Rough times continued Friday at Arbutus Biopharma Corp. as it discontinued clinical development of AB-506, an oral capsid inhibitor, which is in a clinical trial for treating chronic hepatitis B. The decision was made when two healthy volunteers were found to have acute hepatitis.

LONDON – The U.K. government has placed an immediate ban on the export of certain drugs in a bid to prevent wholesalers taking advantage of the fall in the value of the pound against the euro by selling off U.K. stockpiles that have been built up to protect against an interruption in supplies in event of a no-deal Brexit.

Following a speech that seemed more campaign rhetoric than policy, President Donald Trump signed an executive order Thursday that's his answer to the Democrats' proposed Medicare for All Act.

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.