As part of a series of guidances addressing clinical trial diversity, the U.S. FDA issued a draft guidance April 13 focused on improving enrollment of participants from underrepresented racial and ethnic populations.
The biopharma industry signed on to a new pledge to increase the availability of innovative drugs across the EU and shave months from the time patients in some EU member states must wait for access to new drugs. Members of the European Federation of Pharmaceutical Industries and Associations committed to file for pricing and reimbursement in all EU countries as soon as possible and no later than two years after receiving central EU market authorization – if local systems allow it.
Gilead Sciences Inc. said it is increasing manufacturing capacity to match an anticipated increase in demand for its CAR T-cell therapy, Yescarta (axicabtagene ciloleucel), which gained FDA approval for a wider group of lymphoma patients late last week.
Elix Inc. has teamed up with Shionogi & Co. Ltd. to validate a retrosynthetic analysis model for drug discovery that will employ chemical reaction data from Shionogi to explore various routes to synthesizing new molecules.
Policymakers shouldn’t look to march-in rights as a simple solution to make medical products more affordable, according to experts speaking at an Information Technology & Innovation Foundation discussion on how using the march-in provisions of the Bayh-Dole Act as price controls would threaten America’s research universities.
Leading clinicians in the U.K. have set out a blueprint for integrating pharmacogenomic testing into prescribing in all cases where there is a known association between a gene variant and how an individual will respond – or not – to a particular drug.
When it comes to lowering U.S. drug prices, Congress has a lot of options among the several bills that have been introduced in both the House and Senate over the years. But a deadlock between bipartisan measures and partisan proposals has reduced legislative action to mere talk. The deadlock, and the at times hyperbolic debate, continued in yet another congressional hearing March 16 on “the urgent need to lower drug prices in Medicare,” as the Senate Finance Committee billed it.
The bipartisan PREVENT Pandemics Act, which seeks to put into U.S. law many of the lessons learned from the COVID-19 pandemic, marked its first milestone March 15, with the Senate Health, Education, Labor and Pensions (HELP) Committee sending it to the full Senate with a do-pass recommendation on a 20-2 vote.
2023 may be a pivotal year for biosimilars in the U.S. with a number of approved Humira (adalimumab) biosimilars set for staggered launches under agreements with Abbvie Inc. How successful those launches are, including the launch of Boehringer Ingelheim GmbH’s interchangeable, Cyltezo, and potential other interchangeables, will be determined in large part by three pharmacy benefit managers that together control the prescription drug formularies for nearly 80% of Americans covered by Medicare and private insurance.
There’s nothing like beginning-of-the-year price increases to turn up the heat on the prescription drug pricing debate in the U.S. This year is no exception. Citing a mean price increase of 5.1% on brand drugs in the first 25 days of 2022, 13 Democratic lawmakers, led by Sen. Elizabeth Warren (D-Mass.), wrote this week to Steven Ubl, president and CEO of the Pharmaceutical Research and Manufacturers of America, demanding an explanation for those hikes.
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