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2014 will look a lot like 2013 for the pharma industry, analysts say, with patent expirations and cost-containment policies, especially in the EU, depressing revenue growth. Read More
Sponsors of drugs with salt-based active ingredients are urged to follow the United States Pharmacopeia’s (USP) strict naming rules for such drugs, but the FDA may make an exception when the name of the salt contains “vital information” for clinical use, new draft guidance states. Read More
Hot on the heels of Amgen’s state-level campaign to limit dispensation of biosimilars, the biotech is voicing strong opposition to plans by the FDA to allow biosimilars to share the same international non-proprietary name (INN) as the biologic they reference, calling for unique INNs. Read More
India’s Parliamentary Standing Committee on Health and Family Welfare is taking the next step in its effort to regulate the more than 5,000 unapproved fixed dose combination (FDC) products on the market in the country, calling for recommendations from technical experts. Read More
An overhaul of clinical trial regulations in the EU took a big step forward Friday as officials paved the way for revised rules to replace the current clinical trial directive in early 2014. Read More
PhRMA is pushing back against the centerpiece of the FDA’s draft guidance on antibacterial drug development, saying superiority trials for antibacterials that treat drug-resistant infections are “neither routinely possible nor consistently ethical.” Read More