Pelosi aims for feds to negotiate drug prices, even for private insurers

fiercepharma | July 01, 2019

As House Democrats hash out a proposal empowering the federal governments top health official to negotiate lower drug prices, House Speaker Nancy Pelosi is taking it a step further and pushing a plan that could benefit even those Americans with private health insurance. A draft plan spearheaded but not yet released by Pelosi and other House Democratic leaders would ensure that prices negotiated on the most expensive drugs would apply not only to the government but to all payers, including employers and insurers, a Democratic aide said. But first, Democrats must agree on how best to muscle drug companies to the negotiating table, as well as how to prevent Americans from paying more or even losing access to the other drugs they take. Pelosi has faced pressure from progressive House Democrats, who have pushed for a more aggressive approach, including opening up all drugs to negotiations. However bold a plan Democrats produce, any proposal to invite the federal government into price negotiations looks doomed in the Republican-controlled Senate, where GOP leaders have said they will not let it advance. That means the fight over whether the government should cut deals with drugmakers is likely to play out on the members’ 2020 election campaign trails, rather than in the halls of Congress. Democrats could again try to tar Republicans as indifferent to the struggles of Americans who cannot afford healthcare while promoting their own attempts to fulfill 2018 campaign promises to address skyrocketing drug prices.

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PHARMACY MARKET, PHARMA TECH

Jazz Pharmaceuticals Maintains Exclusive Rights to Develop and Sell Zymeworks' Zanidatamab

Jazz Pharmaceuticals plc and Zymeworks Inc. | December 28, 2022

Jazz Pharmaceuticals plc and Zymeworks Inc. recently informed that the former has chosen to keep its exclusive rights to develop and sell Zymeworks' Zanidatamab in key markets, such as the U.S., Europe, and Japan, as part of the license and collaboration agreement made in October 2022. A pivotal trial in previously treated HER2-amplified biliary tract tumors (BTC) found that 41.3% (95% CI: 30.4, 52.8) of recruited patients with HER2-amplified and expressing (IHC2+ and 3+) illness achieved an objective response as judged by independent central review. The median response length was 12.9 months (95% CI: 5.95 to not attained). In this trial, Zanidatamab's safety profile was similar to what had been found in previous studies of monotherapy, while no new safety signals were found. Jazz Pharmaceuticals stated that the compelling top-line clinical data from the pivotal study in patients with BTC demonstrated the transformative potential of Zanidatamab. This big win gives the company more confidence that it can make this medicine better for cancer patients who have big unmet needs. Even though its main focus will be on the ongoing clinical trials for BTC and GEA, these data will add to the growing amount of evidence that Zanidatamab is effective against a wide range of HER2-expressing cancers. Zymeworks expressed that the collaboration with Jazz is going well, which will speed up the global development of Zanidatamab in many types of cancer and may give patients with hard-to-treat cancers and few treatment options access to a basic HER2-targeted drug. Jazz will pay Zymeworks $325 million to exercise its option to develop and sell Zanidatamab in all countries except Asia-Pacific in the fourth quarter of 2022. About Jazz Pharmaceuticals Jazz Pharmaceuticals, founded in 2003 and located in Dublin (Ireland), innovates to improve the lives of patients and their families. The company transforms biopharmaceutical discoveries into innovative medications to reimagine what's possible. About Zymeworks Zymeworks develops next-generation multifunctional biotherapeutics. Zanidatamab is a new Azymetric™ HER2-targeted bispecific antibody being examined in numerous Phase 1, Phase 2, and pivotal clinical trials globally as a targeted therapeutic option for patients with HER2-positive solid tumors. Zanidatamab Zovodotin (ZW49) is a bispecific antibody-drug combination in Phase 1 clinical development. It combines Zanidatamab's unique design and antibody framework with Zymeworks' ZymeLink™ linker-cytotoxin.

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BUSINESS INSIGHTS, PHARMA TECH

KSQ Announces ONO��s Acquisition of Multiple Research-stage Oncology Programs

KSQ Therapeutics | January 30, 2023

KSQ Therapeutics, a leading clinical-stage biotechnology company developing therapies to treat cancer and autoimmune diseases, recently announced that Ono Pharmaceutical (ONO) has acquired multiple research-stage DNA damage response (DDR) programs. The programs were identified using KSQ's CRISPRomics platform technology. All of the programs are new and have the potential to be first-in-class therapies. ONO's Discovery & Research Executive Director/ Senior Executive Officer Toichi Takino commented, "ONO appreciates the ability of KSQ's CRISPRomics platform technology to discover novel therapeutic targets with high selectivity for cancer cells." He added, "Through this acquisition agreement, we expect that the programs acquired from KSQ will lead to the creation of innovative medicines that will help treat cancer patients." (Source – Business Wire) KSQ's Chief Executive Officer Qasim Rizvi commented, "This acquisition of multiple research-stage oncology programs by ONO is further validation of the power of our platform to identify novel oncology targets and develop potential first-in-class programs." He added, "This is an important transaction for KSQ, enabling us to focus on our other programs. We look forward to watching ONO's progress as they advance these programs toward clinical studies." (Source – Business Wire) As per the terms of the agreement, ONO will pay KSQ a double-digit million upfront payment, prospective near-term milestone payments with potential long-term value in the triple-digit millions, and net sales-based royalties. About KSQ Therapeutics Founded in 2015, KSQ Therapeutics is a clinical-stage firm using its CRISPRomics® discovery platform to systematically decode the genome and identify optimal gene targets for oncology and autoimmune disease. It utilizes the platform for innovative drug development across diverse therapeutic domains and is actively creating a proprietary pipeline of tumor- and immune-focused drug candidates. Headquartered in Cambridge, Massachusetts, KSQ was formed by functional genomics thought leaders and CRISPR screening technology pioneers.

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BUSINESS INSIGHTS, PHARMACY MARKET

AEON Biopharma to Become Publicly Listed via Merger with Priveterra Acquisition Corp.; Accelerating Clinical Development of ABP-450

AEON Biopharma | December 14, 2022

AEON Biopharma, Inc. a private clinical-stage biopharmaceutical company focused on the development of its proprietary botulinum toxin complex ABP-450 injection for therapeutic indications, and Priveterra Acquisition Corp. a special purpose acquisition company announced that they have entered into a definitive business combination agreement. Upon closing of the proposed transaction, the combined company will operate as AEON Biopharma, Inc. and is expected to list on Nasdaq under the ticker symbol AEON Uniquely Positioned to Capitalize on Global Therapeutic Neurotoxin Opportunity Since its founding in 2019, AEON Biopharma has been led by Marc Forth, an Allergan plc veteran of 16 years and a former head of the BOTOX® Therapeutic franchise in the United States. AEON has assembled a seasoned team with expertise in neuroscience research, development, regulatory affairs, operations, manufacturing, and commercialization. Its executive team is comprised of industry leaders who have led new drug FDA approvals including multiple indications across multiple neurotoxin products. The global therapeutic neurotoxin market is currently estimated to be $3.0 billion, of which the U.S. represents approximately 84%, and projected to grow to approximately $4.4 billion in 2027. BOTOX®, marketed by Abbvie, Inc., currently holds approximately 95% U.S. market share for therapeutic indications in the neurotoxin space.1 Other neurotoxin competitors have had success with aesthetic indications in the cash-pay consumer-driven market but have been unable to acquire meaningful market share for therapeutic indications due to the indirect influence of pricing dynamics for aesthetic indications that results in a minimal value proposition for both payors and providers. AEON intends to file a unique BLA for therapeutic indications that would be free of any effects on reimbursement that exist for all other toxin competitors that have both therapeutic and aesthetic indications approved under a single BLA. Lead product candidate, ABP-450, is the same botulinum toxin approved and marketed for an aesthetic indication. Its 900 kDa molecular weight, similar to the market leader, will enable providers with a seamless transition to ABP-450 for therapeutic uses. Similar to the approved neurotoxins currently in the market, ABP-450’s commercial success does not depend upon patent protection, creating the possibility for an annuity-like construct of continued revenue generation, should ABP-450 be FDA approved. AEON’s therapeutic-only focus also provides a differentiated business model designed to deliver enhanced value to payors and providers by permitting a traditional pharma pricing model that is not currently available to competitors that also market their products for aesthetic uses approved under a single BLA. The sole focus on therapeutics allows AEON to pursue an original BLA filing that would allow a unique commercial strategy that cannot be employed by other competitors. About AEON Biopharma AEON is a clinical stage biopharmaceutical company focused on developing ABP-450 injection for the treatment of debilitating medical conditions with an initial focus on the neurology and gastroenterology markets. The Company is dedicated to innovation in the rapidly expanding therapeutic botulinum toxin market and believes its therapeutic-only focus will allow AEON to advance safe and effective treatment options to patients, while delivering differentiated economics to payors and physicians. The Company continues to evaluate additional therapeutic indications for development based on a comprehensive product assessment process designed to identify those indications where it believes ABP-450 can attain clinical, regulatory, and commercial success. About Priveterra Acquisition Corp. Priveterra Acquisition Corp. is a blank-check company formed for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization, or similar business combination with one or more businesses in life sciences. Priveterra is sponsored by Robert Palmisano and Priveterra Capital, LLC.

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