After advancing its proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor, bococizumab, into a global phase III development program that included six lipid-lowering and two cardiovascular (CVD) outcome trials (CVOTs), Pfizer Inc. blinked. Read More
DUBLIN – Turnstone Biologics Inc. raised $41.1 million in a series B round to accelerate clinical development of its next-generation oncolytic virus and cancer vaccine platform by deploying the technology in different combination settings, cancer indications and with different antigenic payloads. Read More
Durect Corp. CEO James Brown told BioWorld Today that, although phase Ib results proved encouraging with the endogenous, oral small-molecule DUR-928 in patients with nonalcoholic steatohepatitis (NASH), the phase II trial planned for next year will test the drug in acute kidney damage, an indication where today “the only thing they can do is give you fluids and pray.” Read More
According to the American Heart Association’s website, “your heart muscle needs oxygen to survive. A heart attack occurs when the blood flow that brings oxygen to the heart muscle is severely reduced or cut off completely.” Read More
PERTH, Australia – After completing its IPO in July, Sydney-based Noxopharm Pty Ltd. expects to have the first three clinical trials of its lead compound up and running in the first quarter of 2017. Read More
The Washington Legal Foundation (WLF) and the National Association of Manufacturers filed an amicus brief asking the U.S. Court of Appeals for the Third Circuit to shut down repeat “bites at the apple” from states that choose not to opt out of federal class-action suits. Read More
Tonix Pharmaceuticals Holding Corp., of New York, closed its previously announced underwritten public offering of 9.5 million units, consisting of 9.5 million shares of common stock and warrants to purchase 4.75 million shares of common stock, at an offering price of 55 cents per unit. Read More
Pluristem Therapeutics Inc., of Haifa, Israel, said the U.K.’s regulator cleared the firm’s application for a pivotal phase III trial of PLX-PAD cells in critical limb ischemia for patients unsuitable for revascularization. Read More
Shire plc, of Dublin, reported a $387 million net loss for the third quarter and lowered its full-year guidance, citing an increase in integration costs related to its $32 billion buyout of Baxalta Inc., costs related to licensing SHP647 (formerly Pfizer Inc.’s PF-547659) and reorganization costs associated with the planned closure of a facility in its Los Angeles manufacturing site. Read More
