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Efforts by generic drugmakers to initiate patent litigation early by sending premature Paragraph IV certification notices to innovators are prompting the FDA to crack down on the practice, though it’s not yet clear what actions the agency intends to take. Read More
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is proposing three rules changes to reduce the amount of information included in physician advertising. Read More
Novo Nordisk has aced the first Phase III trial of its hemophilia candidate, giving the drugmaker a needed boost in a tight race with two other competitors vying to be first to market with a new therapy targeting a disease the FDA says demands industry attention. Read More
The Arkansas Supreme Court reversed a $1.2 billion verdict against Johnson & Johnson concerning its marketing practices for the antipsychotic Risperdal, giving the pharma giant another crucial legal victory. Read More
European drugmakers can expect a more globalized European Medicines Agency, according to the regulator’s 2014 work program, which includes an increase in joint inspections with international counterparts, improving the agency’s support for companies in early-stage drug development and completing the rollout of the massive new pharmacovigilance requirements begun in 2012. Read More
The exodus of U.S. drugmakers to Ireland continues as Horizon Pharma Wednesday bought Vidara Therapeutics and pledged to move the combined company to Ireland to take advantage of the country’s low corporate tax rate. Read More
The European Medicines Agency (EMA) has launched a new pilot program intended to speed new therapies to patients via a process that authorizes products for use by targeted populations in stages. Read More
Japanese drugmakers Astellas Pharma and Daiichi Sankyo are planning to form the first-ever large-scale compound library, through which they plan to share 400,000 compounds. Read More
India will no longer allow the importation of drugs that have used up more than 40 percent of their shelf life, the Central Drugs Standard Control Organization said Feb. 13. Read More