Mon.Apr 12, 2021

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5 takeaways from AACR, one of the year's top meetings on cancer drugs

Bio Pharma Dive

The American Association for Cancer Research's virtual conference featured new data on an emerging immunotherapy target, a new kind of cell therapy and a KRAS reboot.

Drugs 358
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Should we be worried about pharma’s supply chain?

World of DTC Marketing

QUICK READ: Pharma supply chain issues are a concern for us all but especially patients. The goal of getting a drug to market as fast as possible so they can recoup drug development costs has the potential for mistakes that could cost lives. Coupled with all this is the continued outsourcing of raw materials and other steps in drug development. Patients should be scared.

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Cavazzoni to succeed Woodcock as the FDA's top drug reviewer

Bio Pharma Dive

Cavazzoni will become director of CDER, a crucial position that Janet Woodcock, the FDA's acting commissioner and a contender for the full-time role, has filled for 24 of the last 27 years.

Drugs 260
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Apple, Google block NHS contact tracing app update on privacy grounds

pharmaphorum

A scheduled update to the NHS COVID-19 app has been blocked because it allows location tracking – something prohibited by Apple and Google, which developed some of the code it uses. . The new version of the app used in England and Wales was due to become available today to coincide with the relaxation of lockdown rules, with the public now able to attend venues such as non-essential shops, pub beer garden, gyms and hairdressers.

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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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Sage, Biogen drug reduces tremors but side effects could limit potential

Bio Pharma Dive

Early Phase 2 data for a pill from the two companies' alliance appeared promising. But most patients had to cut their drug dose due to drowsiness.

Drugs 166
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Take the next step into CROY 2021

Pharma Times

The 2021 Clinical Researcher of the Year – The Americas competition is reaching out to the very best in the industry to take the next step and claim gold.

More Trending

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Genentech and Novartis Win FDA Approval for Self-Injectable Form of Xolair

BioSpace

The U.S. Food and Drug Administration (FDA) approved a prefilled syringe for self-injection of an allergic diseases treatment developed by Novartis and Genentech, a Roche company.

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The power of communication: engaging diverse groups in healthcare

pharmaphorum

Humans are diverse and communications to engage us need to be inclusive. It’s no longer about talking to a group, a cohort or an imagined section of society – especially in healthcare. Page & Page’s Lisa Jane Lishman outlines why communication and the strategies behind it need to be more personal to ensure that people – whoever they are – feel valued and respected.

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Celularity Gains FDA Orphan Drug Status on Strength of Placental Stem Cell Trials

BioSpace

On Tuesday, Celularity received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for its off-the-shelf natural killer cell therapy for malignant gliomas.

Drugs 102
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‘Innovative vaccines on a massive scale’: Sanofi to create $475m vaccine production site in Singapore

BioPharma Reporter

Sanofi will build a digitally-enabled, carbon-neutral vaccine manufacturing center in Singapore: designed to respond quickly to future pandemic risks and able to produce up to four vaccines simultaneously.

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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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FDA Grants vTv’s Type 1 Diabetes Drug Breakthrough Therapy Designation

BioSpace

The U.S. Food and Drug Administration (FDA) granted vTv Therapeutics’ TTP399 Breakthrough Therapy designation for type 1 diabetes. This designation provides companies more support and the possibility of shorter development and review timelines.

Drugs 101
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Doctors still reluctant to prescribe medical cannabis: McMaster

Scienmag

Main concerns relate to possible ill-effects and a lack of understanding regarding their effectiveness as painkillers Credit: McMaster University Hamilton, ON (April 13, 2021) – Ontario doctors are still hesitant to prescribe medical cannabis to patients suffering long-term pain 20 years after it was first introduced, says a new study carried out at McMaster University. […].

Doctors 98
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Amarin CEO Thero to Retire as Company Pivots Focus to Global Markets

BioSpace

Amarin announced the forthcoming retirement of President and CEO John Thero, and the elevation of current head of commercial for Europe and senior vice president Karim Mikhail to the top role.

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Study reveals the 3D structure of human uterine endometrium and adenomyosis tissue

Scienmag

Credit: Niigata University Niigata, Japan- New insights into the three-dimensional (3D) morphology of the human uterine endometrium could advance our understanding of the mechanisms of endometrial regeneration and fertilized egg implantation while clarifying the pathogenesis of menstrual disorders, infertility and endometrium-related diseases such as adenomyosis, endometriosis, endometrial hyperplasia and endometrial cancer.

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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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Treovir’s Oncolytic Virus Product Extends Survival in Children With Brain Tumors

BioSpace

Treovir announced positive findings from a Phase I study of G207 in 12 children with recurrent high-grade glioma, a type of tumor that comprises 30% of all tumors found in the brain and central nervous system as well as 80% of all malignant brain tumors.

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Road salts and other human sources are threatening world’s freshwater supplies

Scienmag

UMD-led study warns cascading effects of salts require coordinated management and regulation to avoid contaminating natural resources Credit: Sujay Kaushal When winter storms threaten to make travel dangerous, people often turn to salt, spreading it liberally over highways, streets and sidewalks to melt snow and ice. Road salt is an important tool for safety, because […].

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Lilly Closes Dermira’s Menlo Park Facility, Cutting 163 Jobs in the Process

BioSpace

Eli Lilly and Company is set to cut 163 jobs as it closes its Dermira facility in Menlo Park and sells off the latter company’s sweat drug Qbrexza, which is being snatched up by Journey Medical.

Drugs 98
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Influence of sea surface temperature in the Indian Ocean on air quality in the Yangtze River Delta region

Scienmag

Credit: Yuyan Li As the foremost economic zone in China, the Yangtze River Delta (YRD) region has recently been experiencing more frequent haze events, resulting in dramatic damages to human and ecosystem health. Anthropogenic aerosol emissions play a key role in affecting the formation of haze events. However, aside from local sources of pollution, some […].

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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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Four Biopharma Companies Raise Hundreds of Millions in Series B Rounds

BioSpace

This morning, multiple companies announced hundreds of millions of dollars were raised in Series B rounds that will be used to advance therapeutics and business development programs.

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Conservationists may be unintentionally spreading pathogens between threatened animal populations

Scienmag

Credit: David Aldridge Moving endangered species to new locations is often used as part of species conservation strategies, and can help to restore degraded ecosystems. But scientists say there is a high risk that these relocations are accidentally spreading diseases and parasites. The new report published today in the journal Conservation Letters focuses on freshwater […].

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At $306 Million, Recursion Pharmaceuticals’ IPO will be Bigger than Expected

BioSpace

After initially indicating it intended to raise $100 million in its Nasdaq debut, the Salt Lake City-based company will now look at bringing in approximately $306 million.

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Leader in global nitrogen cycle research Eric Davidson named Jefferson Science Fellow

Scienmag

Credit: University of Maryland Center for Environmental Science CAMBRIDGE, MD (April 12, 2021)–University of Maryland Center for Environmental Science Professor and Appalachian Laboratory Director Eric A. Davidson, an international leader in global nitrogen cycle research, has been named a Jefferson Science Fellow. Beginning August 2021, he will spend a year as a science advisor to […].

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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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Decentralized trials call for supply chain flexibility: Marken

Outsourcing Pharma

Leaders from the supply chain solutions company share their thoughts on challenges associated with virtual and hybrid trials, and the COVID-19 pandemic.

Trials 84
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ETRI develops a haptic film activated by LEDs

Scienmag

LED-based film-type haptic technology implements localized vibration. various tactile sensations are now possible via independantly controllable vibrations Credit: Electronics and Telecommunications Research Institute(ETRI) A Korean research team succeeded in developing a technology generating various vibration using LED light signals. The technology allows various tactile sensations by area and reduction in size by considerably lowering the […].

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C4X Discovery agrees licensing deal with Sanofi

Pharma Times

Sanofi could pay up to €414m for C4X Discovery’s oral IL-17A inhibitor programme

Licensing 109
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Volcanic pollution return linked to jump in respiratory disease cases

Scienmag

Credit: Dr Evgenia Ilyinskaya Respiratory disease increased markedly following one of Iceland’s largest volcanic eruptions, a new study has found. And the findings could have significant implications for actions taken to protect the health of the 800 million people globally living near active volcanoes. Indeed, only last month (March), lava burst through a crack in […].

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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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CDC, FDA Recommend Pausing J&J COVID-19 Vaccine Rollout Over Blood Clots

BioSpace

The U.S. CDC and the U.S. FDA have identified six cases in the U.S. of a “rare and severe” type of blood clot, which seems to be linked to the COVID-19 vaccine by Johnson & Johnson.

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Bottom-up is the way forward for nitrogen reduction at institutions

Scienmag

Credit: Marine Biological Laboratory WOODS HOLE, Mass. — Nitrogen is an element basic for life — plants need it, animals need it, it’s in our DNA — but when there’s too much nitrogen in the environment, things can go haywire. On Cape Cod, excess nitrogen in estuaries and salt marshes can lead to algal blooms, […].

DNA 84
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Tune In: Key Learnings and Insights from Leaders in Native Advertising

Pharma Marketing Network

Native advertising may mean something different to you depending on what part of the industry you’re in whether it be in advertising or publishing. . Tune in and listen to the Pharma Marketing Network and fellow thought leaders from, ROI Marketplace, MedThink, and Sharecare.com, discuss their learnings and insights on native advertising from each of their respective vantage points – pharma-marketer, publisher, and agency. .

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Blood vessel formation in damaged tissues with mussel adhesive protein

Scienmag

Credit: POSTECH Blood vessels deliver nutrients and oxygen to each organ in our body. They are difficult to completely restore to their original conditions once damaged by myocardial infarction or severe ischemic diseases. This is because various angiogenic growth factors must be applied sequentially in order to restore the vascular structure. Recently, a research team […].

Protein 83
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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.