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The FDA has issued a preliminary list of 20 disease targets under an initiative to spur drugmakers to include patient perspectives earlier in the drug development process. 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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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
The UK’s healthcare cost watchdog has recommended against covering Roche’s leukemia drug Gazyvaro for chronic lymphocytic leukemia (CLL) patients who are ineligible for fludarabine-based therapy. Read More
Better postmarket surveillance of generic drugs and a greater understanding of the bioequivalence of hard-to-compare products will top the FDA’s regulatory science priorities under GDUFA in the new fiscal year, the agency said. Read More