The FDA's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) unanimously concluded Thursday that Amarin Corp. plc provided sufficient evidence of efficacy and safety to support approval of fish oil-based Vascepa (icosapent ethyl) for an indication to reduce the risk of cardiovascular (CV) events in adults with elevated triglyceride levels (≥135 mg/dL) and other risk factors for CV disease. The 16-0 vote followed a day's discussion about potential effects of mineral oil, about the proper age population and the value of labeling. EMDAC's conclusion is only an advisory, as the FDA makes the final decision. FDA representatives at the panel discussion noted the study provided convincing data and waived off most concerns about mineral oil's impact on LDL cholesterol levels and blood pressure. Read More
A second phase II failure to differentiate from placebo in a test of benefits for people with depression has put AV-101, an NMDA receptor antagonist developed by Vistagen Therapeutics Inc., in uncertain territory.
CEO David Giljohann said the first indication in Exicure Inc.'s deal with Allergan plc is antigenic alopecia, but his firm doesn't "have anything else to disclose yet" about other hair loss diseases that the pact will include. Read More
It appears that the spirit of giving has come early, with leading biopharmaceutical companies providing investors with a surprise present of a significant jump in their share prices in October. The reversal in the sector's fortunes was catalyzed by an outpouring of positive news, including strong third-quarter financial results that has spilled over into early November. Read More
LONDON – Too little is being done either to prevent pharmaceutical residues entering the environment or to assess the risks that poses, according to an OECD report. Most OECD member countries have risk lists and voluntary monitoring for certain pharmaceuticals in surface waters, but the majority of around 2,000 active pharmaceutical ingredients and their metabolites remain unmonitored and without environmental toxicity data. Read More
SHANGHAI – With abundant venture capital and favorable policies, Chinese biotech companies are actively turning themselves from generic makers into innovation-driven players, but the market is getting crowded by too many companies focusing on the same area and even the same targets, a reality that is leading to a lack of differentiation in biotech innovation. Read More
SAN JOSE, Costa Rica – Hemoalgae, from Cartago, Costa Rica, is moving forward with the extraction and development of molecules of hirudin, a peptide with anticoagulant properties, which impacts the biotech and med-tech sectors. Read More
