article thumbnail

Treatment options for Crohn’s disease expand after Rinvoq approval

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has approved AbbVie’s Rinvoq (upadacitinib) for patients with Crohn’s disease who do not respond to TNF blockers, a common immune suppressant treatment for the condition. Data from two Phase III studies, U-EXCEED and U-EXCEL, involving 857 patients was used to support the approval.

article thumbnail

Incyte signs partnership agreement with CMS for ruxolitinib cream

Pharmaceutical Technology

Incyte has signed a partnership and licence agreement with CMS subsidiary CMS Aesthetics to develop and market ruxolitinib cream to treat autoimmune and inflammatory dermatologic ailments in Greater China and some Southeast Asian countries. Incyte will also receive royalty payments on the net product sales in the territory of CMS. “In

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

First Stelara Biosimilar, Wezlana, Gets FDA Nod for Crohn’s, UC, Psoriasis but Faces Delayed Launch

XTalks

Amgen’s Wezlana (ustekinumab-auub) has received US Food and Drug Administration (FDA) approval as a Stelara biosimilar for the treatment of several inflammatory diseases including Crohn’s disease, ulcerative colitis (UC), plaque psoriasis and psoriatic arthritis. This gives it a significant edge over a simple biosimilar designation.

article thumbnail

FDA sets April date for verdict on Incyte’s vitiligo drug

pharmaphorum

Incyte could be a few month away from a second FDA approval for its Opzelura cream that would make it the first medical treatment to re-pigment the skin of people with vitiligo. billion in this indication alone.

Drugs 110
article thumbnail

FDA clears Incyte’s Opzelura as first vitiligo therapy

pharmaphorum

The FDA has been paying close attention to the safety of JAK inhibitors, and Opzelura was approved with black box warning that includes JAK class-wide wording for risks such as infections, heart-related events and cancer, despite being used on the skin rather than administered systemically.

Sales 98
article thumbnail

Top 30 Pharma and Biotech Companies in 2023: Statistics and Trends

XTalks

Most of the company’s revenue comes from the manufacture and sale of biopharmaceutical products. Paxlovid was first authorized under the FDA Emergency Use Authorization in December 2021 ; however, it has received FDA approval on May 25, 2023. billion in pharmaceutical sales from 2021. billion in 2022, a 23.43

Sales 98
article thumbnail

Dermavant claims its first approval as FDA clears psoriasis drug

pharmaphorum

Roivant group company Dermavant has made the transition to a commercial-stage company after getting FDA approval for Vtama, a drug for psoriasis that it claims could be a game-changer in the treatment of the skin disorder. Otezla – which Amgen acquired for $13.4

Drugs 52