Given the growing importance and prevalence of fixed-dose combination (FDC) drugs, the FDA is rethinking the exclusivity for those that combine a new chemical entity (NCE) with previously approved components.

Drugmakers, patient advocacy groups, insurance companies and medical associations are lining up en masse in opposition to proposed changes to Medicare Part D that focus on the bottom line.

The FDA has cleared 13 drugmakers for the test run of its Secure Supply Chain Pilot Program. Each company along for the ride will get expedited entry for up to five approved drugs or APIs imported into the U.S. over the next two years.

It’s 1984. The year opens with the demise of Ma Bell, as the Bell System is broken into smaller, regional telephone companies. The idea is to end Ma’s nationwide monopoly, but the result is a handful of smaller monopolies since there still is no telephone competition. The Soviet Union leads a boycott of the Summer Olympics being held in Los Angeles, presumably as payback for the U.S. boycott of the 1980 Moscow Games, which was, in turn, a response to the Soviet war in Afghanistan. Even though Time named the computer the “Machine of the Year” two years ago, personal computers...

If brand drugmakers have their way, the EU could be counted among the countries and regions that are the worst in undermining the value of U.S. companies’ intellectual property rights.

A flawed pivotal trial coming on the heels of two well-designed trials that failed wasn’t enough to convince an FDA advisory committee of the benefits of The Medicines Co.’s cangrelor in reducing thrombotic cardiovascular events.

In focusing on individual drug shortages, the FDA is missing opportunities to proactively prevent and mitigate shortages in general, according to the Government Accountability Office (GAO).

Contradicting FDA reviews could have The Medicines Co. swinging when its cangrelor steps up to the plate at the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) meeting Wednesday.

A culturing process designed to determine the growth and biological characteristics of the resulting cell population is enough to render stem cells a drug subject to FDA manufacturing and labeling regulations, a federal appellate court said this week in a ruling upholding a permanent injunction against Regenerative Sciences LLC’s Regenexx-C, a stem cell product used as an alternative to surgery for various orthopedic conditions and diseases.

With the FDA expected to approve its first biosimilar within a year or two, how to name the follow-on biologics has passed from an academic debate to a must-do proposition. Since sponsors must include the name in the dossier when they submit a biosimilar application, those that are getting close to filing need to know pretty quickly how the drugs are to be named, Sumant Ramachandra, senior vice president and chief scientific officer at Hospira Inc., told BioWorld Today.