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A federal judge has ordered Reckitt Benckiser to release documents the company wanted to suppress in an ongoing FTC probe into allegations the company illegally delayed generic competition to its opioid-dependence treatment Suboxone. Read More
The FDA has won a consent decree against a Texas compounder barring the company, Specialty Compounding, from producing and selling sterile drugs until it fixes manufacturing quality deficiencies that led to past reports of bacterial contamination of its products. Read More
With the FDA beginning to approve biosimilars, the next major hurdle for the emerging sector will be in the courts, where brandmakers and would-be competitors are arguing over how they will approach patent infringement lawsuits, especially when it comes to sensitive manufacturing data. Read More
The FDA Tuesday outlined new deadlines and procedures for the way drugmakers seek and conduct meetings with the agency before and during reviews of new product submissions. Read More
The FDA has warned a French drugmaker for data integrity issues related to the production of active pharmaceutical ingredients at its Thailand manufacturing plant. Read More
Spanish regulators are investigating Pfizer sales contracts for possible anticompetitive conduct, following a Supreme Court ruling in November that the drugmaker’s dual-pricing contracts could restrict parallel trade in the EU. Read More
Sponsors of brand, generic and biosimilar drugs applying for marketing authorization through the EU’s centralized procedure must begin including facility inspection information in their applications. Read More
The FDA is warning that Pfizer’s Chantix smoking-cessation aid may cause seizures or, when taken with alcohol, lead to unusual or aggressive behavior. Read More