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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
Hospira has submitted a BLA for anemia drug Retacrit, a proposed biosimilar to Amgen's Epogen and Janssen's Procrit — making it the fourth company to announce submission of a biosimilar application to the FDA. Read More
The European Medicines Agency approved a record number of orphan drugs in 2014, a milestone it says is likely due to increasing early collaboration with sponsors. Read More
The FDA last week approved Daiichi Sankyo’s new blood thinner to treat certain atrial fibrillation patients based on findings the drug is safer than current treatment warfarin. Read More