When Amylin Pharmaceuticals Inc. received the "green light" from the FDA in January to market its glucagon-like peptide-1 (GLP-1) receptor agonist, Bydureon (exenatide), as an adjunct to diet and exercise for improving glycemic control in adults with Type II diabetes, little did anyone know the full reasons why it had taken the company three tries to get approval.
Systems biology is beginning to make an important contribution to personalized medicine. New discoveries about the molecular networks and cellular pathways in cancer cells will provide clinicians with essential information about an individual patient's biological state that will guide them toward the most appropriate drug or combination of drugs for use in their treatment.
Before he died of non-Hodgkin's lymphoma in 2005, Nobel Prize-winning chemist and nanotech pioneer Richard Smalley said, "Twenty years from now, nanoscale missiles will target cancer cells in the human body and leave everything else blissfully alone." That quote provided an introduction to a session at BIO 2012 that examined how nanotechnology had evolved since Smalley's statement more than a decade ago.
BOSTON – Patients are becoming more involved in their own health care decisions, and companies that realize this and integrate those changing dynamics into their own business models will be the ones that ultimately profit and be successful in the future. That was the theme discussed in a panel at BIO 2012, titled "New rules of patient engagement."
BOSTON – "This is like deja vu all over again." The often-used famous quote by Yogi Berra is appropriate since not only has Boston strong ties to baseball, but also to the growth of biotechnology.
As the 72nd annual scientific sessions of the American Diabetes Association (ADA) drew to a close last week, the world's leading diabetes experts were left in no doubt that the market for glucagon-like peptide-1 (GLP-1) receptor agonists is becoming highly competitive.
It is often said that start-up and emerging biotechnology companies require patient capital in order to execute on their business plans. Unfortunately, for Canadian biotechs they have had to be extremely patient waiting for capital.
Following on from the success of the approved first-generation proteasome inhibitor Velcade (bortezomib, Millennium/Takeda Pharmaceutical Co. Ltd.), which jams up the proteasome and nonspecifically inhibits proteins from being degraded, various new proteasome inhibitors are currently in development, including peptide boronic acid analogue MLN9708 (Millennium/Takeda) and carfilzomib (Onyx Pharmaceuticals Inc.).
After a relatively tough year for stem cell companies on the public markets, they finally had something to cheer about – a regulatory milestone that could pave the way for a number of future approvals of stem cell therapies currently in late-stage clinical trials.
Just over a month after the FDA's Oncologic Drugs Advisory Committee (ODAC) voted 7 to 4, with two abstentions, that Marqibo (vincristine sulfate liposome injection) demonstrated a favorable risk-benefit profile as a third-line treatment for adults with Philadelphia chromosome-negative acute lymphoblastic leukemia, Talon Therapeutics Inc. reported the enrollment and dosing of the first patient.
