Bio Pharma Dive
AUGUST 11, 2022
The companies could face liability related to their sales of the heartburn drug, which was withdrawn from market in the U.S. and other countries after impurities related to a likely carcinogen were detected.
Pharmaceutical Technology
AUGUST 11, 2022
Asthma is a chronic respiratory condition that, according to GlobalData’s Epidemiology Database, affects approximately 14% of the UK population, and almost 88 million people in the seven major markets worldwide (US, UK, France, Germany, Italy, Spain, and Japan). Common symptoms include wheezing, shortness of breath, and limited airflow, which can vary in severity.
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Bio Pharma Dive
AUGUST 11, 2022
The deaths were due to acute liver injury, a known risk of Zolgensma and a concern for gene therapies like it.
Pharmaceutical Technology
AUGUST 11, 2022
Gemini Therapeutics has signed a definitive agreement to merge with Disc Medicine in an all-stock deal to create a clinical-stage biopharmaceutical company. To back the merger, Disc raised funds worth $53.5m from a group of healthcare investors led by Access Biotechnology and also include OrbiMed, Atlas Venture and 5AM Ventures among others. The merged company is expected to be named Disc Medicine, which will have corporate headquarters in Watertown, Massachusetts, US.
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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
AUGUST 11, 2022
The company will wind down five trials involving two drug candidates and lay off more staff, prioritizing instead its RNA-editing technology.
Pharmaceutical Technology
AUGUST 11, 2022
Spain’s pharma industry registered an 18.3% rise in IT hiring activity in July 2022 when compared with the previous month, according to GlobalData’s Job Analytics database. The industry’s overall hiring increased by 1.22% in July 2022 when compared with June 2022. Out of the pharma industry’s total hiring activity, IT jobs claimed a 9.33% share in July 2022, recording a decrease of 0.91% over the last three-month average share.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
AUGUST 11, 2022
The US’s pharma industry registered a 5.1% drop in IT hiring activity in July 2022 when compared with the previous month, according to GlobalData’s Job Analytics database. The industry’s overall hiring is decreased by 4.42% in July 2022 when compared with June 2022. Out of the pharma industry’s total hiring activity, IT jobs claimed a 1.92% share in July 2022, recording an increase of 0.06% over the last three-month average share.
Rethinking Clinical Trials
AUGUST 11, 2022
The Helping to End Addiction Long-Term Initiative?, or NIH HEAL Initiative?, recently published 2 funding opportunity announcements soliciting applications focused on sickle cell disease (SCD) pain management. The effort is co-led by the National Center for Complementary and Integrative Health and the National Heart, Lung, and Blood Institute, with support from other NIH Institutes, Centers, and Offices.
Pharmaceutical Technology
AUGUST 11, 2022
UK-based company AstraZeneca’s IT hiring rose 8.9% in July 2022 when compared with the previous month, according to GlobalData’s Job Analytics database. The company’s overall hiring activity increased by 8.89% in July 2022 when compared with June 2022. IT jobs claimed an 8.1% share in the company’s total hiring activity in July 2022, and recorded a 0.25% decline over the last three-month average share.
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 11, 2022
Import of medical devices to the country during the year 2021-22 has seen an increase of 36.8 per cent to $8.54 billion, with the highest growth in terms of imports registered in the category of implants. Exports of medical devices, during the period, grew by 15.4 per cent to $2.92 billion from the $2.53 billion […].
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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
Pharmaceutical Technology
AUGUST 11, 2022
Germany-based company Bayer’s IT hiring declined 6.6% in July 2022 when compared with the previous month, according to GlobalData’s Job Analytics database. The company’s overall hiring activity declined by 5.98% in July 2022 when compared with June 2022. IT jobs claimed a 6.13% share in the company’s total hiring activity in July 2022, and recorded a 0.12% growth over the last three-month average share.
NPR Health - Shots
AUGUST 11, 2022
Revised guidance from the Centers for Disease Control and Prevention looks to minimize COVID-19's disruption of daily life while conceding that the pandemic isn't over.
Pharmaceutical Technology
AUGUST 11, 2022
Luxembourg-based company Eurofins Scientific’s IT hiring declined 1.4% in July 2022 when compared with the previous month, according to GlobalData’s Job Analytics database. The company’s overall hiring activity increased by 0.58% in July 2022 when compared with June 2022. IT jobs claimed a 5.85% share in the company’s total hiring activity in July 2022, and recorded a 0.51% decline over the last three-month average share.
NPR Health - Shots
AUGUST 11, 2022
Mental health advocates celebrated the launch of the 988 Suicide & Crisis Lifeline, but some people voiced concerns that using the service could lead to police involvement or forced hospitalization.
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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.
Pharmaceutical Technology
AUGUST 11, 2022
US-based company Johnson & Johnson’s IT hiring rose 11.0% in July 2022 when compared with the previous month, according to GlobalData’s Job Analytics database. The company’s overall hiring activity increased by 14.48% in July 2022 when compared with June 2022. IT jobs claimed a 4.2% share in the company’s total hiring activity in July 2022, and recorded a 0.21% growth over the last three-month average share.
NPR Health - Shots
AUGUST 11, 2022
After Wisconsin left an 1849 near-total abortion ban in place, some providers began commuting to Illinois to treat patients. These Planned Parenthood partnerships could be a model for the future.
Pharmaceutical Technology
AUGUST 11, 2022
Japan-based company Takeda Pharmaceutical’s IT hiring rose 20.1% in July 2022 when compared with the previous month, according to GlobalData’s Job Analytics database. The company’s overall hiring activity increased by 10.53% in July 2022 when compared with June 2022. IT jobs claimed a 4.84% share in the company’s total hiring activity in July 2022, and recorded a 0.16% decline over the last three-month average share.
STAT News
AUGUST 11, 2022
People who are not up to date with their Covid-19 vaccines and who are exposed to someone infected with the coronavirus no longer need to quarantine, according to updated recommendations issued Thursday by the Centers for Disease Control and Prevention. Instead, they should just wear a mask for 10 days in indoor settings and test on day 5, according to the guidance.
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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.
Pharmaceutical Technology
AUGUST 11, 2022
Alnylam Pharmaceuticals and collaborators have identified rare mutations in the INHBE gene that is expressed in the liver, related to a lower waist-to-hip ratio for body mass index (BMI), which is often used as an indicator of abdominal fat and is correlated with the risk of type 2 diabetes (T2D) and coronary heart disease. Using data from the UK Biobank database, genomic sequencing data for 360,000 individuals were obtained and the findings were confirmed in animal models that demonstrated a hi
STAT News
AUGUST 11, 2022
At this point in the Covid-19 pandemic, you’re surely tired of hearing about a “new variant” of the coronavirus. We’ve got some bad news. The SARS-CoV-2 virus is going to keep evolving , and that means that different versions of the virus will keep emerging, become dominant, and then get outpaced by a different variant. Part of this has to do with what’s called “immune escape,” or “immune evasion.
Pharmaceutical Technology
AUGUST 11, 2022
The US Food and Drug Administration (FDA) has granted Orphan Drug Designation for Aro Biotherapeutics’ ABX1100 to treat Pompe disease. An investigational Centyrin-small interfering ribonucleic acid ( siRNA ) conjugate, ABX1100 acts on the glycogen synthase 1 (Gys1) gene in the muscle. ?Gys1 is an enzyme that synthesises glycogen in muscle. Hindering this enzyme was found to lower glycogen levels and is a new approach to treat Pompe disease.
Pharmaceutical Commerce
AUGUST 11, 2022
Pharmaceutical distribution today is anything but monolithic. While companies in this space are grappling with issues ranging from inflation and supply chain disruption to workforce scarcity and DSCSA implementation, there’s still plenty of room for smaller players to stake out part of the terrain to call their own.
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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.
Pharmaceutical Technology
AUGUST 11, 2022
GentiBio and Bristol Myers Squibb (BMS) have signed a multi-year partnership agreement for developing new engineered Treg therapies for inflammatory bowel disease (IBD) patients. These therapies will be developed for re-instating immune tolerance and repairing tissue in IBD. The alliance will merge the engineered Treg platform of GentiBio for creating stable, scalable, well-selective and long-lasting Tregs with the cell therapy and immunology expertise of BMS.
STAT News
AUGUST 11, 2022
Two children have died from acute liver failure after being administered Zolgensma, a pricey gene therapy sold by Novartis to treat a rare disease. The company this week began notifying physicians and payers about the deaths, which occurred over the past few months in Russia and Kazakhstan. The children passed away approximately five to six weeks after the one-time therapy was infused and between one and 10 days after corticosteroid tapering occurred, which is done to ensure proper liver functio
Pharmaceutical Technology
AUGUST 11, 2022
Germany’s pharma industry registered an 8.6% drop in IT hiring activity in July 2022 when compared with the previous month, according to GlobalData’s Job Analytics database. The industry’s overall hiring increased by 1.24% in July 2022 when compared with June 2022. Out of the pharma industry’s total hiring activity, IT jobs claimed a 2.57% share in July 2022, recording a decrease of 0.25% over the last three-month average share.
STAT News
AUGUST 11, 2022
Tri Vo knew that he had monkeypox before his test came back — what started as painless pimples had turned itchy, then began to feel like glass underneath his skin. It was manageable during the day, but at night, it felt like the glass was vibrating, Vo said. His boyfriend had read about Tpoxx, the only medical treatment available for monkeypox, and he wanted it.
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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.
Pharmaceutical Technology
AUGUST 11, 2022
India’s pharma industry registered a 0.9% drop in IT hiring activity in July 2022 when compared with the previous month, according to GlobalData’s Job Analytics database. The industry’s overall hiring increased by 4.59% in July 2022 when compared with June 2022. Out of the pharma industry’s total hiring activity, IT jobs claimed a 13.9% share in July 2022, recording a decrease of 0.51% over the last three-month average share.
STAT News
AUGUST 11, 2022
As the United States grapples with monkeypox , which has been declared a public health emergency , one of the key strategies that will be used to control its spread is vaccinating high-risk individuals. Demand for monkeypox vaccine far exceeds the supply.
Pharmaceutical Technology
AUGUST 11, 2022
Poland’s pharma industry registered a 4.6% rise in IT hiring activity in July 2022 when compared with the previous month, according to GlobalData’s Job Analytics database. The industry’s overall hiring is decreased by 1.82% in July 2022 when compared with June 2022. Out of the pharma industry’s total hiring activity, IT jobs claimed a 12.3% share in July 2022, recording an increase of 0.34% over the last three-month average share.
STAT News
AUGUST 11, 2022
The Breakthrough Device Program is approaching terminal velocity. The Food and Drug Administration, looking to accelerate access to innovative devices, has now labeled nearly 700 products as breakthroughs while they’re under development. But until recently, relatively few have reached the market. A STAT analysis shows that FDA authorizations of breakthrough devices have picked up significantly this year.
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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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