The majority of patients with acromegaly who switched from therapy with injected somatostatin receptor ligands to Crinetics Pharmaceuticals Inc.’s once-daily, oral drug paltusotine maintained stable levels of insulin-like growth factor 1 in a phase III trial, moving the company’s first-in-class lead closer to becoming the potential new standard of care for the rare hormonal disorder.
One company has developed a promising device and care model to reduce the exacerbations of chronic obstructive pulmonary disease (COPD) that often send patients to the hospital and contribute to accelerated disease progression. Patients who used a wearable remote cardiorespiratory monitoring device developed by Spire Inc. experienced a 64% decrease in cardiopulmonary-specific admissions in a study published in the International Journal of COPD.
The volume of clinical data reported throughout the summer has continued to fall, with only 267 items collected in August, a drop of 10% from July and the lowest amount within the last five months.
DUBLIN – Shares in Pharnext SA plunged by more than 40% Friday on news that the FDA requires the company to undertake a second phase III trial of its Charcot-Marie-Tooth disease type 1A (CMT1A) therapy PXT-3003.
Drug "re-innovation" specialist Bioxcel Therapeutics Inc. is gearing up to discuss a pivotal phase III trial for BXCL-501 with the FDA after top-line results of a phase Ib study showed it reduced schizophrenia-associated agitation while calming trial participants without excessive sedation. H.C. Wainwright & Co. analyst Raghuram Selvaraju called the results "highly favorable" and suggested the drug, a sublingual-formulated version of dexmedetomidine, could reach market as soon as 2021.
After two complete response letters (CRLs), Agile Therapeutics Inc. with its Twirla (levonorgestrel/ethinyl estradiol) contraceptive patch – hounded by FDA concerns regarding manufacture and adhesion properties – might just be on the road to success.
PERTH, Australia – Adelaide, Australia-based Bionomics Inc. reported another trial failure with its lead compound, BNC-210, in elderly patients with agitation, but it is still clinging on to hopes that the compound will show a clinical benefit for post-traumatic stress disorder (PTSD).
