Baxter International Inc. announced that the company has submitted a biologics license application (BLA) to the FDA for the approval...
Fuzeon is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected patients who have received treatment with and failed on regimens containing at least one medicinal product from each of the following antiretroviral classes: protease inhibitors, non-nucleoside reverse transcriptase inhibitors and nucleoside reverse transcriptase inhibitors, or who have intolerance to previous antiretroviral regimens (see section 5.1). In deciding on a new regimen for patients who have failed an antiretroviral regimen, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different medicinal products. Where available, resistance testing may be appropriate (see sections 4.4 and 5.1).
Gilead Sciences, Inc. presented new data reinforcing the efficacy, safety, and tolerability profile of lenacapavir, including patient-reported outcomes (PRO) from the Phase II/III CAPELLA trial
BD (Becton, Dickinson and Company) released findings from a survey conducted by The Harris Poll, between Nov. 14-16, 2022, among 872 U.S. women ages 18 to 64 years old, that indicate a significant gap in women's knowledge about the primary causes of cervical cancer as well as the most effective means of prevention.
ObsEva SA announced that the Phase III clinical trial results from its European confirmatory study of nolasiban (IMPLANT 4) in...
This review will explore quantitative eye and pupil tracking as a potential noninvasive, time-effective, and less technically demanding alternative to current diagnostic tests of MG.
AMAG Pharmaceuticals, Inc. announced positive top-line results from a Phase III randomized, double-blind, non-inferiority clinical trial evaluating Feraheme (ferumoxytol) compared...
Olbetam is indicated as alternative or adjunct treatment to reduce triglyceride levels in patients who have not responded adequately to other treatments such as statin or fibrate treatment for: • hypertriglyceridaemia (Fredrickson type IV hyperlipoproteinaemia); • hypercholesterolaemia and hypertriglyceridaemia (Fredrickson type IIB hyperlipoproteinaemia). Olbetam should be used after other measures have been taken such as dietary changes and other non-pharmacological treatment (e.g. exercise, weight reduction). It has not been shown that treatment of hyperlipoproteinaemia with acipimox leads to a reduction of cardiac morbidity or mortality.
Eli Lilly and Company announced five-year outcomes from a pre-planned analysis of the Phase III monarchE study evaluating two years of adjuvant Verzenio (abemaciclib) in combination with endocrine therapy (ET) compared with ET alone in patients with HR+, HER2-, node-positive early breast cancer (EBC) at a high risk of recurrence. These data were shared in a late-breaking presentation at the 2023 European Society for Medical Oncology (ESMO) Congress.
Adults Urinary incontinence, urgency and frequency in unstable bladder conditions due to idiopathic detrusor instability (motor urge incontinence) or neurogenic bladder disorders (detrusor hyperreflexia) in conditions such as multiple sclerosis and spina bifida. Paediatric population Oxybutynin hydrochloride is indicated in children over 5 years of age for: • Urinary incontinence, urgency and frequency in unstable bladder conditions due to idiopathic overactive bladder or neurogenic bladder disorders (detrusor over activity) • Nocturnal enuresis associated with detrusor over activity, in conjunction with non-drug therapy, when other treatment has failed