FDA and clinical reviews have not found the chances of bleeding to be any greater for Boehringer Ingelheim's Pradaxa than for warfarin, but it continues to top the list for adverse reaction reports, and the FDA has decided to do another data dive into how the two compare.
Chinese regulators do not posses a sterling reputation in their home country, having been caught unprepared as one health scare after another has panicked the population. So when reports began surfacing that children were dying from hepatitis B vaccinations, drug and health regulators sprang into action, launching a probe and putting a hold on millions of doses from the leading hep B vaccine maker.
China, which has been trying to demonstrate adequate oversight of its growing drug industry, is investigating two of its key vaccinemakers after the deaths of 8 children were tied to their hepatitis B vaccines.
Ariad Pharmaceuticals is back in the market with Iclusig. The FDA is allowing the Cambridge, MA-based company to again sell the leukemia drug, but with tighter restrictions to face. Ariad has a lot of ground to regain to return to its former glory.
After agreeing this month to allow the U.S. FDA to send more people there so it can boost its oversight of drug production, Chinese authorities this weekend reported rounding up 1,300 suspected counterfeiters and confiscating $362 million worth of fake drugs and raw materials.
The FDA approved a powerful new painkiller from Zogenix despite opposition from its own advisory panel. Now, attorneys general from 28 states have jumped in to ask the agency to reconsider.
It's well-documented that antibiotic resistance is a growing public health threat. Drug-resistant bacteria infect about 2 million Americans a year, causing at least 23,000 deaths, according to CDC data. Now, to keep resistance from mounting, the FDA is rolling out a plan to cut down on antibiotics use in livestock, enlisting the drugs' producers--companies like Eli Lilly and Zoetis--to help them do it.
AstraZeneca and Bristol-Myers Squibb are heading back to the FDA with the once-spurned dapagliflozin, claiming they've addressed the diabetes drug's cancer risks, but agency staff remains wary of the novel treatment's dangers.
The pharma giant is recruiting new patients while expanding the program with a new Phase III study for early-stage patients--without changing the dosing regimen.
With the American Society of Hematology meeting in New Orleans, a slew of blood cancer studies are in the spotlight. Three of the releases caught our eye, because they're significant new data on drugs already on the market.