Fri.Apr 01, 2022

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Yet another gene therapy developer turns to layoffs

Bio Pharma Dive

Taysha Gene Therapies is narrowing its research efforts and cutting around 35% of its workforce, the latest in a series of layoffs announced by makers of genetic medicines.

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Parsortix system identifies key drug targets in cancer metastasis

Pharma Times

Study demonstrates ability of the Parsortix system to isolate circulating tumour cells, targeting the metastatic spread of cancer

Drugs 115
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Sanofi API spinout takes step toward market listing

Bio Pharma Dive

French regulators have approved plans by Sanofi to list the new EUROAPI business on Euronext Paris beginning May 6.

Marketing 148
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ICSs – an opportunity to improve Patient & Market Access at a local level

pharmaphorum

With the new Health and Care Bill edging ever closer to receiving Royal Assent, life sciences companies in the UK are preparing to navigate the most significant piece of NHS legislation in a decade. The new bill, which is expected to come into force on 1st July, will see Clinical Commissioning Groups replaced with Integrated Care Systems (ICSs) as statutory bodies across England.

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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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Monkeys routinely consume fruit containing alcohol, shedding light on our own taste for booze

Scienmag

For 25 years, UC Berkeley biologist Robert Dudley has been intrigued by humans’ love of alcohol. In 2014, he wrote a book proposing that our attraction to booze arose millions of years ago, when our ape and monkey ancestors discovered that the scent of alcohol led them to ripe, fermenting and nutritious fruit. A new […].

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NICE recommends flash devices to type 1 diabetes patients

Pharma Times

New technology could reduce finger pricking by 50% while also providing patients with continuous data about blood sugar levels

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How the Medicaid Copay Accumulator Rule Will Hurt Prescription Affordability

Drug Channels

Today’s guest post comes from Fauzea Hussain, Vice President of Public Policy at McKesson. Fauzea succinctly describes the complicated and contradictory aspects of the Centers for Medicare & Medicaid Services' Final Rule on Best Price, a.k.a. the Medicaid copay accumulator rule. She then outlines how the rule, if implemented, is likely to hurt patients.

Drugs 85
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Wildfire smoke exposure in early pregnancy affects infant monkey behavior

Scienmag

Infant monkeys conceived while their mothers were naturally exposed to wildfire smoke show behavioral changes compared to animals conceived days later, according to a new study from researchers at the California National Primate Research Center at the University of California, Davis. The work is published April 1 in Nature Communications. Credit: California National Primate Research […].

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NICE ends UK access disparity to osteoporosis drug Evenity

pharmaphorum

NICE has reversed its stance on UCB and Amgen’s severe osteoporosis therapy Evenity, saying out can be prescribed on the NHS for women with the disease in England and Wales who are at high risk of fractures. The move – which comes after an agreement by UCB to reduce the price of the drug – makes Evenity (romosozumab) the first novel therapy for the bone-wasting condition to be available to the NHS across the UK in more than a decade.

Drugs 59
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CRISPR and HIV: New technique in human blood unveils potential paths toward cure

Scienmag

Scientists at Northwestern Medicine are using new advances in CRISPR gene-editing technology to uncover new biology that could lead to longer-lasting treatments and new therapeutic strategies for Human Immunodeficiency Virus (HIV). Credit: Northwestern University Scientists at Northwestern Medicine are using new advances in CRISPR gene-editing technology to uncover new biology that could lead to longer-lasting […].

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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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Vertex Pharma makes progress in quest for non-opioid pain drug

pharmaphorum

The search for an alternative to opioid drugs for pain relief has dragged one for decades, with little success, but Vertex Pharma thinks that could be about to change. The company has become the first to demonstrate that a drug targeting the NaV1.8 sodium channel is more effective than placebo at reducing pain in proof-of-concept studies, paving the way for larger studies that could be used to support regulatory filings.

Drugs 59
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University of Kentucky patient, domestic violence survivor triumphs, one step at a time

Scienmag

LEXINGTON, Ky. (April 1, 2022) — “Deep breaths, April. Deep breaths.” Credit: Mark Cornelison | University of Kentucky Photo LEXINGTON, Ky. (April 1, 2022) — “Deep breaths, April. Deep breaths.” April Ballentine nods, steeling herself. As she sits inside the lab of the University of Kentucky’s Sports Medicine Research Institute (SMRI), her anticipation stirs up an incredible amount of […].

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Five things to watch as the Biosimilars market heats up in 2022

pharmaphorum

As pressure mounts on the U.S. Congress and the White House to curtail prescription drug prices, many experts continue to point to biosimilars and their promising potential to usher in competition, increase access, and drive down costs for patients—and the U.S. market is just beginning to heat up. In the latter half of 2021, there was lots of exciting movement.

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Higher blood fats more harmful than first thought 

Scienmag

University of Leeds news Credit: Lee Roberts University of Leeds news Embargo: Friday 1 April, 10am London time Increased levels of blood fats in people with type 2 diabetes and obesity are more harmful than previously thought, a new study has found. In patients with metabolic diseases, elevated fat levels in the blood create stress […].

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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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New patent for Sarepta Theraps drug AMONDYS 45

Drug Patent Watch

Annual Drug Patent Expirations for AMONDYS+45 Amondys 45 is a drug marketed by Sarepta Theraps Inc and is included in one NDA. It is available from one supplier. There are…. The post New patent for Sarepta Theraps drug AMONDYS 45 appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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Estimates of the carbon cycle – vital to predicting climate change – are incorrect, Virginia Tech researchers show

Scienmag

Virginia Tech researchers, in collaboration with Pacific Northwest National Laboratory, have discovered that key parts of the global carbon cycle used to track movement of carbon dioxide in the environment are not correct, which could significantly alter conventional carbon cycle models. Credit: Virgina Tech Virginia Tech researchers, in collaboration with Pacific Northwest National Laboratory, have […].

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New patent for Catalyst Pharms drug FIRDAPSE

Drug Patent Watch

Annual Drug Patent Expirations for FIRDAPSE Firdapse is a drug marketed by Catalyst Pharms and is included in one NDA. It is available from one supplier. There are two patents…. The post New patent for Catalyst Pharms drug FIRDAPSE appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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The future of 5G+ infrastructure could be built tile by tile

Scienmag

5G+ (5G/Beyond 5G) is the fastest-growing segment and the only significant opportunity for investment growth in the wireless network infrastructure market, according to the latest forecast by Gartner, Inc. But currently 5G+ technologies rely on large antenna arrays that are typically bulky and come only in very limited sizes, making them difficult to transport and […].

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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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New patent for Nalpropion drug CONTRAVE

Drug Patent Watch

Annual Drug Patent Expirations for CONTRAVE Contrave is a drug marketed by Nalpropion and is included in one NDA. It is available from three suppliers. There are eighteen patents protecting…. The post New patent for Nalpropion drug CONTRAVE appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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Tulane University study shows COVID-19’s lingering impacts on the brain

Scienmag

COVID-19 patients commonly report having headaches, confusion and other neurological symptoms, but doctors don’t fully understand how the disease targets the brain during infection. Credit: Tulane University, Paula Burch-Celentano COVID-19 patients commonly report having headaches, confusion and other neurological symptoms, but doctors don’t fully understand how the disease targets the brain during infection.

Doctors 74
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Talking Ukraine With Intouch Associate Creative Director Svitlana Kochman

Intouch Solutions

The Eastern European country of Ukraine is not in a good place right now. Daily military attacks from Russia have resulted in the decimation of cities and millions of displaced citizens ; but not all have left, and neither do they plan to. In this Q&A, Chicago-based Svitlana Kochman, an associate creative director – and longtime Intoucher – whose mother is Ukrainian, talks about the country, the people, what motivates them to stand their ground, and more.

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Rotman School finance professor received Governor’s Award from the Bank of Canada

Scienmag

Toronto – Claire Célérier, an assistant professor of finance at the University of Toronto’s Rotman School of Management, is the recipient of the Bank of Canada’s Governor’s Award for 2022. The annual award provides financial support to academics who are recognized for their expertise and research in areas important to the Bank’s core functions and […].

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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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Which pharmaceutical companies have the most SPCs in Ireland?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most supplementary protection certificates (SPCs) in Ireland. SPCs are used in European Union and select others to encourage pharmaceutical innovation by compensating…. The post Which pharmaceutical companies have the most SPCs in Ireland? appeared first on DrugPatentWatch - Make Better Decisions.

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Omicron ‘less severe’ than Delta for children ages 4 and younger, study suggests

Scienmag

CLEVELAND—New research from the Case Western Reserve University (CWRU) School of Medicine suggests that the children younger than age 5 who are infected with the COVID-19 Omicron variant have less risk of severe health outcomes than those infected with the Delta variant. The study, published Friday in JAMA Pediatrics, is the first large-scale research effort to […].

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Xtalks Voices: NIH Experts Share Insights on Increasing Clinical Trial Diversity

XTalks

Increasing clinical trial diversity remains a topic of significant importance in the clinical trial space. In the US, up to 80 percent of participants in medical research studies are Caucasian. Black, Hispanic and Native American/Indigenous populations remain grossly underrepresented in clinical trials. This is a problem as responses to treatments can vary between different racial groups owing to differences in genetics, physiology and lifestyle factors.

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After wildfires, California communities struggle with budgets

Scienmag

California is a wildfire hot spot: each year, homes, businesses, and ecosystems are destroyed by fires exacerbated by climate change. But even after the blazes subside, wildfires can still threaten community wellbeing. A new paper by scholars Yanjun (Penny) Liao and Carolyn Kousky, published in the Journal of the Association of Environmental and Resource Economists (JAERE), finds that wildfires […].

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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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New research shows survival rate improvement for extremely pre-term infants

Scienmag

A new study co-authored by a University of Rochester Medical Center (URMC) researcher has found that the survival rates of extremely pre-term babies has increased significantly in the past decade. The paper, “Mortality, In-Hospital Morbidity, Care Practices, and 2-Year Outcomes for Extremely Preterm Infants in the US, 2013-2018,” examined the survival outcomes of 10,877 infants […].

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Repeating the success of platforms such as Netflix in the offline world

Scienmag

Subscription services are dominating people’s lives. Be it using Spotify, which gathers millions of songs from a variety of record labels, for listening to music, or Netflix for watching TV series from different production companies, platforms are already part of everyone’s daily routines. The most notable platforms usually offer online services, but in some countries […].

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Losing a hectare of wetlands could cost upward of $8,000 in flood damages

Scienmag

A first-of-its-kind article coauthored by scholars at Resources for the Future (RFF) and Columbia University in the journal American Economic Review finds that the loss of a hectare of wetlands (roughly the size of two and a half football fields) costs society an average of $1,900 in flood damages per year. In developed areas, that figure jumps to more […].

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Camping reservations: ‘A wicked problem of equity,’ finds UM researchers

Scienmag

University of Montana Assistant Professor Will Rice is a self-avowed “campground nerd.” Credit: Andy Kemmis, University of Montana University of Montana Assistant Professor Will Rice is a self-avowed “campground nerd.” Spring signals the start of high season for campers and Rice – he is of the tenting ilk, more than the motorhome – looks forward […].

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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.