Drug Watch

FDA, EMA accepts marketing applications for bimekizumab in psoriasis
September 22, 2020

UCB announces the U.S. Food and Drug Administration and the European Medicines Agency have accepted the Biologics License Application and Marketing Authorization Application for bimekizumab for the treatment of moderate-to-severe plaque psoriasis in adults.

Sonelokinab demonstrates positive results in phase 2 psoriasis study
September 16, 2020

Merck announces positive results from its phase 2b trial evaluating sonelokinab, an investigational anti-IL-17 A/F nanobody, in adult patients with moderate-to-severe chronic plaque psoriasis.

FDA accepts NDA filing for topical papulopustular rosacea treatment
September 14, 2020

The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) filing for Sol-Gel’s Epsolay, a 5% microencapsulated benzoyl peroxide cream for the treatment of inflammatory lesions of rosacea or papulopustular rosacea.

Spartalizumab phase 3 combination study fails to meet primary endpoint
September 14, 2020

Novartis announces their phase 3 study investigating spartalizumab (PDR001) in combination with dabrafenib (Tafinlar) and trametinib (Mekinist) failed to meet its primary endpoint.

MC2 Therapeutics collaborates EPI Health on newly approved psoriasis topical
September 02, 2020

MC2 Therapeutics and EPI Health announce they have entered into a collaboration agreement for the commercialization of calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064% (Wynzora Cream), a newly U.S. FDA-approved topical treatment for plaque psoriasis in adults.

Alembic Pharmaceuticals launches adapalene gel for acne vulgaris
September 01, 2020

Alembic Pharmaceuticals announces the launch of their bioequivalent and therapeutically equivalent product to Differin Gel 0.3% (Galderma), Adapalene Gel USP 0.3%, a topical retinoid for the treatment of acne vulgaris in patients 12 years and older.

Topical androgen receptor inhibitor approved by FDA for acne
August 28, 2020

Clascoterone cream 1% (Winlevi, Cassiopea), a first-in-class androgen receptor inhibitor, has been approved by the U.S. FDA for treatment of acne vulgaris in patients 12 years and older.

Mirikizumab beats secukinumab in phase 3 plaque psoriasis study
August 26, 2020

Eli Lilly’s mirikizumab demonstrates superiority over secukinumab (Cosentyx, Novartis) as a treatment for moderate-to-severe plaque psoriasis, according to recently released results from the OASIS-2 study.

FDA approves ustekinumab for pediatric psoriasis
August 07, 2020

The U.S. Food and Drug Administration has approved IL-12/IL-23 inhibitor ustekinumab (Stelara, Janssen Pharmaceutical Companies of Johnson & Johnson) for treatment of moderate-to-severe plaque psoriasis in pediatric patients 6-11 years.

Cannabinoid products may alter effects of prescription drugs
August 05, 2020

Researchers have identified and developed lists of medications that may not function properly due to concomitant cannabinoid use in an effort to help medical professionals prescribe prescription drugs safely to their patients.