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European regulators are greatly expanding a public database for reporting suspected adverse drug reactions, adding roughly 1,700 more products to the site, the European Medicines Agency said. Read More
Australian regulators are urging tougher warnings on the cardiovascular risks of over-the-counter non-steroidal anti-inflammatory drugs (NSAIDs), as well as proposing new initiatives to better inform patients about CV risks associated with both the OTC and prescription-based painkillers. Read More
Limiting the concentration of OTC pediatric acetaminophen liquid drugs to 160mg/5mL would mitigate the risk of patients overdosing on the common products to reduce pain and fever, the FDA says. Read More
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 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
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 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