Bio Pharma Dive
FEBRUARY 24, 2021
Agency scientists noted the shot's strong protection against severe COVID-19, even for the virus variant first detected in South Africa and known to weaken vaccine potency.
World of DTC Marketing
FEBRUARY 24, 2021
SUMMARY: In a recent study by The Harris Poll on behalf of TIME, the overwhelming majority of Americans (78%) admitted to delaying routine medical services and health care appointments due to the coronavirus pandemic. The health care industry should invest more in patient outreach, communication and education. Via The NY Times “the coronavirus pandemic has yet to end, but we are already beginning to feel the aftershocks.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Camargo
FEBRUARY 24, 2021
Preparing to meet with the FDA can be challenging and stressful for sponsors, especially when they do not know what to expect. Many have misunderstandings about how meetings should be conducted and what constitutes success. Others find themselves needing to dispel incorrect preconceptions about this interactive process for board members or investors.
BioPharma Reporter
FEBRUARY 22, 2021
Pfizer and BioNTech have dosed the first participants in a Phase 2/3 study for their COVID-19 vaccine in pregnant women; and plan to trial the vaccine in children later this year.
Bio Pharma Dive
FEBRUARY 22, 2021
Lengthy trials won't be needed for updating shots against emerging viral strains, the agency told developers in newly published guidance.
World of DTC Marketing
FEBRUARY 22, 2021
SUMMARY: One of the biggest complaints people have about their health is the lack of sleep caused by many factors, from diet and weight to chronic stress. DTC for a product that can keep people awake for nine hours is a message for potential abuse. Did I mention that they are using a flying pig in their DTC? One of the most common complaints people have is “lack of energy” Consumers have turned to energy drinks which was valued at $53.01 billion in 2018, and is expected to grow at a
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioPharma Reporter
FEBRUARY 23, 2021
Real-world data from England shows that the Pfizer/BioNTech vaccine offers 'clear protection from first dose' and may help interrupt transmission; while Scottish data shows the first doses of vaccines led to a substantial fall in hospital admissions.
Bio Pharma Dive
FEBRUARY 24, 2021
Moderna has delivered a modified version of its vaccine to NIH scientists, while Pfizer has begun testing of an additional booster shot in a clinical trial, both precautionary steps against emerging strains.
World of DTC Marketing
FEBRUARY 25, 2021
SUMMARY: Per the Times, “what if consumers could calculate the benefits and risks of taking a prescription drug as easily as they can gauge the carbohydrates and calories in an Oreo cookie?” Drug facts boxes are needed, but the FDA disagrees. According to the AMA one of the key reasons for non-adherence is that patients may be frightened of potential side effects.
pharmaphorum
FEBRUARY 26, 2021
Healthcare organisations that have been traditionally slow to adopt new technology produced a response to the pandemic that was almost in line with less regulated industries, according to a new report. Findings of research from the cloud communications platform Twilio based on 2,500 enterprise decision makers, including 117 healthcare organisations, showed it took 36 days on average to accelerate a digital transformation strategy.
Advertisement
White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Scienmag
FEBRUARY 23, 2021
Western forests may be less able to regenerate following large-scale diebacks Credit: USGS DURHAM, N.C. — Younger, smaller trees that comprise much of North America’s eastern forests have increased their seed production under climate change, but older, larger trees that dominate forests in much of the West have been less responsive, a new Duke University-led […].
Bio Pharma Dive
FEBRUARY 25, 2021
Tal Zaks, the biotech's chief medical officer for the past six years, will depart in September after playing a high-profile role in the company's coronavirus vaccine development.
BioSpace
FEBRUARY 23, 2021
Biopharma companies may receive NIH funding, but generally, not to the extent that academia does. However, the Genetown Hotbed has several biopharma companies that received significant funds from the NIH in 2020. Here’s a look at the top 10.
pharmaphorum
FEBRUARY 22, 2021
As part of our Patients Insights series, the founder and CEO of Motherhood Understood shares her experience of postpartum depression, talks about the power of peer support, and explains what the wider healthcare community could do to play their part. Within days of giving birth to her first child, Jen Schwartz’s fairy tale view of motherhood lay in tatters at the foot of the bed she found it impossible to leave.
Advertisement
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.
Clinical Trial Podcast
FEBRUARY 23, 2021
Almost everyone I’ve met in clinical research has accidentally discovered this hidden profession. Your interest in science and medicine somehow got you involved in clinical research and clinical trial management. But didn’t you wish you had a crystal clear understanding of “Who’s Who In Clinical Research?”. That’s when this post comes handy. Clinical Research is sometimes also referred to as Medical Affairs or Clinical Affairs.
Bio Pharma Dive
FEBRUARY 22, 2021
The approval of Libtayo in first-line lung cancer will pit Regeneron's drug, developed in partnership with Sanofi, against Merck's top-selling immunotherapy Keytruda.
BioSpace
FEBRUARY 25, 2021
The U.S. FDA approved Sarepta Therapeutics’ Amondys 45 (casimersen) for patients with Duchenne muscular dystrophy (DMD) who have a confirmed mutation amenable to exon 45 skipping.
pharmaphorum
FEBRUARY 26, 2021
Rare diseases impact between 3.5%-5.9% of the world’s population. For Rare Disease Day, RBW Consulting’s Emma Thorp discusses why the consultancy is taking revenue earned from its rare disease clients and using it to fund research into the mental health impact of a rare disease diagnosis. Rare diseases are often chronic and life-threatening, and with a large percentage of cases presenting in young children, a diagnosis has a profound and unique impact on everyone affected.
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.
BioPharma Reporter
FEBRUARY 25, 2021
A program at the University Hospital of TÃbingen is the first in Germany to use whole genome sequencing (WGS) to improve the diagnosis of rare diseases and hereditary cancers.
Bio Pharma Dive
FEBRUARY 22, 2021
Brainstorm Cell Therapeutics said that, following a review of Phase 3 data, the agency felt the results were not enough to support an approval application.
BioSpace
FEBRUARY 22, 2021
Otezla, an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) directed for cyclic adenosine monophosphate (cAMP), may indirectly modulate inflammatory mediators in certain conditions, but the specific underlying mechanisms are not clearly understood.
pharmaphorum
FEBRUARY 23, 2021
Sanofi’s cancer immunotherapy Libtayo (cemiplimab) has a third US indication after the FDA approved it for certain untreated lung cancer patients. The approval in first-line lung cancer, in non-small cell lung cancer patients whose tumours have high PD-L1 expression brings the drug into competition with Merck & Co’s Keytruda (pembrolizumab), which has become the go-to therapy in this disease.
Advertisement
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
Triage Cancer
FEBRUARY 22, 2021
Health Insurance Marketplaces are now open for a Special Enrollment Period (SEP). In the 36 states with Marketplaces on www.HealthCare.gov, individuals have the opportunity to buy a new health insurance policy or change policies until May 15, 2021. While this SEP was created in response to the pandemic, you do not have to have been impacted by COVID-19 to benefit.
Bio Pharma Dive
FEBRUARY 25, 2021
Amondys 45 is now cleared for the estimated 8% of Duchenne patients eligible for treatment. Like other Sarepta drugs, it comes with a high price tag and its clinical benefits haven't been confirmed.
BioSpace
FEBRUARY 23, 2021
BMS is looking to hire "several hundred employees over the next few years," all working to ensure the production of both their clinical and commercial cell therapies.
pharmaphorum
FEBRUARY 25, 2021
Pfizer/BioNTech’s mRNA vaccine against COVID is a technical marvel – but the ultra-cool temperatures required for storage and stability has been tricky to handle. Maryland, US-based company Altimmune is among the biotechs and research labs trying to find more convenient alternatives and believes a nasal vaccine spray that is stable at room temperature could be the answer.
Advertisement
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.
XTalks
FEBRUARY 22, 2021
Clinical research is part of a growing industry that provides individuals with rewarding career options and a ladder to climb. Working in the clinical trials industry allows clinical researchers to work with patients and bring new drugs to market. There are many professions under the clinical research umbrella. To become a professional in this field, one must begin by achieving a bachelor’s degree in a science-related field.
Bio Pharma Dive
FEBRUARY 24, 2021
The cash-and-stock deal gives PRA shareholders roughly one-third ownership of the new company, which will be one of the larger providers of contract research support.
BioSpace
FEBRUARY 23, 2021
The U.S. FDA issued new guidance for vaccine makers as it is preparing for the possibility of needing to approve COVID-19 booster shots against variants of the SARS-CoV-2 virus.
pharmaphorum
FEBRUARY 25, 2021
How has rare disease care changed over the last few years? And what might we expect from the next five? We attended the Rare Disease Day Virtual Parliamentary Event to find out. The rare disease community has a golden opportunity to transform the way care is delivered across all four UK nations – that’s according to speakers at a parliamentary reception held to mark 2021’s Rare Disease Day.
Advertisement
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.
Expert insights. Personalized for you.
321 
Let's personalize your content