By Kate Rawson
Pfizer Inc
The world’s best-selling prescription drug is about to lose patent protection, presenting generic drug companies with their biggest marketing opportunity ever. But potential fraud by first-filer Ranbaxy is complicating the generic landscape for Pfizer’s Lipitor. The stakes are high: How FDA resolves the Ranbaxy debacle will not only determine the winners of the Lipitor battle, but could drive big changes to the generic drug law.
By Kate Rawson
Pfizer Inc
Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
Decision in AstraZeneca’s lawsuit against the Health and Human Services Department is a precedent-setting victory for the government and a blow to manufacturer efforts to block the price negotiation program.
Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.