Tue.Jan 04, 2022

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Avrobio stops work on rare disease gene therapy after unexpected study results

Bio Pharma Dive

The biotech's treatment was one of the furthest along in testing for Fabry, a rare inherited disease that's become a target for gene therapy developers.

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The financial toxicity of treating cancer

World of DTC Marketing

(Stat News) Today, a study followed 380 patients being treated at community oncology groups across the U.S. after they were diagnosed with metastatic colon cancer. They told the researchers that insurance didn’t protect them from serious money problems. While 98% of them had insurance, 71% fell deeper into debt, took out a new loan, sold or refinanced a home, or experienced at least a 20% decline in income — or a combination of these over the year they answered quarterly surveys.

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Biogen brings in a successor to Spinraza

Bio Pharma Dive

The company spent $60 million to secure global rights to an experimental drug developed by Ionis Pharmaceuticals to treat spinal muscular atrophy.

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CPhI Predictions for 2022

Pharma Mirror

CPhI Predictions for 2022: high manufacturing demand to constrain global ingredients, partnering options and available CDMO capacity. Continued stellar growth in pharma sales and innovation bode well for supply side companies and CDMOs Amsterdam: CPhI Worldwide releases its beginning of year pharma market predictions for 2022 combining research from over 350 pharma executives and expert views from 10 CPhI contributors.

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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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MHRA grants approval for Pfizer’s oral COVID-19 antiviral pill

Pharma Times

Pfizer’s Paxlovid has a success rate of nearly 90% as a prophylaxis treatment against severe COVID-19 when administered shortly after the patient has been infected with the virus.

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FDA approves Immix Biopharma Rare Pediatric Disease Designation for cancer treatment

BioPharma Reporter

Biopharmaceutical company ImmixBio has been granted Rare Pediatric Disease (RPD) designation from the US Food and Drug Administration (FDA) for IMX-110 for the treatment of a life-threatening form of pediatric cancer in children, rhabdomyosarcoma.

More Trending

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ATMPS and Assurea team up to ensure audit readiness for cell and gene therapy innovators

BioPharma Reporter

ATMPS Ltd, a UK developer of blockchain-based cell orchestration platforms for advanced therapies is collaborating with US quality and compliance consultancy, Assurea LLC, to develop a fully complaint blockchain approach for end-to-end supply chain management of cell and gene therapies.

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Study finds later school start times prevent sleep deprivation for parents of middle and high school students

Scienmag

A new study by researchers at National Jewish Health finds that parents of adolescents got more sleep when middle and high schools start about an hour later, while the sleep habits of parents of younger children were unaffected by earlier elementary school start times. Credit: National Jewish Health A new study by researchers at National […].

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Multiple UK hospitals declare critical incidents over staff shortages

Pharma Times

In order to help to reduce transmission of the Omicron variant, measures have been instated in hospitals, including a ban on ward visitations.

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Gravitational action of Sun and Moon influences behavior of animals and plants, study shows

Scienmag

The rhythms of activity in all biological organisms, both plants and animals, are closely linked to the gravitational tides created by the orbital mechanics of the Sun-Earth-Moon system. This truth has been somewhat neglected by scientific research but is foregrounded in a study by Cristiano de Mello Gallep at the University of Campinas (UNICAMP) in […].

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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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Artificial intelligence could benefit all aspects of clinical trials: IQVIA

Outsourcing Pharma

An AI expert discusses progress in the field, gaps in understanding, and how predictive modeling and other advanced analytical tools could be put to use.

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3d digital holograms on smartphones?

Scienmag

3D holograms, previously seen only in science fiction movies, may soon make their way into our daily lives. Until now, 3D holograms based on phase shifting holography method could be captured using a large, specialized camera with a polarizing filter. However, a Korean research group has just developed technology that can acquire holograms on mobile […].

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Revised PhRMA Code Took Effect on January 1, 2022, and Certain State Obligations Follow

FDA Law Blog

By Faraz Siddiqui — Happy New Year! On January 1, 2022, the recently revised version of the PhRMA Code on Interactions with Health Care Professionals went into effect. We summarized the major revisions to the Code in a blog post when it was released in August 2021. Many of the updates relate to drug manufacturer practices with regard to speaker events, including meals, choice of venue, and attendance.

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Portable prostate cancer test may help reach underserved men

Scienmag

ITHACA, N.Y. — A highly portable and rapid prostate cancer screening kit could provide early warning to populations with higher incidence of prostate cancer and particularly those with limited access to health care, such as African American men. The proof-of-concept test, described online Nov. 12 in the journal Current Research in Biotechnology, is inexpensive and uses a test […].

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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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Square Health merger throws telehealth firm Push Doctor a lifeline

pharmaphorum

Push Doctor – a digital platform that virtually connects patients with GPs – has been acquired by private healthcare service provider Square Health for an undisclosed fee. Rumours of a deal first emerged last November, amid reports that Push Doctor had been at risk of insolvency and going into administration. The company reported a loss of nearly £8 million (almost $11 million) in the year to 31 July 2021 and finished the period with just over £1 million in cash, reportedly only enough to last

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Study shows troubling lack of knowledge by physicians about the Americans with Disabilities Act

Scienmag

BOSTON – More than 30 years after the passage of the Americans with Disabilities Act (ADA), most physicians still lack basic knowledge about “reasonable accommodations” the law requires them to provide to people with disabilities, a study by researchers at Massachusetts General Hospital (MGH) has found. In a paper published in Health Affairs, the team […].

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Road ahead paved with innovation, opportunities: Syneos Health

Outsourcing Pharma

A forward-looking report from company experts includes a breakdown of the top trends to watch for in pharmaceutical development and in healthcare overall.

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Sunshield successfully deploys on NASA’s next flagship telescope

Scienmag

The James Webb Space Telescope team has fully deployed the spacecraft’s 70-foot sunshield, a key milestone in preparing it for science operations. Credit: Credits: NASA/Chris Gunn The James Webb Space Telescope team has fully deployed the spacecraft’s 70-foot sunshield, a key milestone in preparing it for science operations. The sunshield – about the size […].

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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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Novartis blocks generic to MS blockbuster Gilenya in US patent dispute

pharmaphorum

Novartis has blocked an attempt by Chinese drugmaker HEC Pharma to launch a generic version of its big-selling multiple sclerosis drug Gilenya in the US for almost six years. An appeals court ruling has upheld the validity of a key US patent covering Gilenya (fingolimod), and issued a permanent injunction against HEC Pharma until it expires in December 2027.

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New target may help protect bones as we age

Scienmag

AUGUSTA, Ga. (Jan. 5, 2022) – Drugs we take like prednisone can weaken our bones and so can aging, and scientists working to prevent both have some of the first evidence that the best target may not be the logical one. Credit: Michael Holahan, Augusta University AUGUSTA, Ga. (Jan. 5, 2022) – Drugs we take like prednisone […].

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Biden Administration Doubles Order of Pfizer's Covid Pill

NY Times

President Biden announced that his administration would double its order of Pfizer’s scarce Covid-19 antiviral drug, which has been shown to reduce hospitalizations.

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Opioid use disorder treatment access increases in areas with large Medicaid population

Scienmag

Credit: Vanderbilt Center for Child Health Policy Researchers report that in communities where Medicaid is a more common source of insurance, providers of buprenorphine, an effective treatment for opioid use disorder (OUD), are much less likely to discriminate between Medicaid and privately insured prospective patients, but patients with either type of coverage still […].

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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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Biden Administration Doubles Order of Pfizer's Covid Pill

NY Times

President Biden announced that his administration would double its order of Pfizer’s scarce Covid-19 antiviral drug, which has been shown to reduce hospitalizations.

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The link between electrical voltage and brain flexibility a new study by Tel Aviv university found, for the first time; a direct and significant link between changes in G-protein-coupled receptors and the brain’s ability to adapt to external changes

Scienmag

The Link between Electrical Voltage and Brain Flexibility Credit: Tel Aviv University The Link between Electrical Voltage and Brain Flexibility A new study by Tel Aviv University found, for the first time, a direct and significant link between changes in G-protein-coupled receptors and the brain’s ability to adapt to external changes. The study, published recently […].

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Celebrating 75th Year of Pharmacy Act, 1948

Pharma Tutor

Celebrating 75th Year of Pharmacy Act, 1948. Dr. R. S. Thakur. Chief Editor, Journal of Pharmaceutical Research. Krupanidhi College of Pharmacy, Bengaluru-560035. Email: drramsthakur@gmail.com. . admin. Tue, 01/04/2022 - 16:52. Tags. Pharmapedia. Articles.

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Depression screening improves care for patients with cancer

Scienmag

PASADENA, Calif. — Kaiser Permanente research published January 4, 2022, in JAMA showed depression screening for patients with newly diagnosed breast cancer was highly effective at identifying patients in need of behavioral health care, and the new screening initiative was subsequently and successfully built into the patient care and daily workflow of medical oncology teams […].

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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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Overwhelmed by Omnichannel? We’ve Got Your Back

Intouch Solutions

It’s always been a challenge for marketers to cut through the noise to get their messages across. In the face of skepticism and time constraints on ever-busier and more digitally savvy audiences, what pharma marketers say needs to matter to the recipient ; it must be succinct, seamless, and timely. And of course, we have to find the right paths to engagement.

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Orion’s fireplace: ESO releases new image of the Flame Nebula

Scienmag

Orion offers you a spectacular firework display to celebrate the holiday season and the new year in this new image from the European Southern Observatory (ESO). But no need to worry, this iconic constellation is neither exploding nor burning. The “fire” you see in this holiday postcard is Orion’s Flame Nebula and its surroundings captured […].

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Biogen looks beyond Spinraza in SMA with Ionis deal

pharmaphorum

Spinal muscular atrophy (SMA) therapy Spinraza has been a key earner for Biogen in recent years, but with sales now heading into reverse, the company is looking to extend its franchise. Its latest move is a $60 million upfront licensing deal with longstanding partner Ionis to exercise an option on BIIB115 (ION306), a longer-acting antisense drug still in preclinical development.

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Roundworm associated with lower lung-function and Asthma in younger males

Scienmag

By looking at the exposure to the parasitic roundworm Ascaris lumbricoides/suum in Nothern Europe (Norway, Denmark and Estonia), the study finds that younger men exposed to Ascaris had a striking reduction in lung function and nearly five times higher odds of having asthma compared to the non-exposed. These effects were independent of smoking and other […].

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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.