Fri.Jan 20, 2023

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The impact of climate change on the pharma supply chain

Pharmaceutical Technology

Pharmaceutical supply chains are extremely vulnerable to the effects of climate change and face many challenges from sourcing to distribution. Whether it’s soaring temperatures, extreme cold snaps, or devastating floods, pharmaceutical logistics providers must ensure that shipments reach their destination in their intended condition without defect or delay.

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FDA rejects Lilly Alzheimer’s drug, citing insufficient data

Bio Pharma Dive

The drugmaker had sought an accelerated approval based on promising data from a small mid-stage trial. Results from a larger study are due in the second quarter.

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Moderna takes aim at global expansion plans with manufacturing ramp-up

Pharmaceutical Technology

This week, at the World Economic Forum Annual Meeting, Moderna CEO Stéphane Bancel, said the company plans to build on its exponential growth through the pandemic by expanding its operations globally over the next few years. In 2020, Moderna made a net loss of $747 million while its investigational mRNA vaccines were under development. However, during the Covid-19 pandemic, the US-based biotech rose to prominence as it was one of the first companies to develop Covid-19 vaccines with its mRNA tec

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Why Wall Street shrugged at Lilly’s Alzheimer’s setback

Bio Pharma Dive

Analysts argue the FDA’s choice to decline accelerated approval for donanemab, while surprising, is not the main factor that will determine whether it eventually becomes a commercial success.

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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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Overcoming challenges with scalability in biopharma manufacturing

Pharmaceutical Technology

The demand for mAbs is increasing as they offer patients targeted treatments for a wide range of serious health conditions and diseases. Since the first mAb therapy was approved in 1985, more than 100 mAb treatments are available globally, with hundreds more either in development or awaiting approval. Experts suggest that the current figure in the pipeline is well over 900.

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FDA lifts hold on Astellas gene therapy for Pompe disease

Bio Pharma Dive

The regulator’s decision ends a seven-month study pause that followed a report of one participant experiencing mild symptoms of peripheral neuropathy.

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BeiGene wins expanded approval for leukemia drug, intensifying battle with AbbVie, AstraZeneca

Bio Pharma Dive

The China-based drugmaker hopes Brukinsa’s survival data will help its drug compete with Imbruvica and Calquence.

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Study finds potential association between ROBO2 and anthracycline-related cardiomyopathy

Pharmaceutical Technology

A genome-wide association study (GWAS) published in the Journal of Clinical Oncology has identified a potential association between a genetic variant and anthracycline-related cardiomyopathy in childhood cancer survivors. Anthracyclines are a widely used chemotherapy drug class to treat various forms of cancer. Between 50 and 60% of children with cancer are treated with anthracyclines; however, continuous exposure can lead to cardiac dysfunction, eventually resulting in cardiomyopathy.

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Opinion: The WHO’s new pandemic treaty is good for the world — and the U.S.

STAT News

In December, delegates from more than 180 countries met in Switzerland to discuss the International Treaty for Pandemic Prevention, Preparedness, and Response, which had initially been proposed in December 2021. Support for it gained traction as the Covid-19 pandemic highlighted concerns about global vaccine inequity, genomic data-sharing, and more.

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Friday at the beach in Mogadishu: Optimism shines through despite Somalia's woes

NPR Health - Shots

One of the world's poorest countries, Somalia is coping with conflict, a historic drought and a devastating food crisis. But there's another side to the country. Just take a look at the capital city.

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Buprenorphine deaths did not increase despite wider access during pandemic, study shows

STAT News

The onset of the Covid-19 pandemic led to a sea change in addiction medicine — in particular, increased access to buprenorphine , a drug commonly used to treat opioid use disorder. Now, new data show that despite the medication’s wider availability, deaths involving buprenorphine still constitute a small fraction of overall drug mortality.

Medicine 116
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Regulating immunological memory may help immune system fight disease, study finds

Medical Xpress

Scientists have long sought to better understand the human body's immune responses that occur during various diseases, including cancer and inflammatory diseases.

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Opinion: Even with lawsuits and copay caps, will insulin ever be affordable?

STAT News

In an attempt to tackle the root causes of inflated insulin prices, the state of California filed a lawsuit last week accusing drug manufacturers and pharmacy benefit managers of artificially and illegally jacking up the price of insulin. The sausage-making of how insulin is priced is not for the faint of heart. It’s a complex tangle of drug manufacturers who’ve been resisting generics , health insurance companies trying to keep up impressive profits , plus the wholesalers who dist

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JPM23: Pfizer, Moderna and more look to combine COVID and flu vaccine markets

Fierce Pharma

JPM23: Pfizer, Moderna and more look to combine COVID and flu vaccine markets zbecker Fri, 01/20/2023 - 14:48

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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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Crossed wires? Mixed messages on medicines

pharmaphorum

Leela Barham argues that the latest operational guidance for the NHS in England continues to illustrate a disconnect between the messages in big-ticket policy documents from the central government and the messages from the NHS in England on medicines. With a successor for the 2019 Voluntary Scheme for Branded Medicines Pricing and Access (VPAS) being negotiated and a refresh of the NHS Long-Term Plan being on the to-do list for 2023, there is a chance for more alignment.

Medicine 105
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What is the healthiest cheese? Here are some low-sodium, low-calorie, and low-fat options

Medical Xpress

While the internet is remains agog over the new viral 'Butter Board' trend, snack board purists will remember the blueprint: the charcuterie board. Choc full of cheese, crackers, and occasionally a marmalade and some dark chocolate, the boards are a hallmark of book clubs and housewarmings alike.

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Martin Shkreli runs afoul of FTC for potentially skirting lifetime pharmaceutical industry ban

Fierce Pharma

Martin Shkreli runs afoul of FTC for potentially skirting lifetime pharmaceutical industry ban fkansteiner Fri, 01/20/2023 - 15:34

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Nearly 9 in 10 trans youth say recent wave of anti-LGBTQ policies negatively affected their mental health

Medical Xpress

The recent explosion in anti-LGBTQ rhetoric across the country is dramatically affecting LGBTQ youth—especially transgender and nonbinary kids and young adults—according to a poll released Thursday.

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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

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At the first March for Life post-Roe, anti-abortion activists say fight isn't over

NPR Health - Shots

Seven months after overturning the constitutional right to an abortion, anti-abortion rights activists are celebrating their victories and planning their next steps at their annual march in D.

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Finding a new way: Orienteering can train the brain, may help fight cognitive decline

Medical Xpress

The sport of orienteering, which draws on athleticism, navigational skills and memory, could be useful as an intervention or preventive measure to fight cognitive decline related to dementia, according to new research from McMaster University.

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STAT+: FTC wants ‘pharma bro’ Martin Shkreli held in contempt for violating lifelong ban on working in pharma

STAT News

The U.S. Federal Trade Commission asked a federal judge to hold “pharma bro” Martin Shkreli in contempt for failing to provide the agency with information needed to determine whether he is violating an order that permanently banned him from working in the pharmaceutical industry. In a motion filed federal court in New York, the FTC and seven state regulators argued that Shkreli has failed to comply with their requests to provide documents and sit for an interview as part of their i

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Female and male hearts respond differently to stress hormone in mouse study

Medical Xpress

A new study published in Science Advances shows female and male hearts respond differently to the stress hormone noradrenaline. The study in mice may have implications for human heart disorders like arrhythmias and heart failure and how different sexes respond to medications.

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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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Is mesothelin a key to tackling solid tumors? Some biotech companies are betting that it is

STAT News

On Target is a recurring feature from STAT that dives deep into the most promising drug targets in oncology. This column is adapted from a new STAT report , “Targeting cancer: the new frontier of immunotherapy and precision oncology.” Scientists working to produce immunotherapies for solid tumor cancers have spent decades searching for biological targets that can help them distinguish between healthy cells and cancerous ones.

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Post-Obamacare, more adults with schizophrenia have health insurance

Medical Xpress

The national uninsurance rate for adults under age 65 with schizophrenia decreased by 50% after the implementation of the Affordable Care Act (ACA) in 2014, according to University of Massachusetts Amherst research published this week in JAMA Psychiatry.

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STAT+: Pharmalittle: FDA rejects Lilly application for Alzheimer’s drug; Sanofi offers a warranty for a medicine

STAT News

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is still in the works. For now, we expect to engage in our usual ritual of promenading with the official mascot, take a drive in the countryside with the radio turned up, and hold another listening party with Mrs.

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Rest isn't best: Getting kids back to school sooner after a concussion can mean a faster recovery

Medical Xpress

Contrary to popular belief, rest from school may not always be the best after a concussion, a new study published in JAMA Network Open finds. In fact, an early return to school is associated with a lower symptom burden after suffering a concussion and, ultimately, faster recovery.

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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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STAT+: Up and down the ladder: The latest comings and goings

STAT News

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others.   That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going. And here is our regular feature in which we highlight a different person each week.

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Can blood donors suffer iron deficiency?

Medical Xpress

With the constant need for blood and platelet donations, frequent, regular blood donors are crucial to having a continuous national blood supply. Across Mayo Clinic in Rochester, for example, anywhere between 50 and 70 units of red cells and between 20 and 30 units of platelets are used daily to help save lives.

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AbbVie jacks up Humira price by 8%, joining many other companies with January hikes: report

Fierce Pharma

AbbVie jacks up Humira price by 8%, joining many other companies with January hikes: report kdunleavy Fri, 01/20/2023 - 10:06

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Discovery of 'Goldilocks' effect of nanoparticles offers significant hope for improved vaccines

Medical Xpress

Scientists have discovered there is a "Goldilocks" effect in identifying the size of a "vaccine adjuvant" that can trigger strong immune responses and, as an example, have shown that a safe, biodegradable adjuvant can boost the action of cancer-killing cells—if the particles are the correct size.

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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.