Bio Pharma Dive
JULY 29, 2021
The startup manufacturing specialist National Resilience, which raised $800 million when it launched last year, will pay Bluebird $110 million for the North Carolina facility, bringing its North American network up to 10.
World of DTC Marketing
JULY 28, 2021
SUMMARY: 62% of HCPs spend 3 hours per day accessing digtal resources. More HCPs chose to use smartphones to access digital resources as well and usage has increased when accessing a wide variety of professional content. HCPs increasingly turn to trusted colleagues on digital networks for reliable information. Source: Build Relationships and Personalize Your Interactions With HCPs (Wolters Kluwer).
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Camargo
JULY 27, 2021
How and When to Incorporate PK Design into Your Gene Therapy Development Plan. Gene therapy, which was in its infancy around 30 years ago, is now becoming a more prominent treatment method in many therapeutic areas, from personalized therapy to mass vaccinations against COVID-19. When developing a clinical development program for these increasingly popular therapies, it is important that sponsors use modeling and pharmacokinetic (PK) analysis to evaluate parameters that can be measured while dos
Pharma Times
JULY 27, 2021
Study in adolescents met it primary endpoint, successfully bridging immune responses to those observed in an efficacy study in adults
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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
JULY 28, 2021
Flagship Pioneering, the biotech incubator that created Moderna, is helping fund Ring Therapeutics, a startup hoping to disrupt gene therapy development through the use of a different viral vector.
World of DTC Marketing
JULY 30, 2021
INTRODUCTION: One of the most important factors in your digital initiatives’ success, or failure, is the agency you choose. A lot of agencies are competing for our business. Ensuring you have hired the right one is essential to your brand’s success on both the HCP and consumers’ sides. Many CPG brands are bringing their digital marketing and media buying in-house to reduce costs and ensure that the digital strategies are aligned with key brand insights.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
JULY 25, 2021
The designation was awarded for RVx201, a live-attenuated therapeutic vaccine the company is developing for genital herpes resulting from the herpes simplex type 2 (HSV-2) virus.
Bio Pharma Dive
JULY 30, 2021
One of the country's oldest and largest drug manufacturing plants will shut down Saturday, a casualty of the 2019 merger between Mylan and Pfizer's Upjohn unit. The impact will be felt by a West Virginia city for years to come.
pharmaphorum
JULY 26, 2021
You’ve had your two COVID-19 jabs, but are you actually protected against infection? That’s a question that a fingerprick test launched today in the UK and Ireland could help to answer. The test – originally developed by US manufacturer Chembio Diagnostics – has been introduced into the UK and Irish markets by Guilford-based Luas Diagnostics and tests for the presence of SARS-CoV-2-targeting antibodies in the blood.
BioPharma Reporter
JULY 28, 2021
A study of more than a million vaccinated people has found 'similar safety profiles' for the AstraZeneca and Pfizer/BioNTech vaccines: adding the incidence of rare blood clots was far higher among people with COVID-19 than those who had received either vaccine.
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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
JULY 26, 2021
Biotech jobs are one of the most promising career paths for people who are into life sciences and those who dream of creating change in the world through developing breakthrough medicines and therapeutics.
Bio Pharma Dive
JULY 27, 2021
The FDA reversed an earlier decision to make Keytruda the first immunotherapy available for patients with early-stage breast cancer and also gave the drugmaker a full approval in advanced disease.
pharmaphorum
JULY 26, 2021
A lack of racial diversity in clinical trials is a long-standing, well-documented problem that contributes to the stark health inequalities that have been brought into sharp focus by COVID-19. Tackling it, however, has not been easy, thanks in no small part to the reasons being as complex as they are multi-faceted. But, according to the Pharmaceutical Research and Manufacturers of America (PhRMA), the country’s biopharmaceutical companies are “committed to learning and leading” in a bid to “addr
BioPharma Reporter
JULY 27, 2021
BioNTech aims to develop the first mRNA-based malaria vaccine, hoping to reach clinical trials by 2022. Meanwhile, it is also exploring possibilities to set up mRNA manufacturing facilities on the African continent â which could potentially be used for vaccines against a wide range of diseases.
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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
JULY 29, 2021
?Pfizer has reported several highlights regarding its mRNA COVID-19 vaccine. As the world deal with rising Delta variant cases, Pfizer-BioNTech is still arguing that a third booster shot will be likely.
Bio Pharma Dive
JULY 30, 2021
The agency wants Ardelyx to run another trial to show its drug affects clinical outcomes for patients with chronic kidney disease. Analysts think this could be accomplished, but would take some time.
Pharma Times
JULY 28, 2021
Rate of rare blood clots with low platelets after the second dose is comparable to background rates observed in unvaccinated populations
pharmaphorum
JULY 29, 2021
The use of specialty drugs in the U.S. has skyrocketed in recent years driven primarily by an increase in chronic condition diagnosis and the number of new medications on the market. Krishnanjan Alaparthi explores how tech-driven hub services can help manage the complexities of specialty pharma. It’s estimated specialty medications account for 75% of the approximately 7,000 prescription drugs currently in development, and by 2022, more than 60% of the 600 drugs expected to gain FDA approval will
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
JULY 26, 2021
Bryan Dechairo, newly appointed president and CEO of Sherlock Biosciences, learned early in his career to fill gaps and seize opportunities. “When you see a gap, jump in and solve those problems, and you’ll be at the forefront of science rather than following others,” he told BioSpace.
Bio Pharma Dive
JULY 26, 2021
With the decision by Bristol Myers, each of the two accelerated cancer drug approvals an FDA advisory panel voted to overturn in April have now been voluntary withdrawals.
XTalks
JULY 29, 2021
For its newest Lay’s potato chip flavors, Frito-Lay looked to its other products for inspiration rather than elsewhere for innovation in its Flavor Swap line. Aptly dubbing it “a chip in a chip that was already a chip,” Best Products began circulating images of a bag of Cool Ranch Doritos-flavored Lay’s chips a few months back. Now, the inception-worthy chip has become a reality, with two other “new” flavors launching by its side.
pharmaphorum
JULY 27, 2021
Drug delivery specialist Aptar Group has agreed a deal to take a near two-thirds share in Voluntis, a French developer of digital therapeutics (DTx), with a view to taking full control of the company later this year. Illinois-headquartered Apar – which makes inhalers, syringe components, eye drop bottles and other delivery systems for pharmaceuticals, cosmetics and other sectors – is paying €8.70 per share in the initial deal, which will give it a 64.6% stake in the company.
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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
JULY 26, 2021
Merck's Keytruda won FDA approval for the treatment of patients with high-risk, early-stage triple-negative breast cancer. The approval marked the 30th for Keytruda.
Bio Pharma Dive
JULY 29, 2021
An injectable insulin from Viatris has become the first-ever biosimilar product that can be directly substituted for a marketed biologic, a long-awaited decision that could put pricing pressure on other diabetes drugs.
Eye on FDA
JULY 29, 2021
In the face of a crisis situation, it is a given that the clarity and thoroughness of the communications response is key to resolving the issue and mitigating any reputational damage. Perhaps no other decision by the Food and Drug Administration has garnered as much controversy, as the recent one to authorize the accelerated approval a new treatment for Alzheimer’s.
pharmaphorum
JULY 29, 2021
Two artificial intelligence (AI) algorithms designed to diagnose people with heart rhythm abnormalities have been approved by the FDA for use with Medtronic’s LINQ II cardiac monitor. The AccuRhythm algorithms can be used to improve the accuracy of detecting atrial fibrillation (AF) – an irregular or rapid rhythm in the upper chambers of the heart – and asystole, a long pause between heartbeats.
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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
JULY 30, 2021
Annovis Bio’s therapy for Alzheimer’s disease is fast-acting and has the potential for Alzheimer’s patients to significantly improve cognition and motor function, according to data presented at the Alzheimer’s Association International Conference® 2021 (AAIC®), held July 26th through 30th.
Bio Pharma Dive
JULY 30, 2021
The big drugmaker surprised analysts and investors this week by projecting Phase 3 results next year, which could put the company on pace with a rival shot from GlaxoSmithKline.
Pharma Times
JULY 26, 2021
Combo therapy includes carflizomib administered alongside lenalidomide, dexamethasone and cyclophosphamide
pharmaphorum
JULY 27, 2021
Flushed with the success of its COVID-19 vaccine, BioNTech has pressed the accelerator on the development of shots for other infectious diseases, and now plans to take malaria and tuberculosis candidates into the clinic next year. Human testing of the malaria shot should get underway by the end of 2022, according to the German biotech, which says it is working with the World Health Organization (WHO), European Commission and other organisations on the malaria project.
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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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