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.
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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Bio Pharma Dive
APRIL 29, 2021
Both companies blamed the impact of COVID-19 on sharp declines in sales of their shingles, pneumonia and HPV shots.
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.
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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 29, 2021
Adverum Biotechnologies has unmasked a Phase 2 study in which a trial participant suffered severe inflammation and vision loss — a finding that could threaten the program’s future in multiple eye diseases.
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.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Scienmag
APRIL 29, 2021
BU researchers used NASA satellite imaging data to analyze 30 years of Earth’s northern forests and found that fires are increasingly hampering forests’ ability to capture and store atmospheric carbon Credit: Courtesy of Jonathan Wang New research indicates that the computer-based models currently used to simulate how Earth’s climate will change in the future underestimate […].
BioSpace
APRIL 29, 2021
Battered by vaccine manufacturing mishaps that led to the contamination of 15 million doses of the Johnson & Johnson vaccine, Emergent BioSolutions is shaking up its leadership to ensure such errors do not occur again.
Scienmag
APRIL 29, 2021
Credit: Heriot-Watt University Exploring extreme environments can put significant operational challenges on the engineering systems we depend upon to safely explore and at times operate within. Within high-value and safety-critical applications, such as space exploration or sub-surface drilling, the extreme and at times dynamic operating conditions within the environment, can make it challenging to understand […].
XTalks
APRIL 29, 2021
Multiple studies have confirmed that conducting clinical trials with a diverse range of ethnicities, genders, ages, and lifestyles is essential, since these factors can impact a treatment’s effectiveness among different groups. In the United States, legislation like the 21 st Century Cares Act has recognized this fact, calling for greater clinical trial diversity.
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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
BioSpace
APRIL 29, 2021
AstraZeneca reported its first-quarter financial reports. As is often the case, they updated their pipeline, and indicated they had dropped a few drugs, including a promising multiple myeloma drug.
Pharma Times
APRIL 29, 2021
Nilemdo and Nustendi recommended for around 70,000 eligible adults in England with high cholesterol
BioSpace
APRIL 29, 2021
The U.S. FDA has released a Complete Response Letter (CRL) following its review of LEO Pharma’s tralokinumab. Further data on a device component is the issue brought to light by the recently completed Biologics License Application (BLA) review.
BioPharma Reporter
APRIL 29, 2021
Adverum Biotechnologies has reported a setback in its trial exploring gene therapy for the treatment of diabetic macular edema (DME).
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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.
BioSpace
APRIL 29, 2021
If you equate virtual reality (VR) to games or pain relief applications, you’re missing one of science’s most amazing tools.
Pharma Times
APRIL 29, 2021
Extension means the 'majority' of people aged 12 years and older with CF in Europe can now access therapy
BioSpace
APRIL 29, 2021
AstraZeneca’s COVID-19 vaccine road to approval has been anything but smooth.
pharmaphorum
APRIL 29, 2021
The UK has ordered an extra 60 million doses of the Pfizer/BioNTech COVID-19 vaccine, which could be used as a potential booster campaign in the autumn. Health secretary Matt Hancock made the announcement in a press briefing, revealing that officials think they may have to boost protection for the population during the winter. The UK looks on course to lift all coronavirus restrictions by 21st June, following a further easing of regulations in mid-May.
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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.
Scienmag
APRIL 29, 2021
Martin J. Blaser, MD, recognized for career-long focus on the microbiome’s effect on human health Credit: Roy Groething Martin J. Blaser, MD, has been awarded the 2020 Prize Medal by the Microbiology Society of Great Britain in recognition of his study of the microbiome and its interactions within the human body that provide protection against […].
Pharma Times
APRIL 29, 2021
ViroCell Biologics will meet the growing demand for viral vectors in clinical trials
Scienmag
APRIL 29, 2021
Credit: Sean Nealon, Oregon State University CORVALLIS, Ore. – Land productivity could be greatly increased by combining sheep grazing and solar energy production on the same land, according to new research by Oregon State University scientists. This is believed to be the first study to investigate livestock production under agrivoltaic systems, where solar energy production […].
BioSpace
APRIL 29, 2021
An investigational Alzheimer's disease drug from Tetra Therapeutics appeared to improve language ability and learning in adults with Fragile X Syndrome, according to a new study reported in Nature Medicine.
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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.
pharmaphorum
APRIL 29, 2021
GlaxoSmithKline’s CEO Emma Walmsley said the company is focused on pursuing its strategy to spin off its consumer business after downbeat set of first quarter results. Pharma sales were down 12% compared with last year’s Q1 to £3.9 billion and its vaccines business has also been hit by a 32% slump as people put off getting vaccinated against shingles with its lead product Shingrix during the pandemic.
Scienmag
APRIL 29, 2021
Older adults were significantly affected by isolation and stress during Oregon’s initial COVID-19 lockdown last spring, but they were also able to find connection and meaning in community, new hobbies and time for themselves, a recent Oregon State University study found. If resilience is understood as the ability to see positives in the midst of […].
pharmaphorum
APRIL 29, 2021
Calliditas Therapeutics could have its first product on the market in the US this autumn, as the FDA has now started a priority review of Nefecon for rare disease primary IgA nephropathy (IgAN). . The Swedish biotech says the IUS regulator has set an action date of 15 September for its review of Nefecon, a novel formulation of the established corticosteroid drug budesonide that could become the first ever approved therapy for IgAN.
BioSpace
APRIL 29, 2021
The U.S. FDA's Oncologic Drugs Advisory Committee did not agree in a recent meeting to maintain the accelerated approval of Bristol Myers Squibb’s Opdivo (nivolumab) as a second-line treatment of hepatocellular carcinoma.
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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.
Scienmag
APRIL 29, 2021
Credit: JAXA Scientists have recreated the reaction by which carbon isotopes made their way into different organic compounds, challenging the notion that organic compounds, such as amino acids, were formed by isotopically enriched substrates. Their discovery suggests that the building blocks of life in meteorites were derived from widely available substrates in the early solar […].
BioSpace
APRIL 29, 2021
Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones.
Scienmag
APRIL 29, 2021
Researchers find first-ever galaxy observed in a ‘blow-away’ state Credit: Credit: Podevin, J.f., 2006 A new study led by University of Minnesota astrophysicists shows that high-energy light from small galaxies may have played a key role in the early evolution of the Universe. The research gives insight into how the Universe became reionized, a problem […].
BioSpace
APRIL 29, 2021
A study found in India that the existing COVID-19 vaccines should be effective against the Indian variant, not just the Pfizer-BioNTech vaccine.
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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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