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The decision follows an FDA review of the final overall survival analysis of the phase 3 trial for the drug, which showed no risk reduction compared to the control treatment. Read More
The FDA issued a nine-observation Form 483 to ImprimisRx’s Ledgewood, N.J., facility for unsanitary conditions and other deficiencies observed during a July 11 to Aug. 5 inspection. Read More
Richmond, Va.-based Indivior, maker of the opioid treatment Suboxone (buprenorphine-naloxone), has announced plans to purchase Opiant Pharmaceuticals, a Santa Monica, Calif., producer of the opioid overdose nasal spray Narcan (naloxone), in a deal valued at $145 million. Read More
The Oregon Attorney General has filed a lawsuit accusing four pharmaceutical companies of filing sham lawsuits to prevent competitors from bringing a lower-priced generic version of their drug to market. Read More
Roche and its Genentech subsidiary announced disappointing topline data from twin phase 3 trials of their antiamyloid antibody, gantenerumab, for treating Alzheimer’s. Read More
Appco Pharma’s Piscataway, N.J. generic drug manufacturing facility was dinged by the FDA for lacking temperature and humidity records for some equipment and other documentation lapses listed in a five-observation Form 483 following an Aug. 8-19 inspection. Read More
In response to requests for a later deadline, the FDA has granted more time to comment on a pair of long-awaited proposed rules on institutional review board (IRB) reviews and informed consent requirements for clinical trials, pushing back the deadline until Dec. 28. Read More