FDA Approves Imcivree for Rare Genetic Obesity Disorders
The FDA has approved Imcivree™ (setmelanotide; Rhythm Pharmaceuticals) for chronic weight management in patients with obesity due to POMC, PCSK1, or LEPR deficiency.
All articles by Brian Park, PharmD
Greater Reductions in HbA1c, Weight Observed With Higher Dulaglutide Dose
Results from the phase 3 AWARD-11 trial evaluating higher doses of dulaglutide showed superior HbA1c and body weight reductions with an investigational 4.5mg dose in patients with type 2 diabetes (T2D) compared with dulaglutide 1.5mg.
Brolucizumab Safety Update Issued Following Reports of Ocular Events
Cases of severe vision loss, inflammation, and potential retinal vasculitis following treatment with Beovu (brolucizumab) injection are currently being investigated by the product’s manufacturer Novartis.
Apabetalone Gets Breakthrough Tx Designation for MACE Prevention
The FDA has granted Breakthrough Therapy designation to apabetalone (Resverlogix Corp) in combination with standard of care therapy, including high-intensity statins, for the secondary prevention of major adverse cardiac events (MACE) in patients with type 2 diabetes mellitus and recent acute coronary syndrome.
Reyvow, a First-in-Class Migraine Treatment, Now Available
Eli Lilly announced the launch of Reyvow (lasmiditan) for the acute treatment of migraine with or without aura in adult patients.
Risankizumab Superior to Secukinumab in Plaque Psoriasis Trial
AbbVie announced positive topline data from a phase 3 study evaluating the efficacy and safety of risankizumab (Skyrizi) compared with secukinumab (Cosentyx; Novartis) in adult patients with moderate to severe plaque psoriasis.
Enhertu Approved for Unresectable or Metastatic HER2-Positive Breast Cancer
The Food and Drug Administration (FDA) has granted accelerated approval to Enhertu (fam-trastuzumab deruxtecan-nxki; AstraZeneca and Daiichi Sankyo) for the treatment of adults with unresectable or metastatic HER2-positive breast cancer who have received 2 or more prior anti-HER2-based regimens in the metastatic setting. The approval was based on results from the phase 2, open-label, single-group,…
Bimekizumab Beats Adalimumab in Plaque Psoriasis Trial
UCB announced positive results from the phase 3 BE SURE study of bimekizumab in the treatment of adults with moderate-to-severe plaque psoriasis compared with adalimumab.
Diagnostic Test for Rapid MRSA Detection Gets Market Clearance
The Food and Drug Administration (FDA) has authorized marketing of a new diagnostic test, cobas vivoDx MRSA (Roche Molecular Systems Inc), to detect methicillin-resistant Staphylococcus aureus (MRSA) bacterial colonization and aid in the prevention and control of MRSA infections in healthcare settings. The cobas vivoDx MRSA test provides rapid phenotypic detection of MRSA colonization through…
Investigational Drug for Non-Muscle Invasive Bladder Cancer Gets Breakthrough Status
N-803 is an IL-15 superagonist complex consisting of an IL-15 mutant bound to an IL-15 receptor α/IgG1 Fc fusion protein
