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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
European regulators this week approved a complicated three-part transaction that would see Novartis and GlaxoSmithKline swapping parts of their companies and creating a consumer healthcare joint venture. Read More
Gilead has expanded its licensing agreements with eight India-based generic drugmakers to market cheaper copies of its pricey blockbuster hepatitis C therapy Sovaldi in 91 developing countries. Read More
Phase III trials of two Ebola vaccines will kick off in the next few weeks in Liberia, according to the National Institute of Allergy and Infectious Diseases. Read More
As negotiators continue to shape the Trans-Pacific Partnership trade deal, the length of patent protection for biologics remains a sticking point with the U.S. continuing to push for 12 years of protection before a biologic drug can be copied. Read More
Reaction is mixed to proposed legislation to revamp portions of the FDA’s drug approvals process, with generics makers already pushing back against a proposal to extend a drug’s patent protection if it serves unmet needs while others are praising parts of the bill that would speed up and simplify approvals. Read More
India’s medicines authority Wednesday detailed a proposed set of steps drugmakers must take to schedule presubmission screening meetings with drug reviewers — codifying an informal system that was launched several years ago. Read More
Europe’s brand and generic drugmakers are proposing a coordinated approach for regulators and industry to quickly identify and respond to drug shortages caused by manufacturing and quality issues. 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