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A series of social media posts by reality TV star Kim Kardashian promoting Duchesnay USA’s morning sickness drug landed the company an FDA warning letter because no risk information was included. Read More
Drugmakers in Australia are urging the Therapeutic Goods Administration to raise the number of patients required for classifying an orphan disease, saying it would bring the threshold in line with the EU, Canada and Switzerland. Read More
GlaxoSmithKline, which last year paid Chinese authorities $483 million to settle corruption charges, is facing similar allegations in Romania. Read More
The Indian government is considering establishing a $78 million venture capital fund to offer loans to drug companies that are building or expanding manufacturing facilities. Read More
Drugmakers doing business in India should prepare for price caps on more drugs as the National Pharmaceutical Pricing Authority rushes to complete price fixes on 98 essential drugs. Read More
Manufacturers of influenza vaccines may obtain marketing authorization in the EU based on less-than-comprehensive applications if they supplement their filings with clinical trial data after a pandemic is declared, the European Medicines Agency says. Read More
The European Medicines Agency is launching a 12-month pilot program to improve the usefulness of postmarket safety data by giving drugmakers targeted advice on postmarket study design. Read More