Sanofi plans sales layoffs—again—in primary care, diabetes

Sanofi | April 04, 2019

Sanofi plans sales layoffs—again—in primary care, diabetes
Sanofi has been hit hard by pricing pressure in diabetes, and now the drugmaker’s U.S. sales force is set for another round of job cuts. A spokeswoman said the company is “re-aligning” its sales employees’ “commercial approach to adapt with changing market dynamics.” The company will start the layoffs in June. Sanofi doesn’t “know at this time how many employees will be impacted,” she added. All layoffs will be in the U.S.  Sanofi has been among a number of drugmakers hit by pricing pressure in diabetes in recent years. The layoffs come after the company reported a decline in 2018 sales versus 2017. For years, its diabetes outfit has been a drag, and the unit again lost ground last year. Diabetes sales slipped 13.8% to €4.5 billion in 2018. Back in 2014 and 2015, Sanofi’s diabetes group generated more than €7 billion in sales.

Spotlight

A thorough knowledge of an active pharmaceutical ingredient’s (API) solid state behavior is essential for reliable drug product manufacturing, patent protection, and formulation viability. This article discusses various aspects of the API in the solid state which can impact pharmaceutical product development.

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PHARMA TECH

TransPerfect Life Sciences Introduces Trial Interactive CTMS Solution

Trial Interactive | November 12, 2021

TransPerfect Life Sciences, a leading provider of services and technologies to support global clinical trials and product development for the biopharmaceutical industry, announced the release of the Trial Interactive (TI) Clinical Trial Management System (CTMS). This release marks the industry's only mobile-first CTMS, placing important actions and information at the fingertips of study managers and CRAs and supporting a full author-to-archive process. Trial Interactive delivers user-friendly document and trial management solutions to help pharmaceutical, biotechnology, medical device, and contract research organizations (CROs) effectively streamline product development life cycles. The platform improves speed, quality, and compliance across site identification, site feasibility, study start-up, site personnel training, regulated content management, eISF, and eTMF management. The addition of TI CTMS enables a single source of truth across the entire life cycle, providing transparency into Trial Interactive solutions and any sponsor or CRO systems of record. A fully connected solution, Trial Interactive offers fast-to-implement and cost-effective solutions in a secure 21 CFR Part 11-compliant environment. Designed by clinical professionals for clinical professionals, TI CTMS benefits include World-Class User Experience – The time-saving and pain-free mobile-first interface, with full-text and segmented metadata search, flexible filtering and exports, dark mode, and one-click navigation, creates the industry's friendliest user experience. By Clinical, for Clinical – Enjoy greater efficiency without the hassle, and get started quickly with no heavy configuration required and best practices built into the default configuration. True SaaS Solution – TI CTMS is a single-study or enterprise SaaS solution developed by experts. TransPerfect's award-winning service teams support rapid implementation plans with full validation. Enterprise Ready – With the flexibility to align with large-scale operations, TI CTMS enables enterprises with complex study teams to easily update the system to meet unique requirements and have access to a comprehensive web services API supporting third-party integrations. Author-to-Archive Platform – Streamline processes and oversight with content management solutions supporting the workflow of documents across the life cycle from site and study personnel to the eTMF in one seamless process. As clinical operations become more decentralized, TI CTMS continues Trial Interactive's mission of providing practical innovation to improve the efficiency of global clinical processes while reducing costs. "Having consulted with many organizations and colleagues over the years about CTMS, we've recognized common challenges like time-consuming configurations, difficult navigation, and user experiences that are clearly developed without the input of clinical operations experts. The end result is that existing platforms have fallen short of the features that study managers and CRAs really needTI CTMS was built by clinical professionals for clinical professionals and cuts configuration times while delivering powerful capabilities in a clean user experience that perfectly addresses the needs of sponsors and CROs." Michael Smyth, Division President of TransPerfect Life Sciences TransPerfect President and CEO Phil Shawe stated, "The launch of TI CTMS comes at a time when conducting remote and decentralized clinical trials is more important than ever. The CTMS is connected to our eTMF and other platform solutions to deliver a mobile-first experience that ensures study teams can work effectively and at scale from any location." About Trial Interactive TransPerfect's Trial Interactive is an industry leader in practical eClinical innovation that simplifies and automates clinical processes for sponsors, CROs, and sites around the world. The 21 CFR part 11 compliant unified platform delivers an author to archive collaboration experience with solutions for clinical document management, site selection, site activation, eLearning, compliance training, quality, and more with seamless solution interoperability and indexing to the eTMF. Trial Interactive is consistently selected by clinical professionals for providing the most comprehensive yet intuitive experience with the most complete offering of technology and expert TMF services. Trial Interactive helps study teams streamline their operations by cutting unnecessary expenses, expediting timelines, reducing compliance risks, and improving operational excellence. About TransPerfect Life Sciences TransPerfect Life Sciences specializes in supporting global development and commercialization of drugs, treatments, and devices designed to improve and save lives. Our comprehensive solutions include eTMF and eClinical technologies, paper TMF migration, pharmacovigilance and safety solutions, translation and language services, and call center support. With offices in over 100 cities worldwide, TransPerfect is the ideal partner to ensure that your global launch makes a global impact. About TransPerfect TransPerfect is the world's largest provider of language and technology solutions for global business. From offices in over 100+ cities on six continents, TransPerfect offers a full range of services in 170+ languages to clients worldwide. More than 5,000 global organizations employ TransPerfect's GlobalLink® technology to simplify management of multilingual content. With an unparalleled commitment to quality and client service, TransPerfect is fully ISO 9001 and ISO 17100 certified. TransPerfect has global headquarters in New York, with regional headquarters in London and Hong Kong.

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DTx Pharma to Present at the Chardan Virtual 4th Annual Genetic Medicines Event

Prnewswire | September 29, 2020

DTx Pharma, Inc. (DTx), a privately-held biotechnology company creating novel RNA-based therapeutics to treat the genetic drivers of disease, announced today that Arthur T. Suckow, Ph.D., CEO of DTx Pharma, will be presenting a company overview and will participate in 1x1 meetings at the Chardan Virtual 4th Annual Genetic Medicines Conference on Monday, October 5th, 2020 at 4:45 pm EDT. "At DTx, we are focused on treating the genetic drivers of disease by applying our FALCON technology platform to expand the therapeutic utility of oligonucleotides," said Dr. Suckow. "We look forward to presenting our company at the Chardan Genetic Medicines event and demonstrating the disruptive potential of our FALCON platform in creating the next wave of RNA-based therapeutics."

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PHARMACY MARKET

Fusion Pharmaceuticals has Signed an Agreement to Build a Radiopharmaceutical Manufacturing Facility

Fusion Pharmaceuticals | June 03, 2021

Fusion Pharmaceuticals Inc., a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines; today announced it entered a 15-year lease agreement with Hamilton, Ontario-based McMaster University, to build a 27,000 square foot Good Manufacturing Practice (GMP) compliant radiopharmaceutical manufacturing facility. The facility, to be made by McMaster and equipped and validated by Fusion, will be designed to support the manufacturing of the Company's growing pipeline of targeted alpha therapies (TATs). Fusion expects the manufacturing facility will be operational by early 2024. "Manufacturing and supply chain are critical components of radiopharmaceutical development and commercialization, and with Fusion's expertise, we believe we are well-positioned to create a facility to scale production in support of our growing pipeline and development collaborations," said Fusion Chief executive officer John Valliant, Ph.D. "We will continue to prioritize manufacturing and supply chain infrastructure in our long-term plans, and this facility is an important milestone in executing those plans. The location of the facility, adjacent to our internal research organization and a world-class University that specializes in medical isotope research and training, enables us to efficiently advance new TATs and hire top-tier talent to support our leading portfolio of radiopharmaceuticals." In conjunction with the execution of the lease agreement, Fusion has entered into a services agreement with its long-time partner, the Centre for Probe Development and Commercialization (CPDC), to provide services relating to certain aspects of the validation of this new manufacturing facility. About Fusion Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Employing a proprietary Fast-Clear™ linker technology, Fusion connects alpha particle emitting isotopes to various targeting molecules to deliver the alpha-emitting payloads to tumors selectively.

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Spotlight

A thorough knowledge of an active pharmaceutical ingredient’s (API) solid state behavior is essential for reliable drug product manufacturing, patent protection, and formulation viability. This article discusses various aspects of the API in the solid state which can impact pharmaceutical product development.