Wed.Jul 21, 2021

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Bluebird, with little fanfare, is first to bring a second gene therapy to market

Bio Pharma Dive

The approval of Skysona for a genetic brain disease is a milestone for one of gene therapy's pioneering companies, but isn't expected to turn Bluebird's financial fortunes around.

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The debate on DTC marketing is going to heat up again

World of DTC Marketing

SUMMARY: DTC marketing is not the reason why prescription drugs cost so much. DTC ads raise awareness around health conditions. DTC ads do NOT lead to unnecessary Rxs. The FDA needs to study what people do when they see a DTC ad. The voices in Washington DC are once again calling for a moratorium on DTC marketing but lawmakers need to understand what DTC marketing actually does as upped to what people believe it does.

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J&J predicts faster coronavirus vaccine sales amid debate over boosters

Bio Pharma Dive

The pharmaceutical company expects $2.5 billion in sales from its shot this year, despite concerns over protection against variants and significant manufacturing setbacks.

Sales 294
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Crowdsourced science refines AI prediction of clinical trial outcomes

pharmaphorum

Think of the R&D dollars that could be saved if artificial intelligence (AI) modelling could tell you at an early stage whether a drug was likely to succeed in clinical trials, and ultimately reach the market. In 2019, a team at Massachusetts Institute of Technology (MIT) in the US came up with just such a model, and found that it was able to perform “better than random” at predicting the outcome of a clinical trial or development programme.

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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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Pfizer, BioNTech ink vaccine supply deal for Africa in step toward addressing criticism

Bio Pharma Dive

The companies aim to deliver 100 million doses per year to 55 African countries in an effort to shrink the wide gap between high- and lower-income countries in coronavirus vaccinations.

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NHS England unveils new Innovative Medicine Fund

Pharma Times

The new fund will build upon the Cancer Drugs Fund to fast-track access to promising new treatments

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Biovac to manufacture Pfizer COVID-19 doses in Africa

BioPharma Reporter

South African biopharmaceutical company The Biovac Institute will manufacture and distribute Pfizer and BioNTechâs COVID-19 vaccine in Africa, with the three companies signing a letter of intent this week.

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BioSpace’s Business Report Highlights Sustained Growth and New Blood

BioSpace

The life sciences is always a frenetic sector when it comes to mergers & acquisitions, initial public offerings (IPOs) and Series A announcements (not to mention B and C rounds). But during the second quarter of 2021, these companies were especially busy bees – all positive signs that the industr.

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New patent for Adamas Pharma drug GOCOVRI

Drug Patent Watch

Annual Drug Patent Expirations for GOCOVRI Gocovri is a drug marketed by Adamas Pharma and is included in one NDA. It is available from one supplier. There are fifteen patents…. The post New patent for Adamas Pharma drug GOCOVRI appeared first on DrugPatentWatch - Make Better Decisions.

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Fel d 1 Protein Sparking Curiosity that Could Change the Cat

BioSpace

Companies such as Indoor Biotechnologies in Virginia are leveraging cutting-edge scientific techniques to not only reduce the amount of the protein expressed but completely knock it out.

Protein 98
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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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Policy changes to kidney allocation may unintentionally reduce access to transplant for South Carolina

Scienmag

Researchers at MUSC Health look at the outcome of the Organ Procurement and Transportation Network’s latest allocation changes and argue for further improvement Credit: MUSC Health The average American spends 5 days each year in line by some estimates. Many of these lines are for things like a cup of coffee, movie theater tickets or […].

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Chinese Government Blocks WHO Investigators from Returning to Wuhan Lab

BioSpace

WHO Investigators have attempted to return to the Wuhan lab to find the origins of the novel coronavirus but are now being blocked by the Chinese government.

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New algorithm flies drones faster than human racing pilots

Scienmag

Credit: Robotics and Perception Group, University of Zurich To be useful, drones need to be quick. Because of their limited battery life they must complete whatever task they have – searching for survivors on a disaster site, inspecting a building, delivering cargo – in the shortest possible time. And they may have to do it […].

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Ken Frazier Joins Investment Firm to Focus on Health Assurance Initiatives

BioSpace

Merck’s former chief executive officer and current executive chairman, Kenneth Frazier, has stepped down from his post at the pharmaceutical company to join venture capital firm General Catalyst as its newest chairman of health assurance initiatives.

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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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Origami comes to life with new shape-changing materials

Scienmag

Credit: Purnendu Imagine opening up a book of nature photos only to see a kaleidoscope of graceful butterflies flutter out from the page. Such fanciful storybooks might soon be possible thanks to the work of a team of designers and engineers at CU Boulder’s ATLAS Institute. The group is drawing from new advancements in the […].

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Gov’t reveals new strategy to improve support and care for autistic people

Pharma Times

The Autism Strategy will be backed by nearly £75m in the first year, which includes £40m through the NHS Long Term Plan

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Bidirectional impact of cardiovascular disease, cancer in Blacks focus of new AHA center

Scienmag

Credit: Kim Ratliff, Augusta University Cardiovascular disease and cancer, the nation’s top two killers, share common ground like obesity and chronic inflammation, as well as a disproportionate impact on Black Americans. A new American Heart Association-funded center at the Medical College of Georgia is working to better understand the bidirectional dynamic, including how to intervene […].

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COVID-19: Vaccines vs. Delta Variant, CDC Predicts Rising Death Toll in Unvaccinated and More

BioSpace

As COVID-19 begins yet another surge across the U.S., there is some promising news about the effectiveness of vaccines. Here’s a look at some top COVID-19 stories.

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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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Study shows cancer misinformation common on social media sites

Scienmag

Credit: Huntsman Cancer Institute A new study published online today in the Journal of the National Cancer Institute reports that one third of the most popular cancer treatment articles on social media contain misinformation. Further, the vast majority of that misinformation has the potential to harm cancer patients by supporting approaches that could negatively impact […].

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Leading Autoimmune Diseases to Undergo Robust Improvement in Treatment by Major Pharma Companies

Delveinsight

As per the American Autoimmune Related Diseases Association (AARDA), nearly 50 million people in the USA are affected by autoimmune diseases such as rheumatoid arthritis, psoriasis, and lupus. These diseases are the second leading cause of chronic illness in the United States. The prevalence is rising at a significant pace at par with heart disease and cancer and mounting a significant burden on the healthcare infrastructure and the degraded quality of life to the affected population.

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New approach eradicates breast cancer in mice

Scienmag

Credit: Photo by L. Brian Stauffer CHAMPAIGN, Ill. — A new approach to treating breast cancer kills 95-100% of cancer cells in mouse models of human estrogen-receptor-positive breast cancers and their metastases in bone, brain, liver and lungs. The newly developed drug, called ErSO, quickly shrinks even large tumors to undetectable levels. Led by scientists […].

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Myovant, Gedeon Richter’s uterine fibroids med Ryeqo bags EU approval

Pharma Times

EC has cleared Ryeqo for the treatment of moderate to severe symptoms of uterine fibroids

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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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Reaping the benefits: Training in rice growing system ups yields and well-being

Scienmag

Study shows randomized Bangladesh-based trial of training in agronomy method has advantages for rice output and profits, as well as for the rice farmers’ lives Credit: BRAC, Bangladesh Tsukuba, Japan – Rice is the world’s most commonly grown and consumed crop. It also supports lives and livelihoods, especially in low- and middle-income regions.

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Drug Distributors and J.&J. Reach $26 Billion Deal to End Opioids Lawsuits

NY Times

The agreement would allow funds to begin flowing from the companies to states and communities to pay for addiction and prevention services.

Drugs 100
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Over 1/3 of US Congress members hold healthcare-related financial assets

Scienmag

Credit: McCoy et al, 2021, PLOS ONE (CC-BY 4.0, [link] Over 1/3 of US Congress members hold healthcare-related financial assets, with a median value of $43,000, according to analysis of healthcare conflicts of interest using 11 years of data. ### Article Title: Historical trends in health care-related financial holdings among members of Congress Funding: The […].

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Slingshot Launches with $23 Million for Synthetic Cell Products

BioSpace

Biotech company Slingshot Biosciences announced Thursday it had closed a $23 million Series A financing round led by Northpond Ventures.

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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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Astrophysicist outlines plans for the gravitational wave observatory on the moon

Scienmag

Credit: Karan Jani THE IDEA Vanderbilt astrophysicist Karan Jani has led a series of studies that make the first case for a gravitational wave infrastructure on the surface of the moon. The experiment, dubbed Gravitational-Wave Lunar Observatory for Cosmology, uses the moon’s environment and geocentric orbit to analyze mergers of black holes, neuron stars and […].

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Orbit Discovery raises $7.6m to boost peptide drug discovery services

Pharma Times

The latest funding round was led by Oxford Sciences Innovation

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To save a species, check its ID

Scienmag

New tool differentiates endangered salt marsh harvest mouse from abundant look-alike Credit: William Thein It’s hard to save what you can’t identify. That’s been a problem for the endangered salt marsh harvest mouse, which is found only in the salty, brackish waters of the San Francisco Bay area. The mouse competes for space with about […].

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In Wake of Biogen Aduhelm Approval, Roche in Talks with FDA Over Own Alzheimer’s Drug

BioSpace

The antibody is still being evaluated in clinical studies, with a large-scale Phase III trial expected to wrap in the second half of 2022.

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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.