While the U.S. House and Senate push forward with controversial legislative packages aimed at making prescription drugs more affordable for Americans, other bills that would impact the biopharma sector are making their own way through Congress, being absorbed into the larger pricing packages or getting tacked on to unrelated legislation.

LONDON – The industry has hit out at a proposal by the U.K.'s opposition Labour party to create a state-owned generic drugs company to supply the National Health Service and to force companies to cut the cost of expensive proprietary products.

Wednesday's House subcommittee hearing on H.R. 3, which tasks Medicare with directly negotiating prescription drug prices in the U.S., may have been an exercise in futility. Although both Republicans and Democrats in Congress still agree that something has to be done to lower drug prices, they are beyond compromise on key aspects of H.R. 3, the Lower Drug Costs Now Act.

The recent FDA approval of Ibsrela (tenapanor), Ardelyx Inc.’s treatment for irritable bowel syndrome with constipation in adults, brings, according to the agency’s data, the number of new molecular entities (NMEs) to 27 this year. With just three months remaining, it appears that the biopharma sector is on pace with the five-year average of about 43 NMEs approved annually. 

Glaxosmithkline plc has won FDA approval to market Nucala (mepolizumab) for use in children as young as 6 with severe eosinophilic asthma (EA). The therapy already had FDA approval as an add-on maintenance treatment for kids with the same condition ages 12 and older. Approval of the sBLA, submitted last November, catches the U.S. market up to the EU, where Nucala has been approved as an add-on treatment for children ages 6 to 17 since August 2018.

Depending on who's talking, the U.S. patent system may, or may not, be in dire need of reform. In a Senate Judiciary subcommittee hearing Wednesday on the bipartisan STRONGER Patents Act, Sen. Chris Coons (D-Del.) stressed the need to undo the precedent set by the Supreme Court's 13-year-old eBay decision that weakened injunctive relief in infringement cases and to resolve some of the unintended consequences of the 2011 America Invents Act (AIA).

SAO PAULO, Brazil – Latin America is following the lead of other developed markets by ramping up its focus on personalized medicine, but there are challenges, including the higher costs of those medicines and a lack of regulations.

There have been studies comparing approval rates of the FDA and the EMA, but an analysis of the scientific basis behind those decisions is difficult.

Drug pricing legislation will be high on the to-do list when the U.S. Congress returns from its August recess next week, as both the Senate and the House are expected to take action this month on competing packages of provisions aimed at controlling prescription drug prices.

SEOUL – South Korea's investors have become very interested in the global cell and gene therapy market. Licensing and M&A deals in the field have been active – a good sign for Korean biopharma firms eager to tap in.