Bio Pharma Dive
MARCH 18, 2021
A treatment that sprays synthetic messenger RNA into the lungs failed to help cystic fibrosis patients, a blow to efforts to use the technology for more than vaccines.
World of DTC Marketing
MARCH 18, 2021
SUMMARY: The FDA wants to look at how certain brand names affect consumer and health care providers’ perceptions about the efficacy and the medical conditions for which they’re indicated. This is just another example of how clueless the FDA is regarding patient behavior and prescription drugs. A brand name is only as effective, or ineffective, as the messaging and brand experience that goes with it.
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Bio Pharma Dive
MARCH 18, 2021
An FDA request for more data, which comes on the heels of troubling results from a safety study of Pfizer's Xeljanz, could push back by three months AbbVie's plans to get Rinvoq approved in psoriatic arthritis.
Pharma Mirror
MARCH 18, 2021
With the acquisition of the Spanish manufacturer STE Tecpharm, S. L., Romaco strengthens its position as a turnkey supplier of processing technologies. In particular, Tecpharm’s patented drum coaters will complement Romaco Innojet’s granulation and fluid bed technologies. On 18 March 2021, Romaco Holding GmbH announced the purchase of the Spanish manufacturer of processing technology STE Tecpharm, S.
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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
MARCH 18, 2021
The two drug regulators each believe the benefits of the shot outweigh the risks after investigating rare and unusual clotting events that have led more than 20 countries to halt vaccinations.
pharmaphorum
MARCH 18, 2021
The demise of the pharmaceutical sales representative has been greatly exaggerated over the years. But in the wake of the COVID-19 pandemic, there is an even greater need to re-examine the rep’s role. How can a field force evolve to deal with current challenges and be future-fit for the way we will be working in the post-pandemic world? The current restrictions on face-to-face meetings have exacerbated the trend of sales reps’ reduced access to healthcare customers.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
MARCH 18, 2021
An EMA advisory committee’s review of AstraZeneca’s COVID-19 has concluded that there is no increase in the overall risk of blood clots with this vaccine. The chair of the Pharmacovigilance Risk Assessment Committee (PRAC), Dr Sabine Straus, told a press briefing today that the vaccine “is safe and effective and its benefits continue to be far greater than its risks.”.
BioSpace
MARCH 18, 2021
The U.S. Food and Drug Administration approved a new treatment for relapsing forms of multiple sclerosis. This morning, Janssen announced Ponvory (ponesimod) has been greenlit as the only oral disease-modifying therapy studied against an established oral comparator for this indication.
BioPharma Reporter
MARCH 18, 2021
Researchers have highlighted nutrition as a possible factor influencing the effectiveness of the COVID-19 vaccine, as recent news establishes a link between vitamin D levels and an adequate immune response.
Triage Cancer
MARCH 18, 2021
Cancer-related fatigue is the most prevalent symptom of cancer patients at diagnosis, during treatment, and potentially for years post-treatment. Let’s understand more about what it is and why you should be discussing it with your care team. What is Cancer-Related Fatigue? The National Comprehensive Cancer Network (NCCN) defines cancer related fatigue (CRF) as: ‘a distressing, persistent, subjective sense of tiredness or exhaustion related to cancer or cancer treatment that is not proportional t
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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
BioPharma Reporter
MARCH 18, 2021
Seekyo, a startup biotechnology company specializing in the development of âsmart chemotherapyâ drugs that limit harmful side effects, has raised in excess of â650,000 (US$775K) in bridge funding.
Scienmag
MARCH 18, 2021
Credit: Kim Ratliff, Augusta University When the COVID-19 pandemic forced medical students out of classrooms and clinical rotations this time last year, the state of Georgia’s only public medical school had to quickly rethink its traditional curriculum. Faculty and staff at the Medical College of Georgia at Augusta University were able to quickly adapt and […].
BioPharma Reporter
MARCH 18, 2021
The European Medicine Agency (EMA) says its safety committee has ruled that COVID-19 Vaccine AstraZeneca is safe and effective, and the benefits of its use outweigh any possible risks.
BioSpace
MARCH 18, 2021
The results published in the NEJM state that pegcetacoplan met the study’s primary endpoint for efficacy, demonstrating an advantage over eculizumab with a statistically significant improvement in adjusted means of 3.8 g/dL of hemoglobin at week 16 (p<0.001). An impressive 85% of patients were tr.
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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.
Scienmag
MARCH 18, 2021
Researchers aim to find out Credit: Schlegel Villages, Ontario, Canada MONTREAL, MARCH 18, 2021 – Long-term care homes have been at the epicentre of the COVID-19 pandemic in Canada, with 70 percent of COVID-19 deaths having occurred in long-term care or nursing homes. The Government of Canada, through its COVID-19 Immunity Task Force (CITF), is […].
BioSpace
MARCH 18, 2021
A Phase III trial from Idera Pharmaceuticals did not reach the primary endpoint of ORR in patients with anti-PD-1 refractory advanced melanoma treated with a combination regimen comprising ipilimumab and the company’s investigational agent tilsotolimod.
pharmaphorum
MARCH 18, 2021
AstraZeneca has launched a digital toolkit for people living with chronic health conditions, a year after it started working with digital health specialist BrightInsight on the project. The toolkit – or the AMAZE Disease Management Platform to give it its full name – is designed to bring patients with conditions like asthma, chronic obstructive pulmonary disease (COPD), heart failure, chronic kidney disease, and diabetes close to healthcare providers.
BioSpace
MARCH 18, 2021
The approval was for Arcalyst (rilonacept), a weekly, subcutaneously-injected, recombinant fusion protein that blocks interleukin-1 alpha (IL-1?) and interleukin-1 beta (IL-1?) signaling.
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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
MARCH 18, 2021
Credit: Photo: L. Brian Stauffer, University of Illinois. URBANA, Ill. – Opioid use has dramatically increased in the 21st century, especially among young adults. A new study from the University of Illinois provides insights on usage patterns among Illinois high school students to help inform prevention and treatment strategies. “The societal and personal costs of […].
BioSpace
MARCH 18, 2021
A COVID-19 nasal spray vaccine developed by Rokote Laboratories Finland Ltd., is preparing for Phase I trials in Finland…if it can win funding.
XTalks
MARCH 18, 2021
With many leading plant-based food brands based in the US, Americans might assume that a majority of plant-based meat and dairy innovation takes place at home. But new data from Mintel’s Global New Products Database (GNPD) suggests that the US is actually falling behind compared to its European counterparts. In 2020, more than 20 percent of global food company launches were plant-based meat or dairy brands.
BioSpace
MARCH 18, 2021
Two years after uBiome announced it was filing for bankruptcy and closing its doors, the company’s co-founders and former co-chief executive officers have been indicted for fraud and money laundering.
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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.
Scienmag
MARCH 18, 2021
Study dates emergence to as early as October 2019; simulations suggest in most cases zoonotic viruses die out naturally before causing a pandemic Credit: National Institute of Allergy and Infectious Diseases Using molecular dating tools and epidemiological simulations, researchers at University of California San Diego School of Medicine, with colleagues at the University of Arizona […].
BioSpace
MARCH 18, 2021
A new nonhuman primate Alzheimer’s disease model developed by researchers from University of California, Davis and elsewhere could open the door to getting better therapies into human testing.
Scienmag
MARCH 18, 2021
University of Virginia School of Engineering and Northwestern University researchers create a new polymer-based electrical insulation for circuits that could help put more power in smaller spaces Credit: Austin Evans CHARLOTTESVILLE, Va. – Progress in the field of integrated circuits is measured by matching, exceeding, or falling behind the rate set forth by Gordon Moore, […].
BioSpace
MARCH 18, 2021
It’s been another strong week of biopharma companies making their debut on a stock exchange. Over the past 48 hours, three companies, Finch Therapeutics, Connect Biopharma and Gain Therapeutics, all made their debut on the Nasdaq.
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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
MARCH 18, 2021
Unique, complex information in analog methods likely gives brain more details to trigger memory A study of Japanese university students and recent graduates has revealed that writing on physical paper can lead to more brain activity when remembering the information an hour later. Researchers say that the unique, complex, spatial and tactile information associated with […].
Pharma Times
MARCH 18, 2021
GSK’294 is designed to deliver long-acting suppression of IL-5 in severe eosinophilic asthma patients
Scienmag
MARCH 18, 2021
Vaccination alone is unlikely to contain COVID-19 infections in the UK but gradual reopening and high vaccine uptake could minimize future waves of infection COVID-19 vaccines being rolled out in the UK are effective in preventing severe disease, but the extent to which they prevent against infection is still unclear. First modelling study looking at […].
Pharma Times
MARCH 18, 2021
Hubs will be located at King’s College London, NHS Blood and Transplant in Bristol and the University of Sheffield
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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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