Discussions with Alimera ahead of a January advisory committee meeting led the FDA to conclude that the company’s diabetic macular edema drug would be approvable with labeling changes and additional safety data — foregoing the need for the meeting and additional clinical trials. Read More

The push for trial data transparency — by regulators and pharma alike — kept sponsors and clinical sites on their toes in 2013. Both sides agreed that more transparency is needed, but they diverged on how to accomplish the goal. India announced new standards for ethics boards and patient compensation, while Japan’s Pharmaceutical and Medical Devices Agency launched an R&D and strategy consulting arm to fine-tune the development of novel products and speed regulatory approvals. Buzz words included “personalized medicine,” “enrichment trials” and “centralized monitoring.” Use this roundup of news highlights in 2013 to plan your clinical trial strategy for the year ahead. Read More

Novartis’ valsartan woes escalated Thursday as Japan followed the U.S. in filing a legal complaint against the Swiss drugmaker over its marketing practices for the blood pressure drug. Read More

Less than a month after AstraZeneca said it was buying out Bristol-Myers Squibb’s part of its diabetes pipeline partnership, the FDA Wednesday approved their type 2 diabetes drug Farxiga. Read More

The Centers for Medicare & Medicaid Services (CMS) plans to force makers of antidepressants and immunosuppressants to compete for inclusion on Medicare Part D formularies, which it hopes will compel drugmakers to lower prices. Read More

The FDA has set a deadline of November 2014 to revise its current good manufacturing practice (cGMP) regulations to strengthen its oversight of pharma supplier quality. Read More

A champion in the global fight against counterfeit drugs is adding an unusual voice to growing calls for relaxing the U.S. ban on the personal importation of prescription drugs. Read More

The drug industry wants the FDA to drop plans to require drugmakers to report manufacturing stoppages that will result in shortages within five days of the stoppage occurring. If any timeline is imposed, 15 days is adequate, industry says. Read More