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ADMP Soars On FDA Nod, It Is Advantage OXFD, LLY In Good Spirits


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.

Read on...

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 drug generated sales of $96.6 million in the first quarter of 2017.

LLY closed Thursday's trading at $82.05, up 0.55%.

Oxford Immunotec Global PLC (OXFD) has received a favorable Markman claim construction ruling in its patent infringement lawsuit against Qiagen Inc., Quest Diagnostics, Inc., and Laboratory Corp. of America Holdings.

In 2015, Oxford Immunotec had sued Qiagen, Quest Diagnostics, and Laboratory Corp. of America Holdings for allegedly infringing 6 of its patents related to T-SPOT TB test, a method for diagnosing TB infection.

Oxford Immunotec's T-SPOT.TB test has been approved for sale in over 50 countries, including the United States, where it has received pre-market approval from the FDA and Europe, where it has obtained a CE mark, as well as Japan and China.

OXFD closed Thursday's trading at $15.13, up 5.22%.

Skyline Medical Inc. (SKLN) has been notified that its STREAMWAY System meets all requirements and can now be affixed with the CE mark and marketed in 32 European countries.

STREAMWAY system, which is a direct-to-drain fluid disposal system designed specifically for medical applications, such as radiology, endoscopy, urology and cystoscopy procedures, has already received FDA clearance.

Revenue derived from sale of STREAMWAY systems and disposable supplies in 2016 was $456,000 compared with $654,000 in 2015.

SKLN closed Thursday's trading at $1.72, up 5.52%.

by RTTNews Staff Writer

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