Pharma back in hot seat as 2020 presidential election gets into gear

fiercepharma | June 28, 2019

Once again, we are watching presidential debates with too many candidates to fit on one stage. And once again, pharma is proving itself an easy target. As the first Democratic presidential debates kicked off this week, candidates took numerous shots at drugmakers in an early sign the industry will face plenty of tough questions throughout the 2020 cycle. The candidates blasted corporate power in the U.S. in general—and pharma in particular, using words like "corruption" and "greed." They raised some familiar ideas for cracking down on drug prices, including Medicare price negotiations. And as one might expect, they vowed to take action against pharma, rather than just talk about it. Sen. Elizabeth Warren said the current economic setup has benefited “giant drug companies” and other industries, but it hasn’t helped regular citizens. “When you've got a government, when you've got an economy that does great for those with money and isn't doing great for everyone else, that is corruption, pure and simple,” she said. Sen. Cory Booker said pharma companies "often have monopolistic holds on drugs" and use that power to raise prices. The senator’s state is home to several of the top drugmakers worldwide, including Merck & Co. and Johnson & Johnson. He's pledged to not take pharma's contributions this election cycle. Drugmakers have hiked prices routinely for years, and critics have spent years pushing back. Politicians have made plans to lower prices and spent considerable time debating the issue, but Sen. Bernie Sanders said now is the time for action.

Spotlight

We recognize that using data standards is a big shift for industry, but we think it’ll be really helpful for developers as well as the FDA staffers. Data standards help our reviewers organize the data and also help them access the data much more efficiently, saving time.

Spotlight

We recognize that using data standards is a big shift for industry, but we think it’ll be really helpful for developers as well as the FDA staffers. Data standards help our reviewers organize the data and also help them access the data much more efficiently, saving time.

Related News

PHARMA TECH

Nucleai Announces a Partnership with Sirona Dx for AI-Driven Discovery of Novel Spatial Biomarkers in Solid Tumors

Nucleai and Sirona Dx | July 14, 2022

Nucleai, a leader in AI-powered spatial biology transforming precision medicine by unlocking the power of pathology data, and Sirona Dx, a leading provider of multiomic single-cell analytical services, today announced a collaboration to advance the discovery of novel spatial biomarkers in solid tumors. The partnership combines Nucleai’s powerful AI spatial analytics platform with Sirona Dx’s leading multiplex assay development expertise to identify novel spatial signatures in high-plex assays that predict response to therapy and inform treatment decisions. Through this strategic collaboration, Sirona Dx will provide Nucleai and its customers with a CRO partner that will enable the deployment of AI-based diagnostic algorithms to support biopharma clinical trials. Nucleai’s robust computational AI-powered spatial biology algorithm supports various image modalities and cancer indications, offering a highly customizable, deployable solution across the drug development ecosystem. These capabilities earned Nucleai the position of one of the top 10 spatial biology companies in 2022. “Multiplex imaging technologies have improved rapidly over the years; however, identifying actionable insights from all the data collected remains immensely challenging. This powerful synergy between Sirona Dx and Nucleai is very exciting as it will allow us to identify actionable spatial signatures that can predict response to immunotherapy.” Avi Veidman, Co-Founder & Chief Executive Officer of Nucleai Sirona Dx is recognized as the original pioneers of spatial biology, having launched the first spatial-omics CRO service to biopharma in 2018. Today, their technology-agnostic, spatial biology suite includes the leading multiplexed imaging platforms and combines deep technical expertise required to develop high-performance multiplexed assays as large as 50 markers. Sophisticated multiplexed tissue imaging capabilities contributed to their selection as a Top 10 CRO of 2021 by Medhealth Outlook. “We are delighted to announce a partnership with Nucleai,” said Andrew Brown, Ph.D. Chief Commercial Officer at Sirona Dx. “Nucleai’s AI-driven analytical capabilities are exceptional. Our combined expertise in multiplexed tissue assay development, data generation and state-of-the-art analysis will unlock new spatial insights and accelerate the spatial biology revolution in precision medicine.” About Nucleai Nucleai is an AI-powered spatial biology company with a mission to transform drug development and clinical treatment decisions by unlocking the power of pathology data. Nucleai provides pharmaceutical companies, contract research organizations, and diagnostics laboratories with a state-of-the-art AI platform to improve clinical trials and clinical decision-making. About Sirona Dx Sirona Dx is a technical, CLIA accredited CRO, founded in 2016 to accelerate the pace of immunotherapy and targeted therapy development. With a leading-edge menu of specialized high complexity, single-cell proteomics and genomics services, Sirona Dx supports exploratory biomarker programs and advanced precision medicine initiatives to deliver safer and more effective treatment solutions.

Read More

BUSINESS INSIGHTS

Pharma Tech Holdings SA Obtains a Capital Commitment Agreement of CHF 30 million from Global Investor LDA Capital

Pharma Tech | August 09, 2022

Pharma Tech Holding SA announced it has secured a CHF 30 million investment to support its portfolio investments from LDA Capital Ltd, a global investment group with expertise in cross border transactions including the agriculture, Agri-tech, and CBD industries. Established in 2019, PTH is a Swiss based holding company, which invests into innovative businesses with high technological value and scalability potential, mainly in Switzerland and Europe, with a focus on the health-tech, Agri-tech, and functional food. This investment will allow PTH to mainly invest and support its portfolio company Blue Sky Swisse SA a JV between PTH and listed company IGEA PHARMA NV IGPH - ISIN NL0012768675. BSS focuses on the extraction of natural active principles from vegetable matrices, vegetable waste, and renewable sources to deliver B2B products under the form of CBD oil, Terpenes and Waxes. The factory located in Biasca, will be built to the state of art of extraction technology by super critical CO2 and will be energy self-sufficient through the use of solar photovoltaic panels and district heating. BSS will grant for highest CBD quality also due to a proprietary extraction process, starting from the farming performed under strict control and culminating with the immediate freezing of the flowers after harvest, with the target to also sell “all natural” formulations to increase bioavailability thus enhancing the possible applications. Last, but not least, BSS will invest in the agricultural raw material chain and will create an aeroponic green house in Ticino, to deliver a high quality GMP Pharmaceutical CBD oil. LDA Capital agreed to commit an amount of up to CHF 30 million in cash within a maximum of three years. This Capital Commitment will be released based on drawdowns by PTH, that PTH has the right to exercise at its sole discretion. “We’re thrilled with this partnership and are so glad that LDA Capital recognizes the value of PTH and its portfolio company, with the aim of creating one of the most innovative hub for health-tech, agri-tech and functional food,” Sabina Del Nigro, CEO at PTH About Pharma Tech Holding Pharma Tech Holding SA is a holding company based in Lugano, Switzerland, which invests into innovative businesses with high technological value and scalability potential, mainly in Switzerland and Europe, with a focus on the health-tech, Agri-tech, and functional food. About LDA Capital LDA Capital is a global alternative investment group with expertise in cross border transactions worldwide. Our team has dedicated their careers to international & cross border opportunities having collectively executed over 250 transactions in both the public and private middle markets across 43 countries with aggregate transaction values of over US$11 billion.

Read More

BUSINESS INSIGHTS

Astellas and Sutro Biopharma Announce Worldwide Strategic Collaboration to Advance Novel Immunostimulatory Antibody-Drug Conjugates (iADCs)

Sutro Biopharma, Inc.; Astellas Pharma Inc. | June 28, 2022

Astellas Pharma Inc. and Sutro Biopharma, Inc. announced a worldwide, strategic collaboration and licensing agreement focused on the discovery and development of novel immunostimulatory antibody-drug conjugates. The collaboration leverages the unique cancer-fighting potential of iADCs as a novel modality, enabled by Sutro’s ability to engineer complex conjugated antibodies, and Astellas’ global oncology R&D expertise. “We are delighted to work with Astellas, a premier biopharmaceutical company with substantial expertise in immuno-oncology, on this novel modality. iADCs hold promise well beyond the existing success of ADCs. Sutro’s unique conjugation technology enables dual conjugations that site-specifically incorporate a potent cytotoxin that can directly kill tumor cells together with an immunostimulatory component that has the potential to locally prime an immune response to the patient’s particular tumor cells. We look forward to collaboratively exploring the potential of this approach to treat cold tumors and bring new drug therapies to patients who do not respond to existing immunotherapies.” William J. Newell, Sutro’s Chief Executive Officer Naoki Okamura, Chief Strategy Officer, at Astellas commented, "Astellas considers Immuno-Oncology as one of the Primary Focuses of its R&D strategy; our goal is to bring effective drugs to patients who do not respond to existing immune checkpoint inhibitors. Sutro is a leading company in the area of iADCs, a new modality, and has its own original iADC technologies. The strategic partnership with Sutro will help us expand our pipeline and widen the choice of cancer immunotherapies.” A key challenge with cancer immunotherapies, including immune checkpoint inhibitors, is the tumor microenvironment*1 within cold tumors creating barriers to immune cell infiltration and thus preventing the cure. The immune checkpoint inhibitors approved to date are efficacious as a monotherapy in only about 20% of cancer types, which vary widely*1. This strategic partnership will engage in the development of iADCs, a next generation modality with the potential for effective and efficient approaches for treatment of cold tumors so as to bring new drug therapies to patients who do not respond to existing therapies. An iADC, which combines an antibody with a small molecule compound that induces immunogenic cell death*2 in addition to an immune activating molecule, has the potential to boost the anti-cancer action. This partnership will enable Astellas and Sutro to mutually leverage strengths in their respective fields to accelerate iADC development for three distinct biological targets; Sutro will engage in research and preclinical studies to identify candidate compounds and then Astellas will pursue clinical development. Sutro has advanced technologies for linking drugs to antibodies and proprietary component parts, including candidate antibodies and linkable cytotoxins and immunostimulatory molecules. For development of iADCs, Astellas will utilize the strength of its global R&D and commercialization capabilities in the area of antibodies and the small molecular components. These iADCs may have the potential to provide new therapeutic options for treatment of cancers for which no broadly effective therapy is currently available. Under the terms of the agreement, Sutro will receive an upfront cash payment of US$90 million to develop iADCs for three biological targets and may be eligible to receive up to US$422.5 million in development, regulatory and commercial milestones for each product candidate, and tiered royalties ranging from low double-digit to mid-teens on worldwide sales of any commercial products that may result from the collaboration, subject to Sutro’s cost and profit sharing option for the United States. Sutro has the option to share in the costs and profits for developing and commercializing product candidates in the United States. If Sutro exercises this option for a particular product candidate, Astellas and Sutro will equally share the costs of such co-development and co-commercialization, with the resulting profits/losses from co-commercialization also shared equally in the United States.

Read More