Beigene receives its first FDA approval for a MCL drug

Pharmaceutical Technology | November 15, 2019

The accelerated approval was based upon overall response rate (ORR) results from two single-arm trial; ORR data was assessed by an independent review committee. Continued approval of Brukinsa is contingent on a confirmatory trial. In a Phase II trial, 84% of patients receiving Brukinsa achieved ORR, with 59% having a complete response and 24% a partial response. Median duration of response was 19.5 months, and there was an 18.4 month median follow-up time. Similar results were observed in a Phase I/II study; there was an 84% ORR, a 22% complete response rate and a 62% partial response rate, while median response duration was 18.5 months and study follow-up was 18.8 months. Beigene CEO, co-founder and chairman John Oyler said: “Today’s FDA approval of Brukinsa, following the previously granted Breakthrough Therapy designation in this indication, validates it as an important treatment option for people with relapsed or refractory MCL.

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Siemens http://www.siemens.com/pharma invited to a User forum on “Paperless Manufacturing”. Experts discussed benefits and challenges of this key topic. Result: the integration of automation and MES plays a key role. Lower cost, improved quality and streamlined processes can be realized by paperless manufacturing.


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BUSINESS INSIGHTS

Can-Fite Granted Key NASH Patent in Israel

Can-Fite BioPharma Ltd. | May 17, 2022

Can-Fite BioPharma Ltd. a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, announced that its patent titled "An A3 Adenosine Receptor Ligand For Use In Treating Ectopic Fat Accumulation" has been granted by the Israel Patent Office. This patent has been issued in approximately 40 countries and territories including Japan, South Korea, Hong Kong, Mexico, and in the European Union. It addresses the use of the A3 Adenosine Receptor ligand, the target receptor for Can-Fite's drug platform technology, for the treatment of ectopic fat accumulation particularly in fatty liver as manifested in non-alcoholic fatty liver disease and non-alcoholic steatohepatitis. The treatment of NASH is a market estimated to reach $35 billion by 2025. Can-Fite is currently enrolling and treating patients in a Phase IIb NASH study of its liver drug candidate Namodenoson. The multi-center, randomized, double blind, and placebo controlled study of biopsy-confirmed NASH patients will measure efficacy periodically through biomarkers, with a primary efficacy endpoint determined by liver biopsy at the end of the treatment period. In a prior Phase IIa study, Namodenoson met endpoints including reduced liver fat content, anti-inflammatory effects, and decreased body weight with excellent safety. “The treatment of NASH is an enormous unmet need that Can-Fite seeks to meet through our advanced stage clinical trial and our expanding patent estate for the use of our target A3AR in the treatment of fatty liver disease,” Can-Fite CEO Dr. Pnina Fishman About Namodenoson Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor. Namodenoson is being evaluated in a pivotal Phase III trial as a second line treatment for hepatocellular carcinoma, and in a Phase IIb trial as a treatment for non-alcoholic steatohepatitis. A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug. About Can-Fite BioPharma Ltd. Can-Fite BioPharma Ltd. is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, liver, and inflammatory disease. The Company's lead drug candidate, Piclidenoson has completed enrollment in a Phase III trial for psoriasis. Can-Fite's liver drug, Namodenoson, is being evaluated in a Phase IIb trial for the treatment of non-alcoholic steatohepatitis (NASH), and enrollment is expected to commence in a Phase III trial for hepatocellular carcinoma (HCC), the most common form of liver cancer. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company's third drug candidate, has shown efficacy in the treatment of erectile dysfunction. These drugs have an excellent safety profile with experience in over 1,500 patients in clinical studies to date.

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BUSINESS INSIGHTS

Pack4U acquires leading pharmacy technology company Catalyst Healthcare

Pack4U | January 07, 2022

Pack4U, a connected health services company, acquires long-time technology partner Catalyst Healthcare whose patented AdhereNet® platform links pharmacists, patients, and care teams to effectively manage drug complexity and improve medication adherence. "We are dedicated to improving patient outcomes at scale. Bringing this domain knowledge in-house is vital for Pack4U. Catalyst's CEO Shane Bishop is a pharmacy thought leader and we are excited about building the next phase of Pack4U with the Catalyst team on board. Catalyst's proprietary and patented platform strengthens our ability to meet the needs of patients, providers and health plans by offering a full, end-to-end, connected care solution seamlessly integrated with our vast clinical team across all states." Pack4U President, Rahul Chopra Pack4U provides in-home and virtual services that connect patients with pharmacists for oversight, medication delivery, remote monitoring, and care coordination. Our complete suite of connected health IP fortifies Pack4U's ability to personalize care, improve health outcomes, and lower total cost of care across North America. "I am extremely excited to see these organizations come together and to join the team that is transforming in-home healthcare," said Shane Bishop. "Pack4U's extensive and diverse team of pharmacists combined with Catalyst's adherence solutions, create opportunity for a new patient monitoring paradigm. With central fills for scale and community pharmacy adoption, we will reach more people to change more lives." "This collaboration follows our aggressive growth in 2021. It expands our vision of in-home care via a full suite of managed services featuring patient specific, in-home medicine dispensing, always-on patient engagement, electronic medicine administration record and supply chain software for centralized filling," said Rahul Chopra. About Pack4U Pack4U Inc is a tech-enabled health services company. We connect people with community pharmacists to manage drug complexity and maximize health benefits through personalized medication delivery, virtual monitoring, and proactive care. Our fully automated, high-volume central fill pharmacy hubs, proprietary health platform and medication adherence network power a robust, scalable solution to chronic condition management that leads to better patient outcomes and total cost of care reduction.

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BUSINESS INSIGHTS

Clearmind Medicine to Partner with Microdose for Psychedelic Capital

Clearmind Medicine Inc. | March 25, 2022

Clearmind Medicine Inc. a psychedelic medicine biotech company focused on the discovery and development of novel psychedelic-derived therapeutics to solve widespread and undertreated health problems, announced that its CEO, Dr. Adi Zuloff-Shani and Mark Haden, VP Business Development, will be presenting in the Psychedelic Capital: March 2022 virtual event. While the presentation is live streamed, lifetime access to recordings will be available to all ticket holders. About Clearmind Medicine Inc. Clearmind is a psychedelic pharmaceutical biotech company focused on the discovery and development of novel psychedelic-derived therapeutics to solve widespread and underserved health problems, including alcohol use disorder. Its primary objective is to research and develop psychedelic-based compounds and attempt to commercialize them as regulated medicines, foods or supplements. The Company’s intellectual portfolio currently consists of four patent families. The Company intends to seek additional patents for its compounds whenever warranted and will remain opportunistic regarding the acquisition of additional intellectual property to build its portfolio.

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PHARMA TECH

AmerisourceBergen Partners with Chronicled to Optimize Pharmaceutical Chargeback Accuracy Using Blockchain-Powered Technology

AmerisourceBergen | April 22, 2022

Global healthcare company AmerisourceBergen announced its partnership with Chronicled, the administrator of the MediLedger Network, to leverage a new blockchain-powered solution designed to enhance pharmaceutical chargeback accuracy and significantly reduce chargeback rejections. The blockchain solution will allow AB to streamline and optimize the complex process of pharmaceutical chargebacks while creating greater connectivity for its suppliers and customers. Over the past three years, AB has collaborated closely with Chronicled to design and pilot the technology for commercial use. Chronicled provides AB and industry partners with a shared, decentralized infrastructure that offers real-time visibility and contract updates to significantly reduce chargeback disputes and improve pricing accuracy. The blockchain-powered solution effectively enforces the accuracy and integrity of chargebacks submitted across AB’s pharmaceutical supply chain. “At AmerisourceBergen, it’s our responsibility to develop and leverage innovative solutions that create seamless and efficient experiences for our customers and the patients they serve every day. This wouldn’t be possible without trusted partnerships across the supply chain. Being a part of the MediLedger Network and deploying this type of blockchain technology is a crucial step forward in AmerisourceBergen’s ongoing digital transformation journey.” Dina Barton, Vice President, Contracts & Chargebacks at AmerisourceBergen Chargeback errors can occur for many reasons, but always result in manual processing, duplicate effort, and back-and-forth communication between trading partners to resolve them. Suppliers, wholesalers, and GPOs are constantly looking for ways to reduce errors, minimize chargeback disputes, and streamline this process. The Contracts & Chargebacks solution on the MediLedger Network will help AB provide its partner suppliers and GPOs a single source of truth for GPO membership, customer identifier data, and contract pricing data that stays aligned between trading partners on the network. The network itself uses this aligned reference data to enforce chargeback accuracy. Blockchain technology and increased collaboration across the industry are essential in driving efficiencies, reducing costly errors, and significantly improving the chargeback process. "We are excited and thrilled to have AmerisourceBergen join the MediLedger Network," said Susanne Somerville CEO of Chronicled. "We share AmerisourceBergen’s commitment to innovation and driving efficiencies across the industry and look forward to supporting their partners joining the network.” By creating greater connectivity with supplier partners and customers, AB expects this new solution will deliver higher quality results across its supply chain network. 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 42,000 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. About Chronicled Chronicled, a San Francisco-based technology company, enables automation, trust, and automatic settlement for intra-company transactions in the Life Sciences and Healthcare industry. Through the industry leading blockchain-powered MediLedger Network, Chronicled offers trading partners a new way to manage revenue, automate manual processes, and eliminate revenue leakage, while ensuring pricing accuracy and efficiency for health care providers and dispensers.

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Spotlight

Siemens http://www.siemens.com/pharma invited to a User forum on “Paperless Manufacturing”. Experts discussed benefits and challenges of this key topic. Result: the integration of automation and MES plays a key role. Lower cost, improved quality and streamlined processes can be realized by paperless manufacturing.

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