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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
The FDA plans to survey 1,500 adult patients to assess how people perceive prescription drug risks in direct-to-consumer television advertisements. Read More
Daiichi Sankyo will pay the federal government $39 million to resolve allegations it used lavish dinners and other kickbacks to persuade physicians to prescribe more of the company’s drugs. 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