Big pharma sponsors of clinical trials in Ukraine are putting studies on hold in Russia, Ukraine and Belarus as the conflict continues into its third week. As revealed by BioWorld last week, hundreds of clinical trials were being conducted in the two countries at the time Russian President Vladimir Putin gave orders to invade Ukraine on Feb. 20.
Sanofi SA has suffered a setback in its bid to find a successor to Astrazeneca plc’s breast cancer drug Faslodex (fulvestrant) as amcenestrant failed to improve progression-free survival in advanced breast cancer in a mid-stage trial.
Discussions with regulators on a proposed phase III trial design are up next for Bridgebio Pharma Inc., which reported positive phase II data for BBP-418 (ribitol) in patients with limb-girdle muscular dystrophy type 2 (LGMD2i), the first of several clinical readouts expected in 2022, as the Palo Alto, Calif-based company looks to regain its footing after disappointing top-line data for its phase III program in transthyretin amyloid cardiomyopathy leveled the stock late last year.
In top-line data from the Pathway phase III trial with Transcon PTH in hypoparathyroidism, Ascendis Pharma A/S provided “what many have been waiting for: a way of therapy to not only boost serum calcium into the normal range, but to make sure that the kidney issues [are] also handled,” said Aimee Shu, vice president of clinical development in endocrinology and co-director of the study, during a conference call with investors.
Four years after Bristol Myers Squibb Co.’s (BMS) $1.85 billion investment in Nektar Therapeutics Inc., the pair’s collaboration has stumbled mightily with a phase III failure. A first analysis their melanoma study, PIVOT IO-001, showed it missed three primary endpoints. The study of interleukin-2-targeting NKTR-214 (bempegaldesleukin) combined with Opdivo (nivolumab) compared to Opdivo monotherapy as a first-line treatment for previously untreated, unresectable or metastatic melanoma did not meet the primary endpoints of progression-free survival and objective response rate.
Novo Nordisk A/S, best known for its range of diabetes drugs and insulins, has said that growing its rare disease unit will be an important part of its business strategy this decade. Novo Nordisk has actually been operating in rare diseases for 40 years, starting in hemophilia and gradually growing its presence. But the Bagsværd, Denmark-based company has big plans for its rare diseases arm in the next few years, with a pipeline of drugs aimed at the busy hemophilia market and for rare endocrine disorders.
Tyra Biosciences Inc.’s recent deal with Xcures Inc. drew more attention to the already popular FGFR inhibitor space in oncology, as the pair made known a collaboration on a real-world biomarker study involving patients with FGFR-mutant bladder cancer who are given once-daily, oral Balversa (erdafitinib, Johnson & Johnson), a pan-FGFR blocker approved in April 2019.
For about one-third of stroke patients, the cause of their cerebrovascular accident (CVA) is unknown at the time of hospitalization, but crucial to determine to prevent subsequent strokes. Electrocardiogram (ECG) monitoring in the 24 to 48 hours after a stroke detects atrial fibrillation (AF) in about 5% of patients. Remote monitoring with a noninvasive device detects far more cases and provides the opportunity to quickly head off secondary strokes, preserving lives and reducing costs of care, according to a study published by Royal Philips NV researchers.
A new antibiotic combination developed by Venatorx Pharmaceuticals Inc. "may represent a significant improvement over the standard of care" for adults with complicated urinary tract infections (cUTI), said Christopher Burns, the company's co-founder, president and CEO.
Ahead of data due any day from Turning Point Therapeutics Inc. with repotrectinib (repo) in ROS1-positive non-small-cell lung cancer (NSCLC), CEO Athena Countouriotis said her firm’s product already is differentiating itself from the likes of Xalkori (crizotinib, Pfizer Inc.) and Rozlytrek (entrectinib, Roche Holding AG).
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