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The European Medicines Agency has lent its support to an initiative to qualify biomarkers that can provide an early warning on an investigational compound’s risks of causing drug-induced kidney injuries, an endorsement that researchers say is necessary to move to the next phase of development. Read More
The FDA has cited Cadila Pharmaceuticals for poor data integrity practices and sloppy investigations into foul smelling batches of active pharmaceutical ingredients (APIs), violations that the agency threatened could result in an import alert. Read More
Drugmakers can now access all regulatory advice on regenerative medicines in the UK through a single web portal, thanks to a government initiative launched Oct. 13. Read More
The Australian government plans fast-track approvals and joint drug reviews with other countries, following an independent review aimed at making the drug approval process less redundant and easier to understand. Read More
Australia’s medicines authority is urging tougher warnings on the cardiovascular risks of over-the-counter nonsteroidal anti-inflammatory drugs, as well as new initiatives to inform patients about the risks associated with both OTC and prescription versions of the painkillers. Read More
Access to a forthcoming clinical trials portal and database would be limited to authorized users and “super users,” under draft specifications released by the European Medicines Agency.
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European biotech companies are calling on the European Commission to address inconsistencies in the labeling and naming of biosimilars as a way to enhance monitoring and acceptance of the rapidly growing product sector. Read More
The Indian government is mulling a proposal from a local research institute to launch an online registry of foreign and domestic drugs with the aim of improving transparency about the country’s medicines supply. Read More
India’s Central Drugs Standard Control Organization is establishing a panel of experts to review existing forms and procedures and recommend ways to shorten and simplify the drug application process. Read More
The Office of the U.S. Trade Representative is conducting a review of India’s intellectual property regime that focuses in large part on pharma IP issues, including access to affordable medicines. Read More
Pharmaceutical intellectual property rights remain a significant sticking point in a proposed draft of the massive Trans-Pacific Partnership trade pact leaked in October. Read More
Oversight of the EU’s medicines policy will remain under the health directorate, in an about face from plans, announced in September, to shift responsibility to the industry directorate. Read More