On 16 April 2010, Oracle said that it had agreed to buy the drug data management software company Phase Forward for about $685 million in a deal aimed at bolstering its health sciences business
Oracle will pay Phase Forward’s shareholders $17 a share in cash, the companies said, a 30 percent premium over Thursday’s closing price of $13.08.
The deal is expected to close in mid-2010. Oracle said the combination of the companies’ software will enable researchers, physicians, and clinical development professionals to contribute and share data more efficiently.
Phase Forward’s data management software is used by companies including AstraZeneca and Boston Scientific in clinical trials for drug development and patient care.
- Form for non-clinical and clinical studies proposed in a PIP application, Human Medicines, Scientific Guidelines - Medicines for children - Guidance for applicants
- Draft Guideline on clinical investigation of medicinal products in the treatment of diabetes mellitus, Human Medicines, Scientific Guidelines - Clinical Efficacy and Safety
- Overview of comments received on draft guideline on the investigation of bioequivalence, Human Medicines, Scientific Guidelines - Clinical Efficacy and Safety
- Guideline on Clinical Investigation of Medicinal Products used in the treatment of Osteoarthritis, Human Medicines, Scientific Guidelines - Clinical Efficacy and Safety
- Overview of comments received on above draft guideline on clinical investigation of medicinal products used in the treatment of osteoarthritis, Human Medicines, Scientific Guidelines - Clinical Efficacy and Safety
- Concept paper on the need for revision of the points to consider on the Clinical Investigation of Medicinal products other than Nsaids in Rheumatoid Arthritis, Human Medicines, Scientific guidelines - Clinical Efficacy & Safety
January 29, 2010: Guidance for Industry
More FDA news:
- Center for Drug Evaluation and Research News (CDER)
- Center for Biologics Evaluation and Research News (CBER)
