Goldfinch acquires global rights to Takeda’s monoclonal antibody

Pharmaceutical Technology | October 04, 2019

US-based clinical-stage biotechnology company Goldfinch Bio has entered an agreement with Japanese firm Takeda Pharmaceutical for global rights to a preclinical, peripherally restricted cannabinoid receptor 1 (CB1) monoclonal antibody. Under the agreement, the company will assume the development and commercialisation responsibilities for the treatment of metabolic kidney diseases worldwide. Takeda will have the option to ask Goldfinch Bio to negotiate the sub-licensing of Japanese rights to Takeda before the initiation of pivotal studies. Goldfinch, built on a platform designed to identify kidney-specific targets, combines genomic, transcriptomic, proteomic and clinical data. The company plans to use the platform to identify the subsets of kidney disease patients most likely to respond to the therapy.

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PBMs offer a variety of tools to manage specialty drugs, including the use of specialty pharmacies. In doing so, the quality and continuity of care patients receive is improved, while ensuring that they derive the greatest value from their medications.


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DeepIntent Adds More Leading Data Providers to its Audience Marketplace, Simplifying Pharma Campaign Planning and Optimization

DeepIntent | July 14, 2022

DeepIntent, the leading healthcare advertising technology company built to influence better patient health and business outcomes announced the addition of audience segments from Redi-Data, MedFuse, HealthWise Data, Prognos Health, and TV viewership data from LG Ads Solutions to the DeepIntent Audience Marketplace. These segments are directly integrated into DeepIntent's demand side platform for immediate activation, with the ability to optimize campaigns in real-time toward audience quality and script performance using DeepIntent Outcomes™. Launched in September 2021, Audience Marketplace remains the industry's first and only healthcare-specific data marketplace with ready-to-activate and custom audience segments powered by a variety of medical and pharmacy claims, lab, genomic, contextual, and wellness data providers. In total, DeepIntent now offers hundreds of patients and HCP segments from leading digital health data providers and publishers, including HealthLink Dimensions, Fluent, Doc Delta, and ShareThis. Additionally, over two dozen leading pharmaceutical brands and advertising agencies have made use of custom or ready-to-activate segments available on the marketplace to simplify their campaign planning and tap into Outcomes to optimize their third-party segments. "Audience Marketplace meets an important need to have unique healthcare audience segments included in a healthcare-focused DSP with the ability to optimize towards pharma-specific KPIs, such as Audience Quality, all within a single platform. Many of our customers already use audience segments from our new partners, and their direct integration will make it much easier to execute, measure, and optimize campaigns." Jen Werther, chief strategy officer at DeepIntent Audience Marketplace users benefit from greater convenience, faster time-to-activation, and improved data integrity and reporting compared with conventional methods, which require the use of costly and time-consuming third-party platforms. Segments within the Audience Marketplace are also matched with DeepIntent's industry-leading identity graph to prepare advertisers for the cookieless future, and provide daily physician-level data reporting for healthcare provider audiences. "Using integrated health data and Prognos Clinical Truths™ to ensure relevancy, healthcare marketers can rest easy knowing their messages are reaching the right physicians at the right time. Our partnership with DeepIntent makes the process of onboarding and activating HCP segments from Prognos seamless, and segments can further be optimized toward script performance in real-time when leveraging the advanced machine learning capabilities of DeepIntent Outcomes," said Matt Apprendi, vice president of marketing and media solutions at Prognos Health. About DeepIntent DeepIntent is leading the healthcare advertising industry with data-driven solutions built for the future. Built purposefully for healthcare marketers, DeepIntent's platform is proven to drive higher audience quality and script performance. It enables marketers to plan, activate, measure, and optimize their campaigns all within a single platform. Conceived by former Memorial Sloan Kettering data scientists, DeepIntent empowers nine of the top ten pharmaceutical companies and the leading healthcare advertising agencies to improve patient outcomes through the artful use of advertising, data science, and real-world health data.

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PCI Pharma Services Selects Thoughtworks for Digital Platform Transformation with Agile Approach

Thoughtworks | July 11, 2022

Thoughtworks a global technology consultancy that integrates strategy, design and engineering to drive digital innovation, today announced the signing of a multi-year agreement with PCI Pharma Services, a leading global contract development and manufacturing organization. Thoughtworks will help PCI in its journey to digitize its supply chain, with the goal of accelerating the time it takes to bring clients’ life-changing therapies to market for patients. By co-developing tools for digital business modernization, Thoughtworks will help PCI improve client visibility into its clinical and commercial drug supply chains for pharmaceutical and biotech companies of all sizes in 100+ countries. By digitizing the supply chain, Thoughtworks will help PCI deliver greater insights to clients to increase their overall efficiency, support their business goals and ultimately produce high quality treatments for patients. The agreement includes expanding and adapting pci | bridge, an industry first-of-its-kind, end-to-end data platform that provides real-time status of projects, automatically identifies risks, spots trends and provides business analytics insights. With this modern application programming interface (API), clients have the ability to seamlessly integrate their systems with PCI’s, creating greater transparency and a more simplified process for decision-making. “Digital transformation has been a key differentiating factor for PCI’s business strategy, and the evolution of pci | bridge will be critical to increasing client engagement and maximizing the value of data and analytics for PCI and our external partners. With Thoughtworks’ 28+ years of experience at the forefront of innovation, we look forward to making our clients’ lives easier through this partnership." Wayne Hull, Chief Digital and Technology Officer, PCI Pharma Services With a shared commitment to customer-centricity, the Thoughtworks and PCI product and engineering teams will create a new level of intuitive self-service solutions for clients. The partnership will also simplify the collection and analysis of information to reach business insights faster and streamline processes to develop useful new products for clients. The teams will do this by working side-by-side using agile development methods, including pair programming, test-driven development and continuous integration/continuous delivery (CI/CD) automation. “Recognized as a leader in global CDMO services, PCI Pharma Services is well on its digital transformation journey, providing clients with sophisticated supply chain solutions and a digitally integrated experience unlike anything else in the industry,” said Chris Murphy, Chief Executive Officer, Thoughtworks North America. “We are thrilled to partner with PCI Pharma Services as it empowers its clients to make even more powerful, life-impacting decisions through their expansive data and analytics ecosystems.” About PCI Pharma Services PCI is a leading global CDMO, providing clients with integrated end-to-end drug development, manufacturing and packaging capabilities that increase their products’ speed to market and opportunities for commercial success. PCI brings the proven experience that comes with more than 50 successful product launches each year and over five decades in the healthcare services business. We currently have 30 sites across seven countries and over 4,300 employees that work to bring life-changing therapies to patients. Leading technology and continued investment enable us to address global drug development needs throughout the entire product life cycle – from manufacturing capabilities through the clinical trial supply chain and into commercialization. Our clients view us as an extension of their business and a collaborative partner with the shared goal of improving patients’ lives. For more information, please visit pci.com About Thoughtworks Thoughtworks is a global technology consultancy that integrates strategy, design and engineering to drive digital innovation. We are 11,000+ people strong across 49 offices in 17 countries. Over the last 25+ years, we’ve delivered extraordinary impact together with our clients by helping them solve complex business problems with technology as the differentiator.

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Spotlight Therapeutics Appoints Visionary Global Pharma Drug Developer Antoine Yver, M.D., M.Sc. as First Independent Board Member

Spotlight Therapeutics | July 18, 2022

Spotlight Therapeutics, Inc. a biotechnology company applying new insights to develop cell-targeted in vivo CRISPR gene editing biologics, announced the appointment of Antoine Yver, M.D., M.Sc. to the Spotlight Board of Directors. Trained as an oncologist and immunologist, Dr. Yver’s extensive industry experience and perceptive acumen will be extremely valuable as Spotlight continues to strengthen its highly differentiated TAGE platform and advance lead therapeutic candidates towards the clinic. “We are thrilled to welcome Antoine to Spotlight’s Board of Directors. Few people in our industry enjoy such a remarkable track record of successful drug development, exercising extreme rigor in following the science to deliver practice-changing medicines that serve patients with significant unmet medical needs.” Mary Haak-Frendscho, Ph.D., President and Chief Executive Officer of Spotlight As Executive Vice President and Global Head of Oncology R&D at Daiichi Sankyo, Dr. Yver played a key role in the development of the new breakthrough cancer biologic, Enhertu®, that is redefining breast cancer treatment and promises to set a new standard of care, as well as other Daiichi Sankyo DXd ADCs. From 2009 to 2016, Dr. Yver held executive leadership positions at AstraZeneca, including SVP & Global Head of Oncology Development. Under his leadership, Tagrisso® and Lynparza® were successfully developed and commercialized for patients. Prior to joining AstraZeneca, Dr. Yver held roles at Merck, Johnson & Johnson, Aventis and Rhone-Poulenc Rorer. Dr. Yver is Executive Vice President and Chairman of Development at Centessa Pharmaceuticals plc and currently serves as an Independent Director of the Board of Directors at Sanofi. “I am delighted to join the Spotlight Board and support the mission to unlock the full potential of gene editing and enable effective single administration therapeutics for patients,” said Dr. Yver. “Spotlight’s biologics-based delivery approach has the potential to forge a new generation of cell-targeted in vivo CRISPR gene editing medicines across multiple therapeutic areas.” “Antoine’s deep insights and vast global pharma experience will help propel Spotlight to becoming a clinical stage company,” said Craig Gordon, M.D., Spotlight board member, Founder, CEO, and CIO of GordonMD™ Global Investments. “We look forward to working together to impact the strategic decisions of the company that will ultimately provide benefit to patients.” About Spotlight Therapeutics Established in mid-2018, Spotlight Therapeutics is a privately held biotechnology company advancing a pipeline of cell-targeted in vivo CRISPR gene editing therapies. Spotlight's proprietary technology platform TAGE is a new class of biologics, CRISPR effectors engineered for direct delivery in vivo, to achieve cell-selective therapeutic genome editing. Spotlight's pipeline is advancing its modular programmable CRISPR effectors towards clinical studies in immuno-oncology, ophthalmic diseases and hemoglobinopathies.

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Akorn Announces FDA-approved Generic Cetrorelix Acetate for Injection 0.25 mg

Akorn Pharmaceuticals | August 17, 2022

Akorn Operating Company LLC, a specialty pharmaceutical company, announces that it received FDA approval for a generic version of Cetrorelix Acetate for Injection, 0.25 mg. This is the first approved AP-Rated bioequivalent version of Merck Serono's Cetrotide®.1 "We are pleased to announce the first approved AP-rated generic option for women receiving fertility treatments. As an increasing number of infants are being conceived via the use of ART, Akorn is excited to be able to offer a competitively priced option to support women who undergo this series of treatments. This is a welcome addition to our portfolio of more than 200 specialty and injectable generics." Akorn President and CEO Douglas Boothe Assisted Reproductive Technology (ART) is defined as fertility treatments where eggs or embryos are handled for the purpose of establishing a pregnancy. 2 The FDA granted Akorn a Competitive Generic Therapy (CGT) designation for Cetrorelix, a designation intended to incentivize effective development, efficient review, and timely market entry of drugs for which there is inadequate generic competition. As the first approved applicant with the CGT designation, Akorn's Cetrorelix is eligible for 180 days of CGT market exclusivity, which will begin to run from the commercial launch of Cetrorelix. According to IQVIA, U.S. sales of Cetrorelix through June of 2022 were approximately $63 million with full year U.S. sales projection of approximately $127 million. About Cetrorelix Acetate for Injection 0.25 mg Cetrorelix is used to prevent premature ovulation during controlled ovarian stimulation. Cetrorelix blocks the effects of a natural hormone, called gonadotropin‐releasing hormone (GnRH). GnRH controls the secretion of another hormone, called luteinizing hormone (LH), which induces ovulation during the menstrual cycle. During hormone treatment for ovarian stimulation, premature ovulation may lead to eggs that are not suitable for fertilization. Cetrorelix Acetate for Injection blocks such undesirable premature ovulation. About Akorn Akorn Operating Company LLC, develops, manufactures and markets specialty pharmaceuticals. Since 1971, as an industry leader in generic products in alternate dosage forms such as ophthalmics, injectables, oral liquids, otics, topicals, inhalants and nasal sprays, we focus each day on our mission to improve lives, through the quality, availability and affordability of our products.

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PBMs offer a variety of tools to manage specialty drugs, including the use of specialty pharmacies. In doing so, the quality and continuity of care patients receive is improved, while ensuring that they derive the greatest value from their medications.

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