EMA announces medicine approval recommendations from November meeting

European Pharmaceutical Review | November 18, 2019

The European Medicines Agency’s (EMA) human medicines committee (CHMP) has announced the results of its November 2019 meeting, recommending seven medicines for approval. The committee suggested granting a marketing authorisation for Isturisa (osilodrostat), a treatment for Cushing’s syndrome, a disorder that occurs when the body produces too much corticosteroid hormone. Mayzent (siponimod), for the treatment of adult patients with secondary progressive multiple sclerosis and Sunosi (solriamfetol), for the treatment of excessive daytime sleepiness in patients with narcolepsy and obstructive sleep apnoea, both received a positive opinion from the committee. Tavlesse (fostamatinib) also received a positive opinion from the CHMP to treat primary immune thrombocytopenia, an acquired immune-mediated disorder characterised by the destruction of platelets and impaired platelet production. A conditional marketing authorisation was recommended for Polivy (polatuzumab vedotin) indicated for relapsed/refractory diffuse large B-cell lymphoma.

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Suvoda and N-SIDE Announce Agreement to Deliver Integrated Clinical Trial Optimization and IRT Solutions for Real-Time Demand Planning

Suvoda LLC | May 13, 2022

Suvoda LLC, a global clinical trial technology company that specializes in complex studies in therapeutic areas such as oncology, central nervous system, and rare disease, today announced they have entered into an agreement to partner with N-SIDE — a deeptech company that empowers organizations in the clinical trials industry to make better decisions and optimize the use of critical resources.  To date, the two companies have successfully partnered on more than 100 clinical trials in drug development, activating machine learning based on real-time data and increased efficiency in trial supply. Suvoda's IRT enables the implementation of optimized resupply strategies with adapted IRT algorithms that seamlessly integrate N-SIDE's forecasting and mathematical optimization recommendations. This results in significant cost savings through reduced drug wastage and accelerated trial timelines. Partnership Delivers Faster Start and Flexible Supply Strategy The most successful forecasting and optimization strategies consider the end-to-end supply chain, including impact assessments of trial design decisions. Efficient strategies — like the ones jointly deployed by N-SIDE and Suvoda — must be carefully evaluated and implemented, and have the flexibility to adapt in real-time to the unknowns that come with clinical trials. "As global clinical trials grow more complex, clinical trial professionals need the right partners and tools to help them gain control and account for the 'what ifs' as quickly as possible. N-SIDE has a history of excellence in clinical supply optimization that is unrivaled in the industry, and Suvoda is known for delivering clinical trial technology solutions that are built to manage change quickly. Our seamless integration and deep expertise will enable study teams to focus on other day-to-day decisions, while giving them peace of mind in their drug supply strategy." Anthony Encarnacao, Vice President, Global Partnerships for Suvoda This partnership allows for the inclusion of a flexible IRT solution during the development of the trial protocol, giving Suvoda greater visibility into the supply chain parameters based on the protocol discussions and finalization. Moving IRT more upstream in the startup process helps mitigate the risks and time constraints associated with last minute IRT implementations. Clients also gain access to N-SIDE's real-time monitoring of recruitments, demands, and inventories, supported by Suvoda's data. Coupled with N-SIDE's optimization, sponsors and CROs will experience an expedited IRT contracting, set-up, and build process, with greater optimization after study go-live. "In a world where decisions are made every day by different teams, with different objectives, it is easy to forget the impact that decisions have outside of one's team," explains Amaury Jeandrain, head of BD engineering at N-SIDE. "We connect clinical operations, supply chain, manufacturing, and IRT to ensure a global optimum that reduces drug waste while increasing patient centricity and accelerating trial timelines. And, working with partners like Suvoda, who understand this challenge and are able to bring flexibility and efficiency within their solutions, is a big step towards this objective." About Suvoda Suvoda is a global clinical trial technology company that specializes in complex, life-sustaining studies in therapeutic areas like oncology, central nervous system (CNS), and rare disease. Founded in 2013 by experts in eClinical technologies, Suvoda empowers clinical trial professionals to manage the most urgent moments in the most urgent trials through advanced software solutions delivered on a single platform. Headquartered outside Philadelphia, Suvoda also maintains offices in Portland, OR, Barcelona, Spain, Bucharest, Romania and Tokyo, Japan. The company consistently boasts a Net Promoter Score (NPS) of close to 70, far exceeding the technology industry average of 50, and has been selected by trial sponsors and CROs to support more than 1000 trials across 65 countries. About N-SIDE N-SIDE is a deeptech company that empowers organizations in the life sciences to make better decisions and optimize the use of critical resources. We're doing so by combining deep industry expertise with applied mathematics and artificial intelligence into easy to use and cutting-edge software that transforms uncertainty and complexity into clear decisions. We have been an active player in clinical trial supply chain management for over 20 years and work with the majority of the top 20 pharmaceutical companies. With our software solution, the N-SIDE Suite, and expert services, we streamline the clinical supply of pharmaceutical and biotech companies by accelerating clinical plans, mitigating risks and curbing drug waste. We empower clinical leaders to make better, faster, and safer decisions for patients waiting for life-changing medications. Our successes on over 10,000 trials include an average of 20%-60% of drug waste and cost reduction, with no delays due to drug shortages and an acceleration of 2-6 months of clinical trial timelines.

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MRM Proteomics, Inc. and Agilent Technologies, Inc.: A Collaboration for Progress

MRM Proteomics, Inc. | February 04, 2022

MRM Proteomics, Inc. (MRMP) and Agilent Technologies Inc. are excited to announce their new co-marketing agreement aimed to further advance the capabilities of quantitative proteomic applications and thereby help the scientific community make impactful, novel scientific discoveries. This new partnership will provide a complete solution for quantitative protein and metabolite analysis. Agilent’s advanced expertise and state-of-the-art mass spectrometry technology, along with MRMP’s leadership and experience in peptide and metabolite quantitation will enable the development of new tools and technologies to advance the field of multi-omics. MRMP has developed an array of easy-to-use assay kits designed for “absolute” protein and metabolite quantitation in clinical and/or research biological samples, incorporating Agilent’s robust and sensitive HPLCs and mass spectrometers for analyte separation and detection. The new Agilent 6495C LC/MS Triple Quad, coupled online to an Evosep One HPLC system, allows for higher multiplexity, enabling a greater number of metabolites and proteins to be quantified in significantly less time. Via this partnership, MRMP is excited to develop novel kits specifically designed for the Agilent/Evosep platform, including biological pathway- and disease-specific kits, useful to those in the multi-omics field. Additionally, MRMP commits to hosting regular hands-on and virtual workshops focused on teaching innovative techniques in targeted quantitative proteomics. Participants will learn the essentials of proteomics workflows, sample preparation methodologies, Agilent’s LC/MRM-MS set-up, and data analysis using the popular, open source and readily available Skyline software™. Training in the operation of the Evosep LC system will be included in these programs. Quote from Jennifer Gushue, Associate Vice President of Mass Spectrometry Marketing “The new targeted proteomics workflows that have been developed through our collaboration with MRM Proteomics and Evosep will improve quantification of protein targets in clinical research and accelerate drug development in sample limited environments,” said Jennifer, “This collaboration highlights the capabilities of our 6495 LC/MS Triple Quadrupole as a winning combination with Evosep and MRM proteomics for targeted proteomics and our commitment to driving answers for the toughest analytical challenges.” “We are impressed with the scanning speed of the Agilent 6495C triple quad MS and the quantitation accuracy that has been repeatedly demonstrated with the MRM Proteomics kits. This combined workflow demonstrates great potential for future clinical research studies.” Dr Nicolai Bache, Head of Applications, Evosep

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Labcorp Completes Acquisition of Personal Genome Diagnostics

Labcorp | February 21, 2022

Labcorp a leading global life sciences company, announced that it has closed its acquisition of Personal Genome Diagnostics Inc. (PGDx), a leader in cancer genomics with a portfolio of comprehensive liquid biopsy and tissue-based products. The addition of PGDx and its technology complements and accelerates Labcorp’s existing liquid biopsy capabilities and expands Labcorp’s leading oncology portfolio of next-generation sequencing (NGS)-based genomic profiling capabilities, positioning Labcorp at the forefront of driving better patient outcomes in oncology. About Labcorp Labcorp is a leading global life sciences company that provides vital information to help doctors, hospitals, pharmaceutical companies, researchers, and patients make clear and confident decisions. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations to improve health and improve lives. With over 75,000 employees, we serve clients in more than 100 countries. Labcorp (NYSE: LH) reported revenue of $16.1 billion in FY2021.

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Acorda Therapeutics and Biopas Laboratories Announce Agreement to Commercialize INBRIJA® in Latin America

Acorda Therapeutics, Inc. | May 12, 2022

Acorda Therapeutics, Inc. and Biopas Laboratorie announced that they have entered into distribution and supply agreements to commercialize INBRIJA® in Latin America. INBRIJA is indicated in the United States for the intermittent treatment of episodic motor fluctuations in adult patients with Parkinson's disease (PD) treated with a levodopa/dopa-decarboxylase inhibitor. Under the terms of the agreements, Acorda will receive a significant, double-digit, tiered percentage of the selling price of INBRIJA in Latin America in exchange for supply of the product. Acorda will also receive sales-based milestones. Biopas will have the exclusive distribution rights to INBRIJA in nine countries within Latin America, including Brazil and Mexico. According to current population estimates, there are at least 400,000 people living with Parkinson's disease in Latin America1. Biopas plans on seeking marketing authorization in all countries to make Inbrija available for patients as quickly as possible. “BIOPAS is the leader in commercializing CNS therapies in Latin America and we are delighted to announce these agreements to make INBRIJA available there to people with Parkinson’s disease who suffer from OFF periods. We are also in active discussions with other companies for the rights to commercialize INBRIJA in additional countries.” Ron Cohen, M.D., President and CEO of Acorda Therapeutics “We are excited to be collaborating with Acorda to make INBRIJA available to people with Parkinson’s disease in Latin America. This important partnership supports Biopas’ mission to cover unmet medical needs of patients from Argentina to Mexico. Inbrija further strengthens Biopas’ complete and innovative CNS portfolio now consisting of nine original treatments: for Parkinson’s disease, epilepsy, movement disorders, sialorrea, multiple sclerosis, anxiety, and sleep disorders,” said Pascal Forget, CEO of Biopas. About Acorda Therapeutics Acorda Therapeutics develops therapies to restore function and improve the lives of people with neurological disorders. INBRIJA® is approved for intermittent treatment of OFF episodes in adults with Parkinson’s disease treated with carbidopa/levodopa. INBRIJA is not to be used by patients who take or have taken a nonselective monoamine oxidase inhibitor such as phenelzine or tranylcypromine within the last two weeks. INBRIJA utilizes Acorda’s innovative ARCUS® pulmonary delivery system, a technology platform designed to deliver medication through inhalation. Acorda also markets the branded AMPYRA® Extended Release Tablets, 10 mg. About Biopas Laboratories Biopas is a leading and differentiated Latin American Pharmaceutical company, focused on in-licensing, marketing and selling cutting-edge specialty pharmaceutical products. Biopas offers the best-in-class capabilities in sales, marketing, medical, support functions and provides integral services to support the launch and development of products. All its functions operate in compliance with international standards and regulations. Biopas covers 20+ countries in LatAm through fully owned subsidiaries and is a trusted partner of reputable multinational pharmaceutical companies, and has products in leading positions in CNS, Immunology, Rare Disease, Oncology, and Dermatology.

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