Empagliflozin

The companies estimated that the combined upfront, license and milestone payments heading Variant’s way could potentially exceed $120 million.\n Boehringer Ingelheim has unveiled its second kidney-focused collaboration in recent weeks, this time penning a deal worth over $120 million biobucks with genomics-focused Variant Bio.The alliance will harness Variant’s AI-powered Inference platform to discover and validate new targets for cardiorenal and kidney disease. Variant touts the platform as a way to integrate genomic, deep phenotyping and multiomic data from studies spanning global populations.Boehringer’s bold ambition for the collaboration is to “accelerate the discovery of transformative therapies—turning genetic insights into real-world impact for millions of people living with kidney disease.”The companies didn’t break down the specific financials of the deal, beyond estimating that the combined upfront, license and milestone payments heading Variant’s way could potentially exceed $120 million.“This strategic partnership with Boehringer Ingelheim marks another key milestone for Variant Bio and demonstrates the power of our Inference platform,” said Variant CEO Andrew Farnum.“Combining our AI-driven discovery engine and unique data resources with Boehringer Ingelheim\'s unparalleled expertise in cardiovascular and renal conditions gives us an exceptional opportunity to make a real difference for patients with kidney disease,” Farnum added.Other pharmas have also spied the potential in Variant’s approach. A year ago, Novo Nordisk inked a multiyear research pact to better understand the genetics underlying metabolic diseases across diverse populations. The deal with Variant comes weeks after Boehringer signed another kidney-focused collaboration, offering Rectify Pharmaceuticals up to $448 million to partner on a preclinical program. Boehringer already co-markets Jardiance, which won approval in chronic kidney disease (CKD) in 2023, with Eli Lilly. The German drugmaker is also active in CKD drug development, with a study of the aldosterone synthase inhibitor vicadrostat among its roster of phase 3 trials. 

Just days before the US Health Resources and Services Administration (HRSA) was set to launch a pilot evaluating a rebate-based model of the 340B discount programme, its rollout has been blocked by a federal judge.The American Hospital Association (AHA), along with the Maine Hospital Association and four safety-net hospitals, filed suit at the beginning of December to block the pilot's Jan. 1, 2026 launch, arguing that a rebate system "would inflict hundreds of millions of dollars’ worth of annual costs on hospitals." Judge Lance Walker of the US District Court for the District of Maine sided with the plaintiffs on Monday, issuing an injunction against the pilot as its "economic impact and disruption to services is substantial and… sufficient to demonstrate irreparable injury."Rebate pushCurrently, 340B-eligible hospitals — which serve uninsured and low-income patients — receive significant discounts on drugs upfront, but drugmakers have argued that the programme is rife with abuse, and that large hospital systems exploit the discounts by inflating prices for both uninsured patients and insurers. And for drugs set to debut lower Medicare prices next year thanks to negotiations under the Inflation Reduction Act (IRA), pharmaceutical companies are concerned their products may be subjected to duplicative price concessions if they are also purchased at the 340B price. To avoid potential abuse and "double-dipping," several pharmas, including Johnson & Johnson, Eli Lilly and Bristol Myers Squibb have pushed to adopt a model where hospitals would be required to pay the full amount of a drug upfront, then file for a rebate afterwards. Though their efforts to move to a rebate model were initially rebuffed, HRSA announced in July it would launch a pilot programme "to test…in a methodical and thoughtful approach…a fair and transparent 340B rebate model process." In October, nine therapeutics were accepted for the pilot, including three from J&J: Stelara (ustekinumab), an IL-12/IL-23 inhibitor approved for several autoimmune diseases; oral anticoagulant Xarelto (rivaroxaban); and blood cancer treatment Imbruvica (ibrutinib), which it co-commercialises with AbbVie. Other pilot participants include BMS's anticoagulant Eliquis (apixaban), Boehringer Ingelheim and Eli Lilly's diabetes and heart failure treatment Jardiance (empagliflozin), Merck & Co.'s diabetes drug Januvia (sitagliptin), Novo Nordisk's NovoLog family of insulin products, AstraZeneca's diabetes drug Farxiga (dapagliflozin), and Amgen's Enbrel (etanercept), which is used to treat chronic inflammatory diseases such as rheumatoid arthritis, psoriasis, psoriatic arthritis, ankylosing spondylitis and juvenile idiopathic arthritis. Each product selected for the 340B rebate model pilot was also part of the first round of Medicare price negotiations, which is also set to go into effect on Jan. 1, 2026.'Fatal' errorWhile the Administrative Procedure Act (APA) provides a pathway for US agencies to launch new programmes, it requires that the same be "reasonable and reasonably explained," with an agency tasked with keeping a "record of the relevant factors it considered and…a reasoned explanation for its course of action."However, Walker found that HRSA's rebate pilot did not meet these "vanishingly minimal requirements.""The Agency’s roll out has involved a rather threadbare administrative record that likely fails to consider and reasonably explain the impact of a rebate model on 340B hospitals, who rely on upfront price concessions to stretch few resources as far as possible to serve rural and poor communities," he wrote in his ruling. In the suit, AHA claimed that a rebate model would "impose vast administrative costs to submit, track, recover, and potentially dispute the rebates," while also draining hospitals "of huge sums of money through payments to drug companies that the hospitals then must wait to have refunded," and which drugmakers "have every incentive to slow and stymie the issuance of rebates." Walker took issue with the fact that HRSA is still evaluating administrative costs of its pilot. "This failure to consider administrative costs before approving the manufacturers’ applications under the Rebate Program is fatal under the APA," he concluded. "Defendants cannot fly the plane before they build it."