• IGI Laboratories Inc., of Buena, N.J., received approval from the FDA for its supplemental filing for the site transfer of econazole nitrate cream 1 percent to its manufacturing facility in Buena, N.J.
• Sunovion Pharmaceuticals Inc., of Marlborough, Mass., published results from two pivotal trials supporting FDA approval of Latuda (lurasidone HCL) for major depressive episodes associated with bipolar I disorder in The American Journal of Psychiatry.
Genentech Inc.’s Gazyva (obinutuzumab), formerly known as GA101, became the first therapy approved through the FDA’s breakthrough therapy designation, indicated in combination with chlorambucil to treat previously untreated chronic lymphocytic leukemia (CLL).
Researchers from the National Institute of Allergy and Infectious Diseases have shown that HIV attacks B cells as well as the T cells that are its main host, giving it another weapon in its conquest of the immune system.
Biotech bubbleologists will be out in force following a rough month for the sector, which saw blue-chip companies developing new medicines collectively record their first reversal for more than 18 months.
Back in 2007, an Alzheimer’s disease candidate called Alzhemed missed its endpoint in a large-scale pivotal study, just one of many late-stage failures in the space, along with Myriad Genetics Inc.’s Flurizan, Medivation Inc.’s Dimebon, Eli Lilly and Co.’s semagacestat and bapineuzumab from Pfizer Inc. and Johnson & Johnson/Eland Corp. plc.
Orbimed Advisors LLC closed a new fund of more than $735 million for investment in biopharmaceutical, medical device and diagnostics companies in North America and Europe.
SHANGHAI – China Resources Pharmaceutical Group (CRP) has broken ground on its ¥14 billion (US$2.3 billion) campus in Daxing Biomedical Park in Beijing.
Scientists have picked apart the role of scarring after spinal cord injury and found that there is at least one component of the glial scar that is helpful for tissue regeneration.
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