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Mashup Score: 2FDA accepts Regeneron, Sanofi’s Dupixent for priority review - 2 year(s) ago
The US FDA has accepted Regeneron Pharmaceuticals and Sanofi’s Dupixent (dupilumab) supplemental Biologics License Application (sBLA) for priority review.
Source: Pharmaceutical Business reviewCategories: Healthcare Professionals, Latest HeadlinesTweet
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Mashup Score: 3
ImmunityBio and NantKwest have dosed a first patient in the phase I clinical study of novel Covid-19 vaccine candidate called hAd5-Covid-19.
Source: Pharmaceutical Business reviewCategories: Healthcare Professionals, Latest HeadlinesTweet-
Correcting: @sciencecohen points out that a clinical trial of an Ad5-vectored #Covid19 vaccine has begun in the US. https://t.co/r1MBIZYbYz https://t.co/I4aX22HGsS
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Mashup Score: 0
Sanofi and Regeneron Pharmaceuticals have secured breakthrough therapy status from the FDA for Dupixent (dupilumab) to treat eosinophilic esophagitis (EoE).
Source: Pharmaceutical Business reviewCategories: Healthcare Professionals, Latest HeadlinesTweet-
Sanofi, Regeneron get FDA breakthrough therapy status for Dupixent to treat eosinophilic esophagitis https://t.co/SxbWHYi7Aj via @Pharmaceutical Business review
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Mashup Score: 4TransCon PTH shows promise in phase 2 hypoparathyroidism trial - 4 year(s) ago
Ascendis Pharma said that TransCon PTH has met key objectives in the phase 2 PaTH Forward trial in adult subjects with hypoparathyroidism.
Source: Pharmaceutical Business reviewCategories: Endocrinology, Latest HeadlinesTweet-
RT @DrJas_Cheung: Looks promising. Positive step forward. #ECE2020 @ESEndocrinology https://t.co/slPlmiHiz1
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Mashup Score: 13
Genentech has been given FDA approval for the COVACTA trial to assess the use of its RA drug Actemra (tocilizumab) in COVID-19 patients.
Source: Pharmaceutical Business reviewCategories: Hem/OncsTweet-
RCT (COVACTA) of IL6 receptor antagonist tocilizumab vs placebo in adults hospitalized w/ severe #COVID19 pneumonia opening imminently. Endpts include clin status, mortality, mech vent & ICU variables. Plan for early interim analysis for efficacy. https://t.co/rvetdGLA5F
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Mashup Score: 2
The rolling NDA allows completed portions of an NDA to be submitted and reviewed by the Agency on an ongoing basis. Aurinia has submitted the Nonclinical Module and
Source: Pharmaceutical Business reviewCategories: RheumatologyTweet-
Voclosporin (Aurinia) A Next-generation calcineurin inhibitor being developed for Lupus nephritis. Has Initiated rolling NDA to FDA expects to complete submission by end of the second quarter of 2020 https://t.co/5QXxvEaC9Z
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Mashup Score: 3
This NDA requests FDA approval of tucatinib in combination with trastuzumab and capecitabine for treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients
Source: Pharmaceutical Business reviewCategories: Hem/OncsTweet-
Seattle Genetics gets FDA priority review for tucatinib in locally advanced or metastatic HER2-positive breast cancer - Pharmaceutical Business review https://t.co/wK6EXn1crO
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Mashup Score: 0FDA grants breakthrough therapy status for APR-246 in MDS - 4 year(s) ago
Aprea Therapeutics has secured breakthrough therapy designation from the FDA for its lead molecule APR-246 in combination with azacitidine in MDS.
Source: Pharmaceutical Business reviewCategories: Hem/OncsTweet-
Aprea Therapeutics gets FDA breakthrough therapy status for APR-246 in MDS https://t.co/Sqmbn9rODF via @Pharmaceutical Business review
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FDA accepts Regeneron, Sanofi’s Dupixent for priority review for Eosinophilic Esophagitis https://t.co/OieCBhwEp3 via @Pharmaceutical Business review