Takeda has revealed favourable interim results from its Phase III crossover trial evaluating the safety and efficacy of TAK-755 (recombinant ADAMTS13) replacement therapy for the prophylactic treatment of congenital thrombotic thrombocytopenic purpura (cTTP). cTTP is an ultra-rare, chronic and debilitating blood clotting disorder caused by a… Read More
Janssen has submitted a marketing authorisation application to the European Medicines Agency (EMA) seeking approval of single tablet combination therapy (STCT) of macitentan and tadalafil for pulmonary arterial hypertension (PAH). The single tablet combination therapy of macitentan 10mg and tadalafil 40mg (M/T STCT) is intended for… Read More
The US Food and Drug Administration (FDA) has given approval to Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) injection with Enhanze for subcutaneous (SC) use for the treatment of generalised myasthenia gravis (gMG). The treatment is approved in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. Read More
The US Food and Drug Administration (FDA) has approved Minoryx Therapeutics’ Phase III clinical trial (CALYX) of leriglitazone, to treat adult male X-linked Adrenoleukodystrophy (X-ALD) patients with cerebral Adrenoleukodystrophy (cALD). Patient recruitment is expected to start by the end of Q2 2023 with results anticipated by… Read More
Bellerophon Therapeutics has announced it will close its Phase III study of INOpulse, its treatment for fibrotic Interstitial Lung Disease (fILD), after the trail failed to meet its primary endpoint. The REBUILD clinical trial was designed as a randomised, double-blind, placebo-controlled Phase III study evaluating the… Read More
Positive primary endpoint data from Novartis’ pivotal Phase III NATALEE trial has been presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting. Data showed that Kisqali (ribociclib) plus endocrine therapy (ET), compared to ET alone, lowered the risk of cancer recurrence by 25.2%… Read More
The US Food and Drug Administration (FDA) has approved Pfizer’s bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF) vaccine Abrysvo in individuals 60 years and older. Abrysvo is unadjuvanted and composed of two preF proteins selected to optimise protection against RSV A and B strains and… Read More
Positive results from the ADAURA Phase III trial showed AstraZeneca’s Tagrisso (osimertinib) demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) compared to placebo. The trial assessed osimertinib as an adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor… Read More
Lynparza (olaparib) has been approved in the US for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). The PARP inhibitor, developed by AstraZeneca and Merck (MSD), is approved in combination with abiraterone and prednisone or prednisolone. Read More
The Janssen Pharmaceutical Companies of Johnson & Johnson have submitted a Type II variation application to the European Medicines Agency (EMA) seeking approval of Carvykti (ciltacabtagene autoleucel; cilta-cel) for relapsed and lenalidomide-refractory multiple myeloma. The application is supported by data from the Phase III CARTITUDE-4 study,… Read More
Otsuka and Lundbeck’s Rexulti (brexpiprazole) has become the first pharmacological treatment to be approved in the US for agitation associated with dementia due to Alzheimer’s disease. The Food and Drug Administration (FDA) has approved the companies’ supplemental New Drug Application (sNDA). Agitation is a… Read More
The European Commission (EC) has granted marketing authorisation for Akeega (niraparib and abiraterone acetate [AA]) for adults with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2 mutations (germline and/or somatic). The drug is given in the form of a dual action tablet (DAT), with prednisone or prednisolone,… Read More
A Phase III clinical trial led by physicians in the US has shown that adding investigational drug motixafortide significantly increases the number of stem cells that can be harvested compared with treatment with the standard agent alone. The standard treatment for patients with multiple myeloma often… Read More
The addition of pembrolizumab (Keytruda) to gemcitabine and cisplatin improved overall survival in patients with untreated metastatic or unresectable biliary tract cancer, according to results from the Phase III KEYNOTE-966 clinical trial. The results were presented at the AACR Annual Meeting 2023, held April 14-19 and… Read More
Patients with treatment-naïve resectable non-small cell lung cancer (NSCLC) who received neoadjuvant durvalumab (Imfinzi) plus chemotherapy and adjuvant durvalumab monotherapy had improved event-free survival (EFS) and pathological complete response (pCR) compared with those who received neoadjuvant chemotherapy alone. The results from the Phase III placebo-controlled AEGEAN… Read More
Adjuvant therapy with atezolizumab (Tecentriq) and bevacizumab (Avastin) increased recurrence-free survival of patients with hepatocellular carcinoma (HCC) following surgical resection or ablation, according to the results from a Phase III trial. The results of the IMbrave050 clinical trial were presented at the AACR Annual Meeting 2023,… Read More
