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Within two years, the FDA will begin assigning all facility inspections to specialized teams that have detailed expertise in the lifecycle of the particular drug that is subject to inspection. Read More
A Pennsylvania jury last week ruled that Takeda must pay more than $2 million for downplaying bladder cancer risks of its diabetes drug Actos, a verdict one legal expert believes could embolden other plaintiffs to move forward with their lawsuits. Read More
A European biotech association is calling on the European Union to develop policies addressing inconsistencies in the labeling and naming of biosimilars as a way to enhance the monitoring and acceptance of the growing body of products. Read More
The English government is considering halting reimbursement on costly cancer drugs, which officials concede could restrict patients from receiving certain treatments. Read More
Drugmakers seeking accelerated approval of a presurgical treatment for high-risk, early-stage breast cancer may consider conducting multiple trials rather than a traditional single trial, according to a new FDA guidance that aims to give sponsors an earlier indication as to the success of a drug candidate. Read More
A federal judge has dismissed to a local court a lawsuit alleging AstraZeneca negotiated illegal pay-for-delay settlements with generic firms to keep versions of its heartburn drug Nexium off the market.
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FDA investigators and their European counterparts are comparing training and auditing procedures as the first steps in a new push to increase mutual reliance on each other’s inspections. Read More
A pair of lawmakers has launched a congressional investigation into dramatic price increases on some generic drugs, but GPhA dismisses the scrutiny as being so narrowly focused that it misses the overall savings from the industry as a whole. Read More
The Indian government is mulling a proposal from a research institute to launch an online registry of foreign and domestic drugs that would improve transparency and knowledge of distributed drugs. Read More
Branded drugmakers have expressed guarded optimism at the announcement of high-level intellectual property talks between the U.S. and India, hoping the discussions will resolve long-standing worries over a lack of effective patent protection by the Indian government. Read More