J&J unveils top pipeline prospects, with main focus on cancer

pharmaphorum | May 16, 2018

Johnson & Johnson has shone the spotlight on the most promising drugs in its pipeline, saying it plans to file 10 major drugs between now and 2023. The plans were among a day-long business review, which detailed the latest prospects being developed by Johnson & Johnson’s pharma unit, Janssen. Included on the list are the company’s two big approvals this year – Spravato (esketamine) nasal spray for treatment-resistant depression, and Balversa (erdafitinib). Among the six cancer drugs on the list is the PARP drug niraparib, originally developed by Tesaro, but acquired by GlaxoSmithKline and already approved in breast cancer. The two big pharmas are now developing the drug jointly in prostate cancer as a result of a collaboration agreement between Tesaro and J&J signed in April 2016 before the GSK buyout early this year. J&J also has its own CAR-T therapy – JNJ-4528 targets BCMA, which has sprung from a partnership with China’s Legend Biotech signed in December 2017. The European Medicines Agency last month designated the drug as a “priority medicine” (PRIME), meaning the regulator will fast track it through clinical development and grant a fast review if clinical data looks strong enough. Also in cancer there is lazertinib, an EGFR tyrosine-kinase inhibitor in development for non-small cell lung cancer.

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Entos Pharmaceuticals Announces Senior Leadership Appointments to Expand Executive Team and Accelerate Growth

Entos Pharmaceuticals | March 07, 2022

EDMONTON, Alberta Entos Pharmaceuticals a clinical-stage biotechnology company developing genetic medicines with its Fusogenix proteolipid vehicle (PLV) nucleic acid delivery platform, today announced two executive-level appointments, Dr. Steve Chen as Chief Medical Officer (CMO) and Jason Ding as Chief Business Officer (CBO). Dr. Steve Chen brings over 20 years of academic research and pharmaceutical biotechnology experience across multiple therapeutic areas to Entos. He will be responsible for the strategy, direction, and execution of Entos’ clinical development programs and medical affairs activities. Before this position, Dr. Chen served as the CMO of Cellics Therapeutics and has held leadership positions at La Jolla Pharmaceutical Company, Takeda, Eli Lilly and Company, and Amylin Pharmaceuticals. Dr. Chen also led the clinical research unit at the Center for Human Nutrition at UCLA and was a staff physician for emergency medicine at West Los Angeles Veteran Affairs Hospital. He obtained his medical degree from the Albert Einstein College of Medicine and his B.Sc. and B.A. degrees in Bioengineering and Chinese Studies from UC San Diego. “Steve Chen has a track record of working with companies developing revolutionary therapeutic approaches for complex diseases. We are thrilled to welcome him to our team at such a pivotal time as we continue to expand our footprint and grow our pipeline of Fusogenix PLV nucleic acid therapies.” John Lewis, Ph.D., Founder and Chief Executive Officer of Entos Mr. Jason Ding has almost 20 years of financial and transactional expertise in the life science and healthcare industry. He will oversee Entos’ overall business strategy, building upon the company’s foundation for sustainable, scalable growth and developing partnerships with pharmaceutical companies. Before joining Entos, Mr. Ding served as a Partner and Senior Managing Director in Deloitte’s investment banking practice and as a National Life Sciences & Healthcare Transactions Leader spearheading transactions with a cumulative value of over $1.5 billion in the last two years. He has worked with start-ups, large public companies, and global consulting companies and has been an investor and a Board member for numerous life science and industry organizations. Mr. Ding is a Fellow of the Chartered Professional Accountants of Alberta (FCPA, FCA), a Chartered Business Valuator (CBV), and ICD.D designation with the Institute of Corporate Directors. He received his BSc. and BCom. from the University of Alberta. “We’re excited to have Jason Ding join our team, bringing extensive financial and transactional expertise within the biotechnology and health tech sectors,” said John Lewis, Ph.D., Founder and Chief Executive Officer of Entos. “His insight and perspectives are invaluable as we execute on current partnerships and seek to expand our network to bring next-generation Fusogenix PLV nucleic acid therapies to patients in need.” The appointments come on the heels of exciting momentum for Entos, having entered into a collaboration with Eli Lilly in January, where Lilly acquired rights to Entos’ Fusogenix PLV nucleic acid delivery technology to research, develop and commercialize Fusogenix PLV products for central and peripheral nervous system disease indications. As part of the Alberta provincial government’s effort to grow Canada’s biomanufacturing capacity, Entos also received a commitment of $15.5 million in funding from the province in December 2021 to establish a commercial manufacturing facility in Edmonton, Alberta. About Entos Pharmaceuticals A new reality in genetic medicine lies ahead, one that will be ushered in with the advent of safe, effective, and redosable nucleic acid delivery technologies. At Entos, we develop next generation genetic medicines using our proprietary Fusogenix proteolipid vehicle (PLV) drug delivery system. Fusogenix PLVs are formulated with FAST proteins to enable the delivery of mRNA or DNA into target cells through direct fusion.

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SoniVie receives IDE approval from FDA for its Pilot study to treat Hypertension with its Renal Artery Denervation TIVUS™ technology

SoniVie | June 20, 2022

SoniVie, an Israeli company developing a novel proprietary Therapeutic Intra-Vascular Ultrasound System to treat a variety of hypertensive disorders, announced that on May 5th 2022 the U.S. Food and Drug Administration granted IDE approval for its "REDUCED1" Pilot study to treat Resistant Hypertension Patients with Renal Artery Denervation using TIVUS™, its innovative Ultra-Sound Ablation System. Resistant hypertension is defined as blood pressure higher than 140/90 mmHg despite use of three antihypertensive medications of different classes at the best tolerated doses, one of which must be a diuretic. Millions of people world-wide suffer from resistant hypertension which substantially increases the risk of heart attack, stroke and kidney failure. "We are very pleased that FDA has approved the REDUCED1 study. Sites initiation has started, and many clinical teams have responded very favourably about participating to the study. There is a significant number of patients that may benefit from our technology and we are genuinely happy for this important step towards the introduction of TIVUS™ in the US. There is a lack of effective therapeutic solutions for patients suffering from resistant hypertension, and physicians are looking forward to a safe, effective and easy to use device treatment," Christian Spaulding, CMO, SoniVie Ltd "This is a significant US Regulatory milestone for SoniVie, starting the feasibility study using the Ultra-Sound ablation platform in the US for the Renal Denervation indication. This is a major step and priority in the company's history," says Tomaso Zambelli, CEO, SoniVie LTD. The REDUCED1 study will further expand the Company's clinical experience based on two clinical trials in Renal Denervation performed using the earlier generation of the TIVUS™. Renal Denervation with TIVUS™ is a minimally invasive procedure that uses high-frequency non-focused Ultra-Sound energy to ablate nerves in the renal artery. This causes a reduction in the nerve activity, which may decrease blood pressure. This procedure is designed for patients who suffer from resistant hypertension. About SoniVie SoniVie is a medical device company developing the TIVUS™, the only Ultra-Sound Denervation platform with active development programs in three therapeutic areas: pulmonary artery denervation for pulmonary hypertension, renal artery denervation for resistant hypertension, and lung denervation for chronic obstructive pulmonary disease with chronic bronchitis. These diseases affect millions of patients in the United States and Europe.

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PHARMACY MARKET

IAMA Therapeutics Partners with the Italian Institute of Technology to Embark on Landmark Research on Neuroscience Drug Discovery

IAMA Therapeutics | March 31, 2022

IAMA Therapeutics, a Series A preclinical-stage pharmaceutical company focused on the discovery, development, and commercialization of novel medicines to make a difference in the lives of individuals suffering from brain disorders, today announced a strategic collaboration with the IIT-Istituto Italiano di Tecnologia where they will design and profile new classes of compounds targeting cation cotransporters in the CNS area. This partnership consolidates a scientific collaboration between IAMA Therapeutics and IIT, which signed, together with the Telethon Foundation earlier in 2021, a license agreement, granting IAMA therapeutics an exclusive, worldwide license to research, develop, manufacture, and commercialize a novel class of modulators of intracellular chloride concentration. "We are pleased with and excited by this partnering opportunity with IAMA Therapeutics, a clear example of IIT technology transfer approach. We are setting the Italian way of producing science and tech-based innovation, where the collaboration among brilliant researchers, important founding agencies like Fondazione Telethon, and investors creates the right ecosystem enabling new businesses to emerge." Dr. Matteo Bonfanti, Director of Technology Transfer at Istituto Italiano di Tecnologia "We are very happy for the partnership between IAMA Therapeutics and IIT," said Francesca Pasinelli, General Manager of Fondazione Telethon. "This collaboration is based on innovative science, which was selected and nurtured earlier on by Fondazione Telethon. As part of our focus on fostering development, we funded the project and supported researchers through the technology transfer process together with IIT. Now, this promising research avenue is accessing the resources and competencies necessary to take and accelerate the long and expensive path to patients. It shows what can be accomplished through a timely and coordinated effort to maximize research impact". About IAMA Therapeutics IAMA Therapeutics is a pharmaceutical company that couples emerging advances in drug discovery and neurobiology to build a leading, next-generation neuroscience pipeline. We have developed a platform to identify and advance diverse classes of small molecules to selectively inhibit the sodium potassium chloride cotransporter and other therapeutic targets relevant to treating central nervous system disorders characterized by neuronal imbalance, including primary and secondary autism, epilepsy, and movement disorders. About Istituto Italiano di Tecnologia Istituto Italiano di Tecnologia is a foundation established jointly by the Italian Ministry of Education, Universities, Research, and the Ministry of Economic and Finance to promote excellence in basic and applied research and contribute to Italy's economic development. The primary goals of the IIT are the creation and dissemination of scientific knowledge and the strengthening of Italy's technological competitiveness. To achieve these two goals, the IIT cooperates with academic institutions and private organizations, fostering scientific development, technological advances, and training in high technology. About Fondazione Telethon Fondazione Telethon is a major biomedical charity in Italy whose mission is to advance biomedical research to cure rare genetic diseases. Throughout its 32 years of activity, Fondazione Telethon has invested almost €600 million in funding over 2,700 projects to study 580 diseases, involving more than 1,600 researchers in Italy. As part of its goal to foster development and maximize the therapeutic impact of research, Fondazione Telethon further pursues cooperation with academia, industry, and venture capital through the creation of partnerships and start-ups.

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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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The marketing and sales innovation that once drove success is becoming increasingly ineective in a digital, value-based world. A new wave of customer experience expectations are driving demand for solutions, not just pills. Pharma needs to embrace the next chapter of marketing.

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