Search Results for “Shire ” – Page 2 – media

EU nod for Shire’s longer-acting haemophilia A therapy

Shire’s Adynovi has been approved for use in Europe for on-demand and prophylactic use in patients 12 years and older with the rare bleeding disorder haemophilia A.
- Source: Pharmatimes
- 534
- January 18, 2018
Adynovi haemophilia A New Approvals
Shire’s cytomegalovirus therapy wins ‘Breakthrough’ status

An experimental drug being developed by Shire to treat cytomegalovirus (CMV) infection has been given a boost in the US with a ‘Breakthrough Therapy Designation’.
- Source: pharmatimes
- 512
- January 8, 2018
Company Insight compromised immunity cytomegalovirus virus
FDA clears Shire’s dosing software for haemophilia A SHARE

Irish biotechnology firm Shire has received 510(k) marketing clearance for its myPKFiT for ADVATE [Antihemophilic Factor (Recombinant)] software from the US Food and Drug Administration (FDA).
- Source: medicaldevice-network
- 603
- December 26, 2017
ADVATE FDA haemophilia A Shire
Shire Receives European Approval for Label Extension of FIRAZYR® (icatibant injection) for the Symptomatic Treatment of Acute HAE Attacks in Paediatric Patients

Shire plc (LSE: SHP, NASDAQ: SHPG), the global leader in serving patients with rare diseases, announced today that the European Commission (EC) has approved a label extension granting a new indication for FIRAZYR® (icatibant injection), broadening its use to adolescents and children aged 2 years and older, with hereditary angioedema (HAE) caused by C1-esterase-inhibitor (C1-INH) deficiency. FIRAZYR has been approved in the European Union (EU) since 2008 for symptomatic treatment of acute attacks of HAE in adults with C1-INH deficiency.
- Source: finance.yahoo
- 537
- October 30, 2017
EC FIRAZYR® HAE Shire
Shire Receives Orphan Drug Designation for Gene Therapy Candidate SHP654 (BAX 888) for the Treatment of Hemophilia A

Shire plc (LSE: SHP, NASDAQ: SHPG), the global biotechnology leader in rare diseases, announced the U.S. Food and Drug Administration (FDA) awarded Orphan Drug Designation(ODD) to Shire`s gene therapy candidate SHP654 (also designated as BAX 888), an investigational factor VIII (FVIII) gene therapy for the treatment of hemophilia A. The regulatory agency also granted Shire investigational new drug (IND) status for SHP654.
- Source: finance.yahoo
- 461
- October 27, 2017
FDA hemophilia A Orphan Drug Designation Shire
FDA grants fast-track designation for Shire’s lung drug

The FDA has granted Fast Track designation to Shire's SHP607 for the prevention of chronic lung disease in extremely premature infants.
- Source: Pharmatimes
- 582
- September 14, 2017
chronic Clinical lung New Approvals
EU regulators reviewing Shire’s bleeding disorder drug

European regulators have validated the marketing authorisation application for Shire’s experimental von Willebrand Disease therapy Veyvondi.
- Source: pharmatimes
- 605
- June 26, 2017
EU FDA genetic therapy
Artificial Intelligence Test Determines Risk of Bowel Cancer Recurrence After Surgery

Bowel cancer, commonly referred to as colorectal cancer, can develop anywhere in the large bowel, including the colon and rectum. It ranks among the most prevalent cancers globally, with 1.9 million new cases recorded in 2020. The current protocols for determining the need for chemotherapy for patients with early-stage bowel cancer are not consistently reliable. As a result, some patients receive chemotherapy unnecessarily, while others who might benefit from it do not receive it and may face cancer recurrence. This decision is particularly challenging for stage II colon cancer, where the risk of recurrence post-surgery is generally lower. Now, a new artificial intelligence (AI) test can predict the risk of recurrence in bowel cancers, potentially helping patients avoid unnecessary chemotherapy. This test employs an AI algorithm to measure the concentration of immune cells known as CD3 in tumors at the early stages of bowel cancer. Previous studies have indicated that ...
- Source: drugdu
- 66
- August 5, 2024
Institutions to lead £1.7m-funded network to support people at risk of dementia

The neurodegenerative condition currently affects more than 944,000 people in the UK University College London (UCL) and the University of Exeter are set to co-lead a new national Dementia Network Plus initiative supported by more than £1.7m in funding. The Sustainable Prevention, Innovation and Involvement NETwork (SPIINNET) will help to reduce dementia risk and improve people’s experiences of living with dementia by supporting new projects and engaging with communities. Affecting more than 944,000 people in the UK, dementia is a neurodegenerative condition that affects the ability to remember, think or make decisions in everyday life. The new network will combine researchers from 14 universities with specialist organisations, including King’s College London, the University of Plymouth, Bangor, Cardiff Metropolitan, East Anglia, Northampton, Nottingham, Oxford, Southampton, Stirling, Strathclyde, Sunderland and Worcestershire. SPIINNET aims to utilise existing networks and umbrella organisations to deliver a programme to create connections between the experience, knowledge and ...
- Source: drugdu
- 93
- July 12, 2024
Avidity Bio’s RNA Therapy Flashes Early Signs of Treating a Muscular Dystrophy’s Root Cause

Avidity Biosciences’ RNA therapy for facioscapulohumeral muscular dystrophy has preliminary clinical data showing it knocked down expression of a gene that causes this rare disease. More details will be presented at a medical conference this week. By Frank VinluanAn experimental RNA therapy from Avidity Biosciences has early clinical trial results showing it reduced by half the expression of a gene at the root of a rare, inherited form of muscular dystrophy with no FDA-approved therapies. Furthermore, patients in the study are showing signs of regaining muscle function. Based on these initial results announced Wednesday, Avidity said it plans to accelerate the start of additional cohorts in the Phase 1/2 study that could support an application seeking regulatory approval in this disease, facioscapulohumeral muscular dystrophy (FSHD). More details about the data are coming soon. Avidity plans to present the preliminary results during the Annual FSHD Society International Research Congress meeting, which ...
- Source: drugdu
- 78
- June 14, 2024

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