The FDA's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 10-9 Thursday that a mandate is still needed to rule out an unacceptable increase in cardiovascular (CV) risk for type 2 diabetes drugs intended for glycemic control, regardless of whether a safety signal exists. Read More
DUBLIN – Galecto Biotech AB raised €79 million (US$89.9 million) in a series C round to take its lead galectin-3 inhibitor, TD-139, into a phase II/III trial in idiopathic pulmonary fibrosis (IPF) and to move two additional compounds employing the same mechanism into trials in other fibrotic indications and, potentially, cancer. Read More
89bio Ltd., a San Francisco-based startup focused on nonalcoholic steatohepatitis (NASH) and other liver and metabolic disorders, has closed a $60 million series A financing to advance an asset acquired from Israel's Teva Pharmaceutical Industries Ltd. through proof of concept. Currently in phase I testing, the long-acting glycopegylated fibroblast growth factor 21 (FGF21) analogue arrived at the company with positive preclinical data and an approved investigational new drug application. Read More
The good news is that BACE-1 inhibitors hit their targets. In that sense, in fact, the class has been "incredibly successful," Bruce Albala, executive director of neuroscience clinical development in Eisai Inc.'s neurology business group, told the audience at a symposium titled "Is BACE1 a suitable drug target for prevention and treatment of Alzheimer's disease?" at the 2018 Clinical Trials in Alzheimer's Disease (CTAD) meeting. Read More
Financial reports from biotech's blue chip companies are coming thick and fast and so far none of them, filed during the past couple of days, appear to have harmed their market valuations despite the prevailing general market turbulence. Boston-based Vertex Pharmaceuticals Inc., for example, posted a significant 42 percent third-quarter jump in its total cystic fibrosis (CF) product revenues to $783 million, beating consensus by 2 percent. The company attributed the increase to a rapid uptake of its newest CF drug, Symdeko (tezacaftor/ivacaftor and ivacaftor), in the U.S., which recorded revenues of $255 million, up 37 percent over the previous quarter. Read More
Approved and investigational biologics typically are delivered via intravenous administration that can require expensive, inconvenient and routine hospital or clinic visits. Enable Injections LLC expects that it has a solution with its subcutaneous drug delivery wearable – and the multiple pharma partners it has lined up, including Paris-based Sanofi SA, apparently agree. Read More
Vanc Pharmaceuticals Inc., of Vancouver, British Columbia, plans to change its name to Avricore Health Inc. The board has approved the name change, and the company plans to seek approval for the change from the TSX Venture Exchange. Read More
Wize Pharma Inc., of Hod Hasharon, Israel, closed a private placement resulting in gross proceeds of $4.45 million. Proceeds from the financing will enable the company to advance the development of its lead product, LO2A, including completing trials and supporting the company's international marketing strategy with local territorial distributors. Read More
In a statement Thursday at the headquarters of the Department of Health and Human Services (HHS), President Trump outlined several new initiatives designed to reduce drug prices. He maintained the programs would build upon efforts by the FDA to review applications for generic drugs, which he said resulted in the approval of more than 1,000 generics last year at a savings of almost $9 billion to U.S. consumers, and the impact to patients of S. 2553, Know the Lowest Price Act, and S. 2554, Patient Right to Know Drug Price Act, signed into law earlier this month to end pharmacy gag clauses. Read More
