Health

Pharming announces first patient enrolled in pediatric clinical trial of leniolisib

The multinational Phase III study is evaluating leniolisib tablets in children aged 4 to 11 years with APDS, a rare primary immunodeficiency Pharming Group N.V. (“Pharming” or “the Company”) (EURONEXT Amsterdam: PHARM)/(Nasdaq: PHAR) announces that the first patient has been enrolled in its Phase III clinical trial (NCT05438407) evaluating the investigational drug leniolisib, an oral, selective […]

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Synbio Tech Inc. and Cosmax Group signed an exclusive cooperation agreement to jointly expand the South Korean probiotics market

Synbio Tech Inc. and Cosmax NBT, a major South Korean biotechnology company officially signed an exclusive cooperation agreement to launch Lactobacillus plantarum TWK10® probiotic strain in South Korea, and announced that TWK10® has been approved as an Individual Health Functional Food certification by the Ministry of Food and Drug Safety of South Korea. Under the agreement, COSMAX […]

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Pharming provides update on EMA regulatory review of leniolisib for APDS in Europe

EMA Marketing Authorisation Application for leniolisib changed to standard review timetable Pharming Group N.V. (“Pharming” or “the Company”) (EURONEXT Amsterdam: PHARM) (Nasdaq: PHAR) announces that the European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) has decided to shift its assessment of the Marketing Authorisation Application (MAA) for leniolisib to a standard review timetable.…

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17 ก.พ. 66

Renexxion Ireland Ltd. and Dr. Falk Pharma GmbH Announce Initiation of Phase II Study of naronapride in patients with gastroparesis

Randomized, double-blind, placebo-controlled study to evaluate efficacy of novel pan-GI prokinetic in patients with gastroparesis Renexxion Ireland Limited, a private biopharmaceutical company committed to delivering innovative drugs to patients with high unmet need in gastrointestinal (“GI”) disorders, is pleased to announce that the first patient has been treated in Europe with naronapride, a potential best-in-class […]

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16 ก.พ. 66

Tetracore Announces USDA Purchase of ASF and FMD Diagnostic Test Kits

Tetracore, Inc. (Tetracore®) is pleased to announce its partnership with the United States Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) to provide a stock of PCR kits for both African Swine Fever (ASF) and Foot-and-Mouth Disease (FMD). These kits were purchased for use in the National Animal Vaccine and Veterinary Countermeasures […]

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16 ก.พ. 66

Concept Medical granted Investigational Device Exemption (IDE) approval for their Magic Touch Sirolimus Coated Balloon for the treatment of Below the Knee (BTK) Arterial Disease

Concept Medical Inc. (CMI), on 9th February 2023, received the Investigational Device Exemption (IDE) from the US FDA, for its Magic Touch Sirolimus Coated Balloon. The Magic Touch PTA Sirolimus Coated Balloon Catheter is indicated for the treatment of Below the Knee (BTK) atherosclerotic lesions in Peripheral Arterial Disease. CMI received their first IDE approval for their Magic Touch Sirolimus Coated […]

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14 ก.พ. 66

U.S. Government and Novavax Extend Partnership, Securing Up to 1.5 Million Additional Doses of Novavax’ COVID-19 Vaccine

Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced a modification to its existing agreement with the U.S. Department of Health and Human Services (HHS), in collaboration with the Department of Defense, to deliver up to 1.5 million doses of the Novavax COVID-19 Vaccine, […]

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14 ก.พ. 66

Syntach AB announces partnership with Meditrial CRO to drive clinical development of groundbreaking Cardiac Support System

Syntach AB (“Syntach”) is pleased to announce that it has entered into a partnership agreement with Meditrial Europe Ltd (“Meditrial”) to support the clinical and regulatory strategies of Syntach’s innovative minimally invasive cardiac support system. Over 64 million people suffer from heart failure, one of the most common causes of death globally. Syntach Cardiac Support […]

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