Archive for July 2016
Week In Review
Source: Drug Industry Daily
Read MoreNICE Backs Pfizer’s Bosulif After Cancer Fund Restructuring
The UK’s price watchdog is backing coverage for Pfizer’s Bosulif at a new discounted price, broadening access to the drug that was previously only available through the now-revamped Cancer Drugs Fund. Source: Drug Industry Daily
Read MoreFDA Issues Rebuttal to AstraZeneca Exclusivity Suit
AstraZeneca’s lawsuit against the FDA over the exclusivity of one of its drugs is a “transparent” effort to stifle generic competition for the blockbuster anti-cholesterol drug Crestor, the FDA said in its response to the suit. Source: Drug Industry Daily
Read MoreFDA Sets Compliance Framework for Compounding Near Replicas of Approved Drugs
The FDA is laying out compliance parameters for outsourcing facilities that compound near replicas of approved drugs, urging them not to distribute such products to patients that could use an approved drug. Source: Drug Industry Daily
Read MoreProtocol Deviations Prompt 483s for Clinical Investigators
Three clinical investigators were cited for deviating from their investigational plans recently by the FDA for a litany of different reasons. Source: Drug Industry Daily
Read MoreLegislative Update
Source: Drug Industry Daily
Read MoreFDA Recalls and Import Alerts
Source: Drug Industry Daily
Read MorePfizer Signs Code of Conduct for Opioid Marketing Under Deal With Chicago
Pfizer has pledged to communicate all the risks associated with opioids in future ads under an unusual accord it reached with the city of Chicago. Source: Drug Industry Daily
Read More