Neurocrine stocks up on a biotech's psychiatric drugs
Bio Pharma Dive
NOVEMBER 22, 2021
A new deal with Sosei Heptares hands Neurocrine a "broad portfolio" of drugs for schizophrenia, dementia and other neuropsychiatric disorders.
Mon.Nov 22, 2021
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Does CVS have a crystal ball into the future?
World of DTC Marketing
NOVEMBER 22, 2021
SUMMARY: CVS announced its plans to begin closing its doors –about 900 locations across the country. They know the future isn’t about selling 20 kinds of shampoos and vitamins. In the words of the company’s mission , its goal is to “make high-quality health and pharmacy services safe, affordable and easy to access.” Growth doesn’t mean getting more extensive; it means getting better.
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Bluebird, after delays, gets speedy FDA review for beta thalassemia gene therapy
Bio Pharma Dive
NOVEMBER 22, 2021
The regulator will decide whether to approve Bluebird's treatment by next May, but its evaluation begins more than a year later than the biotech first hoped.
Equal Parts Caregiver and Advocate: Clinical Trials from the Caregiver’s Point of View
Camargo
NOVEMBER 22, 2021
“There are only four kinds of people in the world: Those who have been caregivers, those who are currently caregivers, those who will be caregivers, and those who will need caregivers.”. ~ Roslyn Carter. Each November, National Family Caregiver Month recognizes and honors all those who have dedicated themselves to caring for ailing loved ones. It also helps raise awareness of the often-overwhelming issues they face, so that we can work together as a society to alleviate them.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
Pfizer, BioNTech to seek full approval as COVID-19 vaccine efficacy holds up in young teens
Bio Pharma Dive
NOVEMBER 22, 2021
Four months after vaccination, no 12- to 15-year-olds in the companies' clinical trial developed COVID-19, compared to 30 who received a placebo.
Re-envisioning mental health treatment using clinical VR
pharmaphorum
NOVEMBER 22, 2021
Skip Rizzo, PhD, research director for medical virtual reality at the University of Southern California’s Institute for Creative Technologies (USC ICT), tells us how its virtual reality (VR) therapy BRAVEMIND is changing PTSD treatment and how pharma can leverage clinical VR. “There’s a strong evidence base for VR applications in many areas, but it’s also breaking down barriers to care.
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Elizabeth Holmes Takes the Stand in Self-Defense
BioSpace
NOVEMBER 22, 2021
After months of ongoing testimony from various whistleblowers and investors, Elizabeth Holmes, Theranos founder and CEO, has finally taken the witness stand in her fraud trial.
Bardee: How One Australian Startup is Tackling Food Waste with Flies
XTalks
NOVEMBER 22, 2021
While the food and beverage industry has incorporated many innovations across the supply chain to tackle food waste, one Australian startup is taking a different approach. Bardee, a Melbourne-based agtech startup, harvests Black Soldier flies, whose larvae can be used to break down food waste and convert it into fertilizer for pet food and chicken feed.
Vaccibody Has a New Name and a Fresh Partnership with Regeneron
BioSpace
NOVEMBER 22, 2021
Vaccibody has changed its name to Nykode Therapeutics. “Nykode” means “new code,” which plays on the potential of the company to generate novel codes and innovative patient therapies.
2nd Mitochondria-Targeted Drug Development Summit
pharmaphorum
NOVEMBER 22, 2021
Overcome the Challenge of Treating Unmet Medical Needs Caused by Mitochondrial Dysfunction. The 2nd annual Mitochondria-Targeted Drug Development Summit returns as the only industry-led meeting focused on overcoming the challenge of treating unmet medical needs caused by mitochondrial dysfunction. This forum will specifically focus on targeting mitochondrial dysfunction to develop therapies for chronic diseases caused by mitochondrial DNA mutation/nuclear DNA mutations, muscle dystrophy diseas
The New Age of Decentralized Clinical Trials
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
FDA Approves First Therapy to Treat Ultra-Rare Cancer with Low Survival Rates
BioSpace
NOVEMBER 22, 2021
Shares of Aadi Bioscience were up more than 25% in premarket trading after announcing the FDA greenlit its treatment for a rare and aggressive form of cancer that disproportionately affects women.
Soft food diet increases risks for captive animals released in wild
Scienmag
NOVEMBER 22, 2021
Serving up too much soft food to animals rescued into captivity might reduce their survival chances when released back into the wild. Credit: Dr Rex Mitchell, Flinders University Serving up too much soft food to animals rescued into captivity might reduce their survival chances when released back into the wild. An international team of researchers, […].
With Life-Saving Meds on the Line, FDA Doubles Down on Inspection Goal
BioSpace
NOVEMBER 22, 2021
The U.S. FDA is making up for Covid-lost time this year, doubling the goal for FY 2021 domestic surveillance inspections for food and medical manufacturing facilities.
FDA approves BioMarin drug to treat dwarfism in children
Outsourcing Pharma
NOVEMBER 22, 2021
The US agency has granted approval to Voxzogo, an injectable drug designed to aid growth in children with achondroplasia, the most common form of dwarfism.
Roles and Responsibilities of Specialized Clinical Supply Experts
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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.
Glympse Reports Near-Perfect Accuracy with Liquid Biopsy to Predict NASH
BioSpace
NOVEMBER 22, 2021
This liquid biopsy uses a panel of peptide biosensors to analyze protein activity from a blood sample and provide actionable readouts of the disease state.
How sugar-loving microbes could help power future cars
Scienmag
NOVEMBER 22, 2021
BUFFALO, N.Y. — It sounds like modern-day alchemy: Transforming sugar into hydrocarbons found in gasoline. Credit: Douglas Levere / University at Buffalo BUFFALO, N.Y. — It sounds like modern-day alchemy: Transforming sugar into hydrocarbons found in gasoline. But that’s exactly what scientists have done. In a forthcoming study in Nature Chemistry, researchers report harnessing the […].
Lockdowns in Europe Won’t be Duplicated in US and More COVID-19 News
BioSpace
NOVEMBER 22, 2021
The U.S. CDC has issued new travel warnings as surges of COVID-19 continue throughout the country and the world. For that and other COVID-19 news, read below.
Cell and gene therapies: How can their promise be realized?
BioPharma Reporter
NOVEMBER 22, 2021
The pipeline of advanced therapy is expanding at a rate never seen before, with a number of cell and gene therapies now reaching the market.
The New Age of Decentralized Clinical Trials
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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.
Fundamental particles modelled in beam of light
Scienmag
NOVEMBER 22, 2021
Scientists at the University of Birmingham have succeeded in creating an experimental model of an elusive kind of fundamental particle called a skyrmion in a beam of light. Credit: University of Birmingham Scientists at the University of Birmingham have succeeded in creating an experimental model of an elusive kind of fundamental particle called a skyrmion […].
5 Lessons You Will Learn Working in the Pharma Industry
BioSpace
NOVEMBER 22, 2021
A career in the pharma industry can teach you countless lessons that can help you become more successful. Find out more about what these lessons are.
Study: remote ocean wilderness areas are “living time machines,” teeming with large fish
Scienmag
NOVEMBER 22, 2021
A new, widespread study of the global state of marine coral reef wilderness by WCS, NGS, and university collaborators found that remote ocean wilderness areas are sustaining fish populations much better than some of the world’s best marine reserves. Findings show that remote reefs protect three times as many stocks as marine reserves, and shelter […].
Tonix Cleared to Propel Migraine Therapy into Phase II
BioSpace
NOVEMBER 22, 2021
Tonix expects to begin enrollment in the trial for TNX-1900, an intranasal potentiated oxytocin, during the second half of 2022.
Accelerating Clinical Supply Through Integrated Drug Development
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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.
Mystery of high performing novel solar cell materials revealed in stunning clarity
Scienmag
NOVEMBER 22, 2021
Researchers from the University of Cambridge have used a suite of correlative, multimodal microscopy methods to visualise, for the first time, why perovskite materials are seemingly so tolerant of defects in their structure. Their findings were published today in Nature Nanotechnology. Credit: Alex T. at Ella Maru Studios Researchers from the University of Cambridge have used a […].
Concerns Grow Over Safety of Aduhelm After Death of Patient Who Got the Drug
NY Times
NOVEMBER 22, 2021
Newly published safety data shows that 41 percent of patients in key clinical trials of the Alzheimer’s drug experienced brain bleeding or swelling, though many cases were asymptomatic.
Deep learning reveals how proteins interact
Scienmag
NOVEMBER 22, 2021
Scientist are now combining recent advances in evolutionary analysis and deep learning to build three-dimensional models of how most proteins in eukaryotes interact. (Eukaryotes are organisms whose cells have a membrane-bound nucleus to hold genetic materials.) Credit: Ian Haydon/UW Medicine Institute for Protein Design Scientist are now combining recent advances in evolutionary analysis and […].
Reify Health launches tool to gauge clinical trial diversity
Outsourcing Pharma
NOVEMBER 22, 2021
The StudyTeam Diversity Reporting feature is intended to aid sites and sponsors measure their efforts to reach patients from underrepresented communities.
How Machine Learning Drives Clinical Trial Efficiency
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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.
Deep learning algorithms assist in identifying microplastics in human body
Scienmag
NOVEMBER 22, 2021
The research is supported by the Russian Science Foundation (grant 21-73-00097). Credit: Kazan Federal University The research is supported by the Russian Science Foundation (grant 21-73-00097). “If one wants to evaluate the effects of microplastics on humans and animals, then among the primary instruments will be a technology to detect microplastics in the organisms or […].
UK recognises Covaxin as valid COVID-19 vaccine for travel
Pharma Times
NOVEMBER 22, 2021
The approval of Covaxin follows the WHO Emergency Use Listing for the vaccine
How T Cells recognise infection or disease
Scienmag
NOVEMBER 22, 2021
Monash University researchers have expanded their knowledge of how T cells might recognise infections or disease, providing key insight into how an often-overlooked T cell lineage becomes activated when encountering pathogens such as viruses, bacteria, and cancers. Credit: (C) Dr Erica Tandori Monash University researchers have expanded their knowledge of how T cells might recognise […].
EMA supports molnupiravir prior to formal authorisation
Pharma Times
NOVEMBER 22, 2021
The oral antiviral drug is for the treatment of patients with COVID-19
The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric
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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.
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