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The Therapeutic Goods Administration is looking to Europe for guidance on drug development, including clinical development of biosimilar drugs, investigations of lipid disorder therapies and evaluations of bacterial infections. Read More
A former FDA employee plans to press forward with efforts to remove Lasik eye surgery devices from the market following the agency’s denial of his citizen petition seeking the ban. Read More
Boehringer Ingelheim and Eli Lilly’s type 2 diabetes drug Jardiance has received a preliminary thumbs-down from the UK’s healthcare cost watchdog, which wants to see more cost-effectiveness data comparing the new product with other existing treatments. Read More
Drugmakers operating in Brazil must report all supply chain movements to regulatory authorities in real time, according a new guidance on the country’s drug tracking and tracing system. Read More
Canadian generics maker Apotex has lost a $520 million lawsuit the company brought in front of an international arbitration board against the FDA over import alerts on two of its facilities. Read More
Australia’s main pharma lobby is proposing changes in how its members report gifts to healthcare professionals, but at least one industry expert says the plan’s fine print would allow doctors to opt out. Read More
Drugmakers should consider the effects of price harmonization in the Persian Gulf region when deciding where to launch their products in the global marketplace, a new report concludes. Read More
India’s National Pharmaceutical Pricing Authority asked six manufacturers of generic cancer drugs to submit pricing data in advance of its setting price caps on the products, a move that one industry observer says was expected. Read More
Starting next year, drug companies seeking to market products in Canada will need to provide the regulatory authority with information on proposed names, labels and packages.
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The French National Assembly last month approved a proposal that would allow doctors to use less expensive off-label drugs even if an approved therapy exists — sparking cries from European drugmakers that the government is placing cost savings over patient safety. Read More
Drugmakers are praising a decision by Ireland’s Health Products Regulatory Authority to allow as many as three dozen drugs to be sold through pharmacies without a prescription. Read More
The European Medicines Agency acted properly in rejecting a UK-based pharmaceutical company’s over-the-counter migraine medicine, the European ombudsman says. Read More