Today’s Daily Dose brings you news about how the third time proved to be a charm for Adamis Pharma’s Epinephrine Pre-filled Syringe; favorable Markman claim construction ruling for Oxford Immunotec; encouraging results from Lilly’s phase III trial of Taltz in patients with active psoriatic arthritis and Skyline Medical’s STREAMWAY System securing the CE Mark.
Shares of Adamis Pharmaceuticals Corp. (ADMP) surged more than 53% on Thursday, following FDA approval of its Epinephrine Pre-filled Syringe for the emergency treatment of anaphylaxis.
Anaphylaxis is a potentially life-threatening allergic reaction. Certain medications, especially penicillin, anesthesia and aspirin; insect stings, certain foods and latex can trigger anaphylaxis.
The Company’s Epinephrine Pre-Filled Syringe was turned down by the U.S. regulatory agency in March of 2015 as well as in June 2016.
Adamis Pharma’s Epinephrine Pre-filled Syringe will sport the brand name Symjepi, and is expected to be launched in the second half of this year.
To know the pending FDA decisions of this month, read Biotech Stocks Facing FDA Decision In June.
ADMP closed Thursday’s trading at $5.75, up 53.33%. In after-hours, the stock was up 6.96% to $6.15.
Eli Lilly and Co.’s (LLY) approved psoriasis drug Taltz, in a pivotal Phase 3 trial, has demonstrated significant improvements in disease signs and symptoms at 24 weeks among patients with active psoriatic arthritis who had prior inadequate response or intolerance to TNF Inhibitors.
The study, dubbed SPIRIT-P2, evaluated the safety and efficacy of Taltz (80 mg every four weeks or every two weeks, following a 160-mg starting dose) compared to placebo after 24 weeks in patients with active psoriatic arthritis (PsA) who were previously treated with TNF inhibitors and had an inadequate response to one or two TNF inhibitors or were intolerant to TNF inhibitors.
Taltz was approved by the FDA last March to treat adults with moderate-to-severe plaque psoriasis. The…