New technology and anxiety over expiring patents have driven pharma to triple clinical development of large molecule and biologic drugs over the past decade, says an industry expert. Read More

The FDA and Vanda failed to agree on a prespecified primary endpoint for the new sleep disorder drug, tasimelteon, but that didn’t derail the company’s NDA. Read More

The FDA seems to have side-stepped many of the issues raised by industry in a draft guidance on preclinical considerations for gene/cellular therapies (CGT) while extending a guidance deadline for early-stage CGT development. Read More

In the latest initiative to clean up its troubled clinical trial industry, the Indian government is requiring investigators to video record the informed consent process for each subject in clinical studies. Read More

Following setbacks to its hepatitis C drug program, Idenix Pharmaceuticals has turned to the courts to try to delay Gilead’s competitor hepatitis C treatment, claiming the drug infringes several Idenix-owned patents. Read More

The FDA is demanding Wockhardt investigate whether management was involved in quality data manipulation at its Chikalthana, India, facility before the agency will lift the import ban it has slapped on the plant. Read More

Twenty-five drugmakers, including generic drugmakers Ranbaxy and Perrigo, have agreed to pay the state of Louisiana more than $88 million to settle Medicaid and Medicare fraud charges lodged against them as part of the state’s continuing crusade to recover funds paid out to drug companies improperly. Read More

The White House Office of Management and Budget’s decision to sequester nearly $85 million of FDA user fees is wrong, and should be reversed immediately, lawmakers say. Read More

Teva and Mylan said Nov. 25 they had reached a confidential agreement to settle patent litigation over Teva’s multiple sclerosis drug Copaxone in three European courts. Read More

The FDA is investigating reports that emergency contraceptives such as Teva’s Plan B One-Step lose effectiveness in women over 165 lbs. and don’t work at all for women over 175 lbs. Based on its review, labeling changes for the drugs may be forthcoming. Read More

Drugmakers have 14 additional calendar days to comment on recently revised GDUFA question-and-answer guidance after technical difficulties prevented stakeholders from submitting comments on Regulations.gov. Read More

The Generic Drug User Fee Amendments of 2012 do not allow for a waiver, reduction or postponement of finished dosage form (FDF) facility fees for small and/or foreign businesses, the FDA says in a letter denying a citizen petition submitted by Square Pharmaceuticals. Read More