Today’s Daily Dose brings you news about Karyopharm’s BOSTON study; Synergy Pharma’s upcoming regulatory catalyst related to Trulance; FDA panel review of ABP 215, a biosimilar candidate to Roche’s Avastin; TEVA’s HALO study and AbbVie’s SELECT-NEXT study.
AbbVie’s (ABBV) phase III clinical trial of Upadacitinib in patients with moderate to severe rheumatoid arthritis who did not adequately respond to treatment with conventional synthetic DMARDs has met all primary and secondary endpoints.
In the study, dubbed SELECT-NEXT, at week 12, ACR20 response was achieved by 64 percent patients who received a 15 mg oral, once-daily dose of Upadacitinib and 66 percent of patients who received 30 mg oral, once-daily dose of Upadacitinib compared to 36 percent of patients receiving placebo.
The ACR20 refers to at least 20% improvement in tender and swollen joint counts and in three of the following end points: patient and physician global assessments, pain, disability, and an acute-phase reactant. (Source: PubMed)
ABBV closed Wednesday’s trading at $68.75, up 1.30%.
Allergan plc (AGN) has agreed to acquire Keller Medical Inc., a privately held medical device company, adding Keller Funnel to its plastic surgery portfolio.
The Keller Funnel is a cone-shaped, lubricated plastic funnel that reduces surgeon and patient contact during breast augmentation or reconstruction procedures.
Commenting on the deal, Louis P. Bucky, MD, Clinical Professor of Surgery, Division of Plastic Surgery at the University of Pennsylvania School of Medicine and Chief of Plastic Surgery at Pennsylvania Hospital, said, “The purchase of Keller Medical demonstrates Allergan’s ongoing commitment to excellence in breast augmentation and reconstruction surgery.”
AGN closed Wednesday’s trading at $228.19, down 0.05%.
An FDA panel is slated to review Amgen (AMGN) and Allergan plc.’s (AGN) Biologics License Application for ABP 215, a biosimilar candidate to Roche’s Avastin on July 13, 2017.
The FDA’s final…