Researchers from the University of Washington and Stanford University have used bioinformatics to develop proteins that bound to specific forms of the interleukin-2 (IL-2) receptor, but otherwise had no structural similarity to IL-2. Read More
Trouble surfaced early in the joint meeting of the FDA's Arthritis Advisory Committee (AAC) and the Drug Safety and Risk Management Advisory Committee for Takeda Pharmaceuticals Co. Ltd. with the supplemental NDA for xanthine oxidase inhibitor (XOI) Uloric (febuxostat). Read More
SAN FRANCISCO – Diagnostics are notoriously tough as a business. But the lineup of successful companies that are hitting some of those big benchmarks just seems to be getting longer. A couple of superstars on that front, colorectal cancer screening company Exact Sciences Corp. and immune system-focused Adaptive Biotechnologies Corp. were featured on a panel about the topic at the J.P. Morgan (JPM) Healthcare Conference. Read More
According to the 2019 J.P. Morgan conference playbook released in advance of the investment bank's 37th annual health care meeting in San Francisco, over the past 18 years the NYSE Arca Biotech Index (BTK) outperformed the S&P 500 index approximately 78 percent of the time during event week. With the curtain now closed on the JPM meeting, the public companies involved in the sector will be pleased to learn that this statistic held true for another year. Read More
HONG KONG – After inking a deal last year worth $83 million with Swedish biotech firm Pledpharma AB to acquire the exclusive rights to develop and commercialize Pledox, Japan's Solasia Pharma KK has started the molecule's phase III development in Asia. It's part of a global phase III trial testing the compound, which is used to suppress the development of peripheral neuropathy in colorectal cancer patients. Read More
HONG KONG – American firm Personal Genome Diagnostics Inc. (PGDx) has partnered with China laboratory services provider Guangzhou Kingmed Diagnostics Group Co. Ltd. (Kingmed) to commercialize the cancer detection product PGDx elio assays on the Chinese mainland and in Hong Kong. Read More
One of the more prominent False Claims Act cases to reach the U.S. Supreme Court in recent memory was the Escobar case, which among other things raised the requirements for the materiality of a qui tam relator's allegations. However, the lower courts have exhibited a tendency to interpret the Supreme Court's decision in Escobar in varying ways, according to a new briefing by the law firm of Gibson Dunn, suggesting that those in the life sciences will have to watch carefully as this and other FCA matters work their way through the courts. Read More
Chiesi USA Inc., a Cary, N.C.-based subsidiary of Italy's Chiesi Farmaceutici SpA, confirmed its designation as a Delaware Public Benefit Corporation, joining a small group of pharma companies that have committed to the purpose, accountability and transparency principles required for the status. Read More
