Today's Rundown Amgen to cut 149 staff in retreat from neuroscience R&D Solid Bio sees yet another clinical hold for its DMD gene therapy AstraZeneca plans 2020 filing for anifrolumab in lupus AASLD: Durect's alcoholic hepatitis med repairs liver, cuts mortality in phase 2 AASLD: VBI Vaccines details hep B candidate as it preps 2020 filing Reata's kidney med bardoxolone delivers in phase 3, teeing up FDA filing Regenxbio sues FDA over gene therapy clinical hold Can noninvasive tests advance NASH diagnostics? Intercept analysis suggests so Featured Story | | | Tuesday, November 12, 2019 Amgen has given notice of its intent to lay off 149 people at its Cambridge, Massachusetts, operation by the end of the year. The notice comes weeks after Amgen revealed it was retreating from its East Coast neuroscience operations in a move that would threaten around 180 jobs. |
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Top Stories Tuesday, November 12, 2019 A new clinical hold following serious adverse events are the latest in a string of setbacks for Solid Biosciences and the development of its gene therapy for Duchenne muscular dystrophy. Tuesday, November 12, 2019 AstraZeneca is planning to file for approval of anifrolumab in systemic lupus erythematosus in the second half of next year. The Big Pharma is confident data generated across mid- and late-phase trials show the anti-IFNAR1 antibody works despite a pivotal study missing its primary goal. Tuesday, November 12, 2019 BOSTON—Durect presented data showing that all 19 patients who received its alcoholic hepatitis (AH) treatment were still alive 28 days after treatment. The drug also lowered bilirubin, a marker of liver disease, and reduced scores that reflect the likelihood that a person with AH will die within a certain period of time. Tuesday, November 12, 2019 BOSTON—VBI's Sci-B-Vac protected fewer people after the second dose than GlaxoSmith Kline's Engerix-B did after the third dose, but it protected twice as many people at every time point in the study up until the third dose. In a world where people aren’t very good at completing their vaccinations, it’s important to have a vaccine that acts quickly. Monday, November 11, 2019 Just one month after ending a nine-year partnership with AbbVie, Reata Pharmaceuticals is delivering phase 3 data for its lead program in a rare form of chronic kidney disease. Patients who received the drug had better kidney function after 48 weeks of treatment and sustained that improvement after stopping the drug for four weeks. Monday, November 11, 2019 Regenxbio is taking the FDA to court over a clinical hold. The lawsuit alleges the FDA imposed the hold “without notice or explanation” and has since “rebuffed” Regenxbio’s repeated requests for an explanation of the regulatory action. 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