We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
A House bill would for the first time require drugmakers to create and disclose an expanded access policy in exchange for receiving breakthrough therapy designation, redeeming a priority review voucher or having the drug become a qualified infectious disease product. Read More
The FDA is proposing revisions to an adverse events reporting form that includes for the first time a section for large compounders to submit events. Read More
The FDA plans to consolidate its 16 districts overseeing pharmaceuticals imports into either four or five districts under a reorganization plan that aims to make inspection policies and procedures more uniform regardless of port of entry. Read More
Pfizer’s blockbuster arthritis pain drug Celebrex is facing generic competition for the first time after Teva, Mylan and Actavis launched versions Wednesday. Read More
GPhA is pushing for more states to pass automatic biosimilar substitution laws next year using draft language that eliminates requirements to notify prescribers of a swap with the brand. Read More
European regulators have approved AstraZeneca and Nektar Therapeutics’ opioid-induced constipation drug Moventig for adults that have not responded to laxatives. Read More
Manufacturers of therapies in Japan that combine drugs with either a medical device or a cellular or tissue-based product must determine which category it falls under before filing a marketing application, according to a revised regulation. Read More
Ebola vaccine manufacturers Janssen, GlaxoSmithKline and NewLink Genetics will be sheltered from legal liability under a law that protects companies that produce treatments to combat public health emergencies, HHS said yesterday. Read More
Starting next year, pharmaceutical wholesale distributors must submit annual reports that include detailed contact and state licensure information as well as any significant disciplinary actions taken by state or federal officials, the FDA says. Read More
Brand drugmakers in Europe are calling on the European Commission to implement a system to help resolve patent disputes before the launch of a generic drug, a move they say would address inefficiencies in the current patent litigation system. Read More