MedCity News
JULY 25, 2022
What is clear is that in person and virtual treatment are not oppositional forces to be pitted against one another, but rather two halves of the same coin as both serve an important purpose — getting help to those who need it.
Pharmaceutical Technology
JULY 25, 2022
The COVID-19 pandemic triggered significant changes to the way healthcare operates. Digitalization is now in full swing as medical care integrates with ICT to take the patient experience to the next level. According to Tom Lenaerts, Head of Global Process Engineering at Datwyler, this transformation will reshape the entire healthcare ecosystem. “There are already opportunities for patients to track their health through smart medical devices sending reports directly to their healthcare provider.
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pharmaphorum
JULY 25, 2022
Sachin Grover, lead of solutions vertical at Philips India, tells me about the company’s innovations during India’s COVID outbreak and how they’ve led to increased healthcare access in the region. There is a vast difference in India’s healthcare system between rural and urban areas, but Philips’ team in the region is working hard to close that gap and improve access to healthcare. “It’s been 75 years since India’s independence.
MedCity News
JULY 25, 2022
Commercial insurers have been focused on developing value-based care payment models and ACOs centered on primary care, while other specialty conditions like behavioral health have remained on the sidelines of alternative payment model development. Though challenging to develop VBC models in this space, it needs to change. Here’s how.
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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud
European Pharmaceutical Review
JULY 25, 2022
The European Commission (EC) has issued a draft proposal for a new EU Regulation on blood, tissues and cells (BTC) to help increase the safety and quality of substances of human origin (SoHO). The Regulation will cover all SoHO (eg, blood, tissues, cells, breast milk and microbiota) except solid organs. A major aim of the proposal is to enhance the protection of recipients of SoHO therapies, as well as donors of SoHO and offspring from medically assisted reproduction.
MedCity News
JULY 25, 2022
Enrollment in Medicare Advantage has doubled over the last decade, and about 45% of the Medicare population choose Medicare Advantage, according to a new report by Better Medicare Alliance.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
MedCity News
JULY 25, 2022
Use of computational software in drug research is growing, and some big tech companies are angling for a piece of this market. Cadence Design Systems is entering the life sciences sector through the $500 million acquisition of OpenEye Scientific, a company that provides computational drug design software to the pharmaceutical industry.
PharmaVoice
JULY 25, 2022
A combined venture with Roivant — called Priovant Therapeutics — is looking to be a forerunner in the burgeoning autoimmune disease market.
MedCity News
JULY 25, 2022
Considering these six forces at play will not only create an inherent competitive advantage, but it will also – more importantly – get populations to take health action and ultimately drive improved outcomes.
PharmaVoice
JULY 25, 2022
The latest trial failures in Alzheimer's have shown cracks in the foundation of ingrained theories like amyloid plaque clearance. What will it take to move forward?
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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.
MedCity News
JULY 25, 2022
Private equity firm KKR teamed up with OMX Ventures to lead the seed investment in Replay, a company developing a suite of technologies that could overcome capacity limitations of adeno-associated viruses used for genetic medicines delivery. Duchenne muscular dystrophy is among the disease targets of the new startup.
Pharmaceutical Technology
JULY 25, 2022
The proportion of pharmaceutical companies hiring for machine learning related positions rose in June 2022 compared with the equivalent month last year, with 26.4% of the companies included in our analysis recruiting for at least one such position. This latest figure was higher than the 24.1% of companies who were hiring for machine learning related jobs a year ago and an increase compared to the figure of 26.3% in May 2022.
MedCity News
JULY 25, 2022
The CEO of SCAN Health Plan has a message for others trying to battle health inequity: get out of the planning phase and learn by doing.
PharmExec
JULY 25, 2022
First-party insights bridge marketing and sales to deliver better HCP experiences.
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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
PharmaVoice
JULY 25, 2022
Inozyme Pharma has joined a genomic sequencing program developing a novel rapid test for 388 genetic diseases.
Copyright Clearance Center
JULY 25, 2022
The post UK Law and Artificial Intelligence: UK IPO Issues Problematic Report appeared first on Copyright Clearance Center.
Map My Customers
JULY 25, 2022
When it comes to sales, some might think planning your territories based on geography, and building genuine relationships with your leads is old-school. And while this can vary based on what you sell, recent Field Sales Leadership Guide podcast guest David Sioma demonstrates that this strategy should not be written off—they can in fact lead to exceptional sales success.
pharmaphorum
JULY 25, 2022
Roche has been trumpeting the rapid uptake of its new eye disease drug Vabysmo as it takes on Regeneron and Bayer’s mighty Eylea in the US – and could soon start making inroads against its rival in Europe. Vabysmo (faricimab) has been recommended by the EMA’s human medicines committee as a treatment for neovascular or wet age-related macular degeneration (AMD) and diabetic macular oedema (DME), so could be fully approved and ready to roll out in the next few months, subject to pricin
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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.
Medico Reach
JULY 25, 2022
Client Background. The client is a Healthcare and Wellness Management company that owns a flagship voice-enabled virtual healthcare assistant platform with 150 years of combined medical experience in the industry. Founded in 2018 in Wayne, PA, the application was built to reduce the burden on the current healthcare system and help people manage their health through a sophisticated AI-powered tool.
PharmaTimes
JULY 25, 2022
Imvanex to include protection from monkeypox and diseases caused by vaccinia virus
Pharmaceutical Technology
JULY 25, 2022
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended an update to the conditional marketing authorization (CMA) to include Moderna ’s 50µg booster dose of Covid-19 vaccine, Spikevax, for usage in adolescents aged 12 to 17 years. As per the recommendation, the booster shot is indicated for use in people of this age group a minimum of three months after they receive the initial vaccine regimen.
pharmaphorum
JULY 25, 2022
AstraZeneca and Daiichi Sankyo will hear back from the FDA before the end of 2022 on their license application for Enhertu in HER2-low breast cancer – an indication which could drive the drug into multibillion-dollar sales territory. The two partners said this morning that the FDA will review Enhertu (trastuzumab deruxtecan) under its real-time oncology review process as well as Project Orbis – a project run by the FDA and other regulators that aims to allow patients faster access to new cancer
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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
PharmaTimes
JULY 25, 2022
Therapy effectively treats adults with active lupus nephritis in Europe
Pharmaceutical Technology
JULY 25, 2022
Concept: Austin-based robotics startup Apptronik has unveiled a humanoid robot named Astro. It is a general-purpose robot that can work alongside humans. Nature of Disruption: Astro is a human-centered robotic system that includes vision-based grasping. It leverages ML technology to find, grab and pick up objects. The robot has modern actuation packed into a small form factor.
Clarify Health
JULY 25, 2022
Chuck Feerick, Vice President, Payer Solutions. When I think about what makes value-based care successful, it’s a pretty simple framework: people, process, and technology. At the AHIP conference in Las Vegas, I was pleased to moderate an insightful session about The Technology and Teams Driving Value-Based Transformation with two of our partners.
pharmaphorum
JULY 25, 2022
Zymergen’s brand new plan to shift from a synthetic biology specialist to a drug discovery player has come to an early end, with the sale of the company to rival Ginkgo Bioworks. The all-stock transaction values Zymergen at an approximately $300 million, a fraction of the $1 billion it raised in venture funding with another $530 million from its initial public offering in April 2021.
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Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic
Pharmaceutical Technology
JULY 25, 2022
AstraZeneca and Daiichi Sankyo have received Priority Review for their supplemental Biologics License Application (sBLA) from the US Food and Drug Administration (FDA) of antibody-drug conjugate (ADC), Enhertu (trastuzumab deruxtecan), to treat unresectable or metastatic HER2-low breast cancer in adults. The treatment is intended for HER2-low immunohistochemistry [IHC] 1+ or IHC 2+/in-situ hybridisation [ISH]-negative breast cancer patients who have previously received treatment in the metastati
pharmaphorum
JULY 25, 2022
The EMA has extended the approved indications of Bavarian Nordic’s smallpox vaccine Imvanex for monkeypox, which has now infected tens of thousands of people across dozens of countries worldwide. Imvanex has been approved in the EU since 2013 for smallpox, a virus related to monkeypox , and according to the CHMP should not be approved to protect adults from monkeypox disease.
Pharmaceutical Technology
JULY 25, 2022
The European Commission (EC) has extended Bavarian Nordic ’s smallpox vaccine Imvanex (MVA-BN or Modified Vaccinia Ankara-Bavarian Nordic) marketing authorisation to offer protection from monkeypox. A non-replicating smallpox vaccine, Imvanex was developed in partnership with the US Government. The move to expand the marketing authorization for Imvanex to include protection from monkeypox and disease caused by the vaccinia virus comes after the European Medicines Agency (EMA) Committee for Medic
pharmaphorum
JULY 25, 2022
The EMA’s human medicines committee has recommended approval of Johnson & Johnson’s Tecvayli as a fourth-line therapy for multiple myeloma , joining a growing group of BCMA-targeted therapies for the blood cancer. Tecvayli (teclistamab) is an off-the-shelf bispecific antibody targeting both BCMA and CD3 which is also under review at the FDA and if approved will slot into J&J’s myeloma therapy portfolio alongside Darzalex (daratumumab) – an antibody directed at CD38 – an
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The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.
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