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Committee chairperson Brian Rini said the clinical data supported efficacy in terms of response rate, and that any discrepancies in the safety data were likely simply “what you get when you have a lower number of patients treated in this type of development program.” Read More
Minnesota is suing Novo Nordisk, Eli Lilly and Sanofi for allegedly setting artificially high prices for insulin products and then offering rebates to reap insurer contracts. Read More
PhRMA released new guidelines this week on price transparency in advertising in an effort to preempt tough mandatory regulations released Monday that would require ads to include featured drugs list prices. Read More
The lawsuit sought to hold the drugmakers liable under the state’s Drug Dealer Liability Act (DDLA), which allows parents, employers, insurers and government entities to sue “persons in the community who have joined the illegal drug market.” Read More
The FDA denied a request by Canadian drugmaker Apotex to rescind its approval of a competing ANDA for a potassium chloride oral solution submitted by Novel Laboratories — granted on the same day Apotex qualified for 180-day competitive generic therapy (CGT) exclusivity. Read More
On the heels of CMS’ proposed rule to require disclosure of drug prices in TV ads, the FDA issued draft guidance Tuesday on presenting efficacy and risk information in direct-to-consumer (DTC) promotional materials and drug ads. Read More