Thu.Oct 13, 2022

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Robotic capsule could replace injected biologics

European Pharmaceutical Review

Scientists at MIT have demonstrated that a novel robotic capsule could potentially replace conventional biologic injection methods by tunnelling through the intestinal mucus barrier to deliver insulin. The research, published in the journal Science Robotics described how the new drug delivery system can transport large protein and small-molecule drugs, like vancomycin, an antibiotic peptide.

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Providence denies ‘disturbing’ debt collection practices alleged by senator

MedCity News

Providence issued a response to a letter sent by Sen. Patty Murray of Washington, in which she demanded the health system answer questions about its alleged efforts to aggressively bill patients who qualified for free or discounted care. The response denied that Providence aggressively pursued its poorest patients for medical debt, asserting that its “commitment to those in need has never been stronger.”.

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Star OUTiCO gears up for Uniphar’s Unity for Hope challenge

Star OUTiCO

Star OUTiCO, as part of the Uniphar Group Commercial & Clinical division, is getting ready for this year’s group Unity for Hope initiative, raising vital funds for seven cancer charities across Ireland, the UK, US, and Australia. Launching on Monday 24 th October, Unity for Hope will see companies spread across the Uniphar Group aim to raise an impressive €100k – to be matched by Uniphar up to a further €100k, by reaching 15,000,000 steps – or equivalent cycle rotations – d

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MedCity Pivot Podcast: A conversation with Gilead Sciences VP Anu Osinusi [Sponsored]

MedCity News

Gilead Sciences is a leader in the field of virology treatments. As VP of clinical research for hepatitis, respiratory and emerging viruses at Gilead, Anu Osinusi talked about the pharma company’s work in HIV and hepatitis and how her personal background informed her team’s work in developing a Covid-19 treatment.

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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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Nanoprinted Microelectrode Array for Brain Computer Interfaces

Medgadget

Researchers at Carnegie Mellon University have used a nanoscale 3D printing technique that allows them to customize the microelectrode arrays used for brain computer interfaces. The approach is called Aerosol Jet 3D printing, and the researchers used it to create three-dimensional microelectrode arrays that can be customized for particular patient needs.

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The tale of two organs: Addressing menopause stigma

MedCity News

Should we start treating menopause as a disease condition? In our view, it’s a chronic disease condition that can go beyond two decades for some women, resulting in silent suffering.

More Trending

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Evernow CEO and founder shares why she started a healthcare startup focused on women over 40 [Sponsored]

MedCity News

In response to emailed questions, Alicia Jackson talked about her healthcare background and how the healthcare startup is responding to a shifting legal landscape for women’s health following the overturning of Roe v. Wade by the U.S. Supreme Court. .

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AI-Designed Custom Knee Implants

Medgadget

Scientists at the University of Birmingham in the UK have trialed Generative Design, a design approach that relies on machine learning and artificial intelligence, to create patient-specific knee implants. At present, knee implants are typically created in a limited range of sizes and shapes. While 3D printing has opened some scope for implants that are adapted to an individual’s orthopedic anatomy, few are created with other important variables in mind, such as the activity level of the patient

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Are retail companies the right fit for home health? Remains to be seen, experts say

MedCity News

Walgreens Boots Alliance recently announced it will acquire its remaining 45% stake in home care company CareCentrix for $392 million. The news follows CVS Health’s plans to acquire Signify Health. While retailers could prove beneficial to home health, it’s too early to tell, experts said.

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Coming out of stealth, RIGImmune aims to catch up with ever-mutating viruses

PharmaVoice

President Susan Sobolov discusses how the startup is building on the work of two powerhouse Yale scientists to advance candidates for viruses — and beyond.

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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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‘Paradoxical’ placebo response spells Phase 3 failure for Relmada depression drug

MedCity News

A Relmada Therapeutics drug candidate for major depressive disorder failed a Phase 3 clinical trial, but the biotech isn’t giving up on its pill yet. It’s pinning its hopes on additional studies testing the therapy as an additional treatment alongside other depression drugs.

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Reuters Pharma 2022 – Day 2 coverage

pharmaphorum

Day 2 coverage: Click here to read Reuters: Pharma 2022 Day 1 overview. Click here or the image below to read Reuters: Pharma 2022 Live coverage. The post Reuters Pharma 2022 – Day 2 coverage appeared first on.

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GoodRx goes ‘provider mode’ with new platform

MedCity News

GoodRx is arguably most well-known for its search platform that allows consumers to compare drug prices across different pharmacies. Now, it has launched a similar platform for healthcare providers. The new platform, called “Provider Mode,” is designed to help providers search for drug cost information while they are conducting appointments with their patients.

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Astellas reports effectiveness of potential treatment for VMS

European Pharmaceutical Review

Astellas will present results from a Phase III clinical study evaluating fezolinetant, an investigational oral, non-hormonal compound being studied to potentially treat vasomotor symptoms (VMS) associated with menopause. Fezolinetant is designed as a selective neurokinin 3 (NK3) receptor antagonist. The SKYLIGHT 4 trial results demonstrate the 52-week safety and tolerability of fezolinetant 30mg and 45mg administered once daily.

Safety 91
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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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Report: States struggle to meet federal regulations for mental health care

MedCity News

The law enacted by Congress in 2008, aims to remove insurance-related obstacles to mental health and substance use disorder treatment, but it hasn’t been enforced effectively and there is a lack of oversight.

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Robotic pills could open a world of possibilities for the biologics market

PharmaVoice

As the oral biologic market heats up, Rani Therapeutics is looking to dominate the field with its robotic pill for treatment of chronic conditions.

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What you need to know about the New York State healthcare bonus program

MedCity News

While much of the world was quarantining and working from home during the Covid-19 pandemic, […].

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Osteoporosis treatment options – down to the bare bones

pharmaphorum

It is World Osteoporosis Day this month, and Ben Hargreaves takes a look at what treatment options look like for patients living with the disease. Osteoporosis is a condition that causes bones to become weak and fragile, making them more likely to break due to a fall or even something as minor as a sudden movement. The condition is the most common chronic bone disease, which is more often seen in the elderly population.

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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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NICE partners with health technology assessment bodies

European Pharmaceutical Review

The National Institute for Health and Care Excellence (NICE) is set to work with five health technology assessment (HTA) bodies to find solutions to common challenges in the sector, such as working with regulators and evaluating digital health technologies. In addition to NICE, the bodies involved are: Canadian Agency for Drugs and Technologies in Health (CADTH).

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GSK says RSV vaccine shows 94% efficacy in severe disease

pharmaphorum

GSK’s vaccine against respiratory syncytial virus (RSV) is one of the top prospects in its pipeline, but also one with considerable competition, so needs strong data to support the programme. Thankfully for the company, it seems to be so. This morning, GSK revealed the results from its pivotal AReSVi-006 trial of the RSV shot – called RSVPreF3 OA – having said earlier this year that the study was positive.

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3 top-of-mind challenges for specialty care and how to overcome them

MedCity News

How can specialty practices most effectively engage undertreated and underserved patients while navigating rising rates of workforce shortages, burnout and the financial pressures that come with operating a practice during a pandemic?

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Oncotelic receives BARDA contract for long Covid-19 therapy development

Pharmaceutical Technology

Oncotelic Therapeutics has received a contract from the US Biomedical Advanced Research and Development Authority (BARDA) to develop OT-101 to treat long-term effects of respiratory distress after Covid-19 infection. Under the contract, the company will collect the long-term clinical data from patients with Covid-19 in Peru and Argentina, where the C001-2020-01 trial was carried out.

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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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GSK’s Phase 3 results make it a top contender in chase for first RSV vaccine

MedCity News

Respiratory syncytial virus has no approved vaccines anywhere in the world, but the chase to bring the first one to the market is heating. GSK reported Phase 3 data that position it for regulatory submissions the pharma giant is planning for later this year. Pfizer is also on track to seek regulatory approvals for its RSV vaccine candidate.

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PharmaLex?seals merger with UK’s NeoHealthHub

PharmaTimes

Agreement will be key to building a pan-European market access practice

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Bayer’s Vividion unit forges $930m cancer alliance with Tavros

pharmaphorum

Bayer’s quest to revamp its drug discovery engine continues apace, with the company’s recently acquired Vividion subsidiary forging an alliance with Tavros Therapeutics, aimed at finding new drug targets and biomarkers in oncology. Bayer bought Vividion for $1.5 billion upfront last year, saying that the company would boost its ability to develop medicines against targets once considered “undruggable” The latest deal extends that effort, with Tavros tasked with using its

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3.2m UK birds culled as record avian flu cases increase

PharmaTimes

Virus can be lethal to humans and its spread is likely to accelerate this winter

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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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Partnering Legal & Library to Empower Teams Across the Drug Development Pipeline

Copyright Clearance Center

The post Partnering Legal & Library to Empower Teams Across the Drug Development Pipeline appeared first on Copyright Clearance Center.

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Inceptor Bio and Avectas partner for CAR-T cell therapies development

Pharmaceutical Technology

Inceptor Bio has partnered with cell engineering technology company Avectas to improve CAR-T cell therapies’ development and manufacturing to treat solid tumours. Under the collaboration deal, Inceptor Bio will use the Solupore technology from Avectas instead of electroporation for engineering T cells to yield a healthier T cell. This non-viral technology is well suited to the CAR-T cell process of Inceptor Bio.

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Digital therapeutic cuts IPF-related anxiety by half in pilot study

pharmaphorum

Swedish digital health company Alex Therapeutics has reported encouraging results in a trial of a digital therapeutic (DTx) for anxiety in patients with the respiratory disease idiopathic pulmonary fibrosis (IPF). The cognitive behavioural therapy-based DTx – called Almee (formerly VP04) – is being developed in collaboration with Swedish drugmaker Vicore Pharma to see if it can reduce the psychological symptom burden in adults diagnosed with IPF , a debilitating and progressive disease with no c

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UK approves prescription-only melatonin drug for childhood ADHD

Pharmaceutical Technology

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has approved Colonis Pharma’s melatonin oral solution for the treatment of sleep-onset insomnia in children and adolescents with attention-deficit hyperactivity disorder (ADHD). The therapeutic is meant for youth with ADHD aged 6-17 years who found sleep hygiene measures inadequate.

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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.