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A federal judge has dismissed claims brought by a group of pharmacies that Pfizer and Ranbaxy forged an illegal deal to delay generic competition to Pfizer’s cholesterol drug Lipitor, marking another victory for the manufacturers in the class action filing. Read More
The FDA oncology-drug advisory committee turned down Novartis’ investigational multiple myeloma drug Farydak by a 5-2 vote, citing safety concerns that largely overwhelmed benefits. Read More
A pharmacist advocate is urging manufacturers to provide more information on the reason for and expected duration of a drug shortage, so that healthcare providers can better plan for how the shortage will affect patient care. Read More
Drugmakers participating in an ISPE pilot program on quality metrics received new guidance on what data they need to collect, information that could provide a glimpse of the kinds of data that the FDA will start collecting next fall. Read More
Injectable sterile drug manufacturer Pharmaceutics International received a Form 483 for its failure to adequately investigate particulates in products and conduct design inputs for its combination product. Read More
The FDA has approved Eli Lilly’s Cyramza in combination with paclitaxel for advanced stomach cancer after chemotherapy, following an approval this spring as a single therapy for treating the disease. Read More
The FDA has cleared Janssen and Medivir’s hepatitis C drug Olysio to be used in combination with Sovaldi, making it the latest drug to be paired up with Gilead Sciences’ blockbuster product. Read More
A federal court decision this fall granting orphan drug marketing exclusivity to Depomed’s post-shingles pain drug Gralise will stand, after the FDA withdrew an appeal filed earlier this week. Read More