A recent survey revealed that drugmakers are facing some challenges in using the European Medicines Agency’s PRIME program for priority medicines, which recently marked its one-year anniversary. Source: Drug Industry…

The PTO’s Patent Trial and Appeal Board rejected five Mylan challenges to patents held by UCB Pharma and Pfizer covering the overactive bladder treatment Toviaz. Source: Drug Industry Daily

The FDA granted tentative approval for Merck’s Lusduna Nexvue (insulin glargine injection), as a follow-on basal insulin biologic, a product similar to Sanofi’s flagship Lantus treatment. Source: Drug Industry Daily

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended 11 products for new marketing authorizations this month, including five orphan drugs. Source: Drug Industry Daily

Following Hospira’s recall last month of sterile sodium bicarbonate injections, the FDA has extended the expiration dates for more than 90 lots to help alleviate a critical shortage of injectable…

PhRMA and AdvaMed expressed “grave concerns” about the FDA’s final rule clarifying when tobacco products are regulated as medical products, saying that the rule’s altered “intended use” definition is overbroad…

Merck, Pfizer and Corning have teamed up to produce a new pharmaceutical glass packaging that is more resistant to damage. Source: Drug Industry Daily

The Senate Appropriations Committee unanimously approved a bill on Thursday that would provide a total of $5.2 billion for the FDA in fiscal 2018. Source: Drug Industry Daily

The FDA continued its crackdown on supplement companies over drug claims and cGMP violations, warning companies in New York and Alabama. Source: Drug Industry Daily

The European Commission issued a Statement of Objections to Teva over its 2005 “pay-for-delay” deal with Cephalon in which Teva agreed not to market a cheaper generic for Cephalon’s sleep…