CER Daily Newsfeed

Safety Data on Dupilumab, Ensifentrine for COPD, with MeiLan Han, MD

(11/19, Tim Smith, HCPLive) reports “...Ensifentrine, an inhaled medication, has fewer gastrointestinal side effects compared to roflumilast, improving patient tolerance.” Full

Under-the-Skin Keytruda Comparable to Infused Version in Phase 3 Study, Merck Says

(11/19, Jonathan Gardner, Biopharma Dive) reports “An experimental under-the-skin injection of Merck & Co.’s cancer immunotherapy Keytruda showed similar characteristics as the current intravenous formulation in a Phase 3 clinical trial, the company said Tuesday.” Full

Draft Part D Rule Could Hand Trump Quick Way To Reshape IRA Drug Negotiation Policies

(11/15, Maaisha Osman, InsideHealthPolicy) reports “Biden’s CMS is trying to use a draft prescription drug benefit rule pending at the White House to clarify and codify how it implements the Inflation Reduction Act drug-price controls, but the rule could end up giving the incoming Trump administration a way to quickly shape its own Medicare drug price negotiation policies...The pending rule, which also includes Medicare Advantage, Medicare cost plan programs and PACE policies, is raising concerns it could be treated as a ‘midnight’ rule allowing the Trump administration to insert its own policies before finalizing the rule.” Subscription Required

England's NICE Turns Down Cancer Drug Enhertu—Again—Amid Pricing Stalemate with AZ, Daiichi Sankyo

(11/19, Fraiser Kansteiner, Fierce Pharma) reports “...Talks with AZ and Daiichi to negotiate a fair price for Enhertu for treatment of advanced HER2-low breast cancer in the U.K. have ‘ended without agreement,’ the country’s National Institute for Health and Care Excellence said in a media statement Tuesday. As a result, the agency’s decision not to recommend AZ and Daiichi’s cancer-fighting antibody will remain in place.” Full