Bio Pharma Dive
MARCH 13, 2021
Highly anticipated results from a Phase 2 study of donanemab showed treatment slowed disease progression, but mixed data on other measures could temper optimism in its potential.
World of DTC Marketing
MARCH 17, 2021
SUMMARY: Via the Financial Times , “pharmaceutical companies have never had it so good. The rapid rollout of Covid-19 vaccines has made household names of Pfizer and AstraZeneca, and the whole industry is winning praise for co-operation” However, the bump in reputation will be short-lived because companies need to earn the public’s trust every day, and pharma is already damaging their perception with people.
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pharmaphorum
MARCH 19, 2021
DeepVerge has announced trial data showing its COVID-19 Microtox BT breath test can deliver accurate results in under 60 seconds, with a potential roll-out later this year if further tests support it. The company has already completed of the system that resembles a breathalyser in phase 1 and phase 2 studies with the SARS-CoV-2 virus in the safety of laboratories.
Scienmag
MARCH 16, 2021
Persistent work from scientists at The University of Toledo could aid in diagnosing and treating postural orthostatic tachycardia syndrome Credit: Daniel Miller / The University of Toledo The symptoms of postural orthostatic tachycardia syndrome, or POTS, can be as varied as they are confounding. There can be fatigue, pain, bleeding disorders and anxiety.
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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 16, 2021
Nearly $20 billion was invested in biotechs developing cell-, gene- and tissue-based treatments in 2020, according to a new report from industry group ARM.
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.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
MARCH 16, 2021
Pennsylvania-based Ocugen has struck a deal to sell 100 million doses of a COVID-19 vaccine India’s Bharat Biotech in the United States later this year.
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 16, 2021
IN BRIEF: As a marketer, most of us, like a Jungian archetype, are true Communicators. Yet are those skills only reserved for big budgets, bold pitches, and grand innovations? Or do we, as individuals, have a special responsibility to the public at this moment in time? After all, we are already the translators of science for our clients. . A March 12th, Marist/NPR pole on vaccines is disturbing, but from what I have seen in everyday life, it is worse: · 25% of Black respondents and 28% of white
XTalks
MARCH 17, 2021
Researchers at Purdue University have developed contact lenses with a new integrated technology that can monitor, and may even be able to diagnose, ocular disease progression. The novel technology has been applied to commercial soft contact lenses so they can be used as a bioinstrumentation tool for unobstructed ocular monitoring. Eye health and ocular disease screening and monitoring typically involve the use of an electroretinogram (ERG), which measures the electrophysical activity of the reti
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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
MARCH 17, 2021
The FDA will limit the use of monoclonal antibody treatments developed by Regeneron and Eli Lilly due to concerns the medications are not effective against these new strains.
Bio Pharma Dive
MARCH 15, 2021
Why the Apple Watch will likely be one of the top choices for use by sponsors, CROs and clinical trial teams wishing to use wearables in their trials.
pharmaphorum
MARCH 19, 2021
A host of companies are looking at cough apps to detect the presence of COVID-19. But one company called Hyfe wants to take the idea a step further and use them to detect future pandemics, reports Richard Staines. . The pandemic has seen a plethora of digital tools emerge to help manage patients remotely, with the ubiquitous use of smartphone technology allowing medics to monitor patients’ vital signs without risky face-to-face contact.
Pharma Times
MARCH 15, 2021
Review included available safety data from over 17 million people vaccinated in the EU and UK with COVID-19 jab
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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.
BioSpace
MARCH 16, 2021
France and Germany are two out of more than a dozen countries that suspended deployment of the AstraZeneca-Oxford University vaccine after reports of blood clots were reported.
Bio Pharma Dive
MARCH 15, 2021
Study results for donanemab showed signs of slowing disease progression, but the company believes the FDA won't review until another study confirms that apparent benefit.
pharmaphorum
MARCH 19, 2021
This content is password protected. To view it please enter your password below: Password: The post Protected: Using AI to make a big impact for emerging and mid-sized biopharma companies appeared first on.
Pharma Times
MARCH 16, 2021
Clinical Researcher of the Year – The Americas finalists reveal their positive experiences with the 2020 competition.
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.
BioSpace
MARCH 16, 2021
Algernon Pharmaceuticals has requested a pre-Investigational New Drug meeting with regulators in the hopes of launching a clinical trial in stroke patients for n,n-dimethyltryptamine, a naturally derived psychedelic compound.
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.
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.
Scienmag
MARCH 19, 2021
A new study shows how microplastics found in our daily personal care products can also host pathogens and boost antibiotic-resistant bacteria by up to 30 times once they wash down household drains and enter municipal wastewater treatment plants Credit: NJIT It’s estimated that an average-sized wastewater treatment plant serving roughly 400,000 residents will discharge up […].
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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
MARCH 14, 2021
With more European countries pausing dosing of AstraZeneca’s COVID-19 vaccine over concerns about potential blood clotting side effects, Russia is seeking to fill in the gaps with its Sputnik V vaccine.
Bio Pharma Dive
MARCH 15, 2021
The rivals are now working together on oral and injectable treatments that combine their closely watched experimental drugs lenacapavir and islatravir.
pharmaphorum
MARCH 15, 2021
A clinical trial has found that Novavax’ COVID-19 vaccine is 86% protective against the UK variant of SARS-CoV-2, only slightly lower than the 96% efficacy seen with the original strain of the virus. . The phase 3 trial – which takes Novavax’ NVX?CoV2373 shot a step closer to approval – also found that it was 100% effective in preventing severe COVID-19.
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.
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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.
BioSpace
MARCH 14, 2021
Two of the biggest drugmakers in the HIV space are teaming up on a combination therapy that has the potential to be a game-changer for patients diagnosed with the dangerous virus for which there is no known cure.
Bio Pharma Dive
MARCH 15, 2021
Softbank and Fidelity joined a large group of investors in a $525 million Series C investment into Elevate, a high-powered genetic medicine startup with an unusual business model.
pharmaphorum
MARCH 16, 2021
Roche has launched a new test that will help monitor emerging variants of the SARS-CoV-2 coronavirus. In a statement the company said the cobas SARS-CoV-2 Variant Set 1 Test is designed to detect key spike mutations in virus variants associated with increased human-to-human transmission. Detecting different variants of the virus can help assess the spread of circulating variants and monitor their potential impact on therapeutics, vaccines and public health interventions.
Scienmag
MARCH 19, 2021
Peptomyc’s Omomyc-based therapy against cancer put to the clinical test Credit: VHIO Co-founded back in 2014 by VHIO’s Laura Soucek, CEO of the enterprise, and Marie-Eve Beaulieu, Chief Scientific Officer (CSO) of the company, VHIO-born spin-off Peptomyc S.L. has just announced that it has received approval from the Spanish Agency of Medicines and Medical Devices […].
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