Bio Pharma Dive
FEBRUARY 25, 2022
The FDA OK greatly broadens the number of patients eligible for Jardiance, which first won approval in 2014 as a treatment for low blood sugar in people with diabetes.
World of DTC Marketing
FEBRUARY 25, 2022
Bristol Myers Squibb Co was sued for $6.4 billion on Thursday for allegedly delaying its Breyanzi cancer drug to avoid payments to shareholders of the former Celgene Corp, which the drugmaker bought in 2019. Was it a wise move or incompetence? According to a complaint in Manhattan federal court, Bristol Myers failed to use contractually required “diligent efforts” to win U.S.
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Bio Pharma Dive
FEBRUARY 25, 2022
Separate agreements with Channel Biosciences and Bristol Myers Squibb give Biohaven access to experimental treatments for spinal muscular atrophy and for epilepsy.
Pharma Mirror
FEBRUARY 25, 2022
Cambridge, UK, Framingham, MA (USA), and Dijon, France, Abzena, a partner research organization for integrated services from discovery through to clinical and commercial manufacturing for biologics and bioconjugates, Alira Health, an international patient-centric and technology-enabled advisory firm whose mission is to humanize healthcare, and Oncodesign (ALONC -FR0011766229), a biopharmaceutical company dedicated to precision medicine, announce today that, with the launch of DRIVE™-Biologics,
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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
Intouch Solutions
FEBRUARY 25, 2022
Internships are an ideal way to get real work experience and figure out if you’re a good fit for a particular industry, but how do you score one when much of the professional world is still working remotely? Who’s going to trust an untested employee to work unsupervised on their couch or at their dining room table? Intouch will. We’ve been doing it for the past two years, and we’ve learned that it’s not only possible, but that our interns do exceptionally well , even without ever setting foot in
XTalks
FEBRUARY 25, 2022
EverGrain Ingredients, a barley protein and fiber solutions company, recently received certification from the Upcycled Food Association (UFA) for its entire portfolio of products. The first-of-its-kind certification , which launched last year, allows food and beverage manufacturers that use upcycled ingredients to place the claim on their packaging.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
FEBRUARY 25, 2022
The past two years have shone a spotlight on the UK life sciences industry. Pharma companies are now household names, having been thrust into the public’s consciousness after dominating the headlines through the pandemic. The UK pharma sector should emerge from COVID-19 with a great deal of goodwill in the bank, especially after rapidly developing vaccines that are helping to steer the world out of the pandemic.
Scienmag
FEBRUARY 25, 2022
Durham University astronomer collaborating with a team of international scientists have mapped more than a quarter of the northern sky using the Low Frequency Array (LOFAR), a pan-European radio telescope. The map reveals an astonishingly detailed radio image of more than 4.4 million objects and a very dynamic picture of our Universe, which now […].
Pharma Times
FEBRUARY 25, 2022
Valneva expects to receive a positive CHMP recommendation for the conditional approval of its VLA2001 vaccine
Scienmag
FEBRUARY 25, 2022
Tokyo, Japan – Researchers from Tokyo Metropolitan University have uncovered the mechanism by which osmolytes used to treat high fluid pressure in the eye and skull can cause kidney damage. Using rat kidney cells treated with mannitol, they showed that certain kidney cells underwent a change in their skeletal structure, inducing a transformation that can […].
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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
Pharma Times
FEBRUARY 25, 2022
Figures by National Audit Office estimate that programme prevented up to 262,000 hospitalisations
Scienmag
FEBRUARY 25, 2022
BELLINGHAM, Washington, USA — SPIE, the international society for optics and photonics, is now offering Enhanced Article Processing Charges (APCs) as part of its journal publishing program. The new APC, which can be added to any open access paper accepted for publication in an SPIE journal, covers article summaries written by SPIE partner Impact Science, providing scientists with an […].
pharmaphorum
FEBRUARY 25, 2022
Eli Lilly and Boehringer Ingelheim’s blockbuster diabetes drug Jardiance (empagliflozin) has been granted approval by the US Food and Drug Administration (FDA) for a wider range of heart failure patients. . The approval builds upon previously secured indications, including the use of Jardiance to reduce the risk of cardiovascular death plus hospitalisation for heart failure with reduced left ventricular ejection fraction (LVEF), which the FDA greenlighted in 2021.
Scienmag
FEBRUARY 25, 2022
The spectacular structure of the protective armour of superbug C.difficile has been revealed for the first time showing the close-knit yet flexible outer layer – like chain mail. Credit: Newcastle University, UK The spectacular structure of the protective armour of superbug C.difficile has been revealed for the first time showing the close-knit yet flexible outer […].
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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.
Drug Channels
FEBRUARY 25, 2022
Today’s guest post comes from Jason Zemcik, Vice President of Patient Affordability at TrialCard. Jason discusses two approaches to address the CMS Final Rule on manufacturer coupons and Best Price: the pharmacy copay offer and direct reimbursement to the patient. He goes on to describe TrialCard’s reimbursement capability solutions. To learn more about TrialCard Pay and how to prepare your copay program for the future, register for Solving the Best Price and Co-Pay Challenge – A Framework for A
Scienmag
FEBRUARY 25, 2022
LA JOLLA, CA— T cells play important roles in helping to fight infections and cancers—and they can also drive autoimmune diseases. Now researchers at La Jolla Institute for Immunology (LJI) have discovered new genes in CD4+ “helper” T cell subset that are linked to risk of autoimmune diseases. Credit: Djomas via Shutterstock LA JOLLA, CA— […].
pharmaphorum
FEBRUARY 25, 2022
A new stem cell model, discovered by researchers exploring the human genome, will help scientists to map out the key genomic changes during early development. The finding, made by the Babraham Institute, Cambridge, will be invaluable in the drive to understand the implications of genome activation errors in developmental disorders and embryo loss, as reported in the journal Cell Stem Cell.
Scienmag
FEBRUARY 25, 2022
Physicists searching — unsuccessfully — for today’s most favored candidate for dark matter, the axion, have been looking in the wrong place, according to a new supercomputer simulation of how axions were produced shortly after the Big Bang 13.6 billion years ago. Using new calculational techniques and one of the world’s largest computers, Benjamin Safdi, […].
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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.
pharmaphorum
FEBRUARY 25, 2022
A new treatment for adults with insomnia disorder has been recommended for use in Europe, giving hope to people whose lives are blighted by the condition. Idorsia’s Quviviq (daridorexant) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), which means it is likely to be approved for use in around two months.
Scienmag
FEBRUARY 25, 2022
Nearly 90 percent of COVID-19 patients who qualified for, but did not receive, ECMO (extracorporeal membrane oxygenation) due to a shortage of resources during the height of the pandemic died in the hospital, despite being young with few other health issues, according to a study published in the American Journal of Respiratory and Critical Care Medicine.
NY Times
FEBRUARY 25, 2022
The first checks could be cut in April. The money — from the nation’s three major pharmaceutical distributors and Johnson & Johnson — will be used for addiction treatment and prevention.
Scienmag
FEBRUARY 25, 2022
NEW YORK, February 25, 2022 — Computers are an indispensable part of our daily lives, and the need for ones that can work faster, solve complex problems more efficiently, and leave smaller environmental footprints by minimizing the required energy for computation is increasingly urgent. Recent progress in photonics has shown that it’s possible to achieve […].
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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.
Drug Discovery World podcast
FEBRUARY 25, 2022
The latest episode of the free DDW podcast is titled “ A comprehensive analysis of European biotech ”. It covers three narrated articles written for Volume 22, Issue 3 – Summer 2021 of DDW, read by Megan Thomas. . The articles are “Innovation and opportunity within Europe’s biotech sector”, “Europe’s emerging biotechs: Challenges, opportunities and funding”, and “Why Switzerland continues to punch above its weight as global biotech hub”. .
Scienmag
FEBRUARY 25, 2022
What The Study Did: This survey study assessed changes between April 2020 and April 2021 in material hardships, such as food insecurity and problems paying rent, among U.S. adults and identified their highest priorities for spending stimulus checks. Authors: Brendan Saloner, Ph.D., of the Johns Hopkins Bloomberg School of Public Health in Baltimore, is the […].
BioPharma Reporter
FEBRUARY 25, 2022
A global biomanufacturing training hub will be established in Korea to serve low- and middle-income countries wishing to produce biologicals such as vaccines, insulin, monoclonal antibodies and cancer treatments.
Scienmag
FEBRUARY 25, 2022
Analysis of an adherence promotion strategy, the Medication Adherence Promotion System (MAPS), found that healthcare systems will save over $9,000 per adolescent transplant recipient compared to usual care. Medication adherence strategies that reduce risk of rejection by as little as 3% and cost similar to MAPS will also yield healthcare savings. Among teens with a kidney […].
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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.
Pharma Marketing Network
FEBRUARY 25, 2022
“ Being more focused, more narrow in terms of the meeting objectives, making sure the right people are there, and making sure that you have quick hit type of interventions during the course of the week to keep track of status is serving us very well. I would suggest that even if and when things return to normal, a lot of those practices and a lot of those mindsets of ways of working will probably continue even after.” – Jeff Fayer, Novartis.
Scienmag
FEBRUARY 25, 2022
In 2006, the Abuja declaration brought together states of the African Union to collectively recommend an increase in fertilizer nitrogen (N) use from 8 kg ha?1 to 50 kg ha?1 by 2015 to help enable sub-Saharan Africa (SSA) to achieve food sufficiency and eradicate poverty while improving the soil fertility. Credit: APNI Image In 2006, the Abuja […].
The Pharma Data
FEBRUARY 25, 2022
Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for ABRILADA™ (adalimumab-afzb) as an interchangeable biosimilar to Humira® (adalimumab). The Biosimilar User Fee Act (BsUFA) goal date for an FDA decision is in Q4 2022.
Scienmag
FEBRUARY 25, 2022
BLOOMINGTON, Ind. — A new analysis from Indiana University, the nonprofit Rand Corp. and the University of Michigan highlights the changes in the U.S. health care workforce during the COVID-19 pandemic and found that the average wages for U.S. health care workers rose less than wages in other industries during 2020 and the first six […].
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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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