Merck and Pfizer’s Bavencio approved for renal cell carcinoma

pharmaphorum | May 15, 2019

Merck KGaA and Pfizer’s immunotherapy Bavencio (avelumab) has been approved by the FDA in combination with Pfizer’s Inlyta (axitinib) for the first-line treatment of patients with advanced renal cell carcinoma (RCC). The accelerated approval was based on positive results from the Phase III JAVELIN Renal 101 study, which showed the combination significantly lowered risk of disease progression or death by 31% and extended progression-free survival by 5.4 months for patients with advanced RCC compared with sunitinib. This is good news for a drug that has faced some challenges recently. In March, Merck and Pfizer discontinued an ovarian cancer trial for Bavencio. The decision was based on several emerging factors since the trial’s initiation, including interim results from the separate JAVELIN Ovarian 100 trial announced in December showing that Bavencio was unable to improve progression-free survival when used as a maintenance therapy. That failure came just a few weeks after Merck and Pfizer conceded defeat in another phase III study of Bavencio, the JAVELIN Ovarian 200 trial in platinum-resistant or platinum-refractory ovarian cancer.

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Connectivity in general is becoming an ever more important consideration for production facilities as we endeavour to produce more with less and all the while trying to satisfy an increasing need for more information and communication to and from the production equipment itself.

Spotlight

Connectivity in general is becoming an ever more important consideration for production facilities as we endeavour to produce more with less and all the while trying to satisfy an increasing need for more information and communication to and from the production equipment itself.

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PHARMACY MARKET

Asieris Deepens Strategic Partnership with UroViu to Further Develop Integrated Diagnosis and Treatment Platform for Bladder Cancer

PRNewswire | May 19, 2023

Asieris Pharmaceuticals a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases, announced a strategic collaboration with UroViu Corporation ("UroViu"). Asieris Pharmaceuticals will obtain exclusive global rights to UroViu's patented technology of portable single-use cystoscope in the field of fluorescent imaging. Under the agreement, Asieris Pharmaceuticals will use this patented technology in combination with specific optical imaging agents to conduct research on the application of non-white light imaging technology in the diagnosis and postoperative monitoring of None-Muscle Invasive Bladder Cancer (NMBC). At the same time, Asieris Pharmaceuticals will be responsible for the global commercialization of the sterile single-use fluorescent Cystoscope. Previously, Asieris Pharmaceuticals entered a cooperation agreement with UroViu in 2021 for the exclusive registration and commercialization rights of its portable single-use flexible white light cystoscopy system in mainland China, Taiwan, Hong Kong and Macau. "There is still a huge unmet need for more accessible and safer fluorescent cystoscopy in the diagnosis and surveillance of bladder cancer."Dr. Susan Wang, Senior Vice President of Global Business Development & Strategic Partnership of Asieris said, "We are thrilled to deepen and expand our collaboration with UroViu which enabling us not only to broaden our technology portfolio, but also to expedite the implementation of Asieris' integrated strategy for bladder cancer diagnosis and treatment, aiming to provide more effective disease management options for bladder cancer patients." "We are excited about the possibilities that our expanded Partnership with Asieris will create. Our unique and expanding portfolio of single use endoscopic products are fulfilling UroViu's promise to greatly improve both the patient and provider experience, elevate the standard of care in a field with rapidly advancing technologies," said Bruce OuYang, Founder and CEO of UroViu. About Asieris Asieris Pharmaceuticals founded in March 2010, is a global biopharma company specializing in the discovery, development and commercialization of innovative drugs that treat genitourinary tumors and other related diseases. We strive to improve human health and help people live a more dignified life. We aim to become a global pharma leader that integrates R&D, manufacturing, and commercialization in our areas of focus, as we provide best-in-class integrated diagnosis and treatment solutions for patients in China and worldwide. The company has been developing its proprietary R&D platform and core technologies, exploring new mechanisms of action, and efficiently screening and evaluating drug candidates. With a well-established in-house R&D system and expertise in global drug development, Asieris is committed to launching first-in-class drugs and other innovative products to address huge unmet needs in its areas of focus. Asieris is also enhancing its pipeline for genitourinary diseases via proprietary R&D and strategic partnerships, while closely following cutting-edge technologies and therapeutics. The company strives to discover and identify unmet medical needs, and adopts a forward-looking approach in product planning and life-cycle management. We aim to establish an outstanding portfolio that covers diagnosis and treatment in a bid to benefit more patients in China and globally.

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BUSINESS INSIGHTS, PHARMACY MARKET

Hovione and Laxxon Medical Establish an Agreement for the cGMP Production of 3D Screen Printed Pharmaceutical Applications

PRNewswire | March 23, 2023

Hovione and Laxxon Medical announced a strategic collaboration to advance the use of 3D screen printing technologies for the pharmaceutical industry. This partnership combines Laxxon´s expertise in 3D screen printing, based on their SPID®-Technology, with Hovione's product & process development, engineering and manufacturing expertise in pharmaceutical applications. Under the terms of the agreement, Hovione will establish the Laxxon Medical 3D screen printing technology at Hovione's cGMP production sites first in Portugal and later in the USA. The 3D technology displays numerous advantages including the potential to produce unique or customized dosage forms with characteristics that cannot be achieved with conventional dosage forms, the ability to create tablets of any shape and size, the option to easily adjust the number of active substances and individual components in the composition of the tablet and even to set the dosage individually for each patient for personalized medicines. "Laxxon is thrilled to establish a long-term partnership with Hovione." said Klaus Kuehne, COO of Laxxon Medical. "This partnership will serve as a great accelerator in establishing 3D screen printing within the pharmaceutical industry thus accelerating our ability to serve our customers." "Hovione has a global reputation for their pharmaceutical innovation services, expertise and market access. This agreement marks a significant milestone for Laxxon in terms of our own market strategy and development efforts." said Helmut Kerschbaumer, Laxxon's CEO. "We are looking forward to collaborating with Hovione to promote innovation through 3D screen printing." "We find the Laxxon Medical 3D printing technology to be very innovative and enabling. It not only allows for the customization and production of drug products with complex shapes and structures as well as unique API release characteristics but it also has the potential to reduce the time and cost of drug development" says Dr. Jean-Luc Herbeaux, Hovione´s CEO. He adds "Hovione has a track record of turning emerging pharmaceutical production technologies into reliable and scalable offerings at both developmental and commercial scales. We are excited at the prospect of supporting Laxxon in industrializing its 3D printing technology and make it accessible to a greater number of pharmaceutical and medical device companies." With this partnership the platform will be available from early development phases to routine commercial manufacturing. About Hovione Hovione is an international company with over 60 years of experience in pharmaceutical development and manufacturing operations. As a Contract Development and Manufacturing Organization (CDMO) Hovione has a fully integrated offering of services for drug substance, drug product intermediate and drug product. The company has four FDA inspected sites in the USA, Portugal, Ireland and China and development laboratories in Lisbon, Portugal and New Jersey, USA. Hovione provides pharmaceutical customers services for the development and compliant manufacture of innovative drugs, including highly potent compounds, and customized product solutions across the entire drug life cycle. In the inhalation area, Hovione offers a complete range of services, from API, formulation development and devices. Hovione´s culture is based on innovation, quality and delivery. Hovione was the first Chemical/ Pharmaceutical Company to become a Certified B Corp, is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards.

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BUSINESS INSIGHTS, PHARMACY MARKET

PathAI Announces PathExplore, an AI-powered Pathology Panel to Unlock Untapped Insights from the Tumor Microenvironment

Prnewswire | April 05, 2023

PathAI, a global leader in AI-powered pathology, announced the launch of PathExplore™, the world's first structured, standardized and scalable panel of human interpretable features (HIFs) offering unprecedented resolution of the tumor microenvironment (TME) from H&E whole-slide images. Powered by artificial intelligence, PathExplore1 spatially characterizes the TME with single-cell resolution, giving oncology drug developers the ability to unlock insights to inform the next phase of targeted oncology drug development. The last decade has seen significant strides in oncology therapeutic development, but challenges remain – many cancer patients do not respond to available treatment, and many aren't eligible for potentially transformative therapies because of a lack of actionable insight into their disease. Researchers are looking to the tumor microenvironment, one of the most promising areas of oncology research, for answers and insights that will impact patient outcomes. "PathExplore will enable researchers to identify novel spatial signatures predictive of outcomes," said Andy Beck, M.D., Ph.D., chief executive officer and co-founder of PathAI. "We're hopeful that by giving oncology drug developers access to this level of detail and data from routine H&E samples, this next generation of pathology will drive advances in cancer therapy development." Current technologies to measure and analyze the TME force researchers to make tradeoffs between resolution and scalability. Now with PathExplore, drug developers will have the ability to analyze the TME with deep resolution using a scalable platform that can be deployed on massive numbers of patient samples. PathExplore produces a panel of more than 600 quantitative HIFs: standardized and reproducible measures of counts, densities, areas and spatial relationships across cell types and tissue regions. PathExplore also generates overlay visualizations of cell types and tissue regions, delivered on PathAI's AISight™ Translational Research platform. PathExplore has been trained using over 6.5 million pathologist annotations on 66,000 slides. It is currently available for breast cancer, colorectal cancer, gastric cancer, melanoma, non-small cell lung cancer, pancreatic cancer, prostate cancer, and renal cell carcinoma, with more indications planned to launch later this year, including ovarian and bladder cancers. The standardized, structured quantification of the TME across disease areas will enable reproducible, comparable, and scalable analysis across drug programs. "PathExplore will shift the research paradigm, bypassing long standing constraints we experience with some of the existing multi-omics modalities and allowing for more open exploration and discovery of relationships that were not identifiable by human analysis alone," said Mike Montalto, PhD, chief scientific officer at PathAI. "The degree of granularity, speed, efficiency and scale delivers unmatched insights that will change the way we view the tumor microenvironment." PathAI's HIFs have been used in over 15 scientific abstracts, presentations, and publications. To learn more about PathExplore, visit www.PathExplore.com or visit us at booth 315 at the American Association for Cancer Research (AACR) April 14th-19th in Orlando, FL. About PathAI PathAI is the only AI-focused technology company to provide comprehensive precision pathology solutions from wet lab services to algorithm deployment for clinical trials and diagnostic use. Rigorously trained and validated with data from more than 15 million annotations, its AI-powered models can be leveraged to optimize the analysis of patient samples to improve diagnostic efficiency and accuracy, as well as to better gauge therapeutic efficacy and accelerate drug development for complex diseases.

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