Following more than a year of restructuring and recalibration, Regulus Therapeutics Inc. is facing a new partial clinical hold placed by the FDA on its phase I test of RGLS-4326, an oligonucleotide it's developing for the treatment of autosomal dominant polycystic kidney disease (ADPKD). Read More
In a historic first, all prisoners and people covered through Medicaid in Louisiana got access last week to Asegua Therapeutics LLC's hepatitis C drug, even if they were in the early stages of the disease, thanks to a modified subscription program that's likely to serve as a model for other states in the U.S. looking for ways to pay for pricey cures and treatments emerging from the pipeline. Read More
MEXICO CITY – Merck Sharp & Dohme's MK-8591, a nucleoside reverse transcriptase translocation inhibitor (NRTTI), impressed in both treatment and prevention studies at the 2019 International AIDS Society (IAS) Conference on HIV Science. Read More
TAIPEI, Taiwan – The three-day 2019 BIO Asia-Taiwan Conference and Exhibition opened on Wednesday to discuss how biotechnology could be the next growth engine for Asia. While figures are suggesting Asia is rising as a biotech powerhouse, the region needs to think beyond just capital, talent and patient pool, speakers said. Read More
LONDON – Monitoring low-density lipoprotein cholesterol (LDL-C) levels in patients with coronary heart disease (CHD) fails to identify those who are at highest risk for heart attack or death, according to a new study that used alternative biomarkers to assess the risk of further events. Read More
HONG KONG – The trade feud between South Korea and Japan has worsened since the beginning of July, when the Japanese government said it would impose new regulations on exports to Korea. The new policies are mostly applied to elements of semiconductor technology but also includes some pharmaceutical components and devices, leading to concerns that the regulations will affect Korea's pharmaceutical sector. Read More
The U.S. False Claims Act has been the subject of a substantial body of jurisprudence and policymaking, but the legal terrain has not necessarily grown any more predictable for makers of drugs and medical devices. A new update on FCA prosecutions by the law firm of Gibson Dunn highlights the fluidity of considerations such as the materiality of an allegation of a false claim despite a Supreme Court decision in 2016 (Universal Health Services, Inc. v. United States ex rel. Escobar) that was expected to provide a more stable interpretation of the law, just one example of a legal landscape that still creates substantial uncertainty for companies in the life sciences. Read More
Benchling Inc., of San Francisco, said it closed a $34.5 million series C funding led by Menlo Ventures with new investors Lead Edge Capital and Y Combinator Continuity and returning investors Benchmark and Thrive Capital. Read More
Alexion Pharmaceuticals Inc., of Boston, reported second-quarter revenues of $1.2 billion, a 15% increase compared to $1 billion in the same period last year. Read More
The FDA's Arthritis Advisory Committee (AAC) Thursday will consider a supplemental new drug application for Boehringer Ingelheim GmbH's Ofev (nintedanib) capsules as a treatment for systemic sclerosis-associated interstitial lung disease (SSc-ILD). Read More
