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The Senate is joining the effort to make the FDA more efficient at approving new drugs, laying out criticisms that the agency is slow and inefficient in a report released yesterday and planning hearings on the issue in the spring. Read More
The UK’s health cost watchdog has recommended Alexion’s Soliris for the treatment of patients with atypical hemolytic uremic syndrome, a life-threatening disease that causes abnormal blood clots to form in small vessels in the kidneys. Read More
The House Energy & Commerce Committee that oversees the FDA is planning an overhaul of agency procedures to increase orphan drug development, streamline clinical trials oversight, give industry incentives to find new uses for old drugs and expand U.S. drug manufacturing. Read More
The FDA has given a Teva subsidiary the first greenlight for a generic Nexium in a snub to Ranbaxy, which is suing the agency after having its ANDA first-filer status on the therapy revoked over GMP violations at its India plants. Read More
Antares Pharma received an FDA complete response letter for labeling issues and minor deficiencies in its ANDA for sumatriptan injection USP, the company said in a Monday SEC filing. Read More
NPS Pharma plans to make Natpara available for some patients with hypoparathyroidism in the second quarter of this year, following FDA approval late Friday. Read More
Pharmacists will only notify prescribers that they’ve switched a patient from brand to biosimilar if no database is available to make note of a swap. Read More
UK healthcare cost watchdogs confirmed Friday that Bayer’s Xarelto is cost-effective for preventing blood clots in patients who have had heart attacks. Read More