Bio Pharma Dive
APRIL 30, 2021
Over three days of meetings, a group of FDA advisers discussed the tough trade-offs of accelerated immunotherapy approvals. Their decisions could escalate an already intense debate.
World of DTC Marketing
APRIL 29, 2021
WHAT”S UP WITH THAT: A quick analysis of two pharma websites shows that Facebook, and others, are tracking users. Does pharma even know or care? With the release of Apple’s latest updates, privacy has suddenly become a big issue, especially for Facebook. So why then are some pharma websites tracking visitors for Facebook? As the diagrams below indicate both Enbrel.com and Humira.com are allowing Facebook to track visitors so they can serve them ads.
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BioPharma Reporter
APRIL 27, 2021
Medicago has started a rolling submission with Health Canada for its plant-derived adjuvanted COVID-19 vaccine candidate: championing a unique and versatile platform that can also be scaled up easily.
BioSpace
APRIL 25, 2021
Leaked documents from provincial and municipal governments in China reveal a slew of previously unreported severe adverse events related to COVID-19 vaccines made and administered in China.
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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
Bio Pharma Dive
APRIL 28, 2021
Far along in testing for a hemophilia treatment, BioMarin is expanding its gene therapy research into diseases of the central nervous system and aims to use some of the institute's technology.
World of DTC Marketing
APRIL 27, 2021
QUICK READ: Patients are returning to their doctor’s office, and it’s not uncommon for appointments, or routine visits, to be scheduled weeks or months in advance. I talked to some thought leaders, and they said that they don’t have time for either virtual patient visits or online pharma detailing. About this time, every year, I get my annual physical, which is more like a request for a blood workup.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
APRIL 26, 2021
Technology firm Jolly Good and Teijin Pharma have begun a partnership to develop virtual reality digital therapeutics (VR DTx) for major depressive disorder. The goal of the partnership for approval for the Japanese market from the Pharmaceuticals and Medical Devices Agency (PMDA). Jolly Good has already won a “Home Healthcare Award” in a programme held by Teijin in December last year.
Bio Pharma Dive
APRIL 28, 2021
Product sales fell by 5% in the first quarter, keeping the pressure high for Amgen to deliver on expectations for its KRAS cancer drug Lumakras.
BioPharma Reporter
APRIL 28, 2021
As COVID-19 response initiatives and vaccine rollouts begin to bring the pandemic under control, we consider what changes to clinical trials will be made permanent.
XTalks
APRIL 26, 2021
After years of disappointing malaria vaccine trials, a malaria shot developed by researchers at the Jenner Institute at the University of Oxford has demonstrated an unprecedentedly high efficacy of 77 percent, and may be the magic bullet the world has been waiting for against the deadly disease. The results come from a Phase II trial of the vaccine, called R21/Matrix-M (MM), which have been published in a pre-print study in the journal The Lancet.
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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
pharmaphorum
APRIL 30, 2021
Reports of COVID-19 vaccinations causing blood clots has caused alarm in the general population. However due to the rarity of incidences from vaccination, myGP explores the most common causes of blood clots and how we can prevent them. Over 11 million doses of COVID-19 vaccines have been given across the UK, with blood clotting observed in a small sample of patients.
Bio Pharma Dive
APRIL 29, 2021
The agency threatened to fine Acceleron for not posting study results to clinicaltrials.gov. Whether the action is a sign of a larger crackdown is unclear.
BioPharma Reporter
APRIL 26, 2021
A Phase 2b trial for the University of Oxfordâs malaria vaccine candidate showed 77% efficacy in children, according to a study published in The Lancet. âWe believe this vaccine could have a major public health impactâ, say researchers.
XTalks
APRIL 27, 2021
The US Food and Drug Administration (FDA) has authorized marketing of a new neurological rehabilitation device to assist in maintaining or increasing range of motion as part of muscle re-education in patients undergoing stroke rehabilitation. The device is approved for use in patients 18 years of age and older. More than 795,000 people suffer a stroke each year in the US, many of whom are left with serious long-term disabilities.
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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.
pharmaphorum
APRIL 28, 2021
Today, most drug discovery programmes begin with the identification and validation of disease modifying biological targets. The primary way to uncover these targets is through searching and reviewing published scientific literature. Eric Gilbert explores how data science techniques like text mining are speeding up research into areas such as pancreatic cancer.
Bio Pharma Dive
APRIL 26, 2021
The French pharma has agreed to "fill and finish" up to 200 million vials of Moderna's shot at its New Jersey plant, the third such manufacturing deal it struck with other vaccine developers.
BioSpace
APRIL 25, 2021
AstraZeneca and Sanofi announced that their MELODY Phase III trial of nirsevimab hit the primary endpoint in medically attended lower respiratory tract infections (LRTI) caused by RSV in healthy late preterm and term infants.
Pharma Times
APRIL 29, 2021
The 2021 Marketer of the Year competition is well underway for entries and is looking for the best and brightest to join the ranks.
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
pharmaphorum
APRIL 27, 2021
Cognoa has filed for FDA approval of a digital device that could be used to diagnose autism, which the company argues could redefine care standards. . Autism can be difficult to diagnose as there are no medical markers to show its presence – instead doctors look at the child’s developmental history and behaviour to make a diagnosis. Cognoa hopes to change this with an efficient and accurate approach that could allow diagnosis in primary care that won’t require a lengthy referral to a specialist.
Bio Pharma Dive
APRIL 28, 2021
The deal is another sign of Pfizer's interest in infectious disease beyond COVID-19, following the pharma's participation in an industry investment fund.
Scienmag
APRIL 28, 2021
Credit: Professor Seirian Sumner, UCL Wasps deserve to be just as highly valued as other insects, like bees, due to their roles as predators, pollinators, and more, according to a new review paper led by UCL and University of East Anglia researchers. The study, published in Biological Reviews, compiles evidence from over 500 academic papers […].
XTalks
APRIL 30, 2021
Cinnamon Toast Crunch has expanded their retail availability of its Cinnamon Toast Crunch Cinnadust Seasoning Blend to 4,300 stores nationwide. This seasoning blend was first introduced to the market in September 2020 and has exploded in popularity since then. Cinnamon Toast Crunch Cinnadust Seasoning Blend captures the cinnamon flavors associated with their famous cereal brand.
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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.
Druggist
APRIL 29, 2021
Apixaban (Eliquis®) and warfarin are two popular prescription-only drugs classified as anticoagulants, commonly known as blood thinners. Warfarin has been used as an anticoagulant for a very long time. However, in recent years warfarin’s popularity decreased in place of newer anticoagulants such as apixaban, as reflected by prescribing statistics.
Bio Pharma Dive
APRIL 26, 2021
VX-548 is Vertex's latest attempt to show that blocking a certain sodium channel can offer a new, non-addictive way to treat pain.
Scienmag
APRIL 30, 2021
Credit: Niigata University Niigata, Japan–Researchers from Niigata University , the University of Tokyo, Osaka University and Tokyo Medical University, Japan have developed a new approach that could revolutionize the treatment, prevention, and possibly reversal of the damages caused by liver diseases. This novel strategy exploits small extracellular vesicles (sEVs) derived from interferon-?
XTalks
APRIL 29, 2021
The management of human immunodeficiency virus (HIV) has come a long way since the infection was first identified in the early 1980s. While there is no cure for HIV, current treatments are able to keep the infection in check by suppressing viral replication to reduce viral loads. Sustained viral suppression is achieved through antiretroviral (ARV) therapy, which often consists of a cocktail of two or more ARV drugs that work to inhibit viral replication.
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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.
Pharma Marketing Network
APRIL 28, 2021
Introducing the recipient of the 2020-21 HBA Honorable Mentor Award, Dr. Rod MacKenzie , Chief Development Officer and EVP, Pfizer and the recipient of the 2020-21 HBA STAR Award, Susan Torroella , Chief Operating Officer, ArmadaHealth. What is the Honorable Mentor Award? The Honorable Mentor award recognizes a man who demonstrates a long-term commitment to advancing women in the workforce, is dedicated to developing, mentoring and promoting women in the industry, and is supportive of the overal
Bio Pharma Dive
APRIL 27, 2021
Biogen plans to start a compassionate use program in July that would let a small group of patients with rapidly progressing disease access its drug.
BioSpace
APRIL 27, 2021
As a devastating pandemic increased scientific collaboration globally, CSL was already ahead of the curve with teams spanning the continents, working together to advance lifesaving treatments and technologies.
XTalks
APRIL 28, 2021
Stop Food Waste Day occurs each year on April 28 to educate, raise awareness and fight against food waste globally. Launched in 2017 by the US division of global foodservice leader Compass Group , consumers and corporations across over 30 Compass countries work together to educate and encourage change when it comes to food waste. Exacerbated by the COVID-19 pandemic, the food waste epidemic continues to worsen.
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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.
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