Search Results for “EU” – Page 42 – media

Elon Musk’s brain chip firm says US approval won for human study

By James FitzGerald BBC News Elon Musk’s brain-chip firm says it has received approval from the US Food and Drugs Administration (FDA) to conduct its first tests on humans. The billionaire’s Neuralink implant company wants to help restore people’s vision and mobility by connecting brains with computers. It says it does not have immediate plans to start recruiting participants. Mr Musk’s previous ambitions to begin tests came to nothing. The regulator itself is yet to comment. An earlier bid by Neuralink to win FDA approval was rejected on safety grounds, according to a report in March by the Reuters news agency that cited multiple current and former employees. • What is Neuralink? Neuralink hopes to use its microchips to treat conditions such as paralysis and blindness, and to help certain disabled people use computers and mobile technology. The chips – which have been tested in monkeys – are designed to ...
- Source: drugdu
- 113
- May 29, 2023
【EXPERT Q&A】Could someone explain the WC certification documents for exporting Active Pharmaceutical Ingredients (APIs) to the European Union?

Drugdu.com expert’s response: Active pharmaceutical ingredients (APIs) intended for export to the European Union need to obtain the Good Manufacturing Practice (GMP) certification and Written Confirmation (WC) document issued by the European Medicines Agency (EMA). GMP certification for pharmaceuticals involves rigorous auditing of the manufacturer’s quality management system, production processes, equipment, and personnel, ensuring the produced pharmaceuticals meet the quality and safety requirements of the EU. GMP certification is a prerequisite for obtaining the WC document; only businesses that have passed GMP certification can obtain the WC document and export APIs to the EU market. The WC document is one of the required export documents for APIs to the EU, aiming to ensure that APIs exported to the EU meet the EU’s quality and safety requirements. To apply for the WC document, the API manufacturing company needs to submit the following information to the EMA: 1.Name of the API and its ...
- Source: drugdu
- 99
- May 28, 2023
Neuralink competitor Paradromics gets one step closer to FDA approval for its brain implant

A growing team of nearly 50 employees at the neurotech startup Paradromics is working on a brain implant that sounds like the work of science fiction. And it has caught the attention of federal regulators. Paradromics, founded in 2015, is developing a device that could help patients with severe paralysis regain their ability to communicate by deciphering their neural signals. And on Thursday, the Austin, Texas-based company announced that it has received the Breakthrough Device designation from the Food and Drug Administration for its flagship system, called the Connexus Direct Data Interface. CEO Matt Angle said the designation, in addition to a $33 million funding round the company also announced Thursday, will help Paradromics bring its device to market. Paradromics is part of the emerging brain-computer interface, or BCI, industry. A BCI is a system that deciphers brain signals and translates them into commands for external technologies. Experts believe the ...
- Source: drugdu
- 123
- May 21, 2023
SCOTUS hands win to Sanofi, Regeneron in long-running PCSK9 feud with Amgen

After numerous twists and turns, a highly divisive patent infringement case between Amgen and partners Sanofi and Regeneron has come to an end at the U.S. Supreme Court.The nine justices voted unanimously to uphold (PDF) a lower court ruling invalidating a pair of patents on Amgen’s PCSK9 cholesterol med Repatha. The case stretches back to 2014, when Amgen first sued Sanofi and Regeneron for allegedly treading on Amgen intellectual property with their rival PCSK9 drug Praluent, under development at the time as alirocumab. Praluent and Amgen’s Repatha won U.S. approvals just weeks apart in 2015. Both drugs work to help lower “bad” LDL cholesterol by blocking the protein PCSK9. In 2019, a judge ruled that certain claims of two Amgen patents covering Repatha were invalid. Amgen took that loss to federal appeals court, where it was rejected. The company ultimately petitioned the U.S. Supreme Court to hear the case in ...
- Source: drugdu
- 120
- May 21, 2023
Rapid spread of antibiotic-resistant E. coli across Europe raises concerns

In a recent study published in the journal Eurosurveillance, researchers performed whole genome sequencing (WGS) on 874 Escherichia coli (E. coli) isolates carrying the bla NDM-5 gene, which encodes New Delhi metallo-β-lactamase (NDM)-5. They retrieved the study sample set from 13 European Union (EU)/European Economic Area (EEA) countries between 2012 and June 2022. Background In a survey of carbapenem- and/or colistin-resistant Enterobacterales (CCRE survey) performed across 36 European countries in 2019, researchers detected 62 of 201 carbapenemase-producing E. coli isolates carrying NDM-5 encoding gene ‘blaNDM-5’ in 15 countries. Additionally, they observed that some of these 62 E. coli isolates belonged to high-risk sequence types (STs), which increased the risk of extraintestinal infections. Since these findings were concerning, the European Centre for Disease Prevention and Control (ECDC) requested further investigation into the matter. About the study In the present study, researchers initiated the collection of WGS and epidemiological data on bla ...
- Source: drugdu
- 136
- May 17, 2023
Amgen and TScan Therapeutics partner to identify new Crohn’s disease targets

Amgen and TScan Therapeutics have announced a multi-year collaboration aimed at identifying new targets for Crohn’s disease. The partnership will utilise TScan’s target discovery platform, TargetScan, to identify the antigens recognised by T cells in patients with Crohn’s disease. Amgen will then develop therapeutics based on the discovered targets and will retain all global development and commercial rights. In exchange, TScan will receive an upfront payment of $30m and will be eligible for over $500m in success-based preclinical, clinical, regulatory and commercial milestones as well as tiered single-digit royalties. Under the terms of the agreement, Amgen has an option to expand the collaboration to ulcerative colitis, with each company responsible for its own research expenses. Crohn’s disease and ulcerative colitis are both inflammatory bowel diseases, characterised by chronic inflammation of the gastrointestinal tract. Nearly one in every 100 people in the US are diagnosed with IBD. Despite the availability of ...
- Source: drugdu
- 150
- May 16, 2023
Ariceum and UCB link up to take on immune-related diseases

The companies will use proprietary technology to enable the discovery of peptide-radioisotope conjugates Ariceum Therapeutics and UCB have announced a research partnership agreement to establish and develop novel systemic targeted radiopharmaceuticals for the treatment of solid tumours and immune-related diseases. An essential part of the collaboration will involve the companies utilising each other’s proprietary technology platforms to enable the discovery of peptide-radioisotope conjugates as treatments for a variety of cancers and immune-related diseases. In addition, Ariceum will gain access to UCB’s experience in order to identify novel synthetic macrocyclic peptides by incorporating its mRNA-display technology platform, ExtremeDiversity. Similarly, UCB will benefit from Ariceum’s expertise in the areas of radiochemistry and labelling technology, thereby enhancing its ability to study how this type of technology could lead to the discovery of differentiated products for immune-related diseases. Indeed, the agreement means that each company will have the opportunity to explore multiple targets. Dhaval ...
- Source: drugdu
- 123
- May 15, 2023
European Commission green lights Servier’s Tibsovo

Treatment concerns patients with IDH1-mutated acute myeloid leukaemia and IDH1-mutated cholangiocarcinoma Servier has revealed that the European Commission (EC) has approved Tibsovo – also known as ivosidenib tablets – as a therapy in two vital indications. The first is in combination with azacitidine for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) with an isocitrate dehydrogenase-1 (IDH1) R132 mutation. These individuals will not have been eligible to receive standard induction chemotherapy. The second is as a monotherapy among adult patients with locally advanced or metastatic cholangiocarcinoma in addition to a IDH1 R132 mutation who have previously undergone treatment using at least one prior line of systemic therapy. Tibsovo remains the only IDH1 inhibitor approved across Europe, while it has also received orphan medicine designation recognising the significant benefit brought to patients by the drug. Philippe Gonnard, executive vice president, global product strategy at Servier, explained: “IDH1 ...
- Source: drugdu
- 119
- May 13, 2023
EU countries lay out framework for combating drug shortages

After the European Commission proposed a massive overhaul to the EU’s drug legislation, a group of 19 European countries is launching an effort to reduce the bloc’s supply chain reliance on outside countries. The position paper (PDF) urges the EU to “take more drastic steps” to improve the security of Europe’s supply of medicines. Belgium is leading the charge, and 18 other countries such as France, Germany and Spain are on board. In 2019, more than 40% of global active pharmaceutical ingredients came from China, the countries point out. That, coupled with other factors such as the fact that “almost all API producers depend on China for intermediate inputs,” make Europe and the rest of the world dependent on “a few manufacturers for a large bulk of their medicines supply,” according to the paper. The proposed European Critical Medicine Act would follow in the footsteps of similar acts such as the Critical Raw Materials Act ...
- Source: drugdu
- 142
- May 9, 2023
Researchers evaluate the dual-therapeutic effect of gene therapy in mouse model of osteosarcoma

Reviewed by Lily Ramsey, LLM Investigators at Brigham and Women’s Hospital and collaborating institutions evaluated the dual-therapeutic effect of gene therapy in a clinically relevant model for common form of bone cancer. With a worldwide incident rate of 3.4 cases per million people per year, osteosarcoma is one of the most common bone cancers affecting children and adolescents. The current gold standard treatment option requires extensive surgical intervention and chemotherapy that leads to a poor prognosis and decreased quality of life. Due to the aggressive nature of the disease, the surgical intervention usually involves total reconstruction of the limbs or, in most cases, amputation. Researchers at Brigham and Women’s Hospital, a founding member of the Mass General Brigham healthcare system, in collaboration with investigators at University College Dublin (UCD), Massachusetts Institute of Technology (MIT), and Trinity College Dublin (TCD), have identified a potential therapeutic target and developed a unique delivery ...
- Source: drugdu
- 153
- May 9, 2023

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