Bio Pharma Dive
JULY 11, 2022
Flagship Pioneering’s latest startup aims to use predictive technology to find “variant-proof” treatments and vaccines for infectious diseases before they might be needed.
Pharmaceutical Technology
JULY 11, 2022
Research and innovation in supply chain & logistics in the pharmaceutical sector has declined in the last year. The most recent figures show that the number of supply chain and logistics related patent applications in the industry stood at 17 in the three months ending May - down from 21 over the same period in 2021. Figures for patent grants related to supply chain and logistics followed a similar pattern to filings - shrinking from 2 in the three months ending May 2021 to 1 in the same per
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Bio Pharma Dive
JULY 11, 2022
For $320 million, Vertex said it plans to buy ViaCyte in a deal that would provide “complementary assets, capabilities and technologies” to the ones it picked up through the 2019 acquisition of Semma Therapeutics.
AuroBlog - Aurous Healthcare Clinical Trials blog
JULY 11, 2022
The link between air pollution and autoimmune diseases just got a little clearer thanks to a massive study that dove into the health records of over 6 million Canadians. Led by public health researcher Naizhuo Zhao of McGill University, the study found that long-term exposure to air pollutants was associated with a slightly increased […].
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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 11, 2022
Two months after acquiring Entasis Therapeutics, the firm reached a deal to buy La Jolla Pharmaceutical Co. at a fraction of what La Jolla was worth just a few years ago.
Pharmaceutical Technology
JULY 11, 2022
Innoviva has signed a definitive merger agreement for the acquisition of all of the outstanding shares of La Jolla Pharmaceutical Company for $6.23 for each share in cash or an enterprise value of nearly $149m. As per the deal, Innoviva will acquire La Jolla through its wholly-owned subsidiary. La Jolla focuses on marketing innovative treatments that can enhance outcomes in patients with life-threatening diseases.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
JULY 11, 2022
The US Food and Drug Administration (FDA) has granted approval for the supplemental Biologics License Application (sBLA) of Horizon Therapeutics for the Krystexxa (pegloticase) injection, given along with methotrexate, to help uncontrolled gout patients attain a complete response to treatment. The label expansion for Krystexxa plus methotrexate is based on the data from the randomised, controlled MIRROR clinical trial in adults with the condition.
Bio Pharma Dive
JULY 11, 2022
Gov. Gavin Newsom announced a $100 million budget to create a production facility and to develop affordable insulin products, saying the medicines’ high cost “epitomizes market failures.
AuroBlog - Aurous Healthcare Clinical Trials blog
JULY 11, 2022
The Indian Institute of Management, Bangalore (IIM-B) has now driven its agenda to create the right healthcare leadership workforce with its year-long programme on hospital management. The Institute has devised the curriculum that is directed to benefit healthcare professionals to mould them into management cadre candidates. It would benefit mid-level managers, healthcare consultants, entrepreneurs and […].
Bio Pharma Dive
JULY 11, 2022
Clostridioides difficile infection is a highly contagious disease that affects 500,000 people in the U.S. and results in nearly 30,000 deaths per year.
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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
JULY 11, 2022
The proportion of pharmaceutical companies hiring for digital media related positions rose in June 2022 compared with the equivalent month last year, with 49.4% of the companies included in our analysis recruiting for at least one such position. This latest figure was higher than the 41.4% of companies who were hiring for digital media related jobs a year ago and an increase compared to the figure of 43.1% in May 2022.
Bio Pharma Dive
JULY 11, 2022
The drug’s potential impact on the lung health of idiopathic pulmonary fibrosis patients, many of whom take medicines from Roche and Boehringer Ingelheim, came as a “surprise” given the study’s small size, according to one analyst.
Pharmaceutical Technology
JULY 11, 2022
North America extended its dominance for internet of things (IoT) hiring among pharmaceutical industry companies in the three months ending May. The number of roles in North America made up 56.4% of total IoT jobs - up from 55.1% in the same quarter last year. That was followed by Europe, which saw a 1.1 year-on-year percentage point change in IoT roles.
BioSpace
JULY 11, 2022
Partnering is an important way to grow a business, and John Sharkey, Ph.D., newly-hired VP of business development for GeoVax, is well-positioned to identify strong partners.
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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.
STAT News
JULY 11, 2022
Twenty-three years ago, the field of gene therapy was bursting with the promise of breakthrough treatments. Then it was almost instantly derailed by the death of an 18-year-old clinical trial volunteer named Jesse Gelsinger after he received a genetically engineered virus that had been developed to treat his rare liver condition. An FDA investigation revealed that the principal investigator and/or the team running the gene therapy trial at the University of Pennsylvania failed to disclose that b
NY Times
JULY 11, 2022
The first U.S. application for sale of a nonprescription birth control pill has taken on new meaning after the Supreme Court decision ending the constitutional right to abortion.
STAT News
JULY 11, 2022
Patients with darker skin who received less accurate readings of their oxygen levels using pulse oximeters — the ubiquitous devices clamped on hospitalized patients’ fingers — also received less supplemental oxygen during ICU stays, according to a study published Monday. The new research in the journal JAMA Internal Medicine adds to the evidence that the faulty readings in darker-skinned patients can affect their care and may be one factor explaining racial disparities, such
pharmaphorum
JULY 11, 2022
Annie Kennedy, chief of policy, advocacy, and patient engagement at the EveryLife Foundation for Rare Diseases, tells us why the Foundation sponsored The National Economic Burden of Rare Disease Study, undertaking the challenge of examining the financial impacts of rare diseases. In 2018, the Foundation and its partners elected to perform The National Economic Burden of Rare Disease Study when it recognised that little data existed on who was living with rare diseases and what cost barriers were
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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.
STAT News
JULY 11, 2022
In 2021, funding for health technology companies went on a tear and by July, a rush of mega-deals over $100 million had pushed the total investment to a record-breaking level. The headline from Rock Health’s mid-year funding report said it all: “Another blockbuster year…in six months.” Things have changed, but investors cautioned that it’s not as bad as it looks.
Drug Discovery World
JULY 11, 2022
Biotechnology company Awakn Life Sciences has received funding from Innovate UK to help it advance its ketamine-assisted therapy programme to market in the UK and US. . Awakn Life Sciences has developed a ketamine-assisted therapy programme for treating alcohol use disorder (AUD). The company plans to work with clinical research organisation (CRO) Veristat to deliver its programmes. .
STAT News
JULY 11, 2022
As abortion clinics shutter across the country, providers in states where abortion is still legal are expecting an influx of patients — and they’re hoping technology can help them manage the deluge. Clinicians at brick-and-mortar and virtual abortion sites tell STAT they’re using and exploring technology like virtual assistants, online scheduling, increased virtual visits, and asynchronous messaging to ensure more convenient access to abortion care.
pharmaphorum
JULY 11, 2022
Researchers in the US have developed an app that uses a smartphone camera and artificial intelligence algorithms to assess images of patients’ poo for signs of disorders like irritable bowel syndrome (IBS). The tool is intended as an alternative to patients’ self-reporting stool form and frequency using the seven-point Bristol Stool Scale (BSS), which ranks consistency from hard to liquid but can produce highly variable results.
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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.
STAT News
JULY 11, 2022
WASHINGTON — For the first time, a pharmaceutical company has asked for permission to sell a birth control pill over the counter in the U.S. HRA Pharma’s application on Monday sets up a high-stakes decision for health regulators amid legal and political battles over women’s reproductive health. The company says the timing was unrelated to the Supreme Court’s recent decision overturning Roe v.
BioSpace
JULY 11, 2022
Nanoscope Therapeutics will make two presentations at the 2022 ASRS meeting on their gene therapy programs to treat degenerative retinal diseases, retinitis pigmentosa and Stargardt disease.
Cloudbyz
JULY 11, 2022
Author: Reeshav Mittal , Associate Director, Clinical Operations, Cloudbyz Inc. It is often said that only Relevant Communication is filed in eTMF. What correspondence is considered relevant for a clinical trial? The DIA TMF Reference Model states that the following clinical trial correspondence is relevant : . Agreements, . Significant discussions, .
BioSpace
JULY 11, 2022
Moderna has dosed its first participant in a Phase I clinical trial of mRNA-1215, a vaccine designed to fight the Nipah virus (NiV), a virus contracted in humans through animals.
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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.
Scienmag
JULY 11, 2022
East Hanover, NJ – July 11, 2022 – Silvana Costa, PhD, of Kessler Foundation received a two-year $199,800 grant from the New Jersey Commission on Spinal Cord Research. Her study examines the feasibility of using eye movements as a biomarker of cognitive dysfunction in persons with acute traumatic spinal cord injury (tSCI) with concomitant traumatic […].
BioSpace
JULY 11, 2022
Verve Therapeutics dosed its first patient with VERVE-101, a one-time treatment that aims to permanently lower low-density lipoprotein (LDL) cholesterol in patients and prevent heart disease.
Scienmag
JULY 11, 2022
URBANA, Ill. — A University of Illinois Urbana-Champaign research effort led by Pinshane Huang is accelerating imaging techniques to visualize structures of small molecules clearly — a process once thought impossible. Their discovery unleashes endless potential in improving everyday life applications — from plastics to pharmaceuticals. Credit: Photo by Heather Coit/The Grainger College of Engineering URBANA, Ill. […].
BioSpace
JULY 11, 2022
Roundworms are the cornerstone of scientific discoveries that have helped shape how we understand human disease and treatment. BioSpace takes a look at advances in C. elegans research.
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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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