab Combination Phase IIb Myeloma Trial
* Significant improvement in Overall Response Rate (83%) compared with matched case control group (45%). * Significant overall survival advantage, with a 46% reduction in the risk of death. * Excellent safety profile and significant efficacy bolster HaemaLogiX's plan to progress further Kap...
2023-06-29 19:00
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CPHI & PMEC China 2023 to launch international roadshow in Guangzhou
China's booming Pearl River Delta, a key pharma manufacturing hub, sees rapid internationalisation SHANGHAI, June 29, 2023 /PRNewswire/ -- CPHI & PMEC China will open a special roadshow to be hosted at the PWTC Expo (4-6 September, 2023) in the city of Guangzhou (Guangdong Province). The new add...
2023-06-29 18:10
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Immuno-oncology company Biosyngen opens new cell therapy GMP facility in Singapore
New state-of-the-art facility to develop immunotherapy assets to address unmet needs in cancer treatment SINGAPORE, June 29, 2023 /PRNewswire/ -- Biosyngen, an immune-oncology company with technology targeting the unmet medical needs in solid tumour and lymphoma treatment, today announced the of...
2023-06-29 17:14
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Jacobio Pharma Presents Clinical Results of Glecirasib in Colorectal Cancer
BEIJING, KYOTO and BOSTON, June 29, 2023 /PRNewswire/ -- Jacobio Pharma (1167.HK), a clinical-stage oncology company drugging the undruggable targets, today announced clinical results of its novel KRAS G12C inhibitor glecirasib monotherapy and in combination therapy with cetuximab to treat KRAS G...
2023-06-29 16:31
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Clarity establishes a US Center of Excellence for Targeted Copper Theranostics
SYDNEY, June 28, 2023 /PRNewswire/ -- Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, is pleased to announce the establishment of a ...
2023-06-28 20:58
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Sanyou Forms Partnership with Hangzhou Zhongmei Huadong Pharmaceutical, Catalyzing Innovative Drug Research and Development
SHANGHAI, June 28, 2023 /PRNewswire/ -- Recently, Sanyou Biopharmaceuticals Co., Ltd. (hereinafter referred to as Sanyou) and Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd, a wholly-owned subsidiary of Huadong Medicine Co., Ltd. (SZ.000963) (hereinafter referred to asHuadong Medicine), signed...
2023-06-28 20:00
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Caliway Announces Positive Data from CBL-0201EFP Phase 2-Stage 1 Study of CBL-514 in Treating Moderate to Severe Cellulite
* CBL-514 is the only non-invasive product that can improve 1-level of cellulite severity two weeks after a single treatment. * The highest dose of CBL-514 treatment demonstrated the best efficacy, 87.5% of thighs achieved at least 1-level improvement in cellulite severity two weeks after CBL...
2023-06-28 18:30
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Nuance Pharma's Partner Verona Pharma Submits New Drug Application to US FDA for Ensifentrine for the Maintenance Treatment of COPD
SHANGHAI, June 28, 2023 /PRNewswire/ -- Nuance Pharma announces its partner, Verona Pharma plc (Nasdaq: VRNA), has submitted a New Drug Application ("NDA") to the US Food and Drug Administration ("FDA") for approval of ensifentrine for the maintenance treatment of patients with chronic obstructi...
2023-06-28 17:07
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Xuanzhu Biopharm, a subsidiary of Sihuan Pharmaceutical, Its Innovative Drug Anaprozole Sodium Enteric-coated Tablets Obtains Drug Registration Approval From NMPA
HONG KONG, June 27, 2023 /PRNewswire/ -- Sihuan Pharmaceutical Holdings Group Ltdtogether with its subsidiaries, is pleased to announce that Xuanzhu Biopharmaceutical Co., Ltd. ("Xuanzhu Biopharm"), a non-wholly owned subsidiary of Company, has received a drug registration approval from the Natio...
2023-06-28 09:57
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