| Merck's Ditching of Aranesp Biosimilar Highlights Follow-on-Biologics Pitfalls EP Vantage submits:The developmental and regulatory minefield confronting companies attempting to develop follow-on-biologics (FOBs), or biosimilars, was highlighted again this week with Merck's (MRK) decision to scrap development of MK-2578, its pegylated form of erythropoietin similar to Amgen’s (AMGN) blockbuster anaemia drug Aranesp. MK-2578 was widely expected to be the first biosimilar erythropoietin-stimulating agent (ESA) onto the US market with a launch pencilled in for 2012. However, the FDA has requested cardiovascular outcome data for the product, which Merck believes will be too onerous and lengthy to be worth it. Perceived by some in the market as good news for Affymax through the removal of a key competitor to its own ESA agent, Hematide, the FDA’s stance on cardiovascular safety for these products could set alarm bells ringing at the Californian biotech ahead of crucial phase III data.Complete Story » seekingalpha.com |
Inverness Medical changes name to Alere (AP) Diagnostics company Inverness Medical Innovations Inc. said it changed its name to Alere Inc. Shareholders at the company's annual meeting Wednesday approved the change. us.rd.yahoo.com |
Ranking States By Obesity Rates Colorado has the lowest rate of obese adults and Mississippi has the highest, according to a new government survey that underlines the growing girth of many Americans. online.wsj.com |
Cancer-Targeting Drug Shows Promise Seattle Genetics said its novel blood-cancer treatment, which attacks cancerous cells but ignores healthy ones, shrank tumors in three-quarters of patients with Hodgkin's lymphoma. online.wsj.com |
Fish Oil Helps Little in Pregnancy Fish-oil supplements don't appear to help pregnant women prevent post-partum depression or boost the baby's brain development as previously believed. online.wsj.com |