We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
In a preview of how the U.S. Food and Drug Administration’s new Office of Pharmaceutical Quality will speed generic drug approvals, the office is rolling out a framework for filers of abbreviated new drug applications to respond to minor queries regarding chemistry, manufacturing and control early in the review cycle. Read More
An updated FDA guide on electronically submitting clinical study data, released last month, clarifies a number of requirements for preparing data sets and reviewers’ guides. Read More
The UK’s health cost-benefit watchdog is recommending Gilead Sciences’ blockbuster hepatitis C cure, Sovaldi, be offered through the National Health Service to patients with three additional types of hepatitis C beginning in July. Read More
Global drug regulators have reduced drug approval times over the last 10 years, and while the FDA remains the fastest at approving new drugs, other regulators are closing the gap. Read More
Tekmira Pharmaceuticals is merging with OnCore BioPharma in an effort to develop a cure for hepatitis B and corner a potentially lucrative market. Read More
Dendreon has not demonstrated that its prostate cancer drug Provenge provides enough benefit over less expensive drugs to justify reimbursement, UK healthcare cost watchdog said this week. Read More
Beginning yesterday, all NDAs will undergo a risk assessment by a team of FDA reviewers that will follow the drug from preapproval through manufacturing and into any eventual generic forms in an effort to ensure quality throughout a product’s lifecycle. Read More
Shire will pay $5.2 billion to acquire rare disease manufacturer NPS Pharma, the latest acquisition aimed at boosting the Irish drugmaker’s rare disease portfolio. Read More