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November 05, 2024
Insignis Therapeutics Receives Positive FDA Feedback on IN-001 Clinical Program for Needle-Free Anaphylaxis Treatment
- FDA feedback confirms clear pathway to approval for IN-001
- Key trial focus: PK/PD in healthy subjects, with PK bracketed by standard epinephrine injections
- No placebo-controlled efficacy studies required
NORTH HAVEN, Conn., Nov. 05, 2024 (GLOBE NEWSWIRE) — Insignis Therapeutics, a leader in innovative allergy and anaphylaxis treatments, announced today that it has received positive feedback from the U.S. Food and Drug Administration (FDA) with regard to its clinical development program for IN-001, a needle free epinephrine sublingual spray designed for the emergency treatment of anaphylaxis. IN-001 is based on an FDA-approved epinephrine prodrug that enhances stability and absorption.
Read MoreOctober 07, 2024
Insignis Therapeutics Announces Positive Results from Phase 1 Clinical Study of IN-001 Liquid Epinephrine Sublingual Spray for Anaphylaxis
- Rapid epinephrine absorption with a time to reach the 100 pg/mL threshold concentration in 9 minutes after dosing
- Sustained pharmacokinetics (PK) with plasma epinephrine concentration remaining above 100 pg/mL for 2 hours post-dose, ensuring a durable treatment effect
- Safe and well tolerated, with only mild, transient, and self-resolving adverse events (AEs) reported
NORTH HAVEN, Conn., Oct. 07, 2024 (GLOBE NEWSWIRE) — Insignis Therapeutics, a leader in innovative allergy and anaphylaxis treatments, is excited to announce positive Phase 1 results for IN-001, an investigational liquid epinephrine sublingual spray for anaphylaxis. This study, A24-1889, demonstrated that IN-001 is highly effective and easy to use, offering a promising alternative to current needle-based treatments.
Read MoreAugust 13, 2024
Insignis Therapeutics Receives FDA Fast Track Designation for IN-001 for Anaphylaxis Treatment
- Convenient, needle-free, and simple-to-use liquid epinephrine sublingual spray
- Suitable for all patients, including those with dry mouth conditions, as it does not require saliva for dissolution or absorption
- Unprecedented stability under extreme temperature conditions from -20℃/-4°F to 60℃/140°F, making it the first rugged real-world epinephrine product that can endure extreme heat and cold
- Considerably Longer shelf life than competition products, reducing the need for frequent replacements and ensuring product integrity and performance
July 13, 2017
10 Unforgettable Sailing Destinations
In the time of Spanish rule, and for many years afterwards, the town of Sulaco—the luxuriant beauty of the orange gardens bears witness to its antiquity—had never been commercially anything more important than a coasting port with a fairly large local trade in ox-hides and indigo.
The clumsy deep-sea galleons of the conquerors that, needing a brisk gale to move at all, would lie becalmed, where your modern ship built on clipper lines forges ahead by the mere flapping of her sails, had been barred out of Sulaco by the prevailing calms of its vast gulf. Some harbours of the earth are made difficult of access by the treachery of sunken rocks and the tempests of their shores. Sulaco had found an inviolable sanctuary from the temptations of a trading world in the solemn hush of the deep Golfo Placido as if within an enormous semi-circular and unroofed temple open to the ocean, with its walls of lofty mountains hung with the mourning draperies of cloud.
On one side of this broad curve in the straight seaboard of the Republic of Costaguana, the last spur of the coast range forms an insignificant cape whose name is Punta Mala. From the middle of the gulf the point of the land itself is not visible at all; but the shoulder of a steep hill at the back can be made out faintly like a shadow on the sky. Continue reading “10 Unforgettable Sailing Destinations”
Read MoreJuly 12, 2017
Ruth Levinson
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Read MoreJuly 12, 2017
George Harrison
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Read MoreJuly 12, 2017
Omnilingual
To translate writings, you need a key to the code — and if the last writer of Martian died forty thousand years before the first writer of Earth was born … how could the Martian be translated?
Martha Dane paused, looking up at the purple-tinged copper sky. The wind had shifted since noon, while she had been inside, and the dust storm that was sweeping the high deserts to the east was now blowing out over Syrtis. The sun, magnified by the haze, was a gorgeous magenta ball, as large as the sun of Terra, at which she could look directly. Tonight, some of that dust would come sifting down from the upper atmosphere to add another film to what had been burying the city for the last fifty thousand years. Continue reading “Omnilingual”
Read MoreJuly 12, 2017
The House On The Borderland
Right away in the west of Ireland lies a tiny hamlet called Kraighten. It is situated, alone, at the base of a low hill.
Far around there spreads a waste of bleak and totally inhospitable country; where, here and there at great intervals, one may come upon the ruins of some long desolate cottage—unthatched and stark. The whole land is bare and unpeopled, the very earth scarcely covering the rock that lies beneath it, and with which the country abounds, in places rising out of the soil in wave-shaped ridges.
Yet, in spite of its desolation, my friend Tonnison and I had elected to spend our vacation there. He had stumbled on the place by mere chance the year previously, during the course of a long walking tour, and discovered the possibilities for the angler in a small and unnamed river that runs past the outskirts of the little village.
I have said that the river is without name; I may add that no map that I have hitherto consulted has shown either village or stream. They seem to have entirely escaped observation: indeed, they might never exist for all that the average guide tells one. Possibly this can be partly accounted for by the fact that the nearest railway station (Ardrahan) is some forty miles distant. Continue reading “The House On The Borderland”
Read MoreJuly 12, 2017
Jordan Bellwood
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Read MoreJuly 11, 2017
The Windows of Absolute Night
To most minds mystery is more fascinating than science. But when science itself leads straight up to the borders of mystery and there comes to a dead stop, saying, “At present I can no longer see my way,” the force of the charm is redoubled.
On the other hand, the illimitable is no less potent in mystery than the invisible, whence the dramatic effect of Keats’ “stout Cortez” staring at the boundless Pacific while all his men look at each other with a wild surmise, “silent upon a peak in Darien.” It is with similar feelings that the astronomer regards certain places where from the peaks of the universe his vision seems to range out into endless empty space. He sees there the shore of his little isthmus, and, beyond, unexplored immensity.
The name, “coal-sacks,” given to these strange voids is hardly descriptive. Rather they produce upon the mind the effect of blank windows in a lonely house on a pitch-dark night, which, when looked at from the brilliant interior, become appalling in their rayless murk. Infinity seems to acquire a new meaning in the presence of these black openings in the sky, for as one continues to gaze it loses its purely metaphysical quality and becomes a kind of entity, like the ocean. The observer is conscious that he can actually see the beginning of its ebon depths, in which the visible universe appears to float like an enchanted island, resplendent within with lights and life and gorgeous spectacles, and encircled with screens of crowded stars, but with its dazzling vistas ending at the fathomless sea of pure darkness which encloses all. Continue reading “The Windows of Absolute Night”
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