Thu.Dec 09, 2021

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Fresh data show UniQure's hemophilia gene therapy appears to hold up

Bio Pharma Dive

The amount of blood clotting protein found in patients who received the medicine was nearly the same at six months and 18 months post-treatment, according to results disclosed Thursday.

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Do you have enough money to launch your drug?

World of DTC Marketing

LEAD IN: Pharma budgets are being scrutinized like never before, and DTC/HCP marketers must justify every dollar spent. I’m getting more requests to measure and justify spending for specific bucket tactics, and I believe once politicians get focused, they will scrutinize drug pricing and force negotiations with Medicare tightening internal expenditures even more.

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FDA panel turns down Reata kidney disease drug in unanimous vote

Bio Pharma Dive

The company said it will keep working with the FDA ahead of a Feb. 25 decision date, but the committee's verdict greatly diminishes the drug's chances of an approval.

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Abu Dhabi to Strengthen its Capabilities as a Life Sciences Hub Through a Pharma Collaboration with Belgium

Pharma Mirror

UAE, Abu Dhabi , Abu Dhabi has set its sights on Belgium, as a leading global pharmaceutical hub, to establish a global distribution corridor to serve the world in vaccine delivery and future life science needs. The collaboration builds on the capabilities of Abu Dhabi’s healthcare sector as a leading life sciences hub and the efforts of the HOPE Consortium in providing vaccine solutions for the world.

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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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Intercept, awaiting needed trial data, pulls its NASH drug application in Europe

Bio Pharma Dive

The biotech has lost much of its market value amid delays and regulatory questions for obeticholic acid. But the failures of other drugmakers still leave the company with a chance to rebound.

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Distributed Control System Facilitates Expansion for New Drugs Produced by Contract Manufacturing Organization

Pharma Mirror

Combatting the pandemic has highlighted the importance of the partnership between biopharma organizations and the contract manufacturing organizations (CMOs) that must flexibly handle outsourced production, which can come suddenly and often must quickly be ramped up. For example, to meet the urgent need for COVID-19 related therapies and vaccines early in the pandemic, Thermo Fisher Scientific, a world leader in serving science with annual revenue of approximately $35 billion, had to expand its

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ACT for ALS Passes House while BrainStorm Prepares Moves Ahead with NurOwn

BioSpace

?A U.S. Congress subcommittee unanimously approved the ACT for ALS bill in a decision that could soon pour massive funding into the search for treatment for this debilitating and deadly disease.

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Consumer health innovation – where passion and science meet

pharmaphorum

Heather Barnes, external innovation lead EMEA at Johnson and Johnson Consumer Health, is a scientist who is truly passionate about consumer health. With her background in biochemistry and eye for identifying innovation trends, the future is bright at Johnson & Johnson Innovation. After making her way from early-stage drug development research to her current role, Heather got straight to work on creating sustainable collaborations that made life better for people and their families.

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Cincinnati Children’s Hospital and CTI create joint venture for cell and gene therapy manufacturing

BioPharma Reporter

Cincinnati Children's Hospital Medical Center and research service provider CTI Clinical Trial & Consulting Services will form a company to provide cell and gene therapy manufacturing services to the biotech and pharmaceutical industries.

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Flashfood Grocery App + Mooless Animal-Free Whey Protein – Xtalks Food Podcast Ep. 40

XTalks

Would you take an extra step to browse through an app to save money on groceries and help cut down on food waste? In this episode of the Xtalks Food Podcast, Sydney talks about Flashfood, an app that allows users to shop for soon-to-expire groceries at a discount and divert food waste from landfills. The startup has partnered with around 1,200 grocery stores across the US and Canada and has plans to expand next year.

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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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NICE publish final guidance recommending Aspaveli in adults with ultra-rare blood disorder

Pharma Times

The drug is additionally undergoing assessment with the Medicines and Healthcare products Regulatory Agency for a marketing authorisation in the UK

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Crucial leap in error mitigation for quantum computers

Scienmag

By Monica Hernandez and William Schulz Credit: Christian Jünger/Berkeley Lab By Monica Hernandez and William Schulz Researchers at Lawrence Berkeley National Laboratory’s Advanced Quantum Testbed (AQT) demonstrated that an experimental method known as randomized compiling (RC) can dramatically reduce error rates in quantum algorithms and lead to more accurate and stable quantum computations.

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COVID News Brief: Booster Shots Expand as Omicron Looms

BioSpace

The best way to battle the dominant Delta strain is booster vaccines. So far, initial data suggests boosters are likely to help battle Omicron as well. For that and more COVID-19 news, read on.

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New patent for Teva Branded drug PROAIR RESPICLICK

Drug Patent Watch

Annual Drug Patent Expirations for PROAIR+RESPICLICK Proair Respiclick is a drug marketed by Teva Branded Pharm and is included in one NDA. It is available from two suppliers. There are…. The post New patent for Teva Branded drug PROAIR RESPICLICK appeared first on DrugPatentWatch - Make Better Decisions.

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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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Decades-Old Stool Sample Provides New Insight on HIV Susceptibility

BioSpace

A new study conducted on a 35-year-old blood and stool sample provides new insights into HIV research and the role the gut microbiome may have played in infection among infected individuals.

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Post-Brexit medicines regulation must have international scope

pharmaphorum

Post-pandemic, post-Brexit Britain must create a regulatory framework that both defines and aligns with international standards, or risk being left behind. If the UK creates regulatory frameworks that drastically diverge from those of its “science allies”, it could become a late – or even no – launch market for new treatments. The need for companies to make multiple dossiers and submissions could lead to “profound implications for UK patients needing access to innovative and novel therapies”, sa

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Biotechs Share Promising Breast Cancer Data at San Antonio Symposium

BioSpace

The 2021 San Antonio Breast Cancer Symposium is meeting December 7–10 at the Henry B. Gonzalez Convention Center in San Antonio, Texas, and virtually.

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NIH study traces molecular link from gene to late-onset retinal degeneration

Scienmag

Scientists have discovered that gene therapy and the diabetes drug metformin may be potential treatments for late-onset retinal degeneration (L-ORD), a rare, blinding eye disease. Researchers from the National Eye Institute (NEI), part of the National Institutes of Health generated a “disease-in-a-dish” model to study the disease. The findings are published in Communications Biology.

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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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Experimental mRNA Flu Vaccine Looks Good in the Interim, But Fails to Impress Investors

BioSpace

Shares of Moderna are down nearly 10% this morning despite the company posting positive interim results from an experimental seasonal flu vaccine.

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Mini-jet found near Milky Way’s supermassive black hole

Scienmag

Our Milky Way’s central black hole has a leak. This supermassive black hole looks like it still has the vestiges of a blowtorch-like jet dating back several thousand years. NASA’s Hubble Space Telescope hasn’t photographed the phantom jet but has helped find circumstantial evidence that it is still pushing feebly into a huge hydrogen cloud and then […].

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Research Roundup: Controlling Blood Glucose Levels Decreases Cancer Risk and More

BioSpace

Cancer cells, because of their high metabolism and rapid growth, use up a lot of energy, which is supplied in the body by glucose, or blood sugar.

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UTA researcher hopes crowdsourcing will make resilience-building efforts more equitable

Scienmag

A University of Texas at Arlington researcher is testing how crowdsourcing can help assess and build resilience in communities susceptible to natural disasters. Credit: UT Arlington A University of Texas at Arlington researcher is testing how crowdsourcing can help assess and build resilience in communities susceptible to natural disasters. Michelle Hummel, an assistant professor in […].

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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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COVID-19 Has Brought out the Best – and Worst – in Humanity

BioSpace

A TikTok video went “viral” in November, claiming that vaccine regretters should take complex “detox” baths featuring ingredients such as borax.

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Professor Federico Rosei receives the Urgel-Archambault Award

Scienmag

Professor at the Institut national de la recherche scientifique (INRS) since 2002, Federico Rosei is once again being honoured for his career. The winner of the Prix du Québec Marie-Victorin is also receiving the Urgel-Archambault 2021 Award from Acfas. Credit: Josée Lecompte Professor at the Institut national de la recherche scientifique (INRS) since 2002, Federico […].

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Three More Biopharma Expansions to Round Out the Week

BioSpace

Innocoll Biotherapeutics, Genapsys, and Adicet Bio announced today their relocation and expansion plans.

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Artificial intelligence that can discover hidden physical laws in various data

Scienmag

Researchers at Kobe University and Osaka University have successfully developed artificial intelligence technology that can extract hidden equations of motion from regular observational data and create a model that is faithful to the laws of physics. This technology could enable us to discover the hidden equations of motion behind phenomena for which the laws were […].

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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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Yale Team Unlocks Genetic Door to Deadly Brain Aneurysms

BioSpace

A team of Yale researchers has found a key to unlocking the deadly mystery of brain aneurysms in adults.

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NASA Goddard helps ensure asteroid deflector hits target, predicts and will observe impact results

Scienmag

Although the chance of an asteroid impacting Earth is small, even a relatively small asteroid of about 500 feet (about 150 meters) across carries enough energy to cause widespread damage around the impact site. NASA leads efforts in the U.S. and worldwide both to detect and track potentially hazardous asteroids and to study technologies to mitigate or […].

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Roche's Latest Checkpoint Target Shows Promise for Lung Cancer

BioSpace

Roche announced promising results from the Phase II CITYSCAPE study of tiragolumab plus Tecentriq compared to Tecentriq alone as a treatment for PD-L1-positive metastatic NSCLC.

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New study is good news for people with memory concerns as it provides further validation of popular self-administered cognition test

Scienmag

December 8, 2021, VANCOUVER, Canada — A new study published in Alzheimer’s Research & Therapy finds that a simple, self-administered test, Self-Administered Gerocognitive Examination (SAGE test), developed by researchers at The Ohio State University Wexner Medical Center, College of Medicine and College of Public Health can identify the early, subtle signs of dementia sooner than the […].

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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.