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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
The FDA has asked GSK to restrict its second-line maintenance indication for its ovarian cancer drug Zejula (niraparib) to patients with deleterious or suspected deleterious germline BRCA mutations, maintaining approval for the drug’s first-line indication. Read More
The Federal Trade Commission (FTC) has filed an amicus brief in the U.S. District Court for the District of Delaware arguing that some branded drug manufacturers have a history of using restricted distribution programs to delay the introduction of generic drugs. Read More