Article
Pharmacology & Pharmacy
Sheridan M. Hoy
Summary: Motixafortide is a CXCR4 inhibitor used for mobilizing HSCs and treating cancer. It has been approved in the USA for use in combination with filgrastim to mobilize HSCs for collection and autologous transplantation. Motixafortide also has orphan drug designation for pancreatic cancer treatment in the EU and USA, as well as for acute myeloid leukemia treatment in the USA.
Article
Pharmacology & Pharmacy
Sohita Dhillon
Summary: Elranatamab is a bispecific antibody drug developed by Pfizer for the treatment of multiple myeloma. It activates T cells to kill myeloma cells by targeting CD3 on T cells and BCMA on myeloma cells. Elranatamab has received approval in the USA and is under regulatory review in other countries.
Article
Pharmacology & Pharmacy
Matt Shirley
Summary: Glofitamab is a bispecific monoclonal antibody developed by Roche for the treatment of B-cell non-Hodgkin lymphomas, including DLBCL. It received its first approval in Canada for relapsed or refractory DLBCL. The approval is also being sought in the EU and USA, with a positive opinion received in the EU. Global clinical development of glofitamab is ongoing for the treatment of non-Hodgkin lymphomas.
Article
Pharmacology & Pharmacy
Sean Duggan, Zaina T. Al-Salama
Summary: Leniolisib is an oral selective phosphoinositide 3-kinase-delta (PI3K delta) inhibitor developed by Pharming Group NV and licensed from Novartis for the treatment of immunodeficiency disorders. It received its first approval in March 2023 for the treatment of activated PI3K delta syndrome (APDS) in adult and paediatric patients. The development of leniolisib for Sjogren's syndrome has been discontinued.
Article
Pharmacology & Pharmacy
Susan J. Keam
Summary: Mirikizumab (Omvoh(& REG;)), a humanized IgG4 anti-human IL-23p19 monoclonal antibody, has been approved in Japan in March 2023 for the treatment of ulcerative colitis in patients who have an inadequate response to conventional therapy. It is also granted a positive opinion in the EU for the treatment of adult patients with moderately to severely active UC who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic treatment. This article summarizes the development milestones of mirikizumab leading to its first approval in the treatment of ulcerative colitis.
Article
Pharmacology & Pharmacy
Sohita Dhillon
Summary: Adagrasib is an orally available small molecule inhibitor being developed by Mirati Therapeutics for the treatment of solid tumors with KRAS G12C mutation. It covalently binds to the mutant cysteine and locks the mutant KRAS protein in its inactive state, inhibiting downstream signaling. In December 2022, it received accelerated approval in the USA for KRAS G12C-mutated NSCLC. It is currently under regulatory review in the EU and in development for CRC.
Article
Pharmacology & Pharmacy
Yahiya Y. Syed
Summary: Dorzagliatin is a new drug for the treatment of diabetes that improves glycaemic control by activating glucokinase. It has been approved in China for improving blood sugar control in patients with type 2 diabetes.
Article
Pharmacology & Pharmacy
Sheridan M. Hoy
Summary: Deucravacitinib is a highly selective oral tyrosine kinase 2 (TYK2) inhibitor used for the treatment of various immune-mediated diseases, including psoriasis and inflammatory bowel disease. It has received approvals in the USA and Japan and is undergoing clinical development worldwide.
Editorial Material
Pharmacology & Pharmacy
Hannah A. Blair
Summary: This article summarizes the milestones in the development of spesolimab leading to its first approval for GPP flares.
Article
Pharmacology & Pharmacy
Yvette N. Lamb
Summary: Ganaxolone is a synthetic neuroactive steroid that acts as a positive allosteric modulator of the GABA(A) receptor complex. It has received first approval in the USA for the treatment of seizures associated with CDKL5 deficiency disorder and is undergoing evaluation for other seizure disorders. This article provides a summary of the milestones in the development of ganaxolone leading to its first approval.
Article
Pharmacology & Pharmacy
Matt Shirley
Summary: Faricimab is a bispecific antibody that targets and inhibits both VEGF-A and Ang-2. It has received approvals for the treatment of nAMD and DME in the USA and is currently undergoing clinical development in other countries.
Article
Pharmacology & Pharmacy
Arnold Lee
Summary: Clazosentan, a small molecule being developed by Idorsia Pharmaceuticals, is an endothelin A receptor-selective antagonist. It has been approved in Japan for the prevention of cerebral vasospasm, vasospasm-related cerebral infarction, and cerebral ischemic symptoms after aneurysmal subarachnoid hemorrhage.
Article
Pharmacology & Pharmacy
Sheridan M. Hoy
Summary: Thymic stromal lymphopoietin (TSLP) is a cytokine derived from epithelial cells and is involved in the development of asthma. Tezepelumab is a novel monoclonal antibody that inhibits the action of TSLP. It has been approved for the treatment of asthma and is being evaluated for other diseases.
Article
Pharmacology & Pharmacy
Yahiya Y. Syed
Summary: Molnupiravir is an orally-administered antiviral drug that inhibits the replication of COVID-19 virus by inducing viral error. It has received approval in the UK for the treatment of mild to moderate COVID-19 and emergency use authorization in several countries.
Article
Pharmacology & Pharmacy
Yvette N. Lamb
Summary: Somatrogon, a long-acting human growth hormone, reduces treatment burden with its once-weekly subcutaneous injection. It has received approval in Canada for the treatment of growth hormone deficiency in pediatric patients.
