We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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
To demonstrate value in the age of personalized medicine, drugmakers must adjust their marketing campaigns around patients’ real-world experiences, a new PricewaterhouseCoopers (PwC) report says. Read More
Aegerion Pharmaceuticals CEO Marc Beer’s televised comments about the company’s heart drug Juxtapid have drawn a warning letter from the FDA for failing to mention drug risks and promoting an off-label use. Read More