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FDA officials sought to clear up questions about what standards the agency will apply when approving biosimilars, emphasizing that manufacturers must prove their products are “highly similar” to the reference product in order to win a green light. 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
Bristol-Myers Squibb has withdrawn its NDA for a hepatitis C combination drug of Daclinza and asunaprevir, citing concerns of an insufficient target population. Read More
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