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
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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.
Speaker: Simran Kaur, Co-founder & CEO at Tattva Health Inc.
AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!
Bio Pharma Dive
FEBRUARY 22, 2021
The FDA is widely expected to authorize the drugmaker's one-dose shot.
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.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharma Times
FEBRUARY 22, 2021
Services will be offered to staff who have been affected by the COVID-19 pandemic
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.
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.
BioSpace
FEBRUARY 22, 2021
Israel’s Health Ministry announced results of a study in the country that showed that the Pfizer-BioNTech COVID-19 vaccine was 98.9% effective at preventing COVID-19 deaths.
Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.
The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
Pharma Times
FEBRUARY 24, 2021
Biotech company will be dedicated to accelerating development of potential treatment
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.
Pharma Mirror
FEBRUARY 25, 2021
Borja Guerra has been appointed new Sales & Service Director of Romaco Kilian in Cologne. The Romaco facilities in Bologna and Karlsruhe likewise have new Sales Directors: Massimiliano Cesarini and Ralph Augenstein. Romaco Kilian GmbH in Cologne has acquired a new Sales & Service Director. As of February 2021, Borja Guerra is responsible not only for the Sales & Service department but also for product and project management at the manufacturer of tablet presses for the pharmaceutical
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.
Pharma Times
FEBRUARY 24, 2021
Over 31,000 women in London to be offered the at-home tests
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.
Pharma Mirror
FEBRUARY 23, 2021
SOMERSET, N.J. and GOSSELIES, BELGIUM — Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, and Delphi Genetics, a plasmid DNA (pDNA) cell and gene therapy contract development and manufacturing organization (CDMO) based in Gosselies, Belgium, today announced that they have entered into a final and definitive agreement whereby Catalent will acquire 100% of th
pharmaphorum
FEBRUARY 26, 2021
By most measures the single largest pharma company in the world, US-based Johnson & Johnson (J&J) is also arguably one of the most well-known drugmakers among the general public. . Both these factors can be tied in part to J&J’s strong presence in the consumer sector – but behind household name products is a strong pharmaceutical backbone that has emerged over the company’s long and varied history.
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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
Pharma Times
FEBRUARY 26, 2021
Edison Accelerator to support start-ups to develop AI applications for healthcare
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.
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 […].
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.
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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.
Pharma Times
FEBRUARY 24, 2021
Orphan designation granted for the treatment of retinitis pigmentosa and Leber Congenital amaurosis
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 23, 2021
Public Health England (PHE) published real-world analyses of people in the UK who had received the first shot of the Pfizer-BioNTech COVID-19 vaccine.
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.
Pharma Times
FEBRUARY 23, 2021
Cell and Gene Therapy Catapult report also found a surge in the number of commercially sponsored trials
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.
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.
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.
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