DUBLIN – Obseva SA's stock plunged 65% Thursday on news that it was terminating development of its in vitro fertilization (IVF) drug, nolasiban, after it missed the primary endpoint of a confirmatory phase III trial. The result blindsided both Obseva and investors, as the outcome was at odds with that of a previous phase III study, Implant 2, which had demonstrated a statistically significant and clinically relevant improvement in the rate of successful pregnancy at 12 weeks. Read More
Bowing to congressional pressure, the U.S. Department of Health and Human Services (HHS) Wednesday filed suit against Gilead Sciences Inc. for infringing government patents related to the use of HIV drugs Truvada and Descovy for pre-exposure prophylaxis (PrEP). Read More
Arkuda Therapeutics, a new company targeting progranulin and lysosomal biology to treat neurodegenerative diseases, has completed a $44 million series A financing led by Atlas Venture, its co-creator, and Pfizer Ventures. Funds managed by Tekla Capital Management LLC and Bioinnovation Capital also participated. Read More
Allena Pharmaceuticals Inc.'s phase III URIROX-1 trial of reloxaliase hit its primary endpoint, with a statistically significant reduction in urinary oxalate (Uox) in patients with enteric hyperoxaluria (EH), while its phase II Study 206 trial showed reduced plasma oxalate reduction in patients with EH and advanced chronic kidney disease (CKD). Read More
The oncology field pioneered adaptive trial designs through efforts such as I-SPY 2 (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis 2), Puma Biotechnology Inc.’s phase II study of the pan-HER tyrosine kinase inhibitor neratinib (Nerlynx) as neoadjuvant therapy in metastatic breast cancer, and the ongoing multidrug, biomarker-driven
non-small-cell lung cancer trial known as Lung-MAP. Read More
BEIJING – Chinese biosimilar maker Bio-Thera Solutions Ltd., of Guangzhou, said its BAT-1406 became the first biosimilar referencing Abbvie Inc.'s blockbuster TNF-blocker, Humira (adalimumab), to win a marketing nod in China. It is Bio-Thera's first biosimilar and China's second homegrown biosimilar approved by the National Medical Products Administration (NMPA). Read More
Preclinical animal and cellular models are notoriously bad at predicting drug candidate toxicity in humans. Animal biology is often fundamentally different on that front than in humans, while cells in the lab can't be counted on routinely to replicate the bodily response. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations. Read More
