Sage braces for make-or-break depression data
Bio Pharma Dive
MAY 4, 2021
The biotech's latest earnings call focused less on revenue and more on an experimental drug for depression that's close to having important study results.
Tue.May 04, 2021
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COVID-19 May Increase Risk of Diabetes, New Study Claims
BioSpace
MAY 4, 2021
Patients without diabetes who develop COVID-19 may be at a higher risk of actually developing diabetes following recovery, recent study claims.
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A worrisome side effect stalls a closely watched multiple myeloma drug
Bio Pharma Dive
MAY 4, 2021
Pfizer halted a key trial of one of the most advanced bispecific antibody drugs in development for the blood cancer after several cases of peripheral neuropathy.
Janssen seeks EU approval for first CAR-T therapy cilta-cel
Pharma Times
MAY 4, 2021
Cilta-cel is an investigational CAR-T cell therapy for the treatment of relapsed/refractory multiple myeloma
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
Hidden compliance risks for life sciences companies
pharmaphorum
MAY 4, 2021
The life sciences history industry has some unique challenges when it comes to compliance. But if you think third party compliance risks are bad, don’t take your eye off fourth and fifth parties, says Allan Matheson. Early life science pioneers in foreign markets earned a reputation for lax ethical behaviour, making them a prime target for regulators.
From Insurance Claim Denials to Smiles, Payment and Feeling Empowered
Triage Cancer
MAY 4, 2021
Have you ever received a denial from your insurance company? Me too. Just days before my scheduled breast reconstruction surgery. You probably know how I felt. Blindsided. Frustrated. Angry. . I won't make you read this whole article to learn that I appealed that denial and won. So now I'm one of the 50% of patients who win their insurance appeals. You read that right. 50% of the patients who appeal, win.
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COVID-19 Brings Pressure Testing to Ancillary Supplies and Equipment
Imperical Blog
MAY 4, 2021
Managing ancillary supplies and equipment in clinical trials is complex, and strict import regulations make it a tough challenge. When the COVID-19 pandemic threw the world into the unknown, the global supply chain fell apart. In the blink of an eye, world trade came to a crawl. As the virus became fatal to the world’s population, governments locked down borders.
AstraZeneca’s Farxiga claims first SGLT2 kidney disease OK from FDA
pharmaphorum
MAY 4, 2021
AstraZeneca is already seeing sales rocket for its SGLT2 inhibitor Farxiga in heart failure, and is expected to gather even more momentum after claiming FDA approval in chronic kidney disease (CKD). . The US regulator has cleared Farxiga (dapagliflozin) to reduce the risk of kidney damage, end-stage kidney disease, cardiovascular, death and hospitalisation for heart failure in adults with CKD who are at risk of progression.
10 Resume Mistakes to Avoid at All Costs
BioSpace
MAY 4, 2021
Crafting a well-organized, powerful resume is one of the most important aspects of being on the job market. But, all of your hard work on your job application materials can be undone in a second if you make some of these grave resume mistakes.
Pandemic worsened older adults’ mental health & sleep; others show long-term resilience
Scienmag
MAY 4, 2021
Nearly 1 in 3 express reservations about seeking help if they need it, suggesting need for more screening and reducing stigma on seeking care Credit: University of Michigan Nearly one in five older adults say their mental health has gotten worse since the pandemic began in March 2020, and an equal percentage say their sleep […].
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 Cites Concerns Over ChemoCentryx Trial Data, Sending Stock off a Cliff
BioSpace
MAY 4, 2021
The U.S. FDA cites concerns regarding clinical data for ChemoCentryx’s investigational rare autoimmune disease therapy avacopan. Shares in the company plunged 46.5% lower following the release of the document.
We CARE: a joint initiative by PCR and Stent – Save a Life!
Scienmag
MAY 4, 2021
A global call for action is fostering timely care for patients with heart disease, despite COVID-19 Credit: PCR Paris, France, 3 May 2021. Since the start of the COVID-19 pandemic, patients have been consistently deprived of timely cardiovascular treatment. This is due in part to measures taken in response to the sanitary crisis, but it […].
Clinical News: MDMA and Therapy Significantly Benefits PTSD Patients and More
BioSpace
MAY 4, 2021
BioSpace takes a look at data released this week from some of the numerous ongoing clinical studies to advance potential therapies and treatment for disease. Here are some of them.
TSET HPRC researcher receives federal grant to help low-income Oklahomans quit smoking
Scienmag
MAY 4, 2021
Credit: OU Health OKLAHOMA CITY -Darla Kendzor, Ph.D., co-director of the TSET Health Promotion Research Center, was recently awarded a 5-year, $3.1 million grant from the National Cancer Institute to evaluate the effectiveness of an automated, smartphone-based approach to incentivizing smoking cessation among low-income adults in Oklahoma. Kendzor’s past work has uncovered the detrimental impact […].
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.
Researchers identify new genetic target for acute myeloid leukaemia
Pharma Times
MAY 4, 2021
Targeting a specific mutation in the CUX1 gene may offer a ‘new therapy avenue’ for AML patients
Without commuter traffic, pandemic-era drivers are speeding up, increasing noise pollution
Scienmag
MAY 4, 2021
BU ecologists say higher sound levels in Boston’s Blue Hills Reservation could disrupt wildlife and human health benefits of nature recreation Credit: Photo courtesy of Richard Primack As pandemic lockdowns went into effect in March 2020 and millions of Americans began working from home rather than commuting to offices, heavy traffic in America’s most congested […].
A digital health roadmap for pharma, medical devices and insurance tech
pharmaphorum
MAY 4, 2021
COVID-19 has massively accelerated the uptake of digital health technology across the whole ecosystem, with important implications for pharma, medical device and insurance tech companies. The key trends for these sectors are identified and analysed in a new white paper from Healthware Group that offers guidance on how companies can best adjust to the new digital scenario.
Addressing the persistent controversies and questions in preterm infant nutrition
Scienmag
MAY 4, 2021
Translating the Pre-B project into clinical practice and a research agenda Credit: PAS A hot topic symposia session during the Pediatric Academic Societies (PAS) 2021 Virtual Meeting will address the persistent controversies and questions in preterm infant nutrition. After six years of interdisciplinary expert discussion and critical evidence review, the 2014 vision to develop evidence-informed […].
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.
Pfizer-BioNTech Vaccine Raking In Revenue; Novavax on Its Heels With Adolescent Trials
BioSpace
MAY 4, 2021
Here’s a look at Pfizer-BioNTech, Novavax and the COVID-19 vaccine’s sales, approval in children, additional trials, potential of booster shots, and more.
Laser light makes a comeback (literally)
Scienmag
MAY 4, 2021
Researchers from Osaka University discover phenomenon of reciprocating propagation of laser pulse intensity in free space Credit: Osaka University Osaka, Japan –Straight-line constant-speed propagation in free space is a basic characteristic of light. In a recent study published in Communications Physics, researchers from Osaka University discovered the phenomenon of reciprocating propagation of laser pulse intensity […].
Pfizer ups COVID-19 vaccine revenue estimates
BioPharma Reporter
MAY 4, 2021
Pfizer has upped its 2021 sales forecast for its mRNA COVID-19 vaccine to $26bn: as well as reporting strong Q1 results for the business overall this morning.
Pandemic poses health risk to moms of preschoolers
Scienmag
MAY 4, 2021
Lockdown dramatically increased stress levels, sleep loss Credit: Pennington Biomedical Research Center BATON ROUGE, Louisiana – Stress levels of moms with preschoolers soared during the pandemic, with twice as many of the mothers reporting they lost sleep during the COVID-19 outbreak than before it. “Moms of young children are already less likely to get the […].
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.
Amryt and Chiasma Combine to Form Rare and Orphan Diseases Powerhouse
BioSpace
MAY 4, 2021
Amryt inked an all-stock acquisition deal with Chiasma. The combined company will focus on rare and orphan diseases with three marketed products and a strong development pipeline.
Chronic attack on the aging nervous system
Scienmag
MAY 4, 2021
Credit: Image: Janos Groh / Reprinted by permission from Springer Nature Aging is the biggest risk factor for perturbation of the nervous system, even in the absence of distinct disease or trauma. For yet unknown reasons, the impulse conducting, myelinated projections and synaptic connections between nerve cells are especially vulnerable to aging-related degeneration.
Pfizer Will Seek Approval to Give Covid Vaccine to Children
NY Times
MAY 4, 2021
The company said it also plans to apply this month for full F.D.A. approval — not just emergency authorization — for the vaccine’s use in adults.
Breakthrough study shows no-take marine reserves benefit overfished reefs
Scienmag
MAY 4, 2021
Findings support global “30 by 30” goal of protecting 30 percent of the ocean by 2030 Credit: © Erika Piñeros, for WCS New York, NY (May 4, 2021) – A powerful, long-term study from WCS adds scientific backing for global calls for conserving 30 percent of the world’s ocean. The studied no-take marine protected areas […].
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.
Vicore signs deal with Alex to develop digital therapeutic to support IPF patients
pharmaphorum
MAY 4, 2021
Rare disease specialist Vicore Pharma has signed an agreement with Alex Therapeutics to test a digital therapeutic designed to provide cognitive behavioural therapy support to patients with the lung scarring disease idiopathic pulmonary fibrosis (IPF). The agreement allows for a clinical development programme for Vicore’s digital therapeutic (DTx) VP04.
Long-term monitoring shows successful restoration of mining-polluted streams
Scienmag
MAY 4, 2021
Despite differences in aquatic life and toxic metals in streams across a broad region of the western United States, scientists found common responses to cleanup of acid mine drainage Credit: David Herbst Many miles of streams and rivers in the United States and elsewhere are polluted by toxic metals in acidic runoff draining from abandoned […].
Merck Veteran Roger Perlmutter Emerges From Stealth Mode With Eikon Therapeutics
BioSpace
MAY 4, 2021
Roger Perlmutter, the former president of Merck Research Laboratories, will helm drug discovery startup Eikon Therapeutics, Inc.
Pfizer Reaps Hundreds of Millions in Profits From Covid Vaccine
NY Times
MAY 4, 2021
The company said its vaccine generated $3.5 billion in revenue in the first three months of this year.
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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