Thu.Jun 10, 2021

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Vertex stops work on second rare disease drug after study results disappoint

Bio Pharma Dive

The biotech said its drug for alpha-1 antitrypsin deficiency wasn't potent enough to advance into further testing, but plans to move others into clinical trials next year.

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Using the Internet to reach doctors, numbers don’t matter. What you have to say and how you say are more important.

World of DTC Marketing

SUMMARY: Several online providers promise that they can reach physicians with your message, but I would argue that numbers are only important if they can be measured against key brand objectives. Ask your target audience what THEY use and how they use it to understand each platform’s relevance. According to research from HealthLink Dimensions, more than a third of physicians reported using social networks to communicate with their professional peers, and 59% said they see the value in s

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'The lights are no longer green': Antitrust regulators reassess pharma deals

Bio Pharma Dive

The FTC and its counterparts abroad are rethinking their approach to drugmaker acquisitions. Past scrutiny offers clues where they may look next.

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Kurita Expands Presence in North America

Pharma Mirror

Completes Acquisition of Keytech Water Management of Canada Minneapolis, MN: Kurita Water Industries (Kurita) (Headquarters, Tokyo, Japan), a leading global provider of water treatment solutions, today announced the completion of its acquisition of Keytech Water Management (“Keytech”) through its North American subsidiaries in a stock purchase deal.

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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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Bristol Myers says CAR-T therapy beat chemo, transplant in lymphoma study

Bio Pharma Dive

The results could help support taking CAR-T therapy into earlier lines of cancer treatment, a long-held goal for the complex cellular drugs.

Drugs 278
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Cell and Gene Therapy Catapult forms consortium of over 20 organisations

Pharma Times

Consortium will assess multiple process analytical technologies used in the cell and gene therapy industry

More Trending

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Investing in an HEPA air purifier might not be a bad idea

Scienmag

University of Cincinnati ear, nose and throat specialist says several studies show HEPA air purifier reduce airborne COVID-19 particles Credit: Colleen Kelley/University of Cincinnati As COVID-19 restrictions ease nationwide and more people host indoor gatherings, investing in a high efficiency particulate air (HEPA) purifier might not be a bad idea, says a University of Cincinnati […].

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Vertex Falls After Announcing Key Asset for Rare Disease Will Not Advance

BioSpace

Shares of Vertex fell more than 13% in premarket trading after it announced that it will not advance a novel small molecule corrector of the Z-AAT protein into a Phase III study.

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Machine learning model doubles accuracy of global landslide ‘nowcasts’

Scienmag

Credit: Credits: NASA Every year, landslides – the movement of rock, soil, and debris down a slope – cause thousands of deaths, billions of dollars in damages, and disruptions to roads and power lines. Because terrain, characteristics of the rocks and soil, weather, and climate all contribute to landslide activity, accurately pinpointing areas most at […].

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Three F.D.A. Advisers Resign Over Agency’s Approval of Alzheimer’s Drug

NY Times

The drug, Aduhelm, a monthly infusion priced at $56,000 per year, was approved this week despite weak evidence that it helps patients.

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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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Study sheds light on treatment options for devastating childhood brain cancer

Scienmag

Some but not all radiation therapy can be safely reduced in medulloblastoma Credit: Washington University School of Medicine Medulloblastoma is a rare but devastating childhood brain cancer. This cancer can spread through the spinal fluid and be deposited elsewhere in the brain or spine. Radiation therapy to the whole brain and spine followed by an […].

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PlantFuel Partners with Amazon Launchpad to Sell Its Products on the World’s Biggest Online Marketplace

XTalks

PlantFuel, a premium plant-based nutritional supplement brand, signed an agreement to partner with Amazon’s Launchpad program. Amazon’s Launchpad program empowers and accelerates start-up businesses that will sell their products amazon.com. The program used to be an invitation-only service but recently, small Amazon sellers that make less than $5 million in gross sales can join the program by applying. .

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New study gives clue to the cause, and possible treatment of Parkinson’s Disease

Scienmag

Zebrafish model research reveals clues about molecular triggers of Parkinson’s Disease Credit: Matsui et al., Nat Commun. 2021 Niigata, Japan – Researchers from Brain Research Institute, Niigata University, Japan may have unraveled a new approach that could revolutionize the treatment, prevention, and possibly reversal of the damages that could lead to Parkinson’s Disease (PD).

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Research Roundup: A Cognitive Clock to Measure Brain Health and More

BioSpace

Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones.

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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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Cincinnati children’s awarded grant to develop AI system for preventing school violence

Scienmag

Credit: Cincinnati Children’s CINCINNATI – Scientists at Cincinnati Children’s have been awarded a five-year grant totaling $2.8 million from the National Institute of Child Health and Human Development to develop an automated risk assessment (ARIA) system, which is designed to detect and prevent school violence. The principal investigator of the project is Yizhao Ni, PhD, […].

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Fallout Continues as Third FDA Panel Member Resigns Over Aduhelm Approval

BioSpace

Aaron Kesselheim, a professor of Medicine at Harvard Medical School and has served on the advisory committee since 2015, has stepped down.

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A better understanding of ‘wet markets’ is key to safeguarding human health, biodiversity

Scienmag

Credit: Photo credit: Ginette Lai, Taiwan PRINCETON, N.J.–Great uncertainty surrounds the origins of SARS-CoV-2. Early on, some suggested a link between COVID-19 and a seafood market in Wuhan, China. Other theories are now circulating, though the origins of the virus are still unknown. In response, governments have pushed for the closing of so-called “wet markets” […].

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BeiGene Presents Positive Data in Various Lymphomas at EHA2021

BioSpace

Beigene presented results from three pivotal trials at the 26th EHA2021 Virtual Congress for the effectiveness of their checkpoint inhibitor tislelizumab in relapsed or refractory lymphoma.

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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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Like night and day: Animal studies may not translate to humans without time considerations

Scienmag

In a recent survey of published animal studies, researchers at West Virginia University found disregarding the animals’ circadian rhythms can hamper reproducibility, reliability and validity. Credit: WVU Photo/Jennifer Shephard MORGANTOWN, W.Va. — Imagine being woken up at 3 a.m. to navigate a corn maze, memorize 20 items on a shopping list or pass your driver’s […].

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EHA Updates: Companies Share Positive Data in Different Blood Disorders

BioSpace

The 2021 EHA is in full swing. BioSpace is rounding up several presentations from the past two days. Here are some of them.

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Climate protection: Deep decarbonization by 2050 currently not plausible

Scienmag

Credit: Universitaet Hamburg Today the Hamburg-based Cluster of Excellence “Climate, Climatic Change, and Society” (CLICCS) publishes a new, essential study on climate futures. The study represents the first systematic attempt to investigate whether a climate future with net-zero carbon emissions is not only possible but also plausible. The authors examine plausibility from a technical-economic perspective, […].

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Bayer subsidiary doses first patient with Parkinson’s disease cell therapy

Pharma Times

German pharma company announces progress in its 'two-pronged' cell and gene therapy approach to Parkinson's disease

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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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Astronomers spot a ‘blinking giant’ near the centre of the Galaxy

Scienmag

Credit: Amanda Smith, University of Cambridge Astronomers have spotted a giant ‘blinking’ star towards the centre of the Milky Way, more than 25,000 light years away. An international team of astronomers observed the star, VVV-WIT-08, decreasing in brightness by a factor of 30, so that it nearly disappeared from the sky. While many stars change […].

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Patient Partnership Index 2021 - results announced!

Pharma Times

Three Gold Standards awarded for partnership work in patient advocacy and communications

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New family of atomic-thin electride materials discovered

Scienmag

Credit: Soungmin Bae and Hannes Raebiger An exploratory investigation into the behavior of materials with desirable electric properties resulted in the discovery of a structural phase of two-dimensional (2D) materials. The new family of materials are electrides, wherein electrons occupy a space usually reserved for atoms or ions instead of orbiting the nucleus of an […].

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G7 Leaders Pledge One Billion COVID-19 Vaccines For Nations in Need

BioSpace

Half of these doses will be shared by the U.S., while the U.K. has committed another 100 million shots.

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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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Music listening near bedtime disruptive to sleep, Baylor study finds

Scienmag

Baylor sleep researcher Michael Scullin finds ‘earworms’ continue during sleep, can cause restless nights Credit: Matthew Minard, Baylor University WACO, Texas (June 9, 2021) – Most people listen to music throughout their day and often near bedtime to wind down. But can that actually cause your sleep to suffer? When sleep researcher Michael Scullin, Ph.D., […].

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Double resignation over Aduhelm approval depletes FDA’s CNS adcomm

pharmaphorum

Two members of an FDA advisory committee have now resigned in protest over Monday’s approval of Biogen’s Alzheimer’s disease drug Aduhelm despite an overwhelming vote against doing so. Washington University neurologist Joel Perlmutter was the first to announce he was stepping down from the Peripheral and Central Nervous System Drugs Advisory Committee on the day after the approval, and he was joined yesterday by Mayo Clinic neurologist David Knopman.

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Rockefeller University Press journals release policy on author name change after publication

Scienmag

Journal of Cell Biology (JCB), Journal of Experimental Medicine (JEM), and Journal of General Physiology (JGP) announce an editorial policy allowing swift and confidential updates to author names at any time and for any reason including changes to gender identity, marriage, divorce, religion, or other personal circumstances. “We see this as a necessary step in […].

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Could Elemental Metals Be Key to Effective Alzheimer's Treatments?

BioSpace

This is the first confirmation of elemental metals in human brain tissue. Researchers hope it can contribute to the ongoing Herculean task of finding a cure for Parkinson's and Alzheimer's.

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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.