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BioWorld - Sunday, July 3, 2022
Home » Topics » Dermatologic, BioWorld

Dermatologic, BioWorld
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Stratagraft

Mallinckrodt wins FDA nod for regenerative skin therapy for burns

June 16, 2021
By Jennifer Boggs
No Comments
More than four months after its original PDUFA date of Feb. 2, 2021, Mallinckrodt plc’s Stratagraft gained FDA approval for use in deep partial-thickness thermal burns.
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Stock chart, upward arrow

Wall Street en-Raptured as oral AD drug makes it look EASI in phase Ib

June 14, 2021
By Randy Osborne
No Comments
Rapt Therapeutics Inc. CEO Brian Wong said RPT-193 monotherapy in atopic dermatitis (AD) “looks really promising, but there’s still quite a bit to learn” about the small molecule, designed to inhibit the migration of Th2 cells into inflamed tissues by blocking CCR4. Investors saw enough to push the shares of South San Francisco-based Rapt up 115.5%, or $21.45, to close at $40.02, after trading as high as $41.99 during the day.
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Woman applying skin cream to elbow

Dermavant tees up U.S. launch of dermatology cream with $200M financing

June 8, 2021
By Richard Staines
No Comments
Dermavant Sciences Inc. has announced a $200 million financing deal to clear the way for a potential U.S. launch of its dermatology cream tapinarof, covering a potential milestone payment to Glaxosmithkline plc following a filing in severe psoriasis.
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Gold wireframe handshake

Kyowa Kirin, Amgen ink blockbuster deal for potential atopic dermatitis treatment

June 2, 2021
By Gina Lee
No Comments
Kyowa Kirin Co. Ltd. has partnered with Amgen Inc. to jointly develop and commercialize KHK-4083, Kyowa Kirin’s phase III-ready anti-OX40 fully human monoclonal antibody for the potential treatment of atopic dermatitis. Kyowa Kirin will receive a $400 million up front, while milestone payments could add an additional $850 million. Significant royalty payments on future global sales could sweeten the blockbuster deal.
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Vial of OLX-104C

Olix inks deal to test hair-loss RNAi therapeutic with PCI’s delivery technology

May 7, 2021
By Gina Lee
No Comments
HONG KONG – Olix Pharmaceuticals Inc. has entered an extensive research collaboration to test its RNAi therapeutic, OLX-104C, with Fimanac, PCI Biotech Holding ASA’s delivery technology for nucleic acid-based therapies, with the aim of reducing off-target effects while treating androgenic alopecia, or hair loss.
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FDA icons

Device issues prompt FDA CRL for Leo’s tralokinumab in atopic dermatitis

April 30, 2021
No Comments
The FDA slapped Leo Pharma A/S’ BLA for IL-13 inhibitor tralokinumab with a complete response letter (CRL), making it the latest atopic dermatitis candidate to hit a regulatory setback in the U.S., following delays for three oral JAK inhibitor drugs earlier this month.
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Person scratching arm

Cara jacking up efforts in pruritis, oral Korsuva drives on to phase III

April 29, 2021
By Randy Osborne
No Comments
Despite stock-denting phase II data with the oral version of Korsuva (difelikefalin) for moderate to severe pruritis in patients with moderate to severe atopic dermatitis (AD), Cara Therapeutics Inc. CEO Derek Chalmers said the outcome “prioritizes moving forward. We got what we needed from the phase II trial,” which identified the patients most sensitive to the drug, nailed down a dose spectrum, and equipped the company to power a registrational effort, he said.
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C4X Discovery licenses preclinical IL-17 inhibitor program to Sanofi in $493M deal

April 12, 2021
By Nuala Moran
No Comments
LONDON – C4X Discovery Holdings plc has out-licensed its preclinical oral interleukin-17 (IL-17) inhibitor to Sanofi SA in a potential €414 million (US$493.4 million) deal. Under the terms of the agreement, Sanofi is paying €7 million up front and a further €11 in short-term preclinical milestones, with the balance to follow on reaching development, regulatory and commercialization milestones.
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Hair and scalp under magnifying glass

SALT lick? Concert not cowed by big pharma players in alopecia

March 8, 2021
By Randy Osborne
No Comments
Concert Pharmaceuticals Inc. CEO Roger Tung said determining who leads isn’t easy in the phase III race that pits his firm against Eli Lilly and Co. and Pfizer Inc. in alopecia areata. That’s because neither of the other companies has “been very direct about the timelines they’re on,” he told BioWorld. “We’ve been pretty clear that our goal is to have an NDA filing in early 2023.”
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Anaptysbio’s phase III of imsidolimab misses primary endpoint

March 8, 2021
By Lee Landenberger
No Comments
Anaptysbio Inc. is calling it quits for developing imsidolimab in treating moderate to severe palmoplantar pustulosis (PPP) after its phase II Poplar trial failed to hit its primary endpoint. However, the company said it would continue imsidolimab development for five other indications, including a phase III trial in treating generalized pustular psoriasis (GPP) that’s set to begin in mid-2021.
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