media – Page 216 – DrugDu- Global Leading Pharmaceutical & Medical Device Platform

AMP Publishes Best Practice Guidance for Slice Testing Approach in Diagnostics

As the discovery of genes linked to a variety of inherited conditions accelerates, clinical labs are finding it increasingly challenging to keep up with multiple assays dedicated to specific disease-related gene panels. To streamline this process, labs are adopting a ‘slice testing’ approach that employs a comprehensive capture backbone to analyze data pertinent to a specific gene set. Like conventional disease-focused panels, slice testing sequences a wide array of genes but narrows down the analysis to a pre-selected group of pertinent genes. This method combines the benefits of high-quality gene panels with the wider scope and adaptability of exome sequencing. The Association for Molecular Pathology (AMP, Rockville, MD, USA) has released a detailed report that explores the unique aspects of employing a slice testing strategy for diagnostic purposes. This includes the intricacies of gene selection, analytical performance, coverage, quality, and data interpretation. The report consolidates expert consensus recommendations and findings ...
- Source: drugdu
- 132
- December 29, 2023
AI Accurately Predicts Cancer Outcomes from Tissue Samples

Patient tissue samples are commonly examined on slides by pathologists, a process integral to diagnosis. This traditional method, while effective, is notably time-intensive and subject to variability in interpretations among different pathologists. Moreover, some subtle details in pathology images might escape human observation but could hold critical insights into a patient’s health status. Over recent years, several artificial intelligence (AI) models have been developed to undertake certain tasks typically performed by pathologists, such as classifying cell types or gauging cellular interactions based on proximity. Nevertheless, these models have not fully captured the more intricate aspects of tissue image analysis that pathologists conduct, including recognizing complex cell spatial arrangements and filtering out irrelevant image ‘noise’ that could distort interpretations. Addressing this gap, researchers have now introduced an innovative AI model that is capable of examining the spatial organization of cells within tissue samples, offering precise predictions about cancer patient outcomes and ...
- Source: drugdu
- 137
- December 29, 2023
Key Leadership Lessons for Biotech Executives from a Hospital Administrator

While it may appear that hospital administrators and biotech CEOs have quite dissimilar jobs because they face different challenges daily, this article attempts to conveys the value of some of the underlying principles that one can develop in the field of hospital administration, that may have some value in other healthcare fields and in other executive positions. By PETE O’HEERON When one thinks of the dynamic biotech landscape, with many early-stage firms delving into therapies for diverse maladies, such as cancer or heart disease, to any of a number of rare diseases, the executive leadership image that arises is certainly quite different than one might imagine for a healthcare executive, such as a hospital administrator. While patient health might be an end goal for both, the milieu within which they operate is seemingly quite distinct. It is certainly not typical for individuals to transition between these two realms, and yet, ...
- Source: drugdu
- 161
- December 29, 2023
Cytokinetics Heart Drug’s Trial Data Look Competitive With BMS Med Camzyos

Cytokinetics drug aficamten met the main goal of a pivotal test in obstructive hypertrophic cardiomyopathy. If approved, the daily pill would compete against a Bristol Myers Squibb drug projected to become a blockbuster seller. By FRANK VINLUAN An experimental Cytokinetics drug has Phase 3 data showing it improved the ability of the heart to work during exercise. In addition to meeting this main goal of its pivotal test in a rare cardiovascular disease, the results look competitive with a Bristol Myers Squibb product already on the market. The Cytokinetics drug, aficamten, is a potential treatment for obstructive hypertrophic cardiomyopathy (oHCM), a condition that leads to thickening of heart muscle that makes it harder for the organ to pump blood. Patients experience fatigue and shortness of breath. The condition can progress to heart failure. Cytokinetics reported preliminary Phase 3 results on Wednesday showing that after 24 weeks, treatment with its once-daily ...
- Source: drugdu
- 149
- December 29, 2023
Pfizer’s Hospira recall spree bleeds into 2024 with product pulls for multiple hospital drugs in shortage

After a year plagued by recalls, Pfizer’s sterile injectables unit Hospira seems no closer to righting the ship over its glass-contamination woes. What’s more, the company’s latest product pulls threaten to intensify the ongoing shortages of several critical hospital drugs. Shortly before the holiday, Pfizer’s Hospira announced two separate recalls over the potential presence of glass particulates in vials and syringes of certain meds. In the case of injectable cancer medication bleomycin—of which Hospira is recalling one lot—a confirmed customer report alerted the company to the presence of glass particulates within a single vial, the company said in a notice posted on the FDA’s website. The second recall, which covers three drugs—two strengths of injectable sodium bicarbonate, plus one lot of atropine sulfate injection—kicked off after the company flagged “the potential presence of glass particulate matter” during routine product inspection. In both cases, Pfizer and Hospira said they hadn’t received ...
- Source: drugdu
- 194
- December 29, 2023
Amgen’s request for full approval of Lumakras in lung cancer denied by FDA

Amgen’s request to gain full approval of Lumakras in non-small cell lung cancer has been rejected by the FDA. The California pharma will now have to conduct an additional confirmatory trial to gain the coveted FDA nod. Lumakras was granted accelerated approval in May 2021 to treat second line KRAS G12C-mutated NSCLC. The company was asked by the FDA to launch a confirmatory trial and a dose optimization study to gain a full approval. The therapy faced an advisory committee meeting in October where a panel was asked to consider whether the primary endpoint for the phase 3 CodeBreak 200 trial could be reliably interpreted in Amgen’s study. The committee voted 10-2 against the measure, suggesting that they were unimpressed with Amgen’s trial design. Despite the negative vote, the agency was not expected to remove Lumakras from the market, but instead request another confirmatory trial. Amgen now says that’s exactly ...
- Source: drugdu
- 131
- December 29, 2023
Fosun Diagnostics’ Fully Automated Chemiluminescence Immunoassay Analyzer F-i1000 Obtains EU IVDR Certification

Recently, Fosun Diagnostics announced that its fully automated chemiluminescence immunoassay analyzer, F-i1000, has received approval for EU IVDR CE registration. The issuance of the registration certificate under the IVDR regulation signifies international recognition of the quality of Fosun Diagnostics’ chemiluminescence products and the ability to meet diverse testing requirements for projects in various levels of medical institutions such as hospitals, core laboratories, and clinics, both domestically and internationally. CE certification is granted based on relevant EU laws, regulations, and standards, serving as a passport for products to freely circulate in the EU market. On May 5, 2017, the EU released the In Vitro Diagnostic Medical Devices Regulation (IVDR) (Regulation (EU) 2017/746), replacing the original EU In Vitro Diagnostic Medical Devices Directive (IVDD, Directive 98/79/EC). After the transition period following the regulation’s implementation, in vitro diagnostic medical devices without IVDR CE certification will no longer be allowed to enter the EU ...
- Source: drugdu
- 101
- December 29, 2023
FDA Grants Fast Track Designation to Henlius’ EGFR-Targeting ADC HLX42 for NSCLC Patients with Disease Progression on EGFR Targeted Therapies

Shanghai, China, December 27, 2023 – Shanghai Henlius Biotech, Inc. (2696. HK) announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation(FTD) for HLX42, an investigational EGFR-Targeting ADC that developed by the company based on the collaboration with MediLink Therapeutics, for the treatment of patients with advanced or metastatic EGFR-mutated non-small cell lung cancer whose disease has progressed on a 3rd-generation EGFR tyrosine kinase inhibitor. Previously, HLX42 was approved for conducting clinical trial by the National Medical Products Administration (NMPA) and FDA. Yongqiang Shan, general manager of Henlius’ Global Innovation Center, said: “I am glad to see the continuous progress we have made in advancing our ADC portfolio. The grant of FTD represents FDA’s recognition of HLX42’s potential in addressing serious diseases that filled unmet medical needs. In the future, Henlius will maintain our focus on areas of unmet medical needs and accelerate the development and delivery ...
- Source: drugdu
- 248
- December 29, 2023
WHO to progress plans to develop a model for the medical (care) planning of mass gatherings

The World Health Organization (WHO) will move forward with its plans to develop a set of standards and recommendations that can be adopted and adapted for the medical (care) planning of mass gatherings following the conclusion of a successful two-day consultation that was held at the WHO office in Lyon, France, in November 2023, to explore the proposal further. A technical working group will now be set up to develop and discuss an early draft of the model in the first half of 2024, with the Emergency Medical Teams (EMT) methodology of principles, standards and quality domains forming the bedrock of the work. This will then be followed by further consultations and testing of the agreed model with key stakeholders. The workshop, which was organized by the WHO EMT and other Rapid Response Capacities Unit and Border Health and Mass Gatherings Unit, came on the back of work done in ...
- Source: drugdu
- 115
- December 29, 2023
Innovent and SanegeneBio Enter Strategic Collaboration to Develop siRNA Drug for the Treatment of Hypertension

ROCKVILLE, Md. and SUZHOU, China, Dec 20, 2023 — 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 other major diseases, and Sanegene Bio USA Inc. (SanegeneBio) announce that they have entered into a collaboration agreement to co-develop SGB-3908, an siRNA drug candidate targeting angiotensinogen (AGT) for the treatment of hypertension. Innovent also obtains an exclusive option to license in the future development, manufacturing and commercialization rights of SGB-3908. SGB-3908 is an IND-enabling stage siRNA drug developed based on SanegeneBio’s proprietary LEAD™ (Ligand and Enhancer Assisted Delivery) platform. Under the terms of the agreement, both parties will be jointly responsible for the development of SGB-3908 to certain stage. Innovent will receive an exclusive option to pay different option exercise fees to obtain the exclusive development, manufacturing, and commercialization license of SGB-3908 in ...
- Source: drugdu
- 166
- December 29, 2023

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.