Analysts during a conference call with Macrogenics Inc. characterized themselves as "dead wrong" and called the company's phase III victory "especially sweet" with margetuximab (marge) that was "written off by so many" in HER2-positive metastatic breast cancer. The news sent shares (NASDAQ:MGNX) up 130.4 percent, or $14.49, to close Wednesday at $25.60. Read More
The morning after U.S. President Donald Trump called for unity on bipartisan issues such as bringing down prescription drug prices, ending the HIV epidemic within the decade and advancing the development of treatments for childhood cancers, members of the House of Representatives were back at their battle lines, hurling names and accusations at each other. Read More
Vanda Pharmaceuticals Inc. is challenging the FDA's imposition of a partial clinical hold on its study of the NK1 antagonist tradipitant, saying that the agency has illegally prohibited it from studying the gastroparesis drug in humans for more than 12 weeks "without conducting unnecessary and unethical animal studies," work it said would result in the death of dozens of dogs without producing additional scientific insight. Read More
Sanofi SA's $4.8 billion bet on Nanobody developer Ablynx NV gained further validation Wednesday, with the pharma winning an FDA nod for Cablivi (caplacizumab-yhdp) in rare and sometimes fatal blood disorder acquired thrombotic thrombocytopenic purpura (aTTP). U.S. approval comes about six months after the first commercial nanobody – a single-domain antibody that offers the specificity with the advantages of a smaller-sized molecule – gained approval in Europe for the same indication. Read More
In results that are simple in one sense and profound in another, researchers at Texas A&M University have demonstrated that application of growth factor bone morphogenetic protein 9 (BMP9) could regenerate a joint in mice after an amputation. Read More
Spun out of work from Jan Kraus' lab at the University of Colorado in 2013, Orphan Technologies Ltd. has moved its first drug into the clinic. The Lexington, Mass.-based company is part of the Neopharm group, of Petach Tikva, Israel, a private company owned by a single family. Read More
Pulmatrix Inc., of Lexington, Mass., said it has terminated its previously planned underwritten public offering, with a request to withdraw its original S-1 registration statement filed with the SEC on Dec. 28. The request was made due to market conditions and for strategic reasons. Read More
Corvus Pharmaceuticals Inc., of Burlingame, Calif., presented updated biomarker results from CPI-444, an adenosine A2A receptor antagonist at the Immuno-Oncology 360° Conference in New York during the "Discovery & Preclinical Science Plenary" session, which focused on tumor microenvironment-changing technologies, pegylated cytokines and additional discovery and preclinical data. Read More
Vertex Pharmaceuticals Inc., of Boston, reported full-year cystic fibrosis (CF) product revenues of $3.04 billion, up 40 percent over 2017, while fourth-quarter CF product revenues totaled $868 million. Read More
Gigagen Inc., of South San Francisco, appointed Adam Adler chief scientific officer, Rena Mizrahi vice president of process development, Catherine Medina vice president of operations and Erica Stone director of immuno-oncology. Read More
