EMA resolves dispute over pricey Canary Wharf tenancy

Pharmaphorum | July 05, 2019

After months of wrangling, the EMA finally has a solution to the £500 million financial liability it has faced over the tenancy to its former home in Canary Wharf. The EU regulator – now based in temporary accommodation in Amsterdam – has sub-let the entire 284,704 square feet (26,450 m2)accommodation at 30 Churchill Place to WeWork, a fast-growing shared office-space group. As a result of the deal, the EMA has also now settled its litigation with the Canary Wharf Group. Faced with the prospect of the UK leaving the EU, the EMA opted to move from London to Amsterdam earlier this year. It argued that the Brexit referendum had effectively ‘frustrated’ its lease, making a move away from the UK imperative, and that also meant it should be able to exit the agreement – which expires in 2039 – without prejudice. Canary Wharf, which is owned by Canada’s Brookfield and the Qatar Investment Authority, viewed the situation very differently. In a landmark case for the commercial property sector, it succeeded in arguing in the High Court in February that Brexit was not a sufficient reason to break the lease terms, which involved annual payments of around £17 million in return for 10 floors that could house up to 900 staff. The EMA had appealed the decision, but now that it has a sub-tenant lined up has confirmed that it will withdraw the appeal, accepting that the original High Court ruling would stand. WeWork is due to take over the space in December after a refit. The resolution of the dispute is a massive weight off the shoulders of the EMA, which is still coping with the disruption caused by the relocation and has had to strip back its operations to focus on critical regulatory areas.

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GEA has introduced a cost-effective version of its market-leading PERFORMA™ P rotary tablet press, the PERFORMA Lite. Enhanced with a new state-of-the-art 21 CFR Part 11 and GAMP® compliant control system, which greatly improves ease of operation and maintenance, the PERFORMA™ Lite tablet press is ideal for medium-scale solid dosage form production at rates of up to 320,000 tablets per hour.


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BUSINESS INSIGHTS

BD Completes Acquisition of Parata Systems

BD | July 19, 2022

BD announced it has completed the acquisition of Parata Systems. Parata advances BD's transformative solutions strategy by providing a portfolio of innovative pharmacy automation solutions that power a growing network of pharmacies to reduce costs, enhance patient safety and improve the patient experience for retail, hospital and long-term care pharmacies. As a combined company, BD is positioned to offer a comprehensive set of technologies to the $600 million pharmacy automation market segment that is expected to grow approximately 10% annually to $1.5 billion in the U.S. alone over 10 years. "Completing this acquisition represents an important step towards advancing our 2025 growth strategy around smart, connected care and enabling new care settings. I'd like to officially welcome the Parata team to BD as we join together to uniquely provide a more comprehensive set of smart, connected care technologies to support our customers as they expand care to new settings and centralize their pharmacy operations." Tom Polen, chairman, chief executive officer and president of BD The acquisition builds on BD's legacy and experience of seamlessly integrating teams to drive future growth and innovation. The Parata portfolio will become part of the solutions offered by BD's Medication Management Solutions business within the BD Medical segment. Together, the combined BD and Parata team will help pharmacy leaders address critical trends, such as clinician shortages, wage inflation, centralization of pharmacy services and increased clinical demands on pharmacy staff. About BD BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 75,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.

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BUSINESS INSIGHTS

Simulations Plus Hosts 2nd Annual Pharmacometrics Workshop

Simulations Plus, Inc. | July 04, 2022

Simulations Plus, Inc. a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, today announced record-setting attendance and virtual content delivery for the 2022 Pharmacometrics Spring School using MonolixSuite™. New for 2022 was the introduction of the “NCA, bioequivalence, and beyond! Spring School” course using PKanalix™. Both workshops were held in March 2022. This year’s Spring Schools focused on population modeling for model-informed drug development and simulations of clinical trials using the MonolixSuite, and the analysis of PK data using non-compartmental analysis and bioequivalence calculations using the PKanalix platform. These courses, which were free to the pharmacometrics community, comprised both theoretical discussions and hands-on sessions. In total, there were 936 attendees from over 50 countries. The attendees were industry professionals from regulatory agencies, pharma companies, biotech, and CROs, as well as students and doctoral/postdoctoral researchers, with different backgrounds, who used the skills taught in these courses to make their modeling and simulation work more powerful and efficient. “The positive feedback and momentum from our first Spring School in 2021 carried forward to this year’s program, further substantiating the need to provide the pharmacometrics community with quality material and training. As a leader in providing modeling and simulation (M&S) software tools and services to support the industry and our clients in their efforts to leverage M&S for more efficient drug development, we were very pleased by the strong interest and support from the user community, and we look forward to offering our pharmacometrics workshops again in 2023.” Dr. Jonathan Chauvin, President of the Lixoft division at Simulations Plus About Simulations Plus Serving clients worldwide for 25 years, Simulations Plus is a leading provider in the biosimulation market providing software and consulting services supporting drug discovery, development, research, and regulatory submissions. We offer solutions that bridge machine learning, physiologically based pharmacokinetics, quantitative systems pharmacology/toxicology, and population PK/PD modeling approaches. Our technology is licensed and applied by major pharmaceutical, biotechnology, and regulatory agencies worldwide. Environmental, Social, and Governance (ESG) We focus our Environmental, Social, and Governance efforts where we can have the most positive impact.

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VIEWS AND ANALYSIS

Innovent and IASO Bio Present Updated Data of BCMA CAR-T Cell Therapy (Equecabtagene Autoleucel) at EHA 2022

Innovent Biologics | June 13, 2022

Innovent Biologics, Inc. a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, metabolic, ophthalmology and other major diseases, and IASO Biotherapeutics a clinical-stage biopharmaceutical company engaged in discovering, developing, and manufacturing innovative cell therapies and antibody products, today jointly announced that the updated data from phase 1/2 study of Equecabtagene Autoleucel (Innovent R&D code: IBI326, IASO Bio R&D code: CT103A), a fully-human anti-B cell maturation antigen chimeric antigen receptor T-cell therapy for the treatment of relapsed and/or refractory multiple myeloma (R/R MM), was presented in the form of an oral presentation at the 27th European Hematology Association Annual Meeting in Vienna on June 9-12, 2022. The updated data from the Phase 1/2 study with a longer duration of follow-up in more patients has showed durable and deepening efficacy, manageable safety and long-term in vivo persistence, indicating that Equecabtagene Autoleucel has the potential to be a breakthrough therapy for patients with R/R MM. The updated data is from the 14 clinical sites involved in the Phase 1/2 clinical study of Equecabtagene Autoleucel (ChiCTR1800018137, NCT05066646) in the treatment of patients with R/R MM. As of the data cutoff date of January 21, 2022, 79 patients received recommended phase 2 dose of 1.0×106 CAR-T cells/kg with the median follow-up of nine months (range 1.2, 19.6) and median prior five lines of therapy (range 3,23). Among the 79 patients, 34.2% (27/79) had high-risk cytogenetic abnormalities, 34.2%(27/79)had extramedullary multiple myeloma (EMM), and 15.2%(12/79)had received prior CAR-T therapy. Equecabtagene Autoleucel demonstrated a favorable and manageable safety profile: Among the 79 patients, 94.9% (75/79) experienced cytokine release syndrome (CRS). The majority experienced 1~2 CRS, and no patient experienced grade 3 CRS. The median time to CRS onset was six days after infusion, and the median duration of CRS was five days. Only two patients experienced immune effector cell-associated neurotoxicity syndrome (ICANS), including one patient who experienced grade 1 ICANS and one who experienced grade 2 ICANS. All patients with CRS or ICANS have recovered. Equecabtagene Autoleucel showed favorable and durable efficacy: Among the 79 patients, the overall response rate (ORR) was 94.9% (75/79), with "89.9% (71/79)" of those patients achieving very good partial response (VGPR) or deeper responses, and the complete response/stringent complete response (CR/sCR) rate was 68.4% (54/79). Equecabtagene Autoleucel also demonstrated favorable efficacy in 10 patients with EMM, achieving an ORR of 100% (10/10) and a CR/sCR rate of 90.0% (9/10). In all 79 patients, 92.4% (73/79) achieved minimal residual disease (MRD) negativity, all CR/sCR subjects achieved MRD negativity, and the median duration of MRD negativity was not reached. Equecabtagene Autoleucel demonstrated favorable efficacy in patients who had received prior CAR-T therapy: Among the 12 patients who previously received CAR-T therapy, the ORR was 75.0% (9/12), with 41.7% (5/12) of those patients achieving CR/sCR. Equecabtagene Autoleucel demonstrated robust expansion and prolonged persistence: The expansion of Equecabtagene Autoleucel in peripheral blood reached the peak at a median of 12 days, with a median Cmax of 92,000 copies/ug DNA. Equecabtagene Autoleucel was still detectable in 62.3% (38/61) and 53.3% (8/15) of the subjects who completed 6-months and 12-month follow-ups after infusion. Soluble BCMA in peripheral blood of patients rapidly declined after Equecabtagene Autoleucel infusion and persistently remained below the detectable limit. Equecabtagene Autoleucel has low immunogenicity: 16.5% (13/79) of the subjects tested anti-drug antibody (ADA)-positive after Equecabtagene Autoleucel infusion. Among them,1.3% (1/79) tested ADA-positive before Equecabtagene Autoleucel infusion, and 2.5% (2/79) tested ADA-positive within three months. Prof. Chunrui Li, MD, PhD, from Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, stated "Chimeric antigen receptor (CAR)-T cell therapy is a revolutionary new pillar in cancer treatment. In our previous studies, Equecabtagene Autoleucel has shown excellent efficacy and manageable safety profiles. Its CAR structure contains fully human single-chain fragment variables (scFvs) to bypass potential anti-CAR immunogenicity of the host while retaining antitumor activity. At the 27th EHA conference, we updated the data on the efficacy and safety of Equecabtagene Autoleucel in R/R MM patients with longer median follow-up extended to 9.0 months, the CR/sCR deepened to 68.4%, compared with the CR/sCR of 58.2% with a median follow-up of 7.0 months, which were released at 63rd ASH conference in 2021. The updated data showed long-lasting safety and deepening efficacy of Equecabtagene Autoleucel. We are glad that Equecabtagene Autoleucel also shows favorable efficacy on patients who have relapsed after receiving prior CAR-T therapy. This has meaningful clinical value and is worthy of further exploration in the clinic to potentially bring forth new hope to patients with R/R MM." About Multiple Myeloma (MM) Multiple Myeloma is a deadly blood cancer that often infiltrates the bone marrow causing anemia, kidney failure, immune problems, and bone fractures. For multiple myeloma patients, common first-line drug treatments include proteasome inhibitors, immunomodulatory drugs, and alkylating agents. While treatment may result in remission, most patients will inevitably enter the relapsed or refractory stage as there's currently no cure. As a result, there is a significant unmet need for patients with relapsed/refractory multiple myeloma. In the United States, MM accounts for nearly 2% of all cancer cases, and more than 2% of cancer-related deaths. According to Frost & Sullivan, the number of new MM cases in the United States rose from 30,300 in 2016 to 32,300 in 2020 and is expected to increase to 37,800 by 2025. Additionally, the total number of patients diagnosed with MM increased from 132,200 in 2016 to 144,900 in 2020 and is expected to rise to 162,300 by 2025. In China, the number of new MM cases rose from 18,900 in 2016 to 21,100 in 2020 and is expected to increase to 24,500 by 2025. The total number of patients diagnosed with MM in China increased from 69,800 in 2016 to 113,800 in 2020 and is expected to rise to 182,200 by 2025. About Equecabtagene Autoleucel Equecabtagene Autoleucel is an innovative therapy co-developed by Innovent and IASO Bio, with a fully-human anti- BCMA CAR-T cell therapy which uses lentivirus as a gene vector to transfect autologous T cells. The CAR contains a fully-human scFv, CD8a hinge and transmembrane, and 4-1BB-mediated co-stimulation and CD3ζ activation domains. Based on rigorous screening and comprehensive in vivo and in vitro evaluation, Equecabtagene Autoleucel is proven to have potent and rapid anti-myeloma activity and outstanding safety, efficacy, and persistence results.

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PHARMA TECH

Novotech and Medidata expand partnership to continue advancements in clinical research

Medidata | June 16, 2022

Medidata, a Dassault Systèmes company, announced its renewed, expanded partnership with Novotech, a leading contract research organisation to continue scaling clinical studies in various therapeutic areas from 2022. Leveraging Rave EDC, Rave RTSM, eCOA and eConsent technology from Medidata, Novotech is equipped with flexible, configurable tools that can address clinical research needs at scale and facilitate accelerated drug and device development in Asia Pacific and the U.S. Since its partnership in 2018, Novotech has doubled its growth and has also acquired CRO companies in APAC and the U.S. as well as invested in advanced DCT and data companies to deliver a seamless CRO platform amidst the increasing demand for clinical trials services in the region. The partnership extends access to a suite of end-to-end solutions from Medidata Clinical Cloud, the industry's only unified platform dedicated to clinical research. It also underscores Medidata and Novotech's commitment to work collaboratively towards accelerating clinical trials and research efficiently, while improving clinical trial timelines and patient experiences. The Medidata Clinical Cloud is the only unified technology platform dedicated to clinical research, with solutions that leverage centralized data to address the holistic research process from start to finish. With the physical limitations and fragmentation of healthcare ecosystems caused by the COVID-19 pandemic, the need for digital integration for accelerated clinical development is crucial, and a unified platform allows for streamlined management of studies, sites, users, and access from a single location. "The pandemic has underscored the importance of redesigning how trials are run, with more stakeholders realising the vital role that technology plays in clinical development. Medidata is pleased to continue our strong partnership with Novotech and is dedicated to providing support in their acceleration of clinical studies. Working with leading technologies, we can deliver better patient experiences and accelerate drug development in the new normal in clinical research." Edwin Ng, Senior Vice President, Asia Pacific, Medidata Andries Claassen, Senior Director Biometrics, Novotech, added, "We are excited to continue our partnership with Medidata, with their sustained support in driving clinical research and business growth with customers. Novotech has always invested heavily in the latest technology to provide our clients with better data visibility for improved decision-making. Together, we will help sponsors deliver more efficient, effective, and scalable trials." Medidata is a wholly owned subsidiary of Dassault Systèmes, which with its 3DEXPERIENCE platform is positioned to lead the digital transformation of life sciences in the age of personalized medicine with the first end-to-end scientific and business platform, from research to commercialization. About Medidata Medidata is leading the digital transformation of life sciences, creating hope for millions of patients. Medidata helps generate the evidence and insights to help pharmaceutical, biotech, medical device and diagnostics companies, and academic researchers accelerate value, minimize risk, and optimize outcomes. More than one million registered users across 2,000+ customers and partners access the world's most trusted platform for clinical development, commercial, and real-world data. Medidata, a Dassault Systèmes company (Euronext Paris: FR0014003TT8, DSY.PA), is headquartered in New York City and has offices around the world to meet the needs of its customers. About Dassault Systèmes Dassault Systèmes, the 3DEXPERIENCE Company, is a catalyst for human progress. We provide business and people with collaborative 3D virtual environments to imagine sustainable innovations. By creating virtual twin experiences of the real world with our 3DEXPERIENCE platform and applications, our customers push the boundaries of innovation, learning and production to achieve a more sustainable world for patients, citizens, and consumers. Dassault Systèmes brings value to more than 300,000 customers of all sizes, in all industries, in more than 140 countries. 3DEXPERIENCE, the Compass icon, the 3DS logo, CATIA, BIOVIA, GEOVIA, SOLIDWORKS, 3DVIA, ENOVIA, NETVIBES, MEDIDATA, CENTRIC PLM, 3DEXCITE, SIMULIA, DELMIA, and IFWE are commercial trademarks or registered trademarks of Dassault Systèmes, a French "société européenne" (Versailles Commercial Register # B 322 306 440), or its subsidiaries in the United States and/or other countries. About Novotech Novotech is the leading Asia Pacific biotech specialist CRO with labs, phase I facilities, and drug development consulting services. Novotech has accumulated experience in over 3,700 clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. Novotech is positioned to serve biopharmaceutical clients conducting clinical trials in Asia and globally and serves biotechs globally leveraging deep relationships built with hundreds of Asia-Pacific sites over the last 25 years. As of May 2022, Novotech has over 2,500 FTEs working across our offices in 12 geographies in Asia-Pacific and the United States.

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Spotlight

GEA has introduced a cost-effective version of its market-leading PERFORMA™ P rotary tablet press, the PERFORMA Lite. Enhanced with a new state-of-the-art 21 CFR Part 11 and GAMP® compliant control system, which greatly improves ease of operation and maintenance, the PERFORMA™ Lite tablet press is ideal for medium-scale solid dosage form production at rates of up to 320,000 tablets per hour.

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