FDAnews Drug Daily Bulletin

A district court judge has largely sided with Jazz Pharmaceuticals’ definitions for patents on its narcolepsy drug Xyrem, and the outcome looks like a “clear win” in Jazz’s legal struggle to prevent generic competition from Roxane Laboratories, one analyst says.

Now that CBER’s all-electronic Direct Recall Classification (DRC) program has been extended to non-blood products, problems with biologic drugs flagged in electronic biological product deviation reports (eBPDRs) may trigger recalls of those products under the program.

Eli Lilly has misbranded its radioactive PET drug Amyvid, approved for reviewing displays of brain scans using a black-and-white scale, by featuring a multi-colored brain image on a webpage advertisement and other promotional materials for the product, according to an FDA untitled letter.

An experimental pancreatic cancer treatment from Threshold Pharmaceuticals failed to show statistically significant improvement in overall survival, spooking investors and sending its shares down as much as a third.

Investors apparently have not quite understood what was said recently in Oncolytics Biotech’s update on their Phase III trial of Reolysin (REO 018).

Jennerex has announced positive clinical data from Phase II trial of JX594, a proprietary, engineered oncolytic immunotherapy, in sorafenib-refractory hepatocellular carcinoma (liver cancer, HCC) patients.

China cut the maximum retail prices for some cancer, immune and blood system drugs by an average of 17 percent, the country’s top planning agency said.

Final results of a phase III trial confirm that treatment with abiraterone prolongs overall survival in metastatic castration-resistant prostate cancer that has progressed after docetaxel therapy.

For Diane Gwartney, every waking minute was a battle against the urge to cough.