Merck’s oral MS drug finally gets FDA okay

Merck | April 03, 2019

The US approval for relapsing/remitting and secondary progressive MS comes a couple of years after Merck won European approval for Mavenclad (cladribine), and several years after the first generation of oral MS therapies emerged to steal market share for older, injectable therapies such as Merck’s own Rebif beta interferon brand. Despite its late appearance, analysts think Merck could finally have a blockbuster on its hands, now that safety concerns behind the regulatory days in both the US and Europe seem to have been overcome. Merck KGaA fought for years to get the drug approved after rejection by the FDA and EMA, which was concerned that the drug could be linked to cancer. As it turns out, the drug has been approved in the US with a black box warning for an increased risk of cancer and birth defects, as well as a label that only supports second-line use of the drug. GlobalData suggested recently that Mavenclad has good efficacy compared to rivals such as Biogen’s Tecfidera (dimethyl fumarate), Novartis’s Gilenya (fingolimod) and Sanofi’s Aubagio (teriflunomide), as well as a favourable dosing regimen and several years of additional safety data from its protracted clinical trials programme.

Spotlight

When monitoring the temperature of an environment, the proof is just as important as the result. From food and beverages to pharmaceutical applications, ensuring the results gained from temperature mapping equipment are valid and precise is vital.

Spotlight

When monitoring the temperature of an environment, the proof is just as important as the result. From food and beverages to pharmaceutical applications, ensuring the results gained from temperature mapping equipment are valid and precise is vital.

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Elligo Introduces AI-Driven Clinical Research Study Technology to Expedite Trials

Elligo Health Research | January 25, 2023

On January 24, 2023, Elligo Health Research®, the leading healthcare-enabling research organization, presented the DataAI Connect, a new data and technology platform that will facilitate data-driven, rapid clinical research. DataAI Connect, a scalable, end-to-end data platform, optimizes the clinical research workflow by decreasing human error and rapidly digesting patient data to speed up clinical studies. Elligo has created an industry-first AI-driven platform that sources, processes, analyses, and distributes patient real-world data (RWD) by bringing together data, processes, and clinical expertise. That means an end-to-end solution that solves clinical trial issues directly rather than being an add-on technology. The platform is adaptable and reusable, and it includes the following An RWD repository of electronic health records (EHRs) and clinical data storage that incorporates EHR, clinical trial, and patient data for analytics, artificial intelligence (AI), and research A comprehensive medical records retrieval and analytics solution that transforms data into searchable, actionable insights and personalized patient journey information within minutes using NLP, ML, and clinical experience. A data-driven protocol development service that puts designs to the test in the real world. Elligo's Chief Data Officer, Michael Ibara, commented, "The application of AI approaches to healthcare and clinical study data is moving from the moon-shot approach to more practical applications." He added, "An example of this approach is the process of getting patients' medical records, which involves manual, non-scalable activities such as getting accurate information on patients' providers, asking sites to track down records, and having humans triage hundreds of pages of medical records. The judicious and intelligent application of natural language processing (NLP), machine learning (ML), and other AI approaches increases speed, accuracy and quality, while removing the burden from the sites and patients." (Source – Business Wire) About Elligo Health Research Founded in 2016, Elligo Health Research® is a leading healthcare-enabling clinical research organization. With access to known patients and their HIPAA-compliant healthcare data, its IntElligo® Research Stack technology and eSolutions Research Accelerator PatientSelect approach expedite clinical trials through healthcare. Elligo's Site Solutions, combined with the largest Known Patient Access Network, enable healthcare practices and research sites to engage in clinical studies. Its services expedite the development of novel pharmaceutical, biotechnology, medical device, and diagnostic products through the adaptive involvement of known patients and clinicians.

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BUSINESS INSIGHTS, PHARMA TECH

Arrowhead Pharmaceuticals Announces $25 Million Milestone Payment from Amgen

Arrowhead and Amgen | December 21, 2022

Arrowhead Pharmaceuticals Inc. announced a $25M milestone payment from Amgen. This milestone was triggered by the first subject enrolled in Amgen’s Phase 3 trial of olpasiran. Arrowhead is further eligible to receive up to an additional $535 million in aggregate development, regulatory, and sales milestone payments from Amgen and Royalty Pharma plc. “We are pleased with the great progress on the clinical development of olpasiran, which was developed using Arrowhead’s proprietary TRiMTM technology. This is an important milestone for the program and for Arrowhead, as this is the second TRiMTM-enabled candidate to enter Phase 3 studies. Importantly, as our pipeline continues to advance expeditiously, we anticipate multiple Arrowhead therapies will also reach Phase 3 trials over the coming year.” Christopher Anzalone, Ph.D., Arrowhead’s president and CEO Olpasiran is a small interfering RNA originally developed by Arrowhead using its proprietary Targeted RNAi Molecule, or TRiM, platform and licensed to Amgen in 2016. It is designed to lower levels of lipoprotein(a) (Lp(a)), a genetically determined risk factor for cardiovascular disease. Phase 2 study results from the OCEAN(a)-DOSE study were presented at the American Heart Association Scientific Sessions 2022, where olpasiran demonstrated a significant and sustained reduction in Lp(a) levels over 36 weeks. These data were simultaneously published in the New England Journal of Medicine on November 6, 2022. About Lp(a) Lp(a) is genetically determined1-3 and a presumed independent risk factor for cardiovascular disease. Although an agreed upon threshold for elevated Lp(a) is not firmly established, approximately 20% of adults have Lp(a) >125 nmol/L (or approximately 50 mg/dL).1 Evidence has emerged from pathophysiological, epidemiologic, and genetic studies on the potential role of elevated Lp(a) in contributing to myocardial infarction, stroke, and peripheral arterial disease.3 About Arrowhead Pharmaceuticals Arrowhead Pharmaceuticals develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.

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Certara Acquires AI Company Vyasa to Boost Scientific Innovation

Certara | January 05, 2023

Certara, Inc. announced the acquisition of Vyasa Analytics, LLC, which offers scalable deep-learning software that enables life sciences enterprises to make predictions and answer complicated queries across structured and unstructured bio-medical data. The acquisition will improve Certara's software by giving its end-to-end platform cutting-edge artificial intelligence (AI) features. Certara said it was excited to announce that it had bought Vyasa, a cutting-edge company that would improve its software platforms and give it more options across many product lines. It went on to say that by introducing AI into its product line, the company is establishing capabilities that will allow it to maintain its leadership in biosimulation use cases in drug research and development. Established in 2017, Vyasa software offers businesses a revolutionary artificial intelligence-powered platform that allows them to integrate and analyze material across their company data landscape. LAYAR is a flexible, modular data fabric that can be used to analyze numbers, words, and pictures. It is Vyasa's most important product. It uses artificial intelligence to help people make better decisions during all stages of drug development. About Certara Certara, a pharmaceutical manufacturing firm with headquarters in Princeton, is focused on accelerating the creation of medications by transforming the traditional drug discovery and development process utilizing its biosimulation software, technology, and services. There are around 2,000 biopharmaceutical businesses, academic institutions, and regulatory bodies from 62 countries among its clientele.

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