The U.S. FDA’s approval of Revance Therapeutics Inc.’s Daxxify (daxibotulinumtoxinA-lanm) for the temporary improvement of moderate to severe glabellar lines, or frown lines, in adults, positioned the drug to compete with Abbvie Inc.’s blockbuster, Botox (onabotulinumtoxinA), which tallied $678 million in global net revenues for the second quarter of 2022.
Arcutis Biotherapeutics Inc. has entered into an agreement to acquire Ducentis Biotherapeutics Inc., a preclinical-stage biotechnology company focused on developing novel therapies for inflammation and autoimmune diseases.
The U.S. FDA has become the first global regulator to approve Boehringer Ingelheim GmbH’s spesolimab, the first treatment specifically approved for generalized pustular psoriasis flares in adults, a rare and potentially fatal disease. Branded as Spevigo, it works by inhibiting interleukin-36 and is delivered via intravenous injection. Ingelheim, Germany-based Boehringer Ingelheim is not giving away details about pricing but Carinne Brouillon, a member of the company’s board responsible for human pharma, said Spevigo is “priced similarly to the other biologic therapies used to treat rare dermatologic diseases.”
Since its launch in the U.S. in April, Biolab Sciences Inc.’s Dermistat has facilitated the healing of 80 wounds using its unusual gel-graft formula. The product transforms a patient’s skin cells into a partial thickness skin graft in 48 hours and a full-thickness graft in five to seven days. The autologous graft material speeds recovery following surgery or burns and helps to resolve non-healing wounds.
MC2 Therapeutics A/S has discovered that carbamylation of proteins, peptides and amino acids in the skin, caused by isocyanate, may be the root cause of several urea-associated skin diseases, such as chronic kidney disease-associated pruritus (CKD-aP, or uremic pruritus) and genital lichen sclerosus.
Mas-related G-protein coupled receptor X2 (MRGPRX2) is expressed particularly on mast cells and its activation leads to the mast cell degranulation with release of inflammatory mediators.
Blueprint Medicines has identified new cAMP-dependent protein kinase catalytic subunit alpha (PRKACA) inhibitors reported to be useful for the treatment of Carney complex (NAME syndrome, LAMB syndrome), McCune-Albright syndrome, polycystic kidney disease and cancer.
As the PDUFA date looms for Bristol Myers Squibb Co. with its candidate, deucravacitinib, for psoriasis, others – notably Dice Therapeutics Inc. – strive for new solutions to the skin disease, which has remained problematic for many patients despite approvals of multiple drugs in various classes.
Shares of Pharvaris NV (NASDAQ:PHVS) fell 34% Aug. 22 to close at $12.15 after the company reported the U.S. FDA placed a clinical hold on PHA-121, its oral bradykinin B2-receptor antagonist for hereditary angioedema (HAE), citing a review of nonclinical data. PHA-121, which goes after the same target as well-established injectable HAE drug Firazyr (icatibant, Takeda Pharmaceutical Co. Ltd.), is the active ingredient in Pharvaris’ two lead programs: PHVS-416, a softgel capsule formulation, and PHVS-719, an extended-release tablet formulation.
TFChem SAS has described new cyclic glycoaminoacid derivatives reported to be useful for the treatment of dry skin, atopic dermatitis, aging, inflammatory disorders, fibrosis and psoriasis, among other disorders.
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