Drug sponsors may not have to prove that a proposed medicine-assisted therapy helps addicts completely kick opioids but they will have to detail how well it helps cut dependence to…
Endo Pharmaceuticals has settled with the state of Texas for $13.25 million over allegations of illegal marketing for its drug Lidoderm (lidocaine). Source: Drug Industry Daily
In response to investor concern, the board of Cardinal Health announced on Thursday action it has taken to strengthen its anti-diversion tactics and accountability related to the opioid crisis. Source:…
Allergan opened a new front in the intensifying legal fight over the opioid crisis, suing Pfizer last week to cover any damages the former might incur in hundreds of lawsuits…
The House Energy and Commerce Committee this week sent letters to three major pharmaceutical manufacturers demanding information on the role they may have played in helping trigger the opioid epidemic.…
The New Civil Liberties Alliance (NCLA) filed a petition asking the FDA to stop using ‘improper” agency guidance to impose obligations on drugmakers and instead issue clear rules and notice-and-comment…
Multi-district litigation over Roche’s anti-acne drug Accutane (Isotretinoin) hit a wall this week when the New Jersey Supreme Court ruled against allowing certain expert testimony. Source: Drug Industry Daily
The European Medicines Agency said Wednesday it needs to scale back or suspend more activities, blaming Brexit for staff reductions that are disrupting its ability to function. Source: Drug Industry…
The FDA hit Akorn with a lengthy Form 483 with 13 observations for failing to properly safeguard against microbiological contamination and to monitor conditions in aseptic processing areas following April/May…
A federal court ruled Pfizer can continue to market its biosimilar for Johnson & Johnson’s immunosuppressant drug Remicade (infliximab). Source: Drug Industry Daily