Kadmon Holdings LLC, of New York, filed an S-1 with the SEC seeking to raise up to $115 million in an IPO. The company plans to convert outstanding senior convertible term loans for another $25 million in proceeds. Read More
Viiv Healthcare Ltd., of London, said the FDA approved a supplemental new drug application for dolutegravir 10 mg and 25 mg oral tablets, reducing the weight limit from at least 40 kg to at least 30 kg, in patient, ages 6 to under 12 years old, for the treatment of HIV-1. Read More
Global Blood Therapeutics Inc., of South San Francisco, reported results from its ongoing phase I/II GBT440-001 study in sickle cell disease at the European Hematology Association meeting in Copenhagen, Denmark, including a presentation of 90-day data from a cohort of patients taking 700 mg/day of GBT440, showing a durable reduction in hemolysis from baseline, as evidence by a rapid and sustained reduction in bilirubin starting as early as day four. Read More
Increased production of acetate by the gut microbiome led to activation of the parasympathetic nervous system, which promoted metabolic syndrome. It has been clear that the gut microbiome plays an important role in metabolism, but the molecular links between the two largely remain to be worked out. Read More
SAN FRANCISCO – Mister, can you spare a dime? For drugs – prescription drugs, that is. The industry's drug pricing conundrum was the talk of BIO 2016. Read More
With an eye toward streamlining reviews of increasingly complex medical products and enhancing collaboration between the FDA centers, two leading lawmakers have offered a bill that proposes the establishment of "intercenter institutes" within the agency for major disease areas. Read More
The pharma-to-spinout-to-pharma course traveled by Afferent Pharmaceuticals Inc. in Merck & Co. Inc.'s buyout worth up to $1.25 billion is not the first time and likely won't be the last in neurology, New Leaf Venture Partners managing director Liam Ratcliffe told BioWorld Today. "Despite headwinds in the space and many big companies getting out, we continue to see opportunities," he said. Read More
Sophiris Bio Inc.'s shares (NASDAQ:SPHS) rose 69.2 percent to a $1.98 close on Friday after publishing data showing that a single injection of PRX302 (topsalysin) durably destroyed localized prostate cancer tumor cells in half of the 18 men enrolled in an open-label phase IIa study. Read More
LONDON – The government must put a contingency plan in place to protect U.K. life sciences in the event of a vote to leave the European Union (EU) in the June 23 referendum. Read More
Researchers have developed a method to expand corrected cells in the liver after gene therapy, an approach analogous to bone marrow conditioning that could improve both the efficacy and the safety of gene therapy. Read More
DUBLIN – Uniqure NV and Spark Therapeutics Inc. presented heavily trialed data on their respective gene therapy programs in hemophilia B at the European Hematology Association (EHA) meeting in Copenhagen, Denmark, Saturday. Read More
