Amgen's erenumab shows positive results in second late-stage migraine study - $AMGN phase 3 STRIVE study has shown positive results in migraine patients, meeting primary endpoint of statistically valid change from baseline in mean monthly migraine days at week 24 compared to placebo.It was also successful in another Phase 3 study called ARISE. FDA submissions in 2017.
Mallinckrodt CEO accused of securities fraud by short seller from Citron Research - Mallinckrodt $MNK went down 12% after Andrew Left from Citron accused CEO Mark Trudeau of committing securities fraud."Trudeau has been caught red handed committing securities fraud - exposed by none other than the newly released Medicare drug-spending dashboard," said Citron, bringing an issue up reminiscent of Mylan recently with EpiPen.
Gilead's momelotinib wins some, loses some more - $GILD momelotinib in myelofibrosis matched Incyte's Jakafi in one trial, but failed to show superiority to best alternative therapy in another. Gilead will have more work to do before it can move towards regulatory submissions.
Regeneron and Sanofi's sarilumab beats AbbVie's Humira in late-stage RA study - Regeneron $REGN and Sanofi's $SNY sarilumab showed superiority to AbbVie's $ABBV HUMIRA (adalimumab) in adult patients with rheumatoid arthritis (RA). AES were similar, including serious AEs. Sanofi's U.S. marketing application is currently under review. The FDA issued a CRL last month citing manufacturing deficiencies at the Sanofi site.