media – Page 146 – DrugDu- Global Leading Pharmaceutical & Medical Device Platform

Researchers identify genetic changes responsible for rare childhood immune disorders

Affecting the immune system, various forms of SCID are estimated to affect one in 75,000 to 100,000 newborns A new study led by Newcastle University has identified the genetic changes that are responsible for rare childhood immune disorders that can leave newborns with little to no immune defence against infections. Published in Science Immunology, the study involved experts from the Great North Children’s Hospital, the Wellcome Sanger Institute and their collaborators. Severe combined immunodeficiency (SCID) and Omenn syndrome are two rare genetic disorders that affect the function of children’s immune systems and put them at risk of life-threatening conditions. While the prevalence of Omenn syndrome is unknown, the various forms of SCID are estimated to affect one in 75,000 to 100,000 newborns. Without urgent treatment, including stem cell transplants to replace the faulty immune system, most children affected will not survive their first year of life. Researchers studied 11 children, ...
- Source: drugdu
- 105
- June 3, 2024
FDA Grants Priority Review to Jazz Pharmaceuticals’ Zanidatamab for Multiple Forms of HER-2 Positive Biliary Tract Cancer

Don Tracy, Associate Editor Submission for the FDA approval of zanidatamab was based on promising data from the Phase IIb HERIZON-BTC-01 clinical trial in patients with previously treated, unresectable, locally advanced, or metastatic HER2-positive biliary tract cancer. Jazz Pharmaceuticals announced that the FDA has granted Priority Review to zanidatamab, a bispecific antibody being evaluated for previously treated, unresectable, locally advanced, or metastatic HER2-positive biliary tract cancer (BTC). According to the company, the submission was based on positive results from Cohort 1 of the Phase IIb HERIZON-BTC-01 clinical trial, which showed a confirmed objective response rate (cORR) of 41.3%. The FDA assigned the application with a Prescription Drug User Fee Act target action date of November 29, 2024. A Phase III trial, HERIZON-BTC-302, is evaluating zanidatamab in combination with standard-of-care therapy against standard-of-care therapy alone in first-line advanced or metastatic HER2-positive BTC.1 “The priority review designation for zanidatamab underscores the critical ...
- Source: drugdu
- 135
- June 3, 2024
FDA Approves Breyanzi for Relapsed or Refractory Mantle Cell Lymphoma

Davy James Breyanzi, a CD19-directed CAR T-cell therapy, granted fourth FDA approval to treat a distinct subtype of non-Hodgkin lymphoma.The FDA has approved Bristol Myers Squibb’s (BMS) Breyanzi (lisocabtagene maraleucel) to treat adults with relapsed or refractory (R/R) mantle cell lymphoma (MCL) who were previously administered at least two lines of systemic therapy that included a Bruton tyrosine kinase (BTK) inhibitor.1 The regulatory action marks the fourth indication for Breyanzi to treat a distinct subtype of non-Hodgkin lymphoma. “With Breyanzi, we are delivering on the promise of cell therapy by offering a definitive treatment option for some of the most difficult-to-treat lymphomas,” Bryan Campbell, senior vice president, head of Commercial, Cell Therapy, BMS, said in a press release. “We are proud of the advances we are making to bring our differentiated CAR T cell therapy to the most patients across indications and lines of therapy to ensure treatment options that ...
- Source: drugdu
- 134
- June 3, 2024
BHF awards £35m funding to nine UK universities for cardiovascular disease

Affecting more than 7 million people in the UK, cardiovascular diseases are conditions that affect the heart or circulation The British Heart Foundation (BHF) has awarded a total of £35m in funding to nine universities across the UK to help strengthen world-leading cardiovascular disease research. Provided through BHF’s Research Excellence Awards scheme, the funding will support research environments that encourage collaboration, inclusion and innovation to accelerate lifesaving breakthroughs. Affecting around 7.6 million people in the UK, cardiovascular disease is a term for conditions that affect the heart or circulation, including high blood pressure, stroke, heart disease and vascular dementia. The nine universities to receive part of the funding include Imperial College London (ICL), King’s College London (KCL), the University of Cambridge, Edinburgh, Leeds, Leicester, Manchester, Oxford and University College London. For the next five years, the funding will enable cutting-edge research to address some of the biggest cardiovascular disease challenges, ...
- Source: drugdu
- 154
- June 1, 2024
FDA Grants Priority Review to Keytruda Combination as a First-Line Treatment for Unresectable Advanced or Metastatic Malignant Pleural Mesothelioma

Don Tracy, Associate Editor Priority review designation for Keytruda is based on promising results from the Phase II/III IND.227/KEYNOTE-483 trial, which demonstrated improved overall survival in patients with unresectable advanced or metastatic malignant pleural mesothelioma. Merck has announced that the FDA granted Priority Review designation to its application for Keytruda (pembrolizumab) plus chemotherapy as a first-line treatment for patients with unresectable advanced or metastatic malignant pleural mesothelioma. According to the company, the application was a based on positive data from the Phase II/III IND.227/KEYNOTE-483 trial, which found that Keytruda in combination with chemotherapy significantly improved overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) compared to chemotherapy alone. Further, death was reduced by 21% (HR=0.79 [95% CI, 0.64-0.98]; two-sided p value=0.0324), with a median OS of 17.3 months (95% CI, 14.4-21.3) versus 16.1 months (95% CI, 13.1-18.2) for chemotherapy alone. After a year of treatment, the estimated PFS ...
- Source: drugdu
- 192
- June 1, 2024
Merck Sees Pipeline Diversification Opportunity in $1.3B EyeBio Acquisition

Merck’s EyeBio acquisition brings a lead program ready for pivotal testing in diabetic macular edema. The therapy could pose competition to Eylea, the blockbuster Regeneron Pharmaceuticals eye drug. By Frank VinluanMerck is on the hunt for drugs with blockbuster potential to make up for declining revenue when its top product, the cancer immunotherapy Keytruda, loses patent protection in the next few years. The pharmaceutical giant is getting a contender through the acquisition of a clinical-stage startup whose lead program is on track to begin pivotal testing in diabetic macular edema. According to deal terms announced Wednesday, Merck is acquiring Eyebiotech Limited, or EyeBio, for $1.3 billion in cash up front. Shareholders of the New York-based company could receive up to $1.7 billion more in milestone payments. EyeBio develops drug for retinal conditions in which inflammation leads to the breakdown of the inner blood-retinal barrier. This breakdown leads to vascular leakage, ...
- Source: drugdu
- 120
- June 1, 2024
Tianjin establishes health care group to create a new model for health care industry

The reporter learned from the Tianjin State-owned Assets Supervision and Administration Commission that Tianjin Health and Elderly Care Group Co., Ltd. (hereinafter referred to as Health and Elderly Care Group), a Class II commercial enterprise directly supervised by the commission, was recently established and put into operation. It is promoting the high-quality and coordinated development of the health and elderly care industry by exploring the parallel path of providing market-oriented mid- to high-end health and elderly care services and inclusive elderly care services supported by government policies. According to reports, Kangyang Group is positioned as the main body of investment, operation and implementation of Tianjin’s health and elderly care industry, with the integration of medical care and elderly care as its core, based on “health, medical care, health, elderly care and integration”, covering home, community, institutions and other fields, and will serve the Beijing-Tianjin-Hebei region through market-oriented methods, facing the ...
- Source: drugdu
- 120
- June 1, 2024
Multinational companies target the trillion-dollar medical equipment “trade-in” market

“The introduction of the ‘old for new’ policy is good news for the entire medical market, especially for companies like us that have been rooted in China for many years.” Pu Zhengrong, vice president of Siemens Healthineers Greater China and head of clinical treatment systems, expressed the above views in an interview with China News Service recently. At the 89th China International Medical Equipment (Spring) Fair (CMEF) which just ended in Shanghai, the “old for new” policy for medical equipment was undoubtedly a hot topic. Faced with the trillion-level market released by this policy, a number of multinational companies showed great interest. Chen Jinlei, vice president of GE Healthcare China and general manager of medical imaging business, said that after the “old for new” policy was released, the medical industry, from users to manufacturers, paid close attention to it. “We have developed eight targeted plans for ‘old for new’.” On ...
- Source: drugdu
- 99
- June 1, 2024
HS and NICE announce plan to adopt innovative medical technologies for patients

The proposals will help MedTech developers access NHS funding to fast-track products NHS England and the National Institute for Health and Care Excellence (NICE) have announced a new plan to adopt innovative medical technologies to provide faster access to NICE-recommended products and improve patient outcomes. The proposals set out a route for MedTech developers to access NHS funding to fast-track clinically and cost-effective products to be used by NHS England. Developed by NHS England and NICE with input from the Department of Health and Social Care, as well as other partners including the Office for Life Science and the Medicines and Healthcare products Regulatory Agency, the new plans will also support MedTech innovators and suppliers with automatic funding to support routine commissioning for technologies that meet the required criteria. NHS England’s interim medical director for transformation, Dr Vin Diwaker, said: “Medical technology plays a vital role in the nation’s health ...
- Source: drugdu
- 101
- June 1, 2024
Fresenius Medical Care plans layoffs ahead of California plant closure

Dive Brief Fresenius Medical Care will lay off more than 300 people as part of a planned closure of a manufacturing plant in Concord, California. The cuts will begin in August and continue through mid-2025, according to a Worker Adjustment and Retraining Notification (WARN) filing with California. CEO Helen Giza told investors on a May 7 call that the company is moving production from California to Mexico to reduce costs and improve margins. Dive Insight Fresenius Medical Care, which makes dialysis equipment and operates dialysis centers around the world, is looking to tighten spending in its first year as an independent company. The firm was separated from parent company Fresenius in November, with Fresenius keeping a 32% stake. Giza told investors that “several initiatives are underway” to optimize Fresenius Medical Care’s manufacturing footprint and supply chain. The company will move all dialysis manufacturing operations from Concord, California, to a facility ...
- Source: drugdu
- 156
- June 1, 2024

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.