Drugmakers received the first slice of FDA social media guidance in January, and now the FDA's mailbag is filling up with letters on First Amendment protections, "jurisdictional creep" and other topics from the likes of Pfizer and PhRMA.
Just over a month into its search for "strategic options," ThromboGenics has rounded up a bevy of high-dollar offers that could value the company at as much as $1.3 billion, Bloomberg reports, courted by drugmakers who see promise in its underperforming eye drug.
A contractor has tripped up Shire, which is voluntarily recalling three lots of its Gaucher drug Vpriv after finding stainless steel particulate in a small number of vials of the injected drug. The drugmaker said the problem was traced to the company handling the fill finish for Shire.
Shire is voluntarily recalling three lots of its Gaucher drug Vpriv but emphasized that it does not expect any supply interruption from the recall. Shire has promoted its drug's availability as an indirect selling point against a rival product from Genzyme that ran into supply issues 5 years--a problem the company has long since remedied.
Texas oral drug delivery specialist Neos Therapeutics pulled in $15.5 million in a Series C round of financing to help propel its line of ADHD controlled-release treatments to the market.
Since last August, when the Physician Payments Sunshine Act went into effect, drugmakers and devicemakers have been logging everything they've paid out to doctors. Now, it's finally time to report all those numbers to the Centers for Medicare & Medicaid Services.
Shire has garnered FDA approval to make its orphan drug Vpriv at a plant in Lexington, MA. That means it now has approval at two plants in the U.S. to manufacture the treatment for type 1 Gaucher disease.
Shire CEO Flemming Ornskov has introduced a host of changes at the Ireland-based drugmaker since taking up the reins almost a year ago--and so far, they seem to be paying off. On Thursday, the company announced fourth-quarter earnings that handily beat market forecasts and predicted that growth will build in the year to come.
There's movement at the top of Shire. With CEO Flemming Ornskov about a year into his job, the specialty drugmaker has tapped Susan Kilsby to be its new chairman. She will replace Matthew Emmens, Shire's former CEO and chairman since 2008, who is retiring.
Market rumors about a possible biotech buyout are usually triggered by research and marketing success. In Ariad's case, mere survival sufficed.