media – Page 305 – DrugDu- Global Leading Pharmaceutical & Medical Device Platform

AbbVie achieves win for migraine prevention drug Aquipta in Europe

The European Commission has approved AbbVie’s Aquipta as migraine prophylaxis for adult patients, making it the first daily oral treatment of its class to be approved in the EU for the prevention of both chronic and episodic migraines. Several calcitonin gene-related peptide (CGRP) antibodies are administered subcutaneously or via intravenous infusions. But there is a preference among patients for oral therapies, says Dawn Carlson, vice president, Neuroscience Development at AbbVie, in an interview with Pharmaceutical Technology. Lundbeck’s CGRP antibody Vyepti (eptinezumab), is administered through intravenous infusions, while Amgen’s Aimovig (erenumab) is injected subcutaneously. The approval of Aquipta is based on the results of the two Phase III studies—ADVANCE (NCT03777059) and PROGRESS (NCT03855137), which both met their primary endpoint of a statistically significant reduction in mean monthly migraine days versus placebo, per the 17 August announcement. In the PROGRESS trial, patients in the 60mg Aquipta cohort reported a 6.8-day reduction in ...
- Source: drugdu
- 120
- August 22, 2023
【EXPERT Q&A】What is the procedure for registering medical devices for the Russian market?

Drugdu.com expert’s response: The registration process in Russia mainly consists of the following steps: Submission of Application: First, you need to submit a registration application to the Russian Ministry of Health. This typically includes detailed information about your product such as the name, type, specifications, manufacturer information, etc. Technical Documentation Review: The Russian Ministry of Health will review the technical documentation you have submitted. This might encompass details of your product design, production process, quality control systems, etc. Clinical Evaluation: You might be required to undergo a clinical evaluation to demonstrate the safety and efficacy of your product. This could involve clinical trials or submission of other forms of clinical data. Manufacturer Review: The Russian Ministry of Health might review the manufacturer to ensure compliance with Russian laws and regulations. Obtaining the Registration Certificate: If your product passes the above steps of the review, you will receive a registration certificate. ...
- Source: drugdu
- 341
- August 22, 2023
medical device Russia market
Meta-analysis reports global prevalence of MAFLD of 38.8% in adults

Non-alcoholic fatty liver disease (NAFLD) is a common condition that affects up to 30% of adults in the general population. It is characterized by the accumulation of fat in the liver. It is often associated with other conditions, such as obesity, type 2 diabetes, and metabolic syndrome. The new definition of metabolic dysfunction-associated fatty liver disease (MAFLD) was proposed in 2020. MAFLD is diagnosed based on hepatic steatosis (fatty liver) and at least one of three metabolic risk abnormalities: overweight/obesity, type 2 diabetes, or evidence of metabolic dysregulation. A recent meta-analysis led by Ming-Hua Zheng from the First Affiliated Hospital of Wenzhou Medical University has reported a global prevalence of MAFLD of 38.8% in adults. MAFLD can progress to cirrhosis and promote the development of some critical extrahepatic diseases, such as cardiovascular disease and chronic kidney disease. MAFLD is a severe condition that can lead to cirrhosis and other health ...
- Source: drugdu
- 186
- August 21, 2023
Severe COVID-19 may cause long-term changes to innate immune system

Severe COVID-19 may cause long-lasting alterations to the innate immune system, the first line of defense against pathogens, according to a small study funded by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. These changes may help explain why the disease can damage so many different organs and why some people with long COVID have high levels of inflammation throughout the body. The findings were published online today in the journal Cell. Researchers led by Steven Z. Josefowicz, Ph.D., of Weill Cornell Medicine in New York City examined immune cells and molecules in blood samples from 38 people recovering from severe COVID-19 and other severe illnesses, as well as from 19 healthy people. Notably, the researchers established a new technique for collecting, concentrating and characterizing very rare blood-forming stem cells that circulate in the blood, eliminating the need to extract such cells from ...
- Source: drugdu
- 183
- August 21, 2023
Chimerix’s Drug Candidate Improves Survival for Patients with Incurable Brain Tumor

By Matt Olszewski Pictured: Adult holding child’s hand/gorodenkoff/iStock Biopharma company Chimerix announced Wednesday positive results from two early-stage clinical trials for its first in-class small molecule imipridone, a potential treatment for an incurable and aggressive type of pediatric brain tumor which demonstrated longer survival in this subset of patients. The data, published Wednesday in the journal Cancer Discovery, showed that Chimerix’s ONC201 nearly doubled survival for patients with H3K27M-mutated diffuse midline gliomas (DMG), as compared to previous patients. Diffuse midline gliomas with the H3K27M mutation are aggressive, with a survival rate of 11 months to 15 months. However, the median overall survival was nearly 22 months for tumors that had not recurred at the time of enrollment in the trial. In addition, almost a third of those patients lived longer than two years. “These data further elucidate the underlying novel mechanism of action for ONC201 in a patient population which ...
- Source: drugdu
- 120
- August 21, 2023
FDA Approves Ipsen’s Palovarotene for Ultra-Rare Bone Disease

By Tristan Manalac Pictured: U.S. FDA headquarters in Maryland/iStock, Grandbrothers The FDA on Wednesday approved Ipsen’s palovarotene, now to be sold under the brand name Sohonos, for the treatment of fibrodysplasia ossificans progressiva. Sohonos is an oral medication indicated for the reduction of heterotrophic ossification in adults and children with fibrodysplasia ossificans progressiva (FOP). It is the first medicine authorized by the FDA to treat FOP. “For the first time, doctors have an approved medicine available to them, shown to reduce the formation of new, abnormal bone growth,” Ipsen R&D head Howard Mayer said in a statement. Afflicting approximately 400 patients in the U.S. and 900 globally, FOP is an ultra-rare genetic disease in which muscles and connective tissues are gradually replaced by bone. Patients with FOP often suffer from hindered movements and, in cases where joints are affected, lose their mobility. FOP also manifests as breathing problems and difficulties ...
- Source: drugdu
- 115
- August 21, 2023
US study finds potential new way of improving immunotherapy for tumours

A new study by the University of Pittsburgh and the University of Pittsburgh Medical Centre (UPMC) in the US has revealed a new way to stimulate the immune system to enable immunotherapy to shrink or eradicate aggressive tumours. By equipping oncolytic viruses, genetically modified viruses, with tumour-inhibiting genetic cargo, researchers found that it ‘warms up’ cold tumours in the immune system and helps immunotherapy tackle the tumour. Oncolytic viruses were previously designed to directly eliminate cancer cells. Researchers found that oncolytic viruses could stimulate the immune system, suggesting their potential use with other cancer therapies to remove the brakes on the immune system for T cells to recognise and combat tumours. “Immune checkpoint inhibitors work only in ‘hot’ tumours, which have already been infiltrated by T cells,” said Greg Delgoffe, associate professor of immunology at Pitt’s School of Medicine and director of the Tumor Microenvironment Center at UPMC Hillman Cancer ...
- Source: drugdu
- 130
- August 21, 2023
FDA approves Talvey for heavily pre-treated multiple myeloma

US Food and Drug Administration (FDA) has approved Talvey (talquetamab-tgvs) for the treatment of refractory or relapsed multiple myeloma in adult patients who have received at least four prior lines of therapy. Talvey is a bispecific antibody targeting T-cell CD-3 receptors and G protein-coupled receptor class C group 5 member D (GPRC5D) developed by Janssen. It received accelerated approval as a weekly or biweekly subcutaneous therapy. University of California multiple myeloma programme director Ajai Chari noted in a press release: “Patients at this stage of the disease have a poor prognosis. Talquetamab as a first-in-class therapy is a new option for patients with this difficult-to-treat blood cancer.” The approval was based on meaningful overall response rates (ORR) demonstrated in the Phase II clinical trial data. However, continued approval for Talvey is contingent upon further confirmatory trials showing clinical benefit. To that end, Talvey is only available for use via a ...
- Source: drugdu
- 126
- August 21, 2023
Novo Nordisk spends $1bn to acquire weight loss drug developer Inversago.

Amongst fierce competition in the obesity space, Novo Nordisk has spent $1bn to acquire Inversago Pharma to shore up its weight loss treatment portfolio. The acquisition is expected to be completed by the end of 2023 and will hit the billion-dollar mark, subject to developmental and commercial milestones. The deal, which comes a month after Eli Lilly acquired Versanis and its lead weight loss candidate, bimagrumab, in a $1.9bn deal, will include Inversago’s lead asset INV-202, an oral cannabinoid receptor type-1 (CB1) inverse agonist. Novo Nordisk said it intends to use the candidate for patients with obesity and obesity-related complications. Canada-based Inversago demonstrated the weight loss potential of the candidate in a Phase Ia trial by blocking the CB1 receptor, which plays an important role in appetite regulation and metabolism. INV-202 is currently in a Phase II trial for diabetic kidney disease (NCT05514548). Prior to the 10 August announcement, Novo ...
- Source: drugdu
- 229
- August 21, 2023
GenScript and T-MAXIMUM partner for CAR-T cell therapy development

Genscript Biotech has formed a strategic collaboration agreement with T-MAXIMUM Biotech to develop CAR-T cell therapy. Leveraging GenScript’s CRISPR nucleic acid re-agents, the partnership will focus on developing T-MAXIMUM’s CAR-T cell therapy. GenScript research and development (R&D) and manufacturing vice-president Dr Li Hong stated: “Our R&D-to-GMP-level sgRNA will support their UCAR-T products for solid tumours. While CAR-T cell therapies have made remarkable strides in haematological tumours, addressing the unmet need for solid tumours remains crucial.” T-MAXIMUM will receive a number of CRISPR re-agents from GenScript. These will support the development of T-MAXIMUM’s universal CAR-T products from discovery to commercialisation. GenScript’s partnership with T-MAXIMUM will drive the latter’s strategic development plan, advancing products into Phase II clinical research and enabling market delivery up to 2027. T-MAXIMUM is currently focused on the development of its universal CAR-T cell therapy product, MT027, to treat recurrent high-grade gliomas. T-MAXIMUM CEO Dr Shang Xiaoyun stated: ...
- Source: drugdu
- 172
- August 21, 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.