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BioCryst
BioCryst Pharmaceuticals Reports MHLW Approval of Orladeyo for Hereditary Angioedema
Shots: The MHLW has approved Orladeyo (berotralstat) for prophylactic therapy in pediatric pts (2 to <12 yrs.) with hereditary angioedema (HAE) Approval was based on interim APeX-P trial results in pediatric pts with HAE, which showed early & sustained reductions in monthly attack rates; published in the Annals of Allergy, Asthma & Immunology BioCryst plans to launch…
1 day ago
Haisco Licenses Preclinical Immunology Drug to Sentivera in $1.5B+ Deal
Shots: Haisco has entered into an exclusive licensing agreement with Sentivera to develop, manufacture, & commercialize one of its preclinical immunology assets globally, excl. Greater China, in a deal valued at more than $1.5 billion. The agreement incl. $75.89M in upfront payment & equity consideration, ~$1.46B in development, regulatory & commercial milestones, plus tiered royalties…
1 day ago
Tempus AI Secures FDA Clearance for AI-Enabled Pulmonary Hypertension ECG Tool
Shots: Tempus AI has received FDA 510(k) clearance for Tempus ECG-PH, an AI-enabled software device that analyzes standard 12-lead ECGs for signs associated with pulmonary hypertension (PH) Designed for patients aged 40 and older with cardiovascular symptoms but no known PH history, Tempus ECG-PH identifies ECG patterns associated with elevated mean pulmonary artery pressure Tempus…
2 days ago
Celltrion
Celltrion Reports Launch of Omlyclo 300mg (Biosimilar, Xolair) in Europe
Shots: Celltrion has reported the launch of Omlyclo (300mg in PFS & autoinjector), a biosimilar version of Xolair (omalizumab), for the treatment of pts with allergic asthma & chronic spontaneous urticaria (CSU) in Europe Following the EU launch of Omlyclo 75mg & 150mg last year, Celltrion began rolling out the 300mg dose in Germany, the…
2 days ago
Roche
Roche’ Elecsys pTau217 Test Receives the US FDA Clearance to Rule in or Rule Out Alzheimer’s-Related Amyloid Pathology
Shots: The US FDA has granted clearance to Elecsys pTau217 to measure the phosphorylated Tau (pTau) 217 protein to help rule in or rule out Alzheimer’s-related amyloid pathology in people (≥55yrs.) with signs or complaints of cognitive decline In adults aged 55+ with cognitive decline associated with Alzheimer’s disease, Elecsys pTau217 showed high agreement with…
3 days ago
Takeda
Takeda Reports MHLW Approval of Orzeyful (Oveporexton) for Narcolepsy Type 1
Shots: The MHLW has approved Orzeyful (oveporexton) for the treatment of narcolepsy type 1 (NT1, narcolepsy with cataplexy) in adults Approval was based on extensive data, incl. P-III (FirstLight & RadiantLight) trial assessing Orzeyful (BID) in NT1 pts over 12wks, where FirstLight randomized 168 pts to 3 arms (2mg, 1mg & PBO) & RadiantLight randomized…
3 days ago
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