Search Results for “EC” – Page 72 – media

EC approves UCB’s Zilbrysq as generalised myasthenia gravis add-on therapy

The European Commission (EC) has approved UCB’s Zilbrysq (zilucoplan) as an add-on therapy for certain patients with generalised myasthenia gravis (gMG), a rare autoimmune disease with a global prevalence of 100 to 350 cases per one million people. The marketing authorisation, which specifically applies to adults who are anti-acetylcholine receptor (AChR) antibody-positive, makes Zilbrysq the first once-daily subcutaneous, targeted component 5 (C5) complement inhibitor for gMG. Patients with gMG can experience a variety of symptoms, including severe muscular weakness that can result in double vision, drooping eyelids, difficulty swallowing, chewing and talking, and life-threatening weakness of the muscles of respiration. UCB’s Zilbrysq inhibits complement-mediated damage to the neuromuscular junction through its targeted dual mechanism of action, the company said, adding that the therapy can be used simultaneously with intravenous immunoglobulin and plasma exchange without the need for supplemental dosing. The EC’s decision was supported by positive results from the late-stage ...
- Source: drugdu
- 97
- December 7, 2023
Global donors pledge over $777m to fight neglected tropical diseases at COP28 summit

At the 2023 Reaching the Last Mile (RLM) Forum during the United Nations Climate Change Conference (COP28), global donors pledged $777.2m to help control, eliminate and eradicate neglected tropical diseases (NTDs). The funding will accelerate progress towards achieving the goals outlined in the World Health Organization’s (WHO) 2030 roadmap on NTDs. The forum, hosted by RLM in partnership with the Bill & Melinda Gates Foundation, comprised over 450 government ministers, global health leaders and development experts, philanthropists and civil society leaders to mitigate the effects of the climate crisis on human health. Established in 2020, WHO’s roadmap for NTDs includes eliminating at least one NTD in 100 countries by 2030 and reducing the number of people requiring NTD treatment by 90%. Despite progress, climate change has slowed the reach and prevalence of infectious diseases. NTDs are a diverse group of several parasitic viral, bacterial, fungal and non-communicable diseases that can ...
- Source: drugdu
- 88
- December 7, 2023
Elli Lilly Cancer Drug Lands Its Second FDA Approval This Year

Eli Lilly cancer drug Jaypirca is closing 2023 the same way it started—with an FDA approval. The latest regulatory nod adds two additional types of blood cancers to the list of indications for the therapy. Friday’s accelerated approval for Jaypirca covers the treatment of adults with either chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The once-daily oral drug is a small molecule designed to block Bruton’s tyrosine kinase, or BTK, a cancer-driving enzyme. While other drugs already do this, Lilly’s molecule has an edge. The FDA based its decision on the results of an open-label, single-arm Phase 1/2 study in blood cancers that included more than 100 patients with CLL or SLL previously treated with at least two prior lines of therapy. Participants had received a median of five prior lines of therapy; the FDA said 77% of these patients had discontinued a BTK inhibitor after their cancer ...
- Source: drugdu
- 110
- December 6, 2023
UK-India research project trialling easy-to-use UTI test to support fight against AMR

The University of Edinburgh, the University of Arts London, Silchar Medical College, Assam University and the Indian Institute of Technology Delhi have collaborated on a new UK-India research project, DOSA2, to help combat antimicrobial resistance (AMR). LifeArc, UK Research and Innovation, Economic Social Science Research Council, the Newton fund and the government of India’s Department of Biotechnology will fund and support the Diagnostics for One Health and User Driven Solutions for Antimicrobial Resistance (DOSA) project. Designated as one of the top ten global public health threats facing humanity by the World Health Organization, AMR occurs when bacteria, fungi and parasites change and adapt to antibiotics over time. Globally, urinary tract infections (UTIs) are the second leading cause of antibiotic consumption, often purchased over the counter in India, one of the highest human antibiotic-using countries in the world, and taken without medical supervision, contributing to the global issue of AMR. The ...
- Source: drugdu
- 89
- December 6, 2023
Cancer Research UK and Guardant collaborate to advance cancer detection and treatment

Cancer Research UK (CRUK), its innovation unit, Cancer Research Horizons, and Guardant Health have announced a collaboration to advance the development and precision of cancer detection and treatment. The mission-focused collaboration aims to accelerate the discovery and development of cancer drugs and diagnostics for patients. Affecting 20% of people in the UK, rare cancers are forms of cancer that can occur in unusual places in the body, requiring special treatment. Challenging to treat, rare cancer types include melanoma skin cancer, kidney cancer, brain tumours, non-Hodgkin lymphoma and pancreatic cancer. As part of the agreement, the parties will be able to discuss opportunities for collaboration to support CRUK’s research and development activities. In particular, the agreement will focus primarily on the charity’s clinical trials run by its Centre for Drug Development (CDD), including the DETERMINE trial, as well as other CRUK and Cancer Research Horizon research collaborations. The DETERMINE trial is ...
- Source: drugdu
- 87
- December 6, 2023
Pfizer Nixes Twice-Daily Oral GLP-1 Candidate After High Rates of Side Effects

By Tyler Patchen Pictured: Sign at Pfizer’s headquarters in New York/iStock, JHVEPhoto Pfizer on Friday said it is scrapping an investigational twice-daily oral Glucagon-like peptide-1 receptor agonist candidate after topline data from a Phase IIb trial of obese patients without type 2 diabetes showed high rates of adverse events. While the trial did reach the primary endpoint of a statistically significant change in body weight, there were high rates of adverse events. According to Pfizer, the adverse events in the obesity trial for the twice-daily dosing of GLP-1 danuglipron were mild and included gastrointestinal symptoms that were “consistent with the mechanism” of the candidate. However, the company noted high rates of these side effects. Up to 73% of patients experienced ...
- Source: drugdu
- 193
- December 5, 2023
Generation bio cuts 40% of staff in blow for non-viral gene therapy sector

US-based Generation Bio is cutting its workforce by 40%, becoming the latest company to announce lay-offs to save money this year. The restructuring includes the departure of key personnel, with medical chief Douglass Kerr and development leader Tracy Zimmerman among those leaving. The 29 November announcement adds to a series of setbacks in the field, with the cell therapy startup NexImmune reducing its workforce by over half this year, halting the development of its three adoptive T cell therapies. Generation anticipates that the downsizing and streamlining of its research and development focus will result in a cost-saving of $120m over the next three years, as outlined in a 27 November SEC filing. In April, Takeda announced that it was moving away from the adeno-associated virus (AAV) gene therapies sector amidst difficulties associated with gene therapy research development at the preclinical stage, highlighting that it is unlikely that many current AAV ...
- Source: drugdu
- 92
- December 4, 2023
EU’s IVD guidelines continue affecting early clinical work

The implementation of the In Vitro Diagnostic Medical Devices Regulation (IVDR) by the European Union (EU) continues to be a disadvantage for companies looking to start their clinical trials in the EU, said Malte Oppermann, senior director of clinical operations at Medigene. Oppermann spoke at a session of the Clinical Trials in Oncology (CTO) Europe 2023 conference in Munich, Germany, which took place 28 – 29 November. The session focused on the impact of IVD regulation changes on early-stage clinical trials and the challenges that come with clinical trials that incorporate IVDs. In a nutshell, IVDs are tests carried out on patient samples that can be used to prevent and treat diseases. In oncology, IVDs are used to detect biomarkers, which have become increasingly important in precision medicine. Examples of established biomarkers with approved therapies include the prognostic biomarkers HER2 and BRCA1. The IVDR came into effect on 26 May ...
- Source: drugdu
- 96
- December 4, 2023
Vivos receives FDA 510(k) clearance for oral devices to treat severe sleep apnea

Dive Brief Vivos Therapeutics has received 510(k) clearance for the use of its oral devices in adults with severe obstructive sleep apnea (OSA). The Food and Drug Administration ruling, which comes 11 months after Vivos received clearance for an oral appliance in mild-to-moderate OSA, gives the green light to an application that was previously only possible off-label. The company’s trio of devices, called Complete Airway Repositioning and/or Expansion (CARE) oral appliances, include the DNA, mRNA and mmRNA products. Vivos’ share price increased nearly 834% to $41 when the market closed on Wednesday. The medtech company’s market capitalization was approximately $30.8 million even after the latest jump in its stock, according to Nasdaq. Dive Insight Vivos sells a set of airway repositioning and expansion devices for treating dentofacial abnormalities and OSA. The company has worked to add clearances to use more of the devices in the treatment of OSA, winning a ...
- Source: drugdu
- 92
- December 2, 2023
Pharma’s engagement with healthcare providers has slipped in recent years

In recent years there has been a downward trend in health care provider (HCP) contact in the pharmaceutical industry with 65% of HCPs limiting access to three or fewer companies, said Aaron Bean, the vice president of commercial business consulting at Veeva Europe. At the Veeva Commercial Summit 2023, Bean discussed HCP engagement with the pharmaceutical sector at a media roundtable. He suggested that HCPs’ increased selectiveness could be a result of increased “time pressure” and changes in the way they consume information. Bean was presenting data from Veeva’s February 2023 Pulse Field Trends Report which showed geographic differences in HCP engagement. In data taken from April to September 2022 from European countries, the UK led the shift with 94% of HCPs only contacting three or fewer pharmaceutical companies, compared to 50% in Spain. The same dataset showed that differences also appeared when comparing therapy areas. In oncology, approximately 25% ...
- Source: drugdu
- 120
- December 2, 2023

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