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Rhythm Pharmaceuticals Receives FDA Approval for obesity med targeting genetic defects

Rhythm | December 01, 2020

Stoutness is a significant issue around the world, in any case, for a small amount of patients, hereditary changes instead of propensities are driving the sickness. With its new FDA endorsement for Imcivree, Rhythm Pharmaceuticals is venturing out treating those cases.

For a subset of heftiness patients, hereditary transformations leave them with an "voracious appetite," Rhythm CEO David Meeker, M.D., said in a meeting. Beginning stage hereditary illnesses can leave patients incapable to control corpulence with diet and exercise, and, presently, Rhythm has scored the main FDA endorsement for a focused on medication pointed toward treating them.

Imcivree, once known as setmelanotide, scored a FDA gesture to treat patients who have varieties of the POMC, PCSK1 or LEPR qualities. The medication focuses on the MC4R pathway answerable for directing yearning, and the three qualities remembered for the underlying endorsement are only an initial step, Meeker said. The organization built up a test that takes a gander at around 100 hereditary transformations, and it's trying the medication in other hereditary changes with eyes on expected endorsements down the line.

With obesity, “you can see the forest,” Meeker said, because the problem is everywhere. The challenge is finding patients who could have an underlying genetic mutations causing excessive hunger, he said, noting that “testing becomes key.”

Most people, and most doctors, still think of obesity as a “calories in, calories out,” problem, said Michael Dedekian, medical director of pediatric specialty care at Barbara Bush Children’s Hospital in Maine. Very quickly, though, the medical community’s understanding of obesity is deepening, he said. And, as that’s happening, it’s becoming clear that genetic defects can “wildly disregulate” patients’ hunger. 

With the approval and new knowledge about genetic defects, Dedekian believes the medical community is entering a “whole new era of obesity treatment." Over time, he has no doubt awareness of the genetic mutations driving some cases will increase. When abnormal hunger presents itself in young children, doctors should strongly consider a genetic test, Dedekian said.

Rhythm isn’t planning to deploy a sales force for its initial genetic mutations and will instead focus on “intensive efforts” around disease education and making its test more available, Meeker said. When doctors are confronted with a patient with abnormal hunger, they should be “thinking deep” about the cause, he added.

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The 3-way partnership that is transforming Digital Pharma

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Spotlite360 | July 07, 2021

SPOTLITE360 TECHNOLOGIES, INC. is happy to announce that it has started an initiative to provide tailored supply chain tracing and tracking solutions for pharmaceutical companies, for which it is now in contract discussions with pharmaceutical firms. This effort coincides with an impending regulatory shift in the USD 1.3 trillion pharmaceutical industry1 that will require companies to comply with the Drug Supply Chain Security Act (“DSCSA”), which requires the deployment of electronic tracing systems. The Company has recognized an opportunity to offer solutions to DSCSA compliance by combining RFID and IoT sensors with blockchain, machine learning, and enterprise tracking software licensed from TrackX Holdings Inc. In addition to the cost of complying with new and upcoming laws such as the DSCSA, pharmaceutical sector participants confront the following persistent difficulties in their supply chains: • Every year, about USD 200 billion in counterfeit medicines are sold worldwide. • Pharmaceutical cargo theft costs more than USD 1 billion per year, with a median stolen value of USD 100,000 being more than the industry average. • Inadequate storage and transportation practices (e.g., unrefrigerated trucks, shipment periods that exceed a drug’s shelf life) can cause pharmaceutical damage, which has been highlighted as a multibillion-dollar issue in 2018. The Company’s existing SaaS solution, powered by Spotlite360 technologies tailored to clients in the pharmaceutical industry, will capture real-time and event-driven data that can identify inefficiencies and potential hazards for pharmaceutical firms, potentially mitigating issues such as those listed above. Furthermore, potential benefits to clients in the pharmaceutical industry include accountability of global suppliers, as well as validation of claims relating to environmental, social, and corporate governance (“ESG”) matters by providing proof of origin, reliably authenticating goods, and allowing visibility into the chain of custody. Blockchain technology has already shown to be effective in various pharmaceutical supply chain functions, including DSCSA compliance. In 2020, a major technology company released a study of its blockchain pilot program in collaboration with pharmaceutical behemoth Merck & Co. and the United States Food and Drug Administration (“FDA”), which was judged initially viable as stated in its final report filed to the FDA5. Spotlite360’s newest effort for the pharmaceutical sector aims to set new industry standards by providing an improved value proposition through full visibility and tracking capabilities. About Spotlite360 Technologies Inc. Spotlite360 is a logistics technology solutions provider that unlocks value, opportunities, and efficiency for all supply chain participants. Spotlite360 aims to establish new standards of transparency, integrity, and sustainability in the pharmaceutical, healthcare, and agriculture industries by building on existing applications of IoT technology, distributed ledgers, and machine learning. As authorities worldwide continue to enforce additional tracing and accountability requirements for consumer protection, the need for dependable, cost-effective, and flexible monitoring technology is anticipated to grow. Spotlite360’s flagship SaaS solution has been designed to monitor the movement of a product in real-time by connecting with the systems of all major stakeholders in the supply chain, from raw materials to the hands of the end customer.

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Crescita Therapeutics | December 13, 2021

Crescita Therapeutics Inc. a growth-oriented, innovation-driven Canadian commercial dermatology company, is pleased to announce that it has signed an exclusive commercialization and supply agreement with Egis Pharmaceuticals PLC a leading generic pharmaceutical company in Central Eastern Europe for the rights to Pliaglis in eight countries comprising Hungary, Bulgaria, Czech Republic, Slovakia, Poland, Russia, Latvia and Lithuania. Under the terms of the agreement, Crescita will receive an upfront payment of €0.65M and is eligible for further cumulative sales and regulatory milestone payments over the term of the agreement. Egis will sell Pliaglis through its own commercial infrastructure in CEE and Russia, where the company is well established. Crescita will be the exclusive supplier of Pliaglis at a defined price per unit and will also provide regulatory support to Egis in seeking approval for Pliaglis in the Territories. Egis expects to launch Pliaglis in Poland in early 2023 and will submit the requisite regulatory filings as soon as practicable to ensure that Pliaglis is launched promptly in the other territories. “We are extremely pleased to partner with Egis. With its commitment to innovation, strong international presence and robust sales network, Egis represents a partner of choice in these Territories. Yet again, we have further expanded the footprint of Pliaglis worldwide, where it is now licensed in a total of 40 countries. Pliaglis is a pivotal asset for Crescita and is key to helping unlock the long-term value of our company. We look forward to a strong collaboration with Egis as we continue to secure recurring revenue streams,” added Mr. Verreault." Serge Verreault, President and CEO of Crescita “We are glad to enter such a great and promising partnership with Crescita. Pliaglis will be a flagship product in our new portfolio providing an excellent therapeutic solution in aesthetic dermatology. With its strong R&D focus in dermatology, we hope to further build this partnership and bring additional value-added medical solutions for patients via Egis’ excellent commercial capabilities in the region,” stated Dr. István Hodász, CEO of Egis. About Crescita Therapeutics Inc. Crescita is a growth-oriented, innovation-driven Canadian commercial dermatology company with in-house R&D and manufacturing capabilities. The Company offers a portfolio of high-quality, science-based non-prescription skincare products and early to commercial stage prescription products. We also own multiple proprietary transdermal delivery platforms that support the development of patented formulations that facilitate the delivery of active ingredients into or through the skin. About Egis Pharmaceuticals PLC Egis headquartered in Budapest, Hungary, is one of the leading generic pharmaceutical companies in Central and Eastern Europe. The company’s activities extend to every field of the pharmaceutical value chain: from research and development through the production of active pharmaceutical ingredients and finished drug products to sales and marketing. Egis products are available in 60 countries through its network of subsidiaries and representative offices or partners. About Pliaglis® Pliaglis is a topical local anaesthetic cream that provides safe and effective local dermal analgesia on intact skin prior to superficial dermatological procedures. The formulation contains a eutectic mixture of 7% lidocaine and 7% tetracaine that utilizes Crescita's proprietary phase-changing topical cream Peel technology. The Peel technology consists of a drug-containing cream which, once applied to a patient's skin, dries to form a pliable layer that releases the active ingredients into the skin. Pliaglis is applied to intact skin 20 to 30 minutes prior to superficial dermatological procedures such as dermal filler injections, non-ablative laser facial resurfacing, or pulsed-dye laser therapy and 60 minutes prior to procedures such as laser-assisted tattoo removal. Following the application period, the pliable layer is easily removed from the skin allowing the procedure to be performed with minimal to no pain. In clinical studies, the mean duration of anesthesia has been shown to be in the range of 7 to 9 hours after the application of Pliaglis. Pliaglis is currently approved in over 25 different countries and sold by commercial partners in various countries.

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AmerisourceBergen | October 22, 2021

Today, AmerisourceBergen concluded its second annual ThinkLive Trade virtual event, a three-day online summit geared toward brand, specialty, generic and consumer-product manufacturers. Over the course of the event, AmerisourceBergen leaders discussed the ever-evolving challenges and considerations that these manufacturers face when bringing products to market, and how AmerisourceBergen works with its partners to drive supply chain sophistication, maximize patient access, and move health forward. AmerisourceBergen also introduced its new President of Manufacturer Services and Commercial Solutions, Willis Chandler, during the conference – a new role for the organization.“The last two years have proven how dynamic, fast-paced and essential the pharmaceutical industry and supply chain are to advancing global health—from launching new therapies, to maintaining consistent access to daily prescriptions, to providing frontline workers with the products and resources they need to stay safe amid a pandemic,” said Willis Chandler, who recently stepped into the new role as President of Manufacturer Services and Commercial Solutions from leading AmerisourceBergen’s health systems and specialty services organization. “ThinkLive Trade is an opportune time for us connect with manufacturers and dig deeper into their needs, challenges and opportunities in the year ahead. I plan to carry our key learnings from the conference forward, and I cannot wait to bring more novel solutions to the market in collaboration with our manufacturer partners.” This year’s conference programming included remarks from AmerisourceBergen Chairman, President & CEO Steve Collis, dynamic panel discussions, presentations, awards, virtual networking sessions and more. Content and meetings were facilitated through AmerisourceBergen’s online experience platform, AmerisourceBergenLive. On the first day of the summit, attendees heard directly from AmerisourceBergen executives and customers on the state of the industry, strategies to improve global health equity, and sustainable and responsible approaches to healthcare advancement. Day two of ThinkLive Trade featured discussions on technology and infrastructure enhancements to drive innovation, supply chain continuity​, and AmerisourceBergen’s strategy and focus for the year ahead. The final day of the summit focused on the intersection of healthcare and politics, featuring a fireside chat with, Mark McClellan, MD, PhD, founding Director of the Duke-Margolis Center for Health Policy at Duke University, as well as timely discussions on global generics, specialty pharmaceutical products, biosimilars, and more. “The resilience of the pharmaceutical supply chain in the face of a global pandemic and evolving market dynamics continues to reinforce the value of strategic relationships, Our partners are developing novel therapeutics, creating pharmaceuticals to manage chronic conditions in patients worldwide, producing essential generics to ensure cost-effective medicines are available in today’s marketing, developing consumer products that are essential to fighting this pandemic and beyond, and so much more. We are thankful for their partnership and to all who attended ThinkLive Trade. This week’s conference encouraged meaningful dialogue that will help us advance healthcare efficiency and supply chain reliability in the year ahead.” Janine Burkett, SVP & President, Strategic Global Sourcing at AmerisourceBergen. AmerisourceBergen will also host ThinkLive Commercialization early next year. The event will bring together emerging biotech and biopharma leaders to discuss the latest in launch strategies across different therapeutic categories. About AmerisourceBergen AmerisourceBergen fosters a positive impact on the health of people and communities around the world by advancing the development and delivery of pharmaceuticals and healthcare products. As a leading global healthcare company, with a foundation in pharmaceutical distribution and solutions for manufacturers, pharmacies, and providers, we create unparalleled access, efficiency, and reliability for human and animal health. Our 41,000 global team members power our purpose: We are united in our responsibility to create healthier futures. AmerisourceBergen is ranked #8 on the Fortune 500 with more than $200 billion in annual revenue

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Spotlite360 Introduces Pharmaceutical Industry Initiative for Supply Chain Tracking, Tracing, and Sustainability

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SPOTLITE360 TECHNOLOGIES, INC. is happy to announce that it has started an initiative to provide tailored supply chain tracing and tracking solutions for pharmaceutical companies, for which it is now in contract discussions with pharmaceutical firms. This effort coincides with an impending regulatory shift in the USD 1.3 trillion pharmaceutical industry1 that will require companies to comply with the Drug Supply Chain Security Act (“DSCSA”), which requires the deployment of electronic tracing systems. The Company has recognized an opportunity to offer solutions to DSCSA compliance by combining RFID and IoT sensors with blockchain, machine learning, and enterprise tracking software licensed from TrackX Holdings Inc. In addition to the cost of complying with new and upcoming laws such as the DSCSA, pharmaceutical sector participants confront the following persistent difficulties in their supply chains: • Every year, about USD 200 billion in counterfeit medicines are sold worldwide. • Pharmaceutical cargo theft costs more than USD 1 billion per year, with a median stolen value of USD 100,000 being more than the industry average. • Inadequate storage and transportation practices (e.g., unrefrigerated trucks, shipment periods that exceed a drug’s shelf life) can cause pharmaceutical damage, which has been highlighted as a multibillion-dollar issue in 2018. The Company’s existing SaaS solution, powered by Spotlite360 technologies tailored to clients in the pharmaceutical industry, will capture real-time and event-driven data that can identify inefficiencies and potential hazards for pharmaceutical firms, potentially mitigating issues such as those listed above. Furthermore, potential benefits to clients in the pharmaceutical industry include accountability of global suppliers, as well as validation of claims relating to environmental, social, and corporate governance (“ESG”) matters by providing proof of origin, reliably authenticating goods, and allowing visibility into the chain of custody. Blockchain technology has already shown to be effective in various pharmaceutical supply chain functions, including DSCSA compliance. In 2020, a major technology company released a study of its blockchain pilot program in collaboration with pharmaceutical behemoth Merck & Co. and the United States Food and Drug Administration (“FDA”), which was judged initially viable as stated in its final report filed to the FDA5. Spotlite360’s newest effort for the pharmaceutical sector aims to set new industry standards by providing an improved value proposition through full visibility and tracking capabilities. About Spotlite360 Technologies Inc. Spotlite360 is a logistics technology solutions provider that unlocks value, opportunities, and efficiency for all supply chain participants. Spotlite360 aims to establish new standards of transparency, integrity, and sustainability in the pharmaceutical, healthcare, and agriculture industries by building on existing applications of IoT technology, distributed ledgers, and machine learning. As authorities worldwide continue to enforce additional tracing and accountability requirements for consumer protection, the need for dependable, cost-effective, and flexible monitoring technology is anticipated to grow. Spotlite360’s flagship SaaS solution has been designed to monitor the movement of a product in real-time by connecting with the systems of all major stakeholders in the supply chain, from raw materials to the hands of the end customer.

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BUSINESS INSIGHTS

Crescita Signs Exclusive 8-Country Licensing Agreement with Egis Pharmaceuticals for Pliaglis®

Crescita Therapeutics | December 13, 2021

Crescita Therapeutics Inc. a growth-oriented, innovation-driven Canadian commercial dermatology company, is pleased to announce that it has signed an exclusive commercialization and supply agreement with Egis Pharmaceuticals PLC a leading generic pharmaceutical company in Central Eastern Europe for the rights to Pliaglis in eight countries comprising Hungary, Bulgaria, Czech Republic, Slovakia, Poland, Russia, Latvia and Lithuania. Under the terms of the agreement, Crescita will receive an upfront payment of €0.65M and is eligible for further cumulative sales and regulatory milestone payments over the term of the agreement. Egis will sell Pliaglis through its own commercial infrastructure in CEE and Russia, where the company is well established. Crescita will be the exclusive supplier of Pliaglis at a defined price per unit and will also provide regulatory support to Egis in seeking approval for Pliaglis in the Territories. Egis expects to launch Pliaglis in Poland in early 2023 and will submit the requisite regulatory filings as soon as practicable to ensure that Pliaglis is launched promptly in the other territories. “We are extremely pleased to partner with Egis. With its commitment to innovation, strong international presence and robust sales network, Egis represents a partner of choice in these Territories. Yet again, we have further expanded the footprint of Pliaglis worldwide, where it is now licensed in a total of 40 countries. Pliaglis is a pivotal asset for Crescita and is key to helping unlock the long-term value of our company. We look forward to a strong collaboration with Egis as we continue to secure recurring revenue streams,” added Mr. Verreault." Serge Verreault, President and CEO of Crescita “We are glad to enter such a great and promising partnership with Crescita. Pliaglis will be a flagship product in our new portfolio providing an excellent therapeutic solution in aesthetic dermatology. With its strong R&D focus in dermatology, we hope to further build this partnership and bring additional value-added medical solutions for patients via Egis’ excellent commercial capabilities in the region,” stated Dr. István Hodász, CEO of Egis. About Crescita Therapeutics Inc. Crescita is a growth-oriented, innovation-driven Canadian commercial dermatology company with in-house R&D and manufacturing capabilities. The Company offers a portfolio of high-quality, science-based non-prescription skincare products and early to commercial stage prescription products. We also own multiple proprietary transdermal delivery platforms that support the development of patented formulations that facilitate the delivery of active ingredients into or through the skin. About Egis Pharmaceuticals PLC Egis headquartered in Budapest, Hungary, is one of the leading generic pharmaceutical companies in Central and Eastern Europe. The company’s activities extend to every field of the pharmaceutical value chain: from research and development through the production of active pharmaceutical ingredients and finished drug products to sales and marketing. Egis products are available in 60 countries through its network of subsidiaries and representative offices or partners. About Pliaglis® Pliaglis is a topical local anaesthetic cream that provides safe and effective local dermal analgesia on intact skin prior to superficial dermatological procedures. The formulation contains a eutectic mixture of 7% lidocaine and 7% tetracaine that utilizes Crescita's proprietary phase-changing topical cream Peel technology. The Peel technology consists of a drug-containing cream which, once applied to a patient's skin, dries to form a pliable layer that releases the active ingredients into the skin. Pliaglis is applied to intact skin 20 to 30 minutes prior to superficial dermatological procedures such as dermal filler injections, non-ablative laser facial resurfacing, or pulsed-dye laser therapy and 60 minutes prior to procedures such as laser-assisted tattoo removal. Following the application period, the pliable layer is easily removed from the skin allowing the procedure to be performed with minimal to no pain. In clinical studies, the mean duration of anesthesia has been shown to be in the range of 7 to 9 hours after the application of Pliaglis. Pliaglis is currently approved in over 25 different countries and sold by commercial partners in various countries.

Read More

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Today, AmerisourceBergen concluded its second annual ThinkLive Trade virtual event, a three-day online summit geared toward brand, specialty, generic and consumer-product manufacturers. Over the course of the event, AmerisourceBergen leaders discussed the ever-evolving challenges and considerations that these manufacturers face when bringing products to market, and how AmerisourceBergen works with its partners to drive supply chain sophistication, maximize patient access, and move health forward. AmerisourceBergen also introduced its new President of Manufacturer Services and Commercial Solutions, Willis Chandler, during the conference – a new role for the organization.“The last two years have proven how dynamic, fast-paced and essential the pharmaceutical industry and supply chain are to advancing global health—from launching new therapies, to maintaining consistent access to daily prescriptions, to providing frontline workers with the products and resources they need to stay safe amid a pandemic,” said Willis Chandler, who recently stepped into the new role as President of Manufacturer Services and Commercial Solutions from leading AmerisourceBergen’s health systems and specialty services organization. “ThinkLive Trade is an opportune time for us connect with manufacturers and dig deeper into their needs, challenges and opportunities in the year ahead. I plan to carry our key learnings from the conference forward, and I cannot wait to bring more novel solutions to the market in collaboration with our manufacturer partners.” This year’s conference programming included remarks from AmerisourceBergen Chairman, President & CEO Steve Collis, dynamic panel discussions, presentations, awards, virtual networking sessions and more. Content and meetings were facilitated through AmerisourceBergen’s online experience platform, AmerisourceBergenLive. On the first day of the summit, attendees heard directly from AmerisourceBergen executives and customers on the state of the industry, strategies to improve global health equity, and sustainable and responsible approaches to healthcare advancement. Day two of ThinkLive Trade featured discussions on technology and infrastructure enhancements to drive innovation, supply chain continuity​, and AmerisourceBergen’s strategy and focus for the year ahead. The final day of the summit focused on the intersection of healthcare and politics, featuring a fireside chat with, Mark McClellan, MD, PhD, founding Director of the Duke-Margolis Center for Health Policy at Duke University, as well as timely discussions on global generics, specialty pharmaceutical products, biosimilars, and more. “The resilience of the pharmaceutical supply chain in the face of a global pandemic and evolving market dynamics continues to reinforce the value of strategic relationships, Our partners are developing novel therapeutics, creating pharmaceuticals to manage chronic conditions in patients worldwide, producing essential generics to ensure cost-effective medicines are available in today’s marketing, developing consumer products that are essential to fighting this pandemic and beyond, and so much more. We are thankful for their partnership and to all who attended ThinkLive Trade. This week’s conference encouraged meaningful dialogue that will help us advance healthcare efficiency and supply chain reliability in the year ahead.” Janine Burkett, SVP & President, Strategic Global Sourcing at AmerisourceBergen. AmerisourceBergen will also host ThinkLive Commercialization early next year. The event will bring together emerging biotech and biopharma leaders to discuss the latest in launch strategies across different therapeutic categories. About AmerisourceBergen AmerisourceBergen fosters a positive impact on the health of people and communities around the world by advancing the development and delivery of pharmaceuticals and healthcare products. As a leading global healthcare company, with a foundation in pharmaceutical distribution and solutions for manufacturers, pharmacies, and providers, we create unparalleled access, efficiency, and reliability for human and animal health. Our 41,000 global team members power our purpose: We are united in our responsibility to create healthier futures. AmerisourceBergen is ranked #8 on the Fortune 500 with more than $200 billion in annual revenue

Read More

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