Almost exactly a year after Remsima (infliximab) won approval in Korea as the first ever biosimilar monoclonal antibody (MAb), the Remicade copycat drug won a positive opinion from Europe's Committee for Medicinal Products for Human Use (CHMP), clearing the way for formal European approval within the next three months. Read More
Prosensa Holding B.V., of Leiden, the Netherlands, became the first European biotech company in 10 years to file for its initial public offering (IPO) on the Nasdaq to support development of its products for Duchenne's muscular dystrophy and other programs. It plans to raise about $78 million. Read More
SHANGHAI – Looking to create synergies between its own expertise and growing pool of small and medium biotech ventures in China, Boehringer Ingelheim Pharmaceuticals GmbH (BI) plans to build the first international biopharma contract manufacturing facility (CMO) in the country with mammalian cell technology. Read More
With some neglected tropical diseases (NTDs) making inroads in the U.S., the government must find ways to incentivize R&D for vaccines, diagnostics and treatments for the diseases, Rep. Christopher Smith (R-N.J.) said in opening a House subcommittee hearing on addressing the NTD gap. Read More
Genome editing – the ability to change a DNA sequence at a specific site in the genome – could be useful for improving the scientific understanding, and ultimately the treatment, of a multitude of diseases. Read More
• Vivus Inc., of Mountain View, Calif., responded to statements by First Manhattan Co. (FMC), a 9. 1 percent shareholder, alleging the launch of obesity drug Qsymia (phentermine/topiramate extended release) was mismanaged and Vivus did not adequately address out-of-pocket costs to patients and mismanaged the regulatory process for the drug, branded Qsiva, in the European Union. Read More
• Soligenix Inc., of Princeton, N.J., enrolled and treated all patients in a Phase I trial of SGX203 for pediatric Crohn's disease. The goal of the 24-subject study was to characterize the drug's pharmacokinetic and pharmacodynamic profile of the formulation. Read More
• Glaxosmithkline plc, of London, was granted breakthrough-therapy designation by the FDA for drisapersen for the potential treatment of patients with Duchenne's muscular dystrophy. Phase II U.S. and rest-of-world Phase III data on drisapersen are expected to report in the third and fourth quarters, respectively, of this year. Read More
• Amarin Corp. plc, of Dublin, was issued U.S. Patent notice of allowance No. 13/417,899, "Pharmaceutical Compositions Comprising EPA and a Cardiovascular Agent and Methods of Using the Same." The application covers the use of Vascepa (icosapent ethyl) and statin therapy to reduce triglycerides. Read More
A group from the Japanese Kyoto University has shown that most fibroblasts that are treated with a cocktail of four factors to reprogram them into induced pluripotent stem cells (iPSCs) acquire pluripotency markers, but very few of them managed to go on to establish colonies of iPSCs when they were cultured. Read More
