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Starting this month, active substances found only in medicines authorized at the country level in the EU are subject to centralized review of period safety update reports by the European Medicines Agency. Read More
Biological manufacturers should submit their lot distribution reports (LDRs) using the same electronic messaging standard as those used for drug registration and labeling content of BLAs, says a new draft guidance on LDR electronic submissions. Read More
A federal judge last week denied PhRMA’s request to vacate HHS’s recently modified rule requiring drugmakers to offer steep discounts on some orphan drugs sold to hospitals that serve the poor. In turning down the request, the judge also told the trade group that it must file a new lawsuit to pursue its claims against the department. Read More
Eli Lilly and Takeda Pharmaceuticals have lost their appeal to reverse a combined jury award of $9 billion in punitive damages for hiding bladder cancer risks associated with their diabetes drug Actos, but experts say that verdict will likely be reduced. Read More
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