Oncomed Pharmaceuticals Inc.'s shares dipped as much as 24 percent briefly after the company halted six phase Ib trials testing two Bayer AG-partnered monoclonal antibodies targeting the Wnt pathway in cancer. Trial sites reported "on-target mild-to-moderate" bone-related adverse events, moving the company to stop the trials to amend study protocols for all eight ongoing trials of vantictumab and Fzd8-Fc. Read More
In a Thursday session at BIO 2014 next week, attendees will get a lesson from a panel of experts on how to get a piece of the government funding available for companies developing medical countermeasures (MCMs). Read More
The EMA has retreated from its position of allowing researchers only on-screen access to clinical study reports (CSRs) as part of its new policy on clinical data transparency. Read More
BOGOTA, Colombia – A group of regulatory agencies from Latin America are joining forces to strengthen cooperation, enhance their regulatory capacity and speed up approvals by sharing more information, improving communication channels and mutually recognizing certifications and approvals. Read More
In a recent talk at the NIH, the University of Alabama's David Sweatt gave an overview of how epigenetic mechanisms affect memory formation, as well as very early stage suggestions on how the insights his team has gained into such mechanisms might be targeted therapeutically. Read More
Cesca Therapeutics Inc., of Rancho Cordova, Calif., priced an underwritten public offering of approximately 7.5 million units consisting of an aggregate of approximately 7.5 million common shares and warrants to purchase approximately 2.3 million additional shares, at $1.50 per unit. Read More
Vivus Inc., of Mountain View, Calif., said it has filed a lawsuit in the U.S. District Court for the District of New Jersey against generic firms Actavis Laboratories FL Inc., Actavis Inc. and Actavis plc, in response to an abbreviated new drug application, filed by Actavis. Read More
Hospira Inc., of Lake Forest, Ill., reported data, at the European League against Rheumatism (EULAR) congress, showing that its biosimilar monoclonal antibody Inflectra demonstrated comparable and sustained reductions in disease activity to European reference product Remicade (infliximab, Johnson & Johnson) over one year in patients with rheumatoid arthritis and ankylosing spondylitis. Read More
Acetylon Pharmaceuticals Inc., of Boston, presented an update from ongoing phase Ib studies, showing that HDAC inhibitor ricolinostat (ACY-1215) continued to demonstrate promising activity and tolerability in combination with Revlimid (lenalidomide, Celgene Corp.) or Velcade (bortezomib, Millennium: The Takeda Oncology Co.) in relapsed or refractory multiple myeloma. Read More
Abbvie Inc., of North Chicago, said its new drug application for its all-oral, interferon-free regimen for adults with chronic genotype 1 hepatitis C virus infection was accepted by the FDA and granted priority review. Read More
