Tue.Aug 22, 2023

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What infeasible trial? Lilly shows Roche how it's done with positive Retevmo readout in thyroid cancer

Fierce Pharma

It was only a few weeks ago when Roche said a phase 3 study testing its RET inhibitor Gavreto in a type of thyroid cancer was not doable. | A few weeks ago, Roche said a phase 3 study testing its RET inhibitor Gavreto in a type of thyroid cancer was not doable. Now, Eli Lilly has revealed that a similar trial of its Retevmo was not only feasible but positive.

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Creating the right foundations for omnichannel success

Dominic Tyer

Changing behaviours across commercial organisations will allow pharma to achieve true customer-centricity by delivering the customer experiences its stakeholders demand

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Look out, Teva. Neurocrine's Ingrezza wins Huntington's disease FDA nod to rival Austedo

Fierce Pharma

With a new FDA approval to rival Teva's Austedo, Neurocrine Biosciences’ Ingrezza is debuting in a treatment area with hundreds of millions of dollars of revenue potential. | The FDA approved Ingrezza capsules to treat adult with chorea associated with Huntington’s disease. Ingrezza was first approved in tardive dyskinesia in 2017. With its second approval, the medication’s label now largely stacks up to Teva Pharmaceuticals’ Austedo.

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Innovaccer Unveils AI Suite With Automation Tools For Doctors, C-Suite Execs, Care Managers & More

MedCity News

Innovaccer announced a new suite of healthcare products. It comprises four different solutions — one for answering healthcare executives’ questions about their business metrics, one for automating care planning and documentation, one for generating clinical visit summaries, and one for streamlining workflows at contact centers.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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UK pumps £13M into wide-ranging group of manufacturing projects

Fierce Pharma

Improved vaccines, cutting-edge mRNA medicines and accelerated drug production are at the heart of a new funding project in the U.K., where 17 companies have been selected for government grants to | Improved vaccines, cutting-edge medicines and accelerated drug production are at the heart of a new funding project in the U.K.

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What Are the Highest-rated MA Plans Based on Customer Satisfaction?

MedCity News

Some of the highest-ranked Medicare Advantage plans are SCAN Health Plan, Humana, Excellus BlueCross BlueShield, UPMC for Life and Blue Cross Blue Shield of Texas, according to a new J.D. Power report.

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Here Are 8 Trends for Large Employers

MedCity News

A new Business Group on Health survey revealed several key trends for large, self-insured employers. These trends show a rising prevalence of mental health challenges and a decreasing emphasis on virtual health.

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Teva, Glenmark ?reach $255M price-fixing settlement with DOJ, agree to offload certain meds

Fierce Pharma

After admitting to running a price-fixing scheme as part of a deal with the Department of Justice, not only will generic makers Teva and Glenmark Pharmaceuticals pay hefty fines, but they'll also b | Glenmark Pharmaceuticals will pay $30 million for similar charges. The two will also divest their generic pravastatin products and Teva is required to donate $50 million worth of generics of antifungal cream clotrimazole and antibiotic tobramycin to humanitarian organizations.

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Nashville Entrepreneur Center Gears Up for Virtual Care Delivery Conference September 21 [Sponsored]

MedCity News

Telehealth Academy III, a conference exploring the virtual care delivery landscape, will be one of the highlights of an inaugural week of events organized in the healthcare provider hub of Nashville, referred to as Nashville Healthcare Sessions.

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With new lawsuit, Boehringer Ingelheim becomes latest drugmaker to take aim at IRA

Fierce Pharma

As litigation challenging the Inflation Reduction Act (IRA) piles up, Boehringer Ingelheim has become the latest drugmaker to take aim at the new law. | Boehringer Ingelheim's Eli Lilly-partnered diabetes blockbuster Jardiance will likely make the list of drugs eligible for pricing negotiations, raising the stakes for the company's lawsuit.

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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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Teva, Glenmark To Pay $255M, Divest Cholesterol Drug to Settle DOJ Price Fixing Charges

MedCity News

Generic drugmakers Teva and Glenmark recently became the sixth and seventh drugmakers to resolve criminal charges as a result of the DOJ’s yearslong investigation into generic drug price fixing. The settlement agreement requires both companies to pay hefty fines as well as divest their drug lines for pravastatin, a widely used statin that lowers cholesterol.

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A tale of 2 industries: FDA's Robert Califf weighs in on 'fundamental problem' causing so many shortages

Fierce Pharma

Robert Califf, M.D., is “fired up” about the spate of U.S. drug shortages that now constitutes a “national security threat,” the FDA commissioner said Tuesday. | “I did not come back to FDA to spend all my time on supply chain, but that’s what’s happened,” Commissioner Robert Califf, M.D., said in response to a question about drug shortages during a recent presentation of the Alliance for a Stronger FDA.

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Twitter to 'X' and the Evolving Social Media Landscape for Marketers: Q&A with Mikaela Walker, Marketing and Social Manager at Greater Than One

PharmExec

Amid Twitter's transformation into "X", social media expert Mikaela Walker weighs in on the rebrand's impact for pharma marketing, assesses ongoing brand safety risks, and highlights established social platforms and those gaining traction.

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Novartis to lay off another 100-plus employees at US HQ as global restructuring rolls on

Fierce Pharma

After cutting hundreds of jobs in New Jersey around the start of this year, Novartis is at it again. | Novartis is cutting another 103 jobs at its U.S. headquarters in New Jersey, where the pharma giant just recently executed a 285-person round of layoffs.

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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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UK medicines manufacturing to get innovation boost

European Pharmaceutical Review

According to UK Research and Innovation ( UKRI ), £13 million is set to fund medicine manufacturing in the UK, through a focus on innovation in intracellular drug delivery, digitalisation and automation and nucleic acid medicines. The investment aims to improve vaccines and shorten the time it takes to produce medicines. Winners of a series of competitions centering on the aforementioned topics will obtain funding for UK medicines manufacturing.

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Pfizer's Abrysvo becomes first maternal RSV shot to protect newborns

Fierce Pharma

Already with an approval in hand for older adults, Pfizer’s Abrysvo has become the first vaccine for pregnant women to protect their newborns against respiratory syncytial virus (RSV). | Already with an approval in hand for older adults, Pfizer’s Abrysvo has become the first vaccine for pregnant women to protect their newborns against respiratory syncytial virus (RSV).

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Colon Cancer Screening: Health Empowerment for the Whole Family

MedCity News

While we’re catching a high-risk population through preventive screenings, we are also identifying an entirely separate high-risk population: children of the patients that were just screened and found to have high risk polyps such as greater than 1 cm or with certain advanced characteristics.

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A rare disease research aims to tackle disability discrimination in new lawsuit

PharmaVoice

How a pediatric neurologist is advocating for herself and the disabled community in a legal battle with the Howard Hughes Medical Institute.

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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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Pfizer maternal RSV vaccine approved

European Pharmaceutical Review

Abrysvo is approved for pregnant individuals to prevent lower respiratory tract disease (LRTD) and severe LRTD caused by respiratory syncytial virus (RSV) in infants. The US Food and Drug Administration (FDA)-approved treatment, is the first RSV vaccine indicated for infants from birth to six months of age. It is approved for use at 32 through to 36 weeks pregnancy gestation.

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Ultrasound-Equipped Bra Monitors for Breast Cancer

Medgadget

Researchers at MIT have developed a wearable ultrasound system that is intended to allow women at high risk of breast cancer to perform an ultrasound scan on themselves at home, and may also let patients with early-stage malignancy or suspicious lesions to monitor how they are progressing. The technology can help patients to avoid having to attend a clinic, and may also help them to identify tumors that arise between routine breast checks at a clinic.

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NICE recommends Amryt’s Filsuvez for rare skin disorder

PharmaTimes

Around 670 people in England with epidermolysis bullosa will benefit from the treatment - News - PharmaTimes

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3D Printed Heart Muscle Beats

Medgadget

Researchers at the Harvard John A. Paulson School of Engineering and Applied Sciences have developed a technique that allows them to 3D print a heart ventricle, that can then go on to beat rhythmically. The technology could allow researchers to create heart models to test new cardiac drugs and may even pave the way for fully implantable cardiac components.

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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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Research shows new technique could cut time to detect polio in half

PharmaTimes

This is the first time that this type of scientific method has been used to detect polio - News - PharmaTimes

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Drug Delivery System for Ectopic Pregnancy

Medgadget

Researchers at Oregon State University have developed a drug delivery system that is intended to treat ectopic pregnancy. Often occurring in the fallopian tubes, ectopic pregnancies are non-viable and are the leading cause of maternal death in the first trimester. A drug called methotrexate can be administered to end the pregnancy, but can cause serious side-effects at the concentrations required.

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How Aizon Helps Leading Biotech Company Use AI to Improve Yield

PharmaTech

This case study shares why a leading biotech company reached out to Aizon to identify how artificial intelligence (AI) could be used to further optimize yield. The team was able to analyze five years of historical batch data to discover a direct correlation between hold up volume and time between process operations as well as generating millions of additional recovered revenue.

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Alternative payment models: emerging trends and opportunities for payers

Clarify Health

Today’s healthcare consumers are seeking a different kind of healthcare experience. Patients want more control over their healthcare choices and transparency into the cost and quality of services they receive. The healthcare industry’s shift away from traditional fee-for-service payment models to alternative payment models (APMs) that provide incentives for the quality of outcomes is helping providers and health plans meet those evolving patient expectations.

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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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Maternal Infant Care Product Sales With Mignon Blanc

Evolve Your Success

Adaptability, positivity, and strong relationships are the heartbeat of success in maternal infant care product sales. Embrace the challenge, cultivate partnerships, and let innovation guide your journey to triumph. In this episode, our host Samuel Adeyinka sits with Mignon Blanc as she takes us on a journey through her remarkable career as a product specialist in Maternal Infant Care.

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FDA Approves Ipsen Fibrodysplasia Ossificans Progressiva Treatment

PharmaTech

Ipsen’s Sohonos (palovarotene) capsules are designed to reduce new, abnormal bone formation in soft and connective tissues in individuals with fibrodysplasia ossificans progressiva, a rare bone disease.

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Levita® Magnetics Wins FDA Clearance for Pioneering MARS™ System

Legacy MEDSearch

Levita Magnetics, whose mission is to help more patients get access to better surgery, announced today it has received U.S. Food and Drug Administration (FDA) clearance for its MARS platform. The Levita MARS system is a first-of-its-kind minimally invasive surgical platform aimed at the high-volume abdominal surgery market. Harnessing the power of both magnets and machines, MARS reduces the number of incisions and enables surgeons to have complete control during laparoscopic procedures, all in a

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Willow Biosciences Announces Collaboration with Biopharma Company

PharmaTech

The collaboration partner for Willow is focused on more sustainable methods to manufacture intermediates and APIs at reduced cost and less waste, in addition to looking for Willow’s expertise in developing and scaling key ingredients.

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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.