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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
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
Mylan and Abbott have submitted proposed commitments to the European Commission’s competition oversight body to allay anti-competitive concerns over a proposed merger that would reincorporate Mylan in the Netherlands. 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
India’s drug pricing authority wants manufacturers of fixed-dose combination products that are less than four years old to confirm that the products have been approved and are not prohibited under the country’s drug laws. Read More
The FDA last month warned a Chinese active pharmaceutical ingredient (API) maker for data integrity violations, marking the agency’s 13th warning letter to cite data integrity out of 18 overall warnings released in 2014 for quality violations. Read More
With the FDA stepping up scrutiny of data integrity during facility inspections, drugmakers must be ready to answer tough questions about their electronic record system, an inspections expert said. Read More