FDA committee won’t recommend approval for non-Hodgkin’s lymphoma treatment
GAITHERSBURG, Md. A Food and Drug Administration advisory committee declined to recommend approval for a cancer drug made by Cell Therapeutics, the company announced Monday.
Cell Therapeutics said the FDA’s Oncologic Drugs Advisory Committee voted unanimously that data from clinical trials of pixantrone, a treatment for non-Hodgkin’s lymphoma, did not support its approval. Pixantrone would have been the first drug to treat relapsed or refractory NHL in patients who had received two or more prior therapies.
The FDA is not bound by the recommendations of advisory committees, and the agency is expected to decide whether or not to approve pixantrone on April 23. It does, however, take the recommendations into account when deciding whether or not to approve a drug, and the committee’s vote will likely diminish pixantrone’s chances for winning approval.
Shingles drug may capture half the market, Decision Resources predicts
WALTHAM, Mass. A once-a-day formulation of a Pfizer drug potentially could capture half of the market for a painful complication related to shingles, according to a report by market research firm Decision Resources.
The report found that Pfizer’s drug Neurontin (gabapentin) could take 50% of the market for postherpetic neuralgia, also known as after-shingles pain, which causes pain in patients who have had shingles, a disease that often occurs later in life among people who have had chickenpox. The report was based on surveys of neurologists in the United States and Europe, where those surveyed said it would capture a 40% share of the market.
The report also found concern among experts regarding the pain associated with use of the drug Qutenza (capsaicin), by NeurogesX and Astellas Pharma, which Decision Resources said prevented that drug from earning its clinical gold-standard status.
“Although experts recognize the long-term efficacy of a single administration of Qutenza as a significant advantage, they cite the need to manage the transient path associated with the drug’s administration as a significant disadvantage,” Decision Resources analyst Sami Fam said. “In the balance of these attributes however, experts consider Qutenza a therapeutic option that compares favorably with Lidoderm.”
Lidoderm, known generically as lidocaine, is made by Endo Pharmaceuticals.
Food Lion, Bottom Dollar Food recognize regional store managers
SALISBURY, N.C. An operator of more than 1,300 supermarkets in southeast and mid-atlantic states and a regional supermarket chain recently recognized the regional winners of the companies’ Store Manager Excellence Award.
Food Lion and Bottom Dollar Food said Friday that 24 store managers were honored at a recent leadership event at the companies’ Customer Support Center. From the group of regional winners, eight district winners were honored and then, an overall winner, Emory Turner of Vidalia, Ga., a store manager with Harveys Supermarkets (a banner owned by Food Lion), was selected as the overall company winner of the Store Manager Excellence Award.
The Store Manager Excellence Award selection includes nine areas of focus, including associate development, leadership, strategic decision-making, cross-organizational collaboration and teamwork, executional excellence, extraordinary results, great customer experiences, community involvement and diversity and inclusion.
Regional winners are selected from a group of nearly 100 district winners.