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Amgen is the latest drugmaker caught up in the FDA’s recent flurry of enforcement letters for false or misleading promotional materials. An ad developed by the company for its anemia drug Aranesp omitted risks and inflated efficacy claims, the agency says. Read More
Shortly after Duchesnay received FDA approval for its morning sickness drug Diclegis, the agency says the Canadian drugmaker sent a letter to customers touting the drug’s benefits but none of its risks. Read More
Drugmakers that face multiple disputes with doctors over payments reported to the Centers for Medicaid and Medicare Services (CMS) under the Physician Payment Sunshine Act will likely face an audit by the agency. Read More
Chinese authorities are gearing up to keep the cost of certain drugs sold in the country down via publication of a “low-cost” drug list expected to expand access to generics. Read More
Sanofi has decided to stop pursuing regulatory filing for its blood cancer drug fedratinib after new safety concerns arose from several clinical trials. Read More
Orphan drug incentives, new technology and anxiety over expiring patents have dramatically spurred investment into biotech products, with the number of large molecule, biologic drugs in development tripling over the past decade. Read More
Tamper-evident packaging and registered product trademarks are two features Johnson & Johnson (J&J) employs to minimize a product’s risk of being counterfeited or diverted. Read More
Twenty-five drugmakers have agreed to pay the state of Louisiana more than $88 million to settle Medicaid and Medicare fraud charges lodged against them as part of the state’s continuing crusade to recover funds paid out to drug companies improperly. Read More
In a new “sunshine” bid, Britain’s brand drugmakers will begin disclosing payments made to physicians in connection with the development or sale of medicines, beginning in 2016. Read More
Positive results from the first long-term trial of evolocumab, Amgen’s next-generation heart drug, are heating up the race to develop the emerging class of drugs known as PCSK9 inhibitors. Read More