Ditch the opioid 'negotiating class' proposal, experts say. State attorneys general are better suited to reach a deal

FiercePharma | July 19, 2019

Cities and counties around the U.S. have sued opioid drugmakers and distributors over their alleged role in a nationwide crisis, and plaintiffs recently proposed a “negotiating class” to help the sides reach a settlement. But that idea isn't helping, two experts say. Instead, it's an idea the parties shouldn't sink time into, former Connecticut Deputy Attorney General Perry Zinn Rowthorn told FiercePharma. Rowthorn, along with Connecticut's former Attorney General George Jepsen, this week wrote an op-ed in the Cleveland Plain Dealer picking apart the proposal. The upshot of their argument: State attorneys general, which are running their own investigations and lawsuits, are better equipped to negotiate a settlement favorable to all the plaintiffs involved.

Spotlight

Drug development is a lengthy, complex, and costly process, entrenched with a high degree of uncertainty that a drug will actually succeed.The unknown pathophysiology for many nervous system disorders makes target identification challenging. Animal models often cannot recapitulate an entire disorder or disease.

Spotlight

Drug development is a lengthy, complex, and costly process, entrenched with a high degree of uncertainty that a drug will actually succeed.The unknown pathophysiology for many nervous system disorders makes target identification challenging. Animal models often cannot recapitulate an entire disorder or disease.

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PRACTICE MANAGEMENT

Ascentage Pharma Presents Updates on its Global Clinical Development at the J.P. Morgan 39th Annual Healthcare Conference

Ascentage Pharma | January 14, 2021

Ascentage Pharma, an around the world engaged, clinical-stage biotechnology organization occupied with creating novel treatments for malignant growths, persistent hepatitis B (CHB), and age-related illnesses, introduced at the J.P. Morgan 39th Annual Healthcare Conference (a virtual occasion) at night of January 13, Beijing Time. During the introduction, Dr. Dajun Yang, Chairman and CEO of Ascentage Pharma, furnished business refreshes with an attention on the organization's worldwide R&D outline. Dr. Yang conveyed a generally welcomed introduction on the organization's item pipeline and clinical advancement progress. As a worldwide pioneer in the improvement of therapeutics focusing on the protein-to-protein collaborations, Ascentage Pharma has assembled a pipeline of exceptionally serious resources, a considerable lot of which with first-in-class or top tier possibilities (Table 1). Until now, Ascentage Pharma has gotten 33 clinical preliminary endorsements or clearances, with more than 40 clinical examinations on-circumventing the world. As a main biopharmaceutical organization zeroing in on the improvement of apoptosis-focusing on treatments, Ascentage Pharma has assembled a rich and strong pipeline, with five medication applicants focusing on the three key apoptotic pathways - Bcl-2, IAP, and MDM2-p53, and has progressed all these five competitors into clinical turn of events. APG-2575, the organization's orally-managed novel little atom Bcl-2 inhibitor, pulled in a lot of interest from the business and examination local area, as it is one of only a handful few Bcl-2 particular inhibitors, after venetoclax, that have entered clinical turn of events. It is additionally the principal China-created Bcl-2 inhibitor entering clinical turn of events. In December 2020, Ascentage Pharma delivered refreshed outcomes from the clinical investigations of APG-2575 in the therapy of backslid/obstinate ongoing lymphocytic lymphoma (r/r CLL) which have selected more than 30 patients. Starter results show that an exceptionally reassuring target reaction rate (ORR) of 70% has been reached in evaluable patients. At this meeting, Dr. Yang shared extra subtleties on these outcomes.

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BUSINESS INSIGHTS

Resilience Establishes Multi-Product Development and Manufacturing Collaboration with Takeda’s Plasma-Derived Therapies Business Unit

Resilience | February 16, 2022

National Resilience, Inc. a technology-focused manufacturing company dedicated to broadening access to complex medicines, announced a manufacturing services agreement with Takeda’s Plasma-Derived Therapies Business Unit. As part of the agreement, Resilience will focus on supporting the development and manufacture of multiple products in Takeda’s plasma-derived medicines portfolio out of its facility in Mississauga, Ontario. “I’m proud to establish this relationship with Takeda, a company that has been pioneering plasma-derived therapies for more than 75 years. By bringing new technologies and innovation to biomanufacturing, we aim to help companies like Takeda reach more patients in need.” Rahul Singhvi, Sc.D., Chief Executive Officer of Resilience Resilience’s 136,000 sq ft (12,800 m2) biomanufacturing facility in Mississauga provides process and analytical development, scale up, drug substance and drug product / fill finish manufacturing for a variety of medicines. “We are delighted to form this strategic collaboration with Resilience, leveraging their expertise in both plasma therapy development and manufacturing to complement our current infrastructure and capabilities,” said Andreas Liebminger, Head of Pharmaceutical Sciences and Devices for the Plasma-Derived Therapies Business Unit at Takeda. “Our partnership will allow us to optimally use our combined assets to continue to bolster our portfolio, drive innovation and help more patients around the world realize the benefits of plasma medicines.” About Resilience Resilience is a technology-focused manufacturing company dedicated to broadening access to complex medicines. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. By continuously advancing the science of biopharmaceutical manufacturing and development, Resilience seeks to free its partners to focus on the discoveries that improve patients’ lives.

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PHARMACY MARKET

Ionis and AstraZeneca close deal to develop and commercialize eplontersen

Ionis Pharmaceuticals, Inc. | December 30, 2021

Ionis Pharmaceuticals, Inc. the leader in RNA-targeted therapies, announced the closing of the collaboration agreement with AstraZeneca to develop and commercialize eplontersen, Ionis' investigational antisense medicine for the treatment of transthyretin amyloidosis, following expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Eplontersen, formerly known as IONIS-TTR-LRx, is designed to reduce the production of transthyretin, or TTR protein, to treat ATTR, a systemic, progressive and fatal disease. It uses Ionis' advanced LIgand-Conjugated Antisense technology. As previously announced, the companies will jointly develop and commercialize eplontersen in the U.S. AstraZeneca has an exclusive license for eplontersen outside the U.S., except certain countries in Latin America. Under the terms of the agreement, Ionis will receive a $200 million upfront payment, up to $485 million in development and approval milestones, and up to $2.9 billion in sales-related milestone payments. The collaboration includes territory-specific development, commercial and medical affairs cost-sharing provisions. Ionis is also eligible to earn royalties in the range of low double-digit to mid-20s percentage depending on region. Additional details about the agreement can be found in Ionis' Form 8-K filed with the Securities and Exchange Commission on Dec. 7, 2021. About Ionis Pharmaceuticals, Inc. For more than 30 years, Ionis has been the leader in RNA-targeted therapy, pioneering new markets and changing standards of care with its novel antisense technology. Ionis currently has three marketed medicines and a premier late-stage pipeline highlighted by industry-leading neurological and cardiometabolic franchises. Our scientific innovation began and continues with the knowledge that sick people depend on us, which fuels our vision of becoming one of the most successful biotechnology companies.

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