Individuals who were able to make broadly neutralizing antibodies to HIV were also more prone to producing autoantibodies and had other metrics indicative of immune system dysfunction. Read More
Mallinckrodt plc, of Chesterfield, U.K., confirmed enrollment of the first patient in its phase III study of terlipressin (for injection) in subjects with hepatorenal syndrome (HRS) type 1, an acute, rare and life-threatening condition requiring hospitalization, with no currently approved therapy in the U.S. or Canada. Read More
Silvergate Pharmaceuticals Inc., of Denver, said the FDA approved Qbrelis, an oral solution of ACE inhibitor lisinopril, for the treatment of hypertension in adult patients and pediatric patients, 6 and older, as adjunct therapy for heart failure and as treatment of acute myocardial infarction in adults. Read More
Azurrx Biopharma Inc., of New York, sets terms for its IPO, hoping to raise $15 million from the sale of 2.14 million shares of common stock priced in the range of $6 and $8 each. The company is focused on therapies to treat gastrointestinal disorders. Read More
The FDA has published the long-awaited draft guidance for co-development of a therapeutic drug and a companion diagnostic, but the agency has scheduled an Aug. 18 webinar to address questions associated with the draft, a sign that the document leaves many questions unanswered. Read More
Seres Therapeutics Inc.'s stock-joltingly failed phase II study with SER-109 was not the first or only placebo-controlled microbiome trial against recurrent Clostridium difficile infection (CDI), and better (currently embargoed) news will roll out during scientific sessions this fall from Rebiotix Inc., with RBX2660, CEO Lee Jones told BioWorld Today. Read More
Jazz Pharmaceuticals plc licensed global rights to several early stage blood cancer candidates from Pfenex Inc. in a deal that also included an option on an exclusive license for PF690, a biosimilar of Baxalta Inc.'s acute lymphoblastic leukemia (ALL) therapy, Oncaspar (pegaspargase), access to which could give Jazz wider reach in ALL. Read More
Second-quarter earnings season wrapped up for big pharma with a sales miss by Sanofi SA as it sought to modify its tactical pursuit of Medivation Inc., which reports its financial results after the market close on Aug. 9. Read More
HONG KONG – A new study led by scientists at the Australian National University (ANU) has provided valuable insights into how the function of the human genome depends on RNA-binding proteins, an important discovery that could ultimately lead to the development of new treatments for heart disease. Read More
Figuring out which anaplastic lymphoma kinase inhibitor to use first in ALK-positive NSCLC, and handicapping the prospects for those coming through pipelines, has turned into a major challenge for oncologists, especially as resistance grows to New York-based Pfizer Inc.'s Xalkori (crizotinib), approved in August 2011 as a first-line treatment. Read More
