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AZ gets CRL asking for REMS changes to rare disease sBLA

While the U.S. FDA didn’t ask for more study data or have safety or efficacy concerns, it does want modifications to Alexion, Astrazeneca Rare Disease’s sBLA for Ultomiris (ravulizumab-cwvz) to treat adults with the rare central nervous system disease neuromyelitis optica spectrum disorder. The agency has issued a complete response letter (CRL) requesting changes to Ultomiris’ Risk Evaluation and Mitigation Strategy (REMS) to better validate patients’ meningococcal vaccination status or prophylactic administration of antibiotics before being treated. ....

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Advertiser.ie - Couper's Troopers storm to success in Buccaneers Tag Summer League

Buccaneers Tag Rugby Summer League concluded with an exciting series of finals, Couper’s Troopers taking the top honours. ....

Andrew Henson , Eoin Naughton , Smith Supervalu Monksland , Diarmuid Morrissey , Patrick Egan , Sean Rohan , Adrian Hanley , Kyle Mahon , Charlie Ocarroll , Thomas Cotton , Gerry Odonnell , Niall Tallon , Paul Hynes , Thomas Sheehan , Kieran Abrook , Zoe Langsdale , Lyndon Jones , Kyle Byrne , Atega Awhinawhi , Wesley Hudson , Martin Webster , Conor Galvin , Jack Pollard , Dylan Bruton , Billy Mcmickan , Peter Walpole ,

AstraZeneca to buy Pfizer's rare disease gene therapy portfolio for up to $1 billion

(Reuters) -AstraZeneca said on Friday its Alexion unit had agreed to buy U.S. drugmaker Pfizer's early-stage rare disease gene therapy portfolio for up to $1 billion, plus royalties on sales, as the British drugmaker bets on new genetic therapies. The British company also said Sharon Barr, head of research and development at Alexion, would succeed Mene Pangalos, the long-time biopharmaceuticals head of research at AstraZeneca. ....

United Kingdom , Nivedita Bhattacharjee , Yadarisa Shabong , Gene Therapy , Mene Pangalos , Rare Disease , Sharon Barr ,

PM Group to acquire Cork-based automation specialist

Milestone Solutions provides IT and automation services to large multinational manufacturing companie ....

Dave Murphy , Pm Group , Consumer Protection Commission , Milestone Solutions , Cork Anchored Milestone Solutions ,

BioLight Inks Agreement With Alexion To Explore Technology For Diagnosis Of Retinal Diseases

LONDON (dpa-AFX) - BioLight Life Sciences Ltd. announced Tuesday it has signed a research collaboration agreement with Alexion Pharmaceuticals, Inc. (ALXN), a subsidiary of AstraZeneca plc (AZN ....

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