safety data news from FierceBiotech
News
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 Read more...
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 Read more...
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. Read more...
Morphotek licenses anti-cancer antibody
Morphotek has inked a deal with Human Monoclonals International to get rights to a human monoclonal IgM antibody that is specific to a cancer cell surface antigen. The company hopes to develop a lead Read more...
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 Read more...
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 Read more...
Entereg wins key FDA advisory committee vote
The FDA's gastrointestinal drug advisory committee narrowly endorsed Entereg, a new drug Read more...
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 Read more...
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 Read more...
Sirtris causes stir with positive trial data
Sirtris grabbed some headlines at the JP Morgan gathering in San Francisco with its Read more...
Paid Research Reports
- Drug Repositioning Strategies - Serendipity by design
- eHealthInsight Series: Online Patient Recruitment Strategies - Optimizing the clinical trial process
- Pricing & Reimbursement - Seven Major Markets Update
- Innovative Clinical Trial Design and Management: Trends, success stories and impact upon R&D budgets
- The Emerging Role of Postmarketing Clinical Research: Regulatory issues, strategic drivers and overall trends