Innate Pharma SA, of Marseille, France, opened the phase I/II trial of IPH2201, a first-in-class NKG2A checkpoint inhibitor, tested in combination with ibrutinib (Imbruvica, Pharmacyclics Inc./Johnson & Johnson) in patients with relapsed or refractory chronic lymphocytic leukemia. Read More
Akebia Therapeutics Inc., of Cambridge, Mass., said that the company has reached agreement with both the FDA and EMA regarding key elements of a phase III program testing its lead product, vadadustat, in two separate studies that will collectively enroll about 3,100 nondialysis-dependent chronic kidney disease patients across 500 sites globally. Read More
Nektar Therapeutics Inc., of San Francisco, said it closed a direct private placement of $250 million of 7.75 percent senior secured notes due in 2020 with investment vehicles managed by affiliates of TPG Special Situations Partners. Read More
SHANGHAI – Wechat, China's version of Twitter, broke out in excitement and some surprise when the Nobel prize went public this week. It took a modest researcher with no PhD in her eighth decade to land China's first Nobel Prize for Medicine or Physiology. Read More
TAIPEI, Taiwan – Taipei-based OBI Pharma Inc. has entered a deal with Merck & Co. Inc., of Kenilworth, N.J., for the development and commercialization in Taiwan of its narrow-spectrum macrocyclic antibiotic Dificid (fidaxomicin), which is used to treat Clostridium difficile-associated diarrhea (CDAD). The collaboration represents a long-awaited milestone for OBI as its first major revenue-stream generating deal since its formation in 2002. Read More
HONG KONG – With a nod to proceed from the Korea Food and Drug Administration, Seoul-based Kainos Medicine Inc. is taking its Parkinson's disease candidate, KR-33493, into the clinic with the belief that it represents a fundamental improvement in the battle against the disease as the first to potentially alter Parkinson's rather than just addressing the symptoms. Read More
Theraclone Sciences Inc. and the University of Texas MD Anderson Cancer Center broadened an informal immuno-oncology (IO) relationship in a big way, jointly launching Oncoresponse Inc. to discover and advance therapeutic antibodies against targets identified during the treatment of cancer patients receiving the IO regimens. Read More
Exelixis Inc.'s MEK-inhibitor cobimetinib, given in combination with Roche AG's Zelboraf (vemurafenib), significantly improved overall survival (OS) vs. Zelboraf alone for previously untreated patients with unresectable locally advanced or metastatic melanoma carrying a BRAF V600 mutation, according to new top-line results reported by Exelixis partner Genentech, a unit of Roche. Read More
CEO Vivek Ramaswamy told BioWorld Today that the special protocol assessment (SPA) from the FDA for Axovant Sciences Ltd.'s new phase III trial with RVT-101, a 5-hydroxytryptamine6 (5-HT6) serotonin receptor antagonist to treat Alzheimer's disease (AD), should bolster confidence that his firm is pursuing "the best-validated target" for the stubborn indication. Read More
