Tag:
safety data
Latest Headlines
Latest Headlines
Portal centralizes cardiac study data
In another development for drug researchers, biopharma technology and service provider ERT has launched an online interface called My Study Portal, aimed at enhancing cardiac safety data management
FDA OKs Adolor's Entereg in first approval
Exton, PA-based Adolor hit a major milestone with the FDA's approval of Entereg for postoperative ileus, a common condition following surgery that can extend a patient's hospital stay. This is the
FDA delays Entereg decision
GlaxoSmithKline and Adolor's seemingly never-ending effort to win approval for Entereg has hit yet another delay. The FDA informed the companies that it would not make a decision by Saturday, the
GSK buys Sirtris for $720M
GlaxoSmithKline is acquiring Cambridge, MA-based Sirtris Pharmaceuticals for $720 million. GSK will pay $22.50 per share for the company--an 84 percent premium to Sirtris's closing price Tuesday.
Prana shares soar on IIa Alzheimer's data
Positive efficacy and safety data from a Phase IIa study of an experimental Alzheimer's treatment from Australia's Prana Biotechnology sent its shares soaring more than 50 percent yesterday. The
GSK, Adolor face another Entereg delay
The FDA has told Adolor and GSK that it will take three more months to review Entereg, a anti-constipation drug candidate. The agency is now expected to announce its decision on May 10. Recently, an
Entereg wins key FDA advisory committee vote
The FDA's gastrointestinal drug advisory committee narrowly endorsed Entereg , a new drug
YM shares hit on clinical trial hold
Canada's YM BioSciences saw its stock take a nasty hit after it announced that the FDA had put a mid-stage trial of its AeroLEF pain therapy on hold as it seeks safety data on volunteers in earlier
FDA wants time to ponder Progenics, Wyeth drug
Regulators have tacked on an additional three months of review time for subcutaneous methylnaltrexone--being developed by Wyeth and Progenics--so it can take more time to review safety data on the
Sirtris causes stir with positive trial data
Sirtris grabbed some headlines at the JP Morgan gathering in San Francisco with its
