Adults Archives | PharmaShots

ViiV Healthcare Files NDA for Cabotegravir + Edurant (rilpivirine) to the US FDA to Treat HIV-1 Infection in Adults

April 30, 2019May 2, 2019Tuba Khan

Shots: The submission is based on P-III ATLAS (Antiretroviral Therapy as Long-Acting Suppression) and FLAIR (First Long-Acting Injectable Regimen) studies results assessing Cabotegravir [...]

Novo Nordisk’s Esperoct (turoctocog alfa pegol, N8-GP) Receives CHMP’s Positive Opinion to Treat Hemophilia A in Adolescents and Adults

April 29, 2019May 2, 2019Shiwani Sharma

Shots: The positive opinion is based on largest pre-registration clinical programme assessing Esperoct (FD, IV, q4days) in 270 patients previously treated with severe [...]

Sanofi and Lexicon’s Zynquista (sotagliflozin) Receive EU’s MAA to Treat Type-1 Diabetes in Adults

April 29, 2019May 2, 2019Shiwani Sharma

Shots: The authorization is based on inTandem study consisting of three P-III trials assessing sotagliflozin (200/400 mg) vs insulin as monothx in 3000 [...]

BAROnova’s TransPyloric Shuttle Device Receives FDA’s Approval for the Treatment of Obesity in Adults

April 24, 2019April 26, 2019Tuba Khan

Shots: The approval is based on ENDObesity II study results assessing TransPyloric Shuttle (TPS) vs sham in 302 patients suffering from obesity with [...]

NICE Publishes Final Recommendation for Almirall’s Ilumetri (tildrakizumab) to Treat Moderate-To-Severe Plaque Psoriasis in Adults

April 19, 2019April 24, 2019Tuba Khan

Shots: NICE has recommended Ilumetri (tildrakizumab) as a cost-effective option for the treatment of adults patients with moderate-to-severe plaque psoriasis who are candidates [...]

ViiV Healthcare’s Dovato (dolutegravir/lamivudine) Receives FDA’s Approval to Treat HIV-1 Infection in Adults

April 9, 2019April 24, 2019Shiwani Sharma

Shots: The approval is based on P-III study GEMINI 1 (204861) and GEMINI 2 (205543) study results assessing dolutegravir and lamivudine vs DTG [...]

AbbVie’s Skyrizi (risankizumab) Receives Japanese Ministry of Health, Labour and Welfare (MHLW) Approval to Treat Plaque Psoriasis, Generalized Pustular Psoriasis, Erythrodermic Psoriasis and Psoriatic Arthritis in Adults

March 26, 2019April 24, 2019Shiwani Sharma

Shots: The approval is based on P-II & P-III sustaIMM, ultIMMa-1 and IMMspire study results assessing Skyrizi in Japanese patients with plaque psoriasis, [...]

Adults