Search Results for “EU” – Page 22 – media

Par Pharmaceutical Issues Recall of Single Lot of Treprostinil

Mike Hollan The voluntary recall was ordered due to potential silicon particulate exposure. Endo International plc issued a press release announcing that one of its pharmaceutical companies, Par Pharmaceuticals, is issuing a voluntary recall of a single lot of one of its medications.1 The lot, which is being recalled on the consumer, may potentially be tainted with silicon particulates in the product solution. The recalls order is for one lot of Treprostinil Injection 20mg/20ml (1mg/mL). This specific lot was reportedly distributed to wholesalers between June 16, 2022 and October 17, 2022. According to the company, it has yet to receive any reports of injuries due to the contamination, and the recall appears to be a preemptive move. Endo warns that particulates entering the body through an injected solution may cause of a variety of problems. The particulates may simply cause local irritation or swelling at the site of the injection. ...
- Source: drugdu
- 129
- March 15, 2024
Everest Medicines’ Partner Calliditas Therapeutics Announces U.S. FDA Grants an Additional Seven-Year Orphan Drug Exclusivity Period for Nefecon®

SHANGHAI, March 12, 2024 /PRNewswire/ — Everest Medicines (HKEX 1952.HK, “Everest”, or the “Company”)’s licensing partner Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) announced that the U.S. FDA has granted an orphan drug exclusivity period of seven years for Nefecon®, expiring in December 2030 based on Calliditas obtaining full approval with a new indication for this drug product in December 2023. Following full approval in December 2023, Nefecon® is indicated “to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression”. The exclusivity period reflects the new indication covering all adult patients with primary IgAN at risk of disease progression based on a confirmed reduction of kidney loss reflecting a clinical benefit on kidney function for adult patients with primary IgAN. “We congratulate our partner for receiving seven more years of market exclusivity for Nefecon® in the ...
- Source: drugdu
- 96
- March 15, 2024
Biokin Pharmaceutical has successfully completed the initial payment of USD 800 million under the development and commercialization license agreement with Bristol Myers Squibb for BL-B01D1

As of March 7, 2024, Biokin Pharmaceutical has received an initial payment of USD 800 million from Bristol Myers Squibb under the development and commercialization license agreement for BL-B01D1. Agreement Signing and EffectivenessOn December 11, 2023, SystImmune, Inc., a wholly-owned subsidiary of Biokin Pharmaceutical, entered into an exclusive licensing and collaboration agreement (hereinafter referred to as the “Collaboration Agreement”) with Bristol Myers Squibb (hereinafter referred to as “BMS”, NYSE ticker: BMY) pertaining to the BL-B01D1 (EGFR×HER3 bispecific ADC) project. Under the terms of the Agreement, the Parties will jointly pursue the development and commercialization of BL-B01D1 in the United States. SystImmune will exclusively be responsible for the development, commercialization, and production of BL-B01D1 within Chinese mainland through its affiliated entities, including manufacturing some drugs for supply to regions outside of Chinese mainland. Conversely, BMS will retain exclusive right to develop and commercialize BL-B01D1 in all other regions globally. The Collaboration ...
- Source: drugdu
- 96
- March 13, 2024
KCL joins new project launched by European consortium to improve newborn health

The HYPIEND project consists of 14 partners from eight European countries King’s College London (KCL) has announced that it is one of 14 partners from eight European countries to join the HYPIEND project to improve newborn health. Co-ordinated by the Eurecat technology centre, the five-year study aims to reduce the impact of endocrine disruptors on pregnancy and pre-puberty. Endocrine-disrupting chemicals (EDCs) can be found in products including cosmetics, food, drink and cleaning products. Particularly during pregnancy, infancy and childhood, these products can affect the operation of the hormonal system. The HYPIEND project will analyse the impact on the hypothalamic-pituitaryaxis, the structure where the central nervous system and the endocrine systems connect and regulate hormones that operate body functions such as somatic growth, lactation and stress coping. The project will involve Dr Marika Charalambous, school academic lead, research and impact, at KCL, who will lead group studies of the metabolism and ...
- Source: drugdu
- 131
- March 13, 2024
Rapid AST Platform Provides Targeted Therapeutic Results Days Faster Than Current Standard of Care

Bacteria are outpacing scientific advancements, leading to a worrying increase in antibiotic resistance, a situation the World Health Organization has identified as an emerging global health crisis. The key to countering this trend lies in achieving quicker diagnostic results, comprehensive susceptibility testing across various sample types, and the ability to test against a broad range of commercially relevant antibiotics simultaneously. Now, a rapid antibiotic susceptibility testing (AST) system can provide targeted therapeutic results days faster than the current standard of care. Selux Diagnostics (Boston, MA, USA) has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its proprietary Positive Blood Culture (PBC) Separator. The addition of positive blood culture sample type expands the Selux Next Generation Phenotyping (NGP) System, making this the only FDA-cleared, single-platform technology to deliver rapid AST results for both positive blood culture and isolated colonies. The Selux PBC Separator streamlines the process for ...
- Source: drugdu
- 158
- March 12, 2024
MHRA approves Marinus Pharmaceuticals’ Ztalmy for CDKL5 deficiency disorder

The rare epileptic seizure disorder currently affects around one in 42,000 people in the UK The Medicines and Healthcare products Regulatory Agency (MHRA) has approved Marinus Pharmaceutical’s Ztalmy (ganaxolone) to treat cyclin-dependant kinase-like 5 (CDKL5) deficiency disorder (CDD). The approval marks Ztalmy as the first anti-seizure medication to be used in the UK to treat the rare epileptic seizure disorder. Affecting around one in 42,000 people in the UK, CDD is a rare genetic disorder that occurs from mutations in the CDLK5 gene, which is crucial for normal brain development, causing seizures as early as the first week of life. Ztalmy, taken orally through a dosing syringe, is a steroid that attaches to specific receptors in the brain and aims to stop epileptic seizures from occurring. The approval was supported by evidence from the phase 3 Marigold randomised, double-blind, placebo-controlled clinical trial, which involved 101 patients – 50 who received ...
- Source: drugdu
- 119
- March 12, 2024
TransThera Announced Global Phase 3 Clinical Trial for Cholangiocarcinoma Authorized in the European Union and Orphan Drug Designation for Tinengotinib to Treat Biliary Tract Cancer Granted by European Medicines Agency

TransThera, a clinical-stage biopharmaceutical company dedicated to innovating differentiated drugs globally, today announced that the randomized, controlled, global multicenter Phase 3 trial (FIRST-308) of tinengotinib versus physician’s choice to evaluate the efficacy and safety in subjects with FGFR-altered, chemotherapy- and FGFR Inhibitor-refractory/relapsed cholangiocarcinoma (CCA), has been authorized by regulatory agencies in the European Union (EU) after the authorizations from US, South Korea and Taiwan region. Furthermore, European Medicines Agency (EMA) granted the Orphan Drug Designation(ODD) for tinengotinib for the treatment of biliary tract cancer (BTC) . Tinengotinib, a next-generation FGFR inhibitor with high potency against a variety of FGFR2 kinase domain mutations, has shown promising clinical benefit in subjects with FGFR-altered metastatic CCA who were heavily pretreated with chemotherapy and refractory/relapsed to FGFRi(s). The results of tinengotinib in CCA from the phase I/II clinical trials were presented orally at 2023 ESMO and 2024 ASCO GI conferences. The FRIST-308 clinical trial ...
- Source: drugdu
- 71
- March 12, 2024
The roadmap for generative AI in the pharma industry

AI remained one of the main talking points at CTS Europe, as the roadmap for generative AI was mapped out. In 2022, the launch of the generative Artificial Intelligence (AI) platform ChatGPT broke the record for the fastest-growing consumer application in history. Following the rapid adoption of AI technologies, the pharma sector is now exploring the capabilities and challenges of generative AI as it remains one of the key trends in the industry. However, despite the recent progress in the use of AI in real-world situations, we are still in the early stages of the AI roadmap, research director at GlobalData Josep Bori, at the recently concluded Clinical Trial Supply (CTS) Europe 2024 meeting. Generative AI is a technology capable of generating text, images or other data using generative models, often in response to prompts. Explaining how generative AI works, Bori said: “AI is trying to optimise the output to ...
- Source: drugdu
- 88
- March 9, 2024
Lundbeck Pharmaceuticals’ “Anti-Parkinson’s Category 1 Chemical Drug” Submits Clinical Application in China

March 4), according to the CDE official website, Lundbeck’s clinical trial application for Class 1 chemical drug Lu AF28996 capsules has been accepted. Currently, the drug is undergoing Phase I clinical trials overseas. Parkinson’s disease is a neurological dysfunction disease with complex symptoms and difficult early diagnosis. It is common in middle-aged and elderly people. At present, the main treatment for Parkinson’s disease is drug therapy, with the purpose of reducing symptoms, delaying the progression, and improving the patient’s quality of life. Lu AF28996 is a dopamine D1/D2 receptor agonist developed by Lundbeck Pharmaceuticals. It is a relatively new anti-Parkinson therapy and is currently undergoing Phase I clinical trials overseas. Among them, a study to evaluate the safety, tolerability, etc. of Lu AF28996 in Parkinson’s patients is expected to be completed in 2025. This time, the approval of Lu AF28996’s clinical trial application in China is expected to bring a ...
- Source: drugdu
- 158
- March 7, 2024
Shuangcheng Pharmaceuticals Octreotide Acetate Injection Obtained Certificate of Drug Registration

Hainan Shuangcheng Pharmaceuticals was approved by the State Drug Administration to issue Drug Registration Certificate to Octreotide Acetate Injection. Basic drug information 1, drug name: octreotide acetate injection 2、Dosage form: Injection 3、Specifications: 1ml:0.1mg (C₄₉H₆₆₁₀O₁₀S₂) 4、Registration Classification: Class 4 chemical drugs 5、Drug Approval Number: State Drug License H20243223 6、Prescription drug/over-the-counter drug: prescription drug 7、Listed Licensee: Hainan Shuangcheng Pharmaceutical Co. 8、Manufacturer: Hainan Shuangcheng Pharmaceutical Co. 9, Production Address: Haikou City, Xiuying District, No. 16 Xingguo Road Approved indications Octreotide acetate injection is indicated for the control of symptoms and reduction of plasma levels of growth hormone (GH) and insulin-like growth factor-1 (IGF-1) in patients with acromegaly who are unable or unwilling to undergo surgery or radiation therapy. Treatment of patients with acromegaly who are unable or unwilling to undergo surgery, or treatment of patients with intermittent acromegaly for whom radiation therapy has not yet taken effect; alleviation of symptoms ...
- Source: drugdu
- 122
- March 7, 2024

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