Some researchers at Yale want the world to know that there is no firm FDA standard for proving whether a drug is safe and effective--and they see that as a serious problem that needs to be addressed.
With the FDA's all-clear under its belt, AMRI's once-troubled Burlington, MA, "money pit" is poised to push the Albany, NY, company into new markets, the company's new CEO reportedly told investors at the J.P. Morgan Healthcare Conference last week. The former Teva executive said he's eyeing generics and high-tech drug delivery among potential expansion areas.
Last year, Ariad Pharmaceuticals watched more than $2.5 billion melt off its market cap when the cancer-fighting Iclusig began a downward spiral that would eventually remove it from the market. But now begins the rebuilding project, as the Cambridge, MA, drugmaker has relaunched its sole product with a lot of ground to make up.
Merck's Liptruzet has only been on the market since last May, but it will soon be unavailable. The drugmaker is asking wholesalers to return all lots they have because a potential packaging leak could affect its potency.
Shares of Catalyst Pharmaceutical Partners got a boost from the news that its late-stage drug Firdapse had passed a cardio safety test.
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.