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Hikma Pharmaceuticals will launch its gout treatment, Mitigare, after a federal court rejected Takeda’s arguments to block the product, which would compete with Takeda’s drug Colcrys. 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
The European Medicines Agency wants biosimilars makers to use pharmacodynamic markers alongside pharmacokinetic data to demonstrate biosimilarity. Read More
Drugs approved by regulators such as the FDA, European Medicines Agency, Heath Canada and the UK’s Medicines and Healthcare products Regulatory Agency would be deemed approved in Australia with only minimal in-country review under a proposal being pushed by the drug industry. 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