Bio Pharma Dive
JULY 19, 2022
The cancer drugmaker, which was formed in early 2017 by a group that includes Nobel Prize winner David Baltimore, is one of dozens of biotechs to cut staff this year.
Pharmaceutical Technology
JULY 19, 2022
The US Food and Drug Administration (FDA) has granted approval for Incyte’s Opzelura (ruxolitinib) cream 1.5% as a topical treatment of nonsegmental vitiligo in adults and paediatric patients aged 12 years and above. Opzelura is a topical formulation of a Janus kinase (JAK) inhibitor. With the latest development, Opzelura has became the first treatment for repigmentation in patients with vitiligo to receive FDA approval.
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Bio Pharma Dive
JULY 19, 2022
The cream, known as Opzelura, is now the only treatment approved in the U.S. to repigment skin in patients with the most common form of vitiligo.
Pharmaceutical Technology
JULY 19, 2022
Mentions of cloud computing within the filings of companies in the pharmaceutical industry rose 65% between the final quarter of 2021 and the first quarter of 2022. In total, the frequency of sentences related to cloud computing between April 2021 and March 2022 was 133% higher than in 2016 when GlobalData, from whom our data for this article is taken, first began to track the key issues referred to in company filings.
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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 19, 2022
The pharmaceutical company is considering selling or splitting off its struggling Sandoz division and expects to give an update by the end of the year.
Pharmaceutical Technology
JULY 19, 2022
All aspects of environmental, social, and governance (ESG) are important, and in the healthcare industry, companies must excel across all three. Listed below are the impact of ESG on healthcare, as identified by GlobalData. ESG needs to be at the core of any healthcare company or institution that wants to continue to provide quality care and services.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
JULY 19, 2022
Asia-Pacific was the fastest growing region for robotics hiring among pharmaceutical industry companies in the three months ending May. The number of roles in Asia-Pacific made up 2.6% of total robotics jobs - up from 0.7% in the same quarter last year. That was followed by Europe, which saw a 0.1 year-on-year percentage point change in robotics roles.
Bio Pharma Dive
JULY 19, 2022
The California biotech is exercising its option to acquire GeneTx BioTherapeutics for $75 million after seeing data from the companies’ study of an Angelman syndrome treatment.
Pharmaceutical Technology
JULY 19, 2022
AbbVie has filed a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for its atogepant for prophylaxis of migraine in adults who experience a minimum of four migraine days each month. An oral CGRP receptor antagonist (gepant), atogepant is developed as a preventive migraine treatment. The application is based on the Phase III ADVANCE and PROGRESS clinical trial analysing the safety, efficacy and tolerability of atogepant in adult patients with episodic migraine a
Rethinking Clinical Trials
JULY 19, 2022
At the NIH Pragmatic Trials Collaboratory’s annual Steering Committee this spring, we sat down with investigators from the PRISM Demonstration Projects to discuss their progress in the first year of study implementation. All 3 studies began enrollment last year. The PRISM program (Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing) is a component of the NIH’s Helping to End Addiction Long-term (HEAL) Initiative.
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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
NPR Health - Shots
JULY 19, 2022
A 75-year-old woman became enmeshed in conspiracy theories about COVID. After she got infected, she rejected effective treatments and sought out black market drugs instead.
STAT News
JULY 19, 2022
It has been a mere nine weeks since the United Kingdom announced it had detected four cases of monkeypox, a virus endemic only in West and Central Africa. In that time, the number of cases has mushroomed to nearly 13,000 in over 60 countries throughout Europe, North and South America, the Middle East, new parts of Africa, South Asia, and Australia. The growth in cases and the geographic spread has been rapid and relentless.
NPR Health - Shots
JULY 19, 2022
Dr. Meg Autry is raising money to buy and retrofit a vessel that would operate as a reproductive health clinic in federal waters off the Gulf of Mexico, providing services including surgical abortion.
STAT News
JULY 19, 2022
A sweltering 112 degrees Fahrenheit in North Texas. 97 in Minneapolis. 103 in Nebraska. Nearly 100 degrees in cities across the U.K. Temperatures across the United States and other parts of the world are soaring in the kind of extreme heat waves that are expected to become more common with climate change. Officials are warning the public to do whatever they can to stay cool.
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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.
NPR Health - Shots
JULY 19, 2022
Adults who haven't gotten any COVID-19 shots should consider the new option, the agency said Tuesday. The spike protein vaccine is more typical than the mRNA types being broadly used against COVID.
STAT News
JULY 19, 2022
Ten years ago this month, the Food and Drug Administration approved a daily pill that was up to 99% effective in preventing infection with HIV, the virus that causes AIDS. Expectations were high that this approach, known as oral pre-exposure prophylaxis (PrEP), could change the course of the AIDS pandemic. It hasn’t.
NPR Health - Shots
JULY 19, 2022
The U.S. birth rate has been trending downwards over the past 15 years — so the news that the number of births actually rose in 2021 is making headlines.
BioSpace
JULY 19, 2022
Finding a new job can be a daunting task. From updating your resume to preparing for interviews, there are a lot of moving parts. To help, here are five interview techniques that actually work.
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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.
NPR Health - Shots
JULY 19, 2022
This summer, artisans from Kenya, Mongolia and Uganda shared the story of their centuries-old traditional crafts — including the art of "barkcloth," declared a UNESCO world heritage "masterpiece.
STAT News
JULY 19, 2022
As U.S. overdose deaths soared to devastating new heights in the first year of the pandemic, racial disparities widened sharply, with rates spiking much more among Black people and American Indians and Alaska Natives than among white people, according to a federal report released Tuesday. While overall overdose deaths increased by 30% from 2019 to 2020 — to some 92,000 lives lost — rates increased by 44% among Black individuals and 39% among American Indian and Alaska Native people
pharmaphorum
JULY 19, 2022
Face-to-face discussion educates regulators on what matters most to patients, and guides future decision-making. Regulators are increasingly asking drug developers to include the patient voice in submissions, but the best way to go about this is less clear-cut. In the United States, learning how to navigate forums such as the FDA’s listening sessions and patient-focused drug development (PFDD) meetings could be the key to “truly moving the dial”.
NPR Health - Shots
JULY 19, 2022
Public health experts know what it takes to control a disease outbreak: access to testing and vaccines. But in the last two months of the monkeypox outbreak, the response has not met the need.
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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.
BioSpace
JULY 19, 2022
Women of color continue to be trailblazers in the life science industry, proving that they can be just as, if not more, successful than their peers - even if it isn’t always easy.
STAT News
JULY 19, 2022
An expert panel that advises the Centers for Disease Control and Prevention on vaccine policy voted Tuesday to recommend use of Novavax’s Covid-19 vaccine — an achievement a long time in the making for the Gaithersburg, Md.-based company. The Advisory Committee on Immunization Practices voted 12-to-0 to recommend the vaccine, with several members expressing hope that the vaccine’s makeup may persuade some people who have been reluctant to get vaccinated against Covid to fina
BioSpace
JULY 19, 2022
On Wednesday, Versanis appointed Intercept Pharmaceuticals veteran Mark Pruzanski as chairman and chief executive officer, and John Maraganore has taken a seat on the board.
STAT News
JULY 19, 2022
WASHINGTON — The head of the Food and Drug Administration said Tuesday he has commissioned an independent review of the agency’s food and tobacco programs following months of criticism over its handling of the baby formula shortage and e-cigarette reviews. The announcement comes as FDA Commissioner Robert Califf attempts to push past several controversies that have dominated his second stint running the agency, including the delayed response to contamination problems at the country
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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.
NPR Health - Shots
JULY 19, 2022
NPR's Rachel Martin talks to Meg Autry, an OBGYN and a professor at the University of California at San Francisco, about plans to offer surgical abortions on a floating clinic in the Gulf of Mexico.
STAT News
JULY 19, 2022
For all the advances oncology researchers have made in genomics and precision medicine, one of the most basic questions for cancer patients remains one of the least understood. What should I eat?
XTalks
JULY 19, 2022
The life science industry is dynamic and progressive with 2022 exemplifying significant growth. Agile life science companies that were able to adapt to the challenges of the pandemic and ongoing global regulations prospered since the last two years. The scientific community witnessed an accelerated level of digital investments, breakthroughs in COVID-19 vaccine development, a switch to decentralized, virtual or remote trials plus much more unprecedented innovations.
STAT News
JULY 19, 2022
The Markup has found that Facebook is serving up ads and posts for the “abortion pill reversal” procedure, a medically unapproved and potentially dangerous process that the American College of Obstetricians and Gynecologists says is “not based on science.” Facebook has been circulating this content for years, a practice that both lawmakers and anti-disinformation advocates have publicly criticized.
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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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