Medicaid misclassification bill inspired by EpiPen snafu passes Congress

FiercePharma | April 03, 2019

How long does it take Congress to reach an agreement on drug prices? On the topic of drug misclassifications in Medicaid, about two and a half years. That’s the time that’s passed since Mylan’s famous EpiPen saga and the Justice Department settlement that followed. Finally, lawmakers have passed the Right Rebate Act, hoping to crack down on drug misclassifications that lower drugmaker rebates and cost taxpayers. And now the bill is headed to the president's desk. The legislation allows the Department of Health and Human Services to closely monitor the Medicaid Drug Rebate Program for misclassifications and requires regular reports to make sure it keeps an eye out. Under the bill, the HHS secretary could require drug companies to reclassify medications and impose penalties for drugs that are “knowingly misclassified.”

Spotlight

The pharmaceutical industry is globalizing. Conducting global clinical trials to get a broader and more diverse participant base and expanding into less-saturated developing markets are two significant drivers of globalization. However, this expansion creates the unique and very real logistical challenge of connecting a global network of employees, researchers, clinicians, customers, suppliers, distributors, and manufacturing sites to foster collaboration both inside and outside the organization.

Spotlight

The pharmaceutical industry is globalizing. Conducting global clinical trials to get a broader and more diverse participant base and expanding into less-saturated developing markets are two significant drivers of globalization. However, this expansion creates the unique and very real logistical challenge of connecting a global network of employees, researchers, clinicians, customers, suppliers, distributors, and manufacturing sites to foster collaboration both inside and outside the organization.

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PHARMACY MARKET

CStone and LegoChem Biosciences Enter Global Licensing Agreement for New Antibody Drug Conjugate

CStone | October 29, 2020

CStone Pharmaceuticals declared today a permitting concurrence with Lego Chem Bio sciences, Inc, for the turn of events and commercialization of LCB71, a likely first-in-class/top tier immunizer drug form ("ADC"). Under the understanding, CStone gets the selective worldwide option to lead advancement and commercialization of LCB71 outside the Republic of Korea. LCB will get a forthright installment of US$10 million, and up to US$353.5 million in combined achievement installments, in addition to layered eminences. Frank Jiang, M.D., Ph.D., Chairman and Chief Executive Officer of CStone, said: "We are very pleased to form this partnership with LCB, a leading ADC platform company, to obtain global rights to an asset with highly differentiated attributes in an exciting new field of oncology. The agreement adds the first ADC to CStone's development pipeline, and bolsters our precision medicine franchise with a new modality. We look forward to harnessing its full potential and bringing it to patients around the world." LCB71 is a pre-clinical ADC going into Investigation New Drug ("IND") empowering contemplates. It targets ROR1 (receptor tyro sine kinase-like vagrant receptor 1), a high-potential ADC focus for different strong and hematological malignancies. ROR1 protein articulation is common in an assortment of malignancies including different types of leukemia, non-Hodgkin lymphoma, and bosom, lung, and ovarian tumors. LCB71 has a restrictive tumor-actuated pyrrolobenzodiazepine ("PBD") expert medication poison that tends to the ordinary poisonousness issue related with conventional PBD payloads. It has shown total tumor hindrance over a few pre-clinical disease models, which may convert into a wide helpful record for a scope of strong and hematologic malignancies. Moreover, it uses site-explicit formation for an exact medication counter acting agent proportion. This backings serum half-life and improves its pharmacokinetic profile, and furthermore empowers homogeneous creation and huge scope fabricating. Dr. Yong-Zu Kim, CEO and President of LCB, said: "We are pleased to have reached this agreement with CStone, which has demonstrated extensive oncology expertise, especially in global clinical development. This partnership puts LCB71 on a path to development and commercialization for patients worldwide. We are convinced that CStone is the right partner to secure the future of this important drug." About CStone CStone is a biopharmaceutical company focused on developing and commercializing innovative immuno-oncology and precision medicines to address the unmet medical needs of cancer patients in China and worldwide. Established at the end of 2015, CStone has assembled a world-class management team with extensive experience in innovative drug development, clinical research, and commercialization. With a strategic emphasis on immuno-oncology combination therapies, the Company has built an oncology-focused pipeline of 15 drug candidates, including five late-stage candidates at pivotal trials or registration stages. With an experienced team, a rich pipeline, a robust clinical development-driven business model and substantial funding, CStone's vision is to become globally recognized as a leading Chinese biopharmaceutical company by bringing innovative oncology therapies to cancer patients worldwide. About LegoChem Biosciences LegoChem Biosciences (LCB) is a clinical-stage biopharmaceutical company focusing on the development of next-generation novel therapeutics utilizing its proprietary medicinal drug discovery technology LegoChemistry and ADC platform technology ConjuAll. Since its foundation in 2006, LCB has focused on the research and development of Antibody-Drug-Conjugates (ADCs), antibiotics, anti-fibrotic and anticancer therapeutics based on proprietary platform technologies. Forward-looking Statement The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development.

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PHARMACY MARKET

CPhI India Concludes the 2021 Hybrid Edition of CPhI - P-MEC Expo along with Informa Pharma Intelligence

Informa Pharma Intelligence | December 06, 2021

Informa Pharma Intelligence, one of the leading business intelligence providers and knowledge partner, concluded its involvement at this year's CPhI & P-MEC Expo, a hybrid conclave hosted between 24th to 26th November 2021 at India Expo Centre – Greater Noida, New Delhi, and at the Online Conference & Networking event held between 15th to 30th November 2021. The conclave witnessed participation from key influencers and leading figures across the pharmaceutical industry, and hosted domestic and foreign drug makers, contract service providers and pharma machinery players under one roof, providing them with a chance to craft future growth plans together. India's pharmaceutical market is in the midst of a growth spurt, having increased in value from $21bn in 2016 to $29bn in 2020 – a figure that is expected to reach $41bn by 2024. Key industry drivers include a rise in disease prevalence, economic growth and higher disposable incomes, improvements in the healthcare infrastructure and a growth in the number of people covered by health insurance. In a bid to stay afloat during the need to step up the demand towards high quality, low-cost pharma solutions, CPhI & P-MEC India has curated a gateway to network with industry peers for the latest trends and innovative solutions that the market has to offer. The event is geared towards building pharma community engagements, network amongst the fraternity and source innovative solutions on-site from exhibitors who have footprints both domestically and globally and cover the entire pharma supply chain - from APIs, machinery, technology, packaging, outsourcing, finished products and biopharmaceuticals. Alongside the expo, and under the aegis of the India Pharma Week, an exclusive and strategic closed door CEO Roundtable meeting took place, inviting the top leaders of India's pharmaceutical companies. The 'CEO Roundtable' was conducted on November 24 in partnership with Informa Intelligence, whose perspectives and key discussion points will also yield a white paper report. The pharama industry is anticipated to have a steady growth trajectory and the event organised by CPhI India has focused on the key driving factors for the same. The expansion of medicine manufacturing pertaining to the evolving epidemiological profile of the country will be instrumental for India being the preferred drug manufacturing destination on a global scale. Additionally, the event aims to encourage the development of the research-based pharma fraternity. Concluding the CPhI – P-MEC India show, Mr Poornachandra Tejasvi, Senior Director, Emerging Markets, India, at Informa Pharma Intelligence, said, "We, at Informa Pharma Intelligence, were delighted to witness the overwhelming response at CPhI & P-MEC India 2021 event and we're glad that we could partner with CPhI to host this common platform for the pharmaceutical industry. With challenges and opportunities evolving at a global scale, through this event we looked to discuss the possibilities for not only providing solutions to the healthcare needs of the country but also to the world. With India's strength in global generics market, Indian pharma and biotech companies are now gearing up to transition into R&D and innovation to establish themselves as key players to develop Biosimilars, Novel Chemical Entities, Novel Biological Entities and Innovative Therapies for the global and Indian pharmaceutical markets, for which Informa Pharma Intelligence is closely partnering to aid in this effort. The event provided a great opportunity to reconnect with our stakeholders of the pharmaceutical world and offer data intelligence and analysis on par with the recent industry trends." "The Indian pharmaceutical market is growing exponentially, around twice the world market growth rate. While its generics market is growing strong, it is also evolving into a cradle for new drugs. Therefore, with India being one of the strongest emerging markets in the global pharma industry, it presents great opportunities for all international pharmaceutical companies to explore; we are glad that the platform by CPhI & P-MEC India could enrich the exhibitors with new pharma solutions and help businesses find the right partners, with the hybrid expo showcasing the full drug development supply-chain from exporting, outsourcing, manufacturing, machinery, regulations, pricing, and market access to, packaging, labelling, and digitalization. We look forward to hosting CPhI P-MEC in the coming year's again." Mr.Yogesh Mudras, Managing Director, Informa Markets in India CPhI India is a sister brand of CPhI Worldwide – A key event that all professionals from the international pharmaceutical and allied industries look forward to year on year. CPhI India and its co-located event, P-mec India, are the largest and most comprehensive pharmaceutical industry events in South Asia. This event is specifically important to the country as India is already known as the pharmacy of the world in addition to the vaccine manufacturing prowess showcased in 2019-2020. About Informa Pharma Intelligence Trusted by over 3,000 of the world's leading pharmaceutical, biotech, medical device companies, and CROs, the Pharma Intelligence suite of intelligence solutions, which include Datamonitor Healthcare™, Sitetrove™, Trialtrove™, Pharmaprojects™, Biomedtracker™, Scrip™, Pink Sheet™ and In Vivo™, deliver vital, accurate, and timely intelligence and analysis about the drug development pipeline to pharmaceutical and biomedical decision makers around the world. A global team of subject area experts track and analyse key diseases, clinical trials, drug approvals, and R&D activities, to deliver the data required to make critical decisions and create real-world opportunities for growth. About CPhI Conferences The world's largest pharmaceutical exhibition, CPhI Worldwide represents every stage of the pharmaceutical supply chain - from ingredients and FDF, to machinery, packaging, outsourcing and biopharmaceuticals. Each year the CPhI brand unites more than 100,000 pharmaceutical professionals from all over the world through exhibitions, conferences and online communities. CPhI offers healthcare experts a chance to network, identify business opportunities and expand the global market through online and in-person interactions, with events in Europe, China, Korea, India, Japan, Southeast Asia and North America.

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PHARMA TECH

PathAI Announces Strategic Partnership with Roche to Enable Development and Distribution of Digital Pathology Diagnostics

Roche | October 15, 2021

PathAI, a global leader in artificial intelligence (AI)-powered technology for pathology, and Roche, a global pioneer in pharmaceuticals and diagnostics, announced a strategic partnership to develop and distribute PathAI's AI-powered technology through Roche's uPath enterprise software, enabling broad access to digital pathology diagnostics to support clinical research and companion diagnostic (CDx) programs globally. AI-powered pathology has the potential to inform biomarker development, better identify and treat patients, and enable personalized medicine. However, the digital pathology industry is largely fragmented across various software, hardware and algorithm providers, which has prevented effective implementation of AI platforms in labs. The collaboration between PathAI and Roche now provides a comprehensive menu of AI-powered digital pathology solutions in diagnostics. "This collaboration brings together all of the components required to deliver and commercialize a differentiated AI-based digital pathology medical device including assay, scanner, image management system, and image analysis algorithms. We believe this collaboration will unlock the potential for digital pathology in the CDx setting, offering a differentiated service to biopharma sponsors and ultimately new opportunities to improve patient outcomes," - Dr. Andy Beck, CEO of PathAI. The collaboration will initially involve distribution of PathAI-developed research-use-only (RUO) algorithms through NAVIFY Digital Pathology, the cloud version of Roche's uPath enterprise software, focusing on immuno-oncology in multiple cancer types. The collaboration will also support biopharmaceutical partners with an end-to-end solution for CDx development, leveraging Roche's diagnostic assays and pathology lab solutions with new and expanded innovative imaging tools from PathAI, in addition to the AI tools already provided by Roche. About PathAI PathAI is a leading provider of AI-powered research tools and services for pathology. PathAI's platform promises substantial improvements to the accuracy of diagnosis and the efficacy of treatment of diseases like cancer, leveraging modern approaches in machine and deep learning. Based in Boston, PathAI works with leading life sciences companies and researchers to advance precision medicine. To learn more, visit pathai.com. About Roche Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people's lives. The combined strengths of pharmaceuticals and diagnostics, as well as growing capabilities in the area of data-driven medical insights help Roche deliver truly personalised healthcare. Roche is working with partners across the healthcare sector to provide the best care for each person. Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. In recent years, Roche has invested in genomic profiling and real-world data partnerships and has become an industry-leading partner for medical insights. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognized as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI). The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

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