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

Dermatologic, BioWorld
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Conference data for March 28, 2022: AAD

March 28, 2022
No Comments
New and updated preclinical and clinical data presented by biopharma firms at the American Academy of Dermatology annual meeting, including: Arcutis, Dermavant, Janssen, Leo, Nimbus, Sun, Timber.
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Skin exam
Newco news

Moonlake going after blockbuster indications with dual-targeting nanobody

March 25, 2022
By Nuala Moran
No Comments
Moonlake Therapeutics AG is making headway on its mission to establish a broad dermatology and rheumatology franchise around its sole product, sonelokimab, announcing it is poised to start a phase II study in hidradenitis suppurativa.
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Skin exam

BMS-Nektar phase III melanoma study misses primary endpoints

March 14, 2022
By Lee Landenberger
No Comments
Four years after Bristol Myers Squibb Co.’s (BMS) $1.85 billion investment in Nektar Therapeutics Inc., the pair’s collaboration has stumbled mightily with a phase III failure. A first analysis their melanoma study, PIVOT IO-001, showed it missed three primary endpoints. The study of interleukin-2-targeting NKTR-214 (bempegaldesleukin) combined with Opdivo (nivolumab) compared to Opdivo monotherapy as a first-line treatment for previously untreated, unresectable or metastatic melanoma did not meet the primary endpoints of progression-free survival and objective response rate.
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Quoin collecting EMA tips on NS path as efforts in other quarters roll on

March 10, 2022
By Randy Osborne
No Comments
Quoin Pharmaceuticals Ltd.’s scientific advice briefing document is asking the EMA for ideas on how to proceed with lead asset QRX-003 for Netherton syndrome (NS).
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TYK2 click-through? Other players watch, wait for BMS PDUFA date

Feb. 14, 2022
By Randy Osborne
No Comments

As investors await the Sept. 10 PDUFA date for deucravacitinib from Bristol Myers Squibb Co. (BMS) in psoriasis, handicappers continue to weigh the odds of other tyrosine kinase 2 (TYK2) inhibitors, and ponder what a regulatory victory – or defeat – might mean for the space.


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Therapy for ultra-rare XLHED edges closer as pivotal trial begins

Feb. 2, 2022
By Richard Staines
No Comments
The ultra-rare skin disease X-linked hypohidrotic ectodermal dysplasia (XLHED) can be a heavy burden for children, affecting structures in the skin including sweat glands, respiratory glands, and hair as well as teeth. Though lacking a specific treatment to date, a pivotal clinical trial planned by the Geneva-based nonprofit Esperare Foundation and Pierre Fabre SA could now help bring one about.
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Abbvie, Pfizer JAK inhibitors win refractory atopic dermatitis approvals at FDA

Jan. 18, 2022
By Michael Fitzhugh
No Comments
Two Janus kinase (JAK) inhibitors, Abbvie Inc.'s Rinvoq (upadacitinib) and Pfizer Inc.'s Cibinqo (abrocitinib), have won U.S. FDA approvals for the treatment of people with moderate to severe atopic dermatitis. Reviews of both products for the indication were delayed due to FDA concerns about class risks. Accordingly, each is labeled with a boxed warning regarding risks of serious infection, mortality, malignancy, major adverse cardiovascular events and thrombosis.
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Adbry (tralokinumab)

Leo’s Adbry approved by FDA for atopic dermatitis

Dec. 28, 2021
By Lee Landenberger
No Comments
Privately held Leo Pharma Inc. has worked its way through a complete response letter issued in April to see the FDA approve Adbry (tralokinumab-ldrm) for treating moderate to severe atopic dermatitis in adults. The CRL noted FDA requests for additional data related to the device component, a prefilled syringe of tralokinumab, but it did not request new efficacy or safety data related to the drug product formulation. In April and on Dec. 28, the company did not provide details on the device-related data that were requested.
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Skin irritation on hands

See if Amryt, says Wall Street, forecasting big wins for epidermolysis bullosa player

Oct. 15, 2021
By Randy Osborne
No Comments
A few months after disclosing its merger with Chiasma Inc., Amryt plc rolled out second quarter financials pleasing to Wall Street, where considerable interest has begun to manifest in the company’s epidermolysis bullosa program with Filsuvez, also known as Oleogel-S10.
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No sweat? Brickell phase III data pits gel against Qbrexza

Oct. 7, 2021
By Randy Osborne
No Comments
With its topical gel for primary axillary hyperhidrosis (excessive underarm sweating) in adults and children 9 years of age and older, Brickell Biotech Inc. is gearing up to challenge Journey Medical Corp.’s Qbrexza (glycopyrronium), an anticholinergic agent contained in a single-use, pre-moistened, medicated cloth.
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