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Illinois-based drugmaker Horizon Pharma has acquired the U.S. rights to AstraZeneca’s Vimovo delayed-release tablets in order to bolster the company’s primary care portfolio. Rights outside the U.S. will be retained by AstraZeneca. Read More
The European Commission has granted marketing approval for Bayer and Algeta's Xofigo to treat castration-resistant prostate cancer (CRPC) that has spread to bones but not other organs. Read More
In the wake of record-breaking numbers of drug shortages, particularly generic injectables, the European Federation of Pharmaceutical Industries and Associations (EFPIA) is advising drugmakers to establish a drug shortage task force. Read More
The Supreme Court Nov. 13 dealt generic giant Teva a major blow as it denied the company’s request to stay a lower court’s ruling that will allow generic versions of the drugmaker’s blockbuster brand drug Copaxone to hit pharmacy shelves in May. Read More
Drugmakers have 13 months to revamp how they track drugs after the Senate voted Nov. 18 to send to President Barack Obama’s desk a measure that would establish a nationwide track-and-trace requirement for prescription drugs. Read More
The FDA says someone hacked into CBER’s online submission system last month and may have put users in danger of having their online personal identity stolen. Read More
Baxter International and Cell Therapeutics (CT) on Friday joined together in a strategic partnership to develop and market pacritinib, CT’s investigational JAK2/FLT3 inhibitor for genetic mutations connected to myelofibrosis, leukemia and other types of solid tumors. Read More
Drugmakers should establish a company task force of upper management and quality personnel to prevent drug shortages, according to new good practice guidelines developed by the European Federation of Pharmaceutical Industries and Associations (EFPIA). Read More
Certain drug and biologic manufacturers must notify the FDA at least six months before they believe a product may be permanently discontinued or experience an interruption in manufacturing, according to a new proposed rule announced last month. Read More
A bill that will require drugmakers to establish a pedigree system for pharmaceuticals within one year is expected to reach President Obama’s desk this Friday. Read More