Pelosi pricing plan will yield 100 fewer new drugs White House predicts

FiercePharma | December 04, 2019

As debate over drug pricing proposals rolls on in Washington, White House advisers have concluded House Speaker Nancy Pelosi's aggressive pricing plan would result in 100 fewer new drugs over a decade, lowering Americans' expected lifespan along the way. Unveiled this fall, Pelosi's plan calls for Medicare price negotiations, an international pricing index, potential fines for drugmakers who won't negotiate and more. President Donald Trump originally tweeted that it was “great to see” the plan, but more recently, the White House has backed away from the proposal and instead supported a bipartisan effort in the Senate.

Spotlight

Following on from our review of trends in the current pharmaceutical R&D pipeline, published in March 2019 this supplement takes a look at the industry’s success stories of 2018 – the drugs which were launched on to the market for the first time during the year. Our survey focuses exclusively on new active substances (NASs): new chemical or biological entities where the active ingredient had received no prior approval for human use. This will include vaccines with novel antigenic components. As such, this list represents a subset of all the first launches which Pharmaprojects reported during 2018, excluding the 67 new drug launches with reformulated or non-NAS moieties, or biosimilars. So, to continue our sports theme this year, we’ll be looking at the drugs which successfully crossed the finishing line, hit the bullseye, and lifted the trophy, to become part of pharma’s elite 2018 team. In pharma as in sport, it’s all about winning. Pharma


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BUSINESS INSIGHTS

Everest Medicines Appoints Rogers Yongqing Luo as Chief Executive Officer to Lead Next Stage of Company Growth

Everest Medicines | September 19, 2022

Everest Medicines a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products to address critical unmet needs in Asia Pacific markets, announced that it has appointed Rogers Yongqing Luo as Chief Executive Officer of the Company, effective immediately. Mr. Luo will also serve as an Executive Director on Everest's Board of Directors. Mr. Luo brings to Everest more than 25 years of experience in the healthcare industry with an extensive leadership track record across clinical development, regulatory affairs and commercialization. Previously, Mr. Luo served as President and General Manager, Greater China at Brii Biosciences and CEO of TSB Therapeutics where he spearheaded the rapid registration approval, GMP certification and successful commercialization of the amubarvimab/romlusevimab combination, the first COVID-19 neutralizing antibody treatment in China. Prior to that, he was Global Vice President and China General Manager at Gilead Sciences where he led the clinical development, regulatory approval and successful commercial launch of eight innovative therapeutics, and efforts that rapidly expanded patient access across China. Mr. Luo previously oversaw the successful launch of several high-profile medicines. He managed sales, marketing, government affairs and market access functions for various leading multinational pharmaceutical companies including Roche and Novartis, and worked two years at Novartis headquarter in Switzerland. "As Everest Medicines continues to evolve our business strategy and expand our novel product pipeline at a rapid pace, we are thrilled to have Rogers join the Company to lead Everest through its next phase of growth in becoming a fully-integrated biopharma company in China. With his robust background as a top executive at both biotech startup and large multinational pharma companies, Rogers brings to Everest a unique set of expertise including comprehensive scientific insight, proven outstanding leadership and excellent commercialization capabilities in patient access, and a demonstrated history of successfully advancing early- and late-stage innovative pipeline to commercial launch in Greater China. In particular, Rogers' leadership will strengthen Everest's new product development and commercial capabilities as we progress toward potential approvals of our late-stage anchor product candidates, including Nefecon, Xerava, etrasimod and mRNA vaccines. We look forward to leveraging Rogers' leadership and industry expertise to generate long-term growth and success across the business." Mr. Wei Fu, Chairman of Everest Medicines and Chief Executive Officer of CBC Group "I'm very excited to join Everest and I look forward to working with this talented, world-class team of scientists and industry professionals to further the Company's industry leadership. We will continue to advance our late-stage pipeline towards commercialization and with our strong balance sheet, we aim to execute synergistic business development deals to accelerate our path to become an integrated biopharma," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "We will continue to invest into our discovery platform to build an innovative therapeutic pipeline for the benefit of patients with unmet needs in Greater China and other Asia Pacific markets, and to create sustained, long-term value for our shareholders." About Everest Medicines Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record of high-quality clinical development, regulatory affairs, CMC, business development and operations both in China and with leading global pharmaceutical companies. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules, many of which are in late-stage clinical development. The Company's therapeutic areas of interest include oncology, autoimmune disorders, cardio-renal diseases and infectious diseases.

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PHARMA TECH

ArisGlobal's LifeSphere Regulatory IDMP Product Leader Invited to Chair American National Standards Institute Global MPID Project

ArisGlobal | August 23, 2022

ArisGlobal, the leading provider of life sciences software that automates core drug development functions with its end-to-end technology platform LifeSphere®, today recognizes and applauds the accomplishments of their LifeSphere® Regulatory IDMP product leader, Robin Schilling, for her acceptance into American National Standards Institute (ANSI) and the nonprofit's specific ISO Health Informatics Technical Committee, Working Group 6, which helps develop standardizations for Pharmacy and Medicines Business. ANSI is a private non-profit organization that oversees the development of voluntary consensus standards for products, services, processes, systems, and personnel in the United States. Schilling is the product owner of LifeSphere IDMP, a solution recognized by analyst group Gens & Associates as leading in IDMP Readiness. Schilling's work with ANSI Working Group 6 will include chairing a committee to lead the effort in developing a global Medicinal Product ID under the IDMP umbrella to help improve the efficiency and resilience of the supply chain. IDMP is scheduled to go live in the European Union (EU). The regulation pertains to all companies who are doing business within the EU, not just those who are based there. Both the work being done by ANSI and the EMA will help improve drug and patient safety, while encouraging a global dialogue around drug development. "It is in incredible honor to be a part of the American National Standards Institute and Working Group 6," shares Schilling. "Having a seat at the table to discuss these core, pressing matters in R&D will help improve drug safety, reduce drug shortages, and mitigate supply chain risks by allowing manufactured products and ingredients to be tracked down to the lot level. It's a tremendous move in the right direction and towards continued, growing regulation that keeps patient safety at the center of medicinal products." "Our people are at the heart and soul of what we do, so to have an organization like ANSI recognize the talent and impact Robin Schilling has in the standards and regulations space is well-deserved and commendable. Robin is an excellent example of the incredible talent we have at ArisGlobal. She is a leader on our Regulatory team and has such a robust professional background, we are confident she will do great things and continue to make an impact in our organization and beyond." Clint Wolfe, Chief Human Resource Officer at ArisGlobal About ArisGlobal ArisGlobal is transforming the way today's most successful Life Sciences companies develop breakthroughs and bring new products to market. Our end-to-end drug development technology platform, LifeSphere®, integrates our proprietary cognitive computing engine to automate all core functions of the drug development lifecycle. Designed with deep expertise and a long-term perspective that spans more than 30 years, LifeSphere® is a unified platform that boosts efficiency, ensures compliance, delivers actionable insights, and lowers total cost of ownership through multi-tenant SaaS architecture. About LifeSphere® LifeSphere is the trusted partner for global pharmaceutical and biotechnology companies, health authorities, and contract research organizations. Helping accelerate product development, organize clinical trials, manage compliance, and streamline collaboration across teams, LifeSphere empowers safer, faster life science breakthroughs. As the flagship product of ArisGlobal, LifeSphere is a market-leading solution built on 40 years of industry partnership and continues to evolve in collaboration with hundreds of trusted customers.

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BUSINESS INSIGHTS

Kubota Vision Announces Collaboration Agreement with Leading Diabetes Center

PBOS | September 30, 2022

Kubota Vision Inc. a clinical-stage specialty ophthalmology company and a wholly-owned subsidiary of Kubota Pharmaceutical Holdings Co., Ltd. announced today that the Company and Joslin Diabetes Center have entered into a material transfer and collaboration agreement for our Patient Based Ophthalmology Suite in-home optical coherence tomography device. Joslin Diabetes Center is conducting two clinical studies to evaluate the ability of PBOS to identify cases of diabetic macular edema that may need treatment compared to a commercially-available OCT device. The studies will be led by Dr. Paolo S. Silva at Joslin Diabetes Center. Dr. Silva is the Co-Chief of Telemedicine at the Beetham Eye Institute of the Joslin Diabetes Center. His work is focused on innovative and investigative work in a field at the intersection of clinical care and technology with the hope of providing an ideal model for the delivery of evidence-based, highly effective, and efficient diabetes eye care to the population that needs it the most. Joslin Diabetes Center, which is affiliated with Harvard Medical School, is a one-of-a-kind institution on the front lines of the world epidemic of diabetes — leading the battle to conquer diabetes in all of its forms through cutting-edge research and innovative approaches to clinical care and education. Dr. Silva stated, “Through these studies, we will determine if home-based in-home optical coherence tomography is useful in the evaluation of diabetic macular edema and how we monitor patients at risk for losing vision from the condition.” “Diabetic retinopathy is one of the most common diseases in the world. The use of our technology brings us great excitement as we continue to focus on the development of medical devices and explore further possibilities.” Ryo Kubota, MD, PhD, Chairman, President, and CEO of Kubota Vision Inc. About PBOS PBOS is a low cost, home-based, ophthalmic self-monitoring OCT device. This small handheld device addresses needs in mobile Health applications for self-monitoring of retina health by patients, in the home and in remote field locations. The PBOS aims to improve ophthalmic treatment outcomes in patients diagnosed with and treated for wet age-related macular degeneration, diabetic macular edema and other neovascular retinal diseases. PBOS is being designed to detect nascent disease progression and support patient re-treatment prior to irreversible vision loss due to disease progression. Key features are low cost and a patient-friendly design, to be used directly by patients at home. PBOS is being designed to capture changes in retinal anatomy. Network connectivity and cloud-based technologies are used to alert the patients and their physicians of disease progression and re-treatment needs. About Kubota Vision Inc. Kubota Vision Inc. is a wholly owned subsidiary of Kubota Pharmaceutical Holdings Co., Ltd. committed to translating innovation into a diverse portfolio of drugs and devices to preserve and restore vision for millions of people worldwide. Kubota Pharmaceutical group’s pipeline includes a wearable device for myopia control using Kubota GlassTM technology and a handheld OCT device for the monitoring of neovascular retinal diseases, to be used directly by patients.

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BUSINESS INSIGHTS

Ligand Pharmaceuticals Announces Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)

Ligand Pharmaceuticals | August 02, 2022

Ligand Pharmaceuticals Incorporated announced that effective August 1, 2022, Ligand’s Board of Directors approved the grant of non-qualified stock option awards to purchase an aggregate of 90,073 shares of its common stock, 5,000 restricted stock units and 4,000 performance stock units the target level to six non-executive employees. The options were granted on August 1, 2022, and the grant date for the RSUs and the PSUs will be the date on which Ligand files a Form S-8 Registration Statement to register the shares pursuant to Ligand’s 2022 Employment Inducement Plan. The awards were granted under the Inducement Plan as employment inducement awards pursuant to NASDAQ Listing Rule 5635(c)(4). The Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously employees of Ligand, or following a bona fide period of non-employment, as an inducement material to such individuals’ entering into employment with Ligand, pursuant to Nasdaq Listing Rule 5635(c)(4). The options have an exercise price of $89.70 per share, which is the closing price of Ligand’s common stock on The Nasdaq Global Select Market on August 1, 2022. The stock options have a term of ten years and will vest over four years, with 12.5% of the shares vesting six months after the employee’s commencement of employment and the balance of the shares vesting in 42 equal monthly installments thereafter, subject to the grantee’s continued service on such vesting dates. The RSUs will vest over three years on the first three anniversaries of the grantee’s commencement of employment, subject to continued service through each applicable vesting date. The PSUs will vest based on the achievement of certain total shareholder return objectives and the completion of the contemplated spin-off of OmniAb, Inc. from Ligand. The number of shares earned under the PSUs may be up to 6,500 in the aggregate if maximum performance levels are achieved. About Ligand Pharmaceuticals Ligand is a revenue-generating biopharmaceutical company focused on developing or acquiring technologies that help pharmaceutical companies discover and develop medicines. Our business model creates value for stockholders by providing a diversified portfolio of biotech and pharmaceutical product revenue streams that are supported by an efficient and low corporate cost structure. Our goal is to offer investors an opportunity to participate in the promise of the biotech industry in a profitable, diversified and lower-risk business than a typical biotech company. Our business model is based on doing what we do best: drug discovery, early-stage drug development, product reformulation and partnering. We partner with other pharmaceutical companies to leverage what they do best (late-stage development, regulatory management and commercialization) ultimately to generate our revenue. Ligand’s OmniAb® technology platform is a patent-protected transgenic animal platform used in the discovery of fully human monoclonal and bispecific therapeutic antibodies. The Captisol® platform technology is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Ligand’s Pelican Expression Technology® is a robust, validated, cost-effective and scalable platform for recombinant protein production that is especially well-suited for complex, large-scale protein production where traditional systems are not. Ligand has established multiple alliances, licenses and other business relationships with the world’s leading pharmaceutical companies including Amgen, Merck, Pfizer, Sanofi, Janssen, Takeda, Gilead Sciences and Baxter International.

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Spotlight

Following on from our review of trends in the current pharmaceutical R&D pipeline, published in March 2019 this supplement takes a look at the industry’s success stories of 2018 – the drugs which were launched on to the market for the first time during the year. Our survey focuses exclusively on new active substances (NASs): new chemical or biological entities where the active ingredient had received no prior approval for human use. This will include vaccines with novel antigenic components. As such, this list represents a subset of all the first launches which Pharmaprojects reported during 2018, excluding the 67 new drug launches with reformulated or non-NAS moieties, or biosimilars. So, to continue our sports theme this year, we’ll be looking at the drugs which successfully crossed the finishing line, hit the bullseye, and lifted the trophy, to become part of pharma’s elite 2018 team. In pharma as in sport, it’s all about winning. Pharma

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