Thu.Aug 25, 2022

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What is pharma’s responsibility for online health information?

World of DTC Marketing

Research has shown that 74% of all U.S. adults use the Internet, and 61% have looked for health or medical information on the Internet. Additionally, 49% have accessed a website that provides information about a specific medical condition or problem. Many people get health information from the Internet but are left on their own to determine if it’s credible.

Doctors 227
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Blister material as a source of nitrosamine impurities

European Pharmaceutical Review

Following numerous recalls, the industry is striving to investigate the causes, sources and ways to mitigate carcinogenic nitrosamine impurities. In a recent paper, published in the International Journal of Pharmaceutics , researchers identified nitrocellulose blister packaging as a potential source of N -nitrosodimethylamine (NDMA) and N -nitrosodiethylamine (NDEA) impurities.

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Smart Socks Help Prevent Falls Among At-Risk Patients

Medgadget

Researchers at the Ohio State University Wexner Medical Center have tested the PUP (Patient is Up) Smart Socks, developed by a medtech company called Palarum , in their ability to reduce falls among at-risk patients. The socks contain pressure sensors that alert caregivers when a patient is attempting to stand up. This can include situations such as a patient getting out of bed to go to the toilet.

Patients 127
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In the current venture climate, tech for pharma is recession-proof

MedCity News

Specialty drugs reportedly reached 50 percent of all drug spending in 2020, a figure that has increased significantly over the last decade.

Pharma 134
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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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

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EC grants approval for BioMarin’s gene therapy to treat Hemophilia A

Pharmaceutical Technology

The European Commission (EC) has granted conditional marketing authorisation (CMA) for BioMarin Pharmaceutical ’s gene therapy, Roctavian (valoctocogene roxaparvovec), to treat adults with severe haemophilia A (congenital Factor VIII deficiency). The treatment is indicated for patients with no history of Factor VIII inhibitors and any detectable antibodies to adeno-associated virus serotype 5 (AAV5).

Medicine 105
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CMS calls on states to tie Medicaid payments to quality measures for nursing homes

MedCity News

States that do this can improve staffing and outcomes for patients in nursing facilities. Some states, like California and Illinois, have already implemented initiatives that incentivize nursing homes through Medicaid payments.

Patients 117

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Rural Americans have difficulty accessing a promising cancer treatment

MedCity News

After settling in rural New Mexico, a cancer patient had to move 750 miles east and live in a trailer to access CAR-T treatment at the MD Anderson Cancer Center.

Patients 109
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Oncolytic viruses: past and present

European Pharmaceutical Review

IN 2022, treating glioblastoma (GBM) remains an uphill battle. Current therapeutic options show limited success and neuro-oncology teams often struggle to balance their benefits with a patient’s quality of life. Cutting-edge strategies, however, are now revisiting the use of oncolytic viruses – viruses that selectively infect and kill cancer cells – which may broaden and advance the therapeutic landscape.

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Stanford spinout 3T Bio snags $40M for immunotherapies targeted to solid tumors

MedCity News

Artificial intelligence and machine learning are key to 3T Biosciences’ approach to identifying novel drug targets and engineering better, safer cancer immunotherapies. The Stanford spinout is now out of stealth with a $40 million Series A financing and a plan to reach the clinic within two years.

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J&J gets first approval for multiple myeloma bispecific Tecvayli

pharmaphorum

Johnson & Johnson has its first worldwide regulatory approval – in the EU – for Tecvayli, one of two much-anticipated bispecific antibodies the drugmaker has developed for patients with multiple myeloma. The double-headed antibody binds to CD3 on T cells and redirects them to BCMA-expressing myeloma cells, with the aim of stimulating an immune attack on the tumour, which remains incurable despite a slew of new therapies reaching the market in recent years.

FDA 94
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How Machine Learning Drives Clinical Trial Efficiency

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.

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TEFCA promises true data interoperability, but industry must address security challenges

MedCity News

There’s no doubt that a full rollout of Trusted Exchange Framework and Common Agreement (TEFCA will save lives and improve patient care and outcomes. Challenges remain, however, centered on how to maintain data privacy and security as the number of electronic connections increases exponentially among data networks.

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Accelerating timelines for development and manufacture of multi-specific antibodies

European Pharmaceutical Review

Novel treatment options for an array of ever more biologically complex disease modalities require therapies that can simultaneously engage multiple targets. Drug developers have responded by creating diverse families of bispecific (bsAb) and multi-specific antibody (msAb) therapies often comprising three or more polypeptide chains. Depending on the specific product, critical quality attributes, formulation requirements and selected programme design, it is now possible for standard monoclonal ant

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15 million Medicaid/CHIP enrollees will lose coverage after Covid-19 public health emergency ends

MedCity News

Based on historical data, about 17.4% of Medicaid/CHIP enrollees will leave the program once the Covid-19 public health emergency ends. This is because the continuous enrollment requirement, which prohibited states from disenrolling Medicaid participants, will halt.

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Amazon healthcare push shifts with closure of telehealth service

pharmaphorum

Amazon’s ambitious plan to disrupt the healthcare category seems to have had a course correction after the online retail giant announced it plans to shut down its telehealth service Amazon Care. It’s a dramatic change in direction, coming just a few months after Amazon was trumpeting its intention to make the three-year-old telehealth service available to employers nationwide in the US.

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Roles and Responsibilities of Specialized Clinical Supply Experts

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.

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INVEST Pitch Perfect winner: BeCare Link brings MS assessments to patients’ homes

MedCity News

BeCare Link has developed software that enables the traditional in-person multiple sclerosis assessment to be done remotely on a patient’s own mobile device. The startup was named the winner of MedCity’s recent Pitch Perfect contest.

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Efficient water determination accelerates API development

European Pharmaceutical Review

DURING THE development of new types of active pharmaceutical ingredients (APIs) or medicinal products, scale-up at a pilot plant is an important proof of concept. Offering the opportunity to assess the efficacy of a synthesis and refine it prior to production stages, these facilities are both critical and integral to development processes. Various analyses of batches are essential to success, with one of the central quality parameters assessed in pilot plants being water content.

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What do retail and pharmacy have in common? How RFID technology can serve as part of a comprehensive solution to diversion

MedCity News

Understanding the tools and technology being used throughout the medication pathway, including how RFID supports drug diversion monitoring and prevention, is important now more than ever.

Retail 98
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Sandoz to become standalone company

European Pharmaceutical Review

Novartis has announced that it intends to separate Sandoz , its generics and biosimilars division into a new publicly traded standalone company. The 100 percent spin-off aims to establish Sandoz as the premier European generics company and a global leader in biosimilars, maximising shareholder value. For both the Innovative Medicines and Sandoz businesses, the spin-off would enable enhanced focus and the ability to pursue independent growth strategies.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

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.

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Koye Pharma allies with Sonde on vocal biomarkers for COPD

pharmaphorum

Indian drugmaker Koye Pharma has partnered with Sonde Health to develop its vocal biomarker technology – which aims to diagnose diseases from voice patterns – for use in chronic obstructive pulmonary disease (COPD). Mumbai-based Koye is the first pharma company to partner with Sonde Health on the technology, which is also being used in a standalone app to monitor people’s mental health and wellbeing.

Pharma 84
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Genetic mapping reveals cancer growth

Teachntest

Genetic mapping reveals cancer growth Genetic mapping refers to the techniques used to determine the location of a gene and the distances between genes. The distances between different sites within a gene can also be described using gene mapping. The goal of all genome mapping is to place a collection of molecular markers on the […].

Pharma 82
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Twice yearly HIV treatment approved in Europe

European Pharmaceutical Review

The European Commission (EC) has granted marketing authorisation to a new, twice yearly treatment option for people whose HIV no longer effectively responds to their current therapy. Gilead’s Sunlenca ® (lenacapavir) injection and tablets was granted authorisation in adults with multi-drug resistant HIV infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen.

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What Distinguishes COVID-19, the Flu, and RSV?

Teachntest

As though nurturing wasn’t sufficiently hard, COVID-19 has made the “wiped out kid questions” really befuddling: Is it simply a cold or something different? Might I at any point send my youngster to school? When would it be a good idea for me to call their medical services supplier? “Each youngster goes through a test […].

Medical 76
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Accelerating Clinical Supply Through Integrated Drug Development

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.

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Imre adds Two Pharma Industry Leaders to Strengthen Practice Expertise

PharmExec

Sam Ingram and Hui Tang reinforce the agency's commitment to digital experience and data & analytics.

Pharma 97
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Janssen’s teclistamab gets CMA from European Commission

PharmaTimes

Teclistamab is the first bispecific antibody worldwide to be approved for patients with relapsed and refractory multiple myeloma

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Health Innovators – Amy Abernethy and Jennifer Goldsack Part Two

pharmaphorum

Verily’s Amy Abernethy and DiMe’s Jennifer Goldsack return for a second conversation on data and healthcare, this one focusing on specific use cases and examples. In part two, Jenn and Amy talk a little more about the work they do and list out some of the most promising use cases for data-driven approaches in healthcare including clinical research and chronic care.

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Alpha Cognition announces bioequivalence study results for Alzheimer’s

PharmaTimes

In 2019, there were over 850,000 people with dementia in the UK, representing one in every 14 people aged 65 and over

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

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

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Miracor Medical Announces FDA IDE Approval For PiCSO® Pivotal Study

Legacy MEDSearch

Miracor Medical SA (Miracor Medical) has announced the approval of an Investigational Device Exemption (IDE) from the FDA, enabling the company to initiate a pivotal study with its Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) technology. The PiCSO-AMI-II multicenter, randomized trial will enroll 300 patients with anterior ST-segment Elevation Myocardial Infarction (STEMI) presenting with TIMI flow 0, 1, and 2 within 12 hours of symptom onset.

Medical 52
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Sonoma signs deal to set up manufacturing centre for cell therapies

Pharmaceutical Technology

Sonoma Biotherapeutics has signed a lease agreement for setting up an 83,000ft² research and development (R&D) and manufacturing centre for cell therapies. The centre, which will expand the company’s operations in Seattle, US, will aid in the R&D and manufacturing at scale its gene-modified regulatory T cell (T reg ) therapy pipeline for autoimmune and inflammatory ailments.

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AI-derived cancer vaccines: the pharmaphorum podcast

pharmaphorum

Today on the pharmaphorum podcast, Editor in Chief Jonah Comstock welcomes Hedi Ben Brahim and Eric Quéméneur, CEO and chief science officer respectively of Transgene, to discuss cancer vaccines in general and Transgene’s recent work in the space in particular. . Topics include: how cancer vaccines differ from other vaccines, how AI is driving the creation of new therapeutic cancer vaccines, how cancers evade the immune response, and TG4050, the newest drug candidate Transgene presented recentl

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Financial Markets Sneeze – Biotech Industry Analysis 2022

Medico Reach

Financial markets around the world saw the peak of Biotech indices in 2021. The people who saw this as an investment opportunity soon discovered it was not the case. The volatile nature of the stock market hit this sector severely. Biotech Radar founder Bertrand Delsuc commented, “It’s more of a total eclipse for Biotech, at least on the public markets.” In this article, we’ll do thorough Biotech industry analysis and find how financial markets impact Biotech companies.

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

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.