After excitement on Wall Street early in the day about pivotal phase III data with obeticholic acid (OCA) in patients with liver fibrosis due to nonalcoholic steatohepatitis (NASH), shares of New York-based Intercept Pharmaceuticals Inc. (NASDAQ:ICPT) settled to close at $117.57, up $6.75. Read More
Inventiva SA, of Daix, France, said a phase IIb trial evaluating the company's lead candidate, lanifibranor, for the treatment of diffuse cutaneous systemic sclerosis failed to meet its primary endpoint, sending company shares (PARIS:IVA) down 49.5 percent to close at €4.13 (US$4.68) on Tuesday. Investigators found no statistically significant difference between the placebo and lanifibranor-treated groups for the primary outcome of mean absolute change from baseline in a multipoint measure of skin thickness. Read More
DUBLIN – Pfizer Inc.'s and Eli Lilly and Co.'s venerable antibody, tanezumab, a longtime clinical candidate for various pain indications, is lumbering toward the finish line. The two partners reported a second positive phase III readout inside a month. This time around, it's in patients with chronic lower back pain. The higher dose of the drug (10 mg) used in the study attained the primary endpoint of a statistically significant improvement in pain at 16 weeks, as compared with placebo. A lower dose (5 mg) did not attain statistical significance at the same time point. Read More
WASHINGTON – Later this year, 21 principal investigators working in six countries will press the start button on an identical series of experiments in each of their labs and begin to generate data for the first brain-wide neural model of decision-making in mice. Read More
WASHINGTON – The use of machine learning to analyze large datasets is throwing up more and more spurious signals and accelerating the reproducibility crisis in biomedical research. Read More
PERTH, Australia – Adelaide-based Bionomics Inc. is reviving lead compound BNC-210 after a deeper analysis of phase II data showed a positive effect in post-traumatic stress disorder (PTSD). Read More
Although the rebate system used to set list prices for insulin products in the U.S. bears all the hallmarks needed for a Racketeer Influenced and Corrupt Organizations (RICO) action, a federal judge ruled that patients lack the standing, at least in the Third Circuit, to bring such actions against drug companies because they don't buy the drugs directly from the manufacturer. Read More
Ico Therapeutics Inc., of Vancouver, British Columbia, said it upsized its nonbrokered private placement to CA$1.25 million (US$942,695). Each unit issued consists of one common share and one common share purchase warrant exercisable at $0.075 for 36 months from the date of the closing. The private placement is expected to occur in several closings. Read More
Spark Therapeutics Inc., of Philadelphia, said for the year ended Dec. 31, it recognized $64.7 million in total revenue, of which $27 million was due to net product sales of Luxturna (voretigene neparvovec-rzyl), its gene therapy for treating retinal dystrophy arising from biallelic RPE65 mutations, and $37.8 million as earned in contract revenue. Read More
Saniona AB, of Copenhagen, completed preclinical development for SAN-711, a selective GABA-A alpha3 modulator for itching and neuropathic pain. The company plans to start a phase I study in summer 2019. Read More
After first saying no, the U.K.'s National Institute for Health and Care Excellence (NICE) published draft guidance recommending Perjeta (pertuzumab, Roche Holding AG) for treating people who have had surgery for early HER2-positive breast cancer and whose cancer has already spread to their lymph nodes. Read More
