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Unauthorized knock-offs of Gilead’s pricey blockbuster hepatitis C therapy, Sovaldi, may soon hit the market in India after the government refused to grant it patent protection. Read More
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
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
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
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
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
Drugmaker Eisai says it is outraged by NHS England’s decision to remove its cancer therapy Halaven from a special fund that reimburses cancer drugs not considered cost-effective by the UK’s pricing watchdog. Read More
Manufacturers developing biosimilars in Europe want regulators to go back to comparing their therapies with the reference product based on the actual amount of active ingredient in a dose rather than a proposed standard that compares dosages and routes of administration. Read More