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Amylyx
News
Amylyx Pharmaceuticals Reports the First Participant Dosing in P-III (LUCIDITY) Study Evaluating Avexitide in PBH
SShots:Amylyx has dosed the first participant in its pivotal P-III (LUCIDITY) study of avexitide (90mg) for post-bariatric hypoglycemia (PBH), with recruitment completion expected in 2025 and topline data in the H1’26The P-III (LUCIDITY) study evaluating avexitide (QD) vs PBO in ~75 PBH patients post Roux-en-Y gastric bypass surgery includes a 6wks. screening…
May 1, 20250Comments
Vertex Pharmaceuticals
News
Vertex Pharmaceuticals’ Alyftrek Receives the CHMP’s Positive Opinion for the Treatment of Cystic Fibrosis
SRShots:   The CHMP has recommended Alyftrek (deutivacaftor/tezacaftor/vanzacaftor) to treat patients (≥6yrs.) with cystic fibrosis (CF), having at least one non-class I mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Alyftrek is approved in the US and UK and is under review in Canada, Switzerland, Australia, and New ZealandVanzacaftor &…
May 1, 20250Comments
Spotlight_Barbara Albientz
SPOTLIGHT
Reuters Pharma 2025: Post-Conference Talks Featuring Barbara Albientz
Barbara Albientz, Chief Commercialization Officer, Helvion Pharmaceuticals, joins PharmaShots’ Managing Editor Himanshu Sehgal for a riveting dialogue exchange. Barbara shares her experience from the recently held Reuters Events Pharma 2025, where she joined as an affirmative team member for the debate Reality Check: Is Omnichannel Actually Working?Barbara believes AI will be crucial in segmenting…
May 1, 20250Comments
Regulus Therapeutics
News
Novartis to Acquire Regulus Therapeutics for ~$1.7B
Shots:Novartis to acquire Regulus Therapeutics incl. its lead asset, farabursen via its wholly owned subsidiary, which will merge with Regulus upon closing, resulting in Regulus becoming an indirect wholly owned subsidiary of NovartisAs per the deal, Regulus will get ~$0.8B upfront, with shareholders receiving $7/share in cash, & ~$0.9B upon achievement of a…
May 1, 20250Comments
Teleflex
News
Teleflex’s QuikClot Control+ Hemostatic Device Receives the US FDA’s 510(k) Clearance to Temporary Control All Bleeding Grades
Shots:The US FDA has granted 510(k) clearance for label expansion of QuikClot Control+ Hemostatic Device to control all grades of internal & external bleedingLabel expansion was supported by real-world evidence from an observational study evaluating QuikClot Control+ in 603 US emergency, trauma, & surgical pts across all bleeding grades & varied anatomical sites…
April 30, 20250Comments