Bio Pharma Dive
OCTOBER 20, 2022
The gene editing startup is one of less than two dozen biotech companies to debut on Wall Street this year, as the pace of IPOs remains far off last year’s trajectory.
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 20, 2022
It’s long been popular advice for people looking to lose weight to avoid late night snacking. It’s no wonder, with a host of research showing that late night eating is linked to greater body weight and increased risk of obesity. But until now, few studies have actually investigated precisely why late night eating is linked […].
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Bio Pharma Dive
OCTOBER 20, 2022
The deal gives AbbVie an experimental medicine for idiopathic pulmonary fibrosis, as well as a platform for designing antibody drugs that can target proteins known as GPCRs.
Pharma Mirror
OCTOBER 20, 2022
Home care is an indispensable aspect of the health care system that provides individuals with long-term support and services, allowing them to remain in their homes instead of being placed in nursing facilities or hospitals. Medication management is one of the most crucial components of in-home care because it enables the proper execution of treatment plans for various patients.
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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
OCTOBER 20, 2022
Synthetic biology technology developed by the startup, Refuge Biotechnologies, could help Gilead produce safer and more effective CAR-T treatments for certain blood cancers.
Pharmaceutical Technology
OCTOBER 20, 2022
RANKINGS 2022 Excellence Social Commended. Pharmaceutical Technology Excellence Rankings - The Verdict. Pharmacy, health and beauty company Walgreens is ranked in our SOCIAL category in the 2022 Pharmaceutical Technology Excellence Rankings. The company is ranked in large part due to its work during the COVID-19 pandemic improving access to vaccines and key medical information for vulnerable communities through its COVID-19 Vaccine Equity Initiative.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
OCTOBER 20, 2022
Ayala Pharmaceuticals has signed a definitive merger agreement with biotechnology company Advaxis, which discovers, develops and markets immunotherapies. Advaxis’ immunotherapies are based on a technology that leverages engineered Listeria monocytogenes. The business combination would result in a merged company that will mainly focus on developing and marketing Ayala’s AL102 and Advaxis’ ADXS-504.
NPR Health - Shots
OCTOBER 20, 2022
While the U.S. considers finally banning the carcinogen, a group of men have come forward, saying they were exposed repeatedly while working at a chemical plant in New York.
Pharmaceutical Technology
OCTOBER 20, 2022
The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for Novavax ’s adjuvanted Covid-19 vaccine, NVX-CoV2373, as a booster for use in people aged 18 years and above. The booster is indicated for use after a minimum of six months following a vaccine regimen with an authorised or approved Covid-19 shot. NVX-CoV2373 can be given to people for whom an mRNA bivalent Covid-19 booster vaccine, authorised by the FDA, is either not clinically appropriate or accessible.
NPR Health - Shots
OCTOBER 20, 2022
In her new book, writer — and mother of six — Gabrielle Blair makes the case that the abortion debate should focus much more on men's roles in unintended pregnancy.
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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
OCTOBER 20, 2022
PIC Therapeutics has raised $35m in a Series A funding round led by OrbiMed to develop therapies for drug-resistant breast cancer. New investors Lumira Ventures and Harrington Discovery Institute also took part in the financing. The funding round saw participation from current investors of the company, Advent Life Sciences and Belinda Termeer. This participation extended initial seed funding, which is crucial to meet key milestones.
BioSpace
OCTOBER 20, 2022
While worthy advances have recently been made in sickle cell disease, companies such as Graphite Bio, bluebird bio, Vertex Pharmaceuticals and Editas Medicine have loftier ambitions.
pharmaphorum
OCTOBER 20, 2022
And the LIVE coverage continues as we head into Day Two… This day is set to hold even more points of interest, with the demonstration ‘CX innovation: building experiences that work for customers’ (moderated by Healthware Group’s global head of digital strategy and customer engagement Yannick Valenti), as well as the masterclass ‘How to maximise learning science to affect behaviour change’ with Meducate Global’s president, Lawrence Sherman, and MD of Healthware MedComms & SWM, Francis M
STAT News
OCTOBER 20, 2022
In 2018, the researcher Pranav Rajpurkar was working on an algorithm that could find blood clots in patients’ legs from ultrasound images. It spotted them very well, but when he went looking for what the algorithm had picked up on in the images to make its predictions, he saw it had been cheating: it was looking at the metadata in the top right corner of every ultrasound.
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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
OCTOBER 20, 2022
Jan Egeland of the Norwegian Refugee Council, which has been awarded the Hilton Humanitarian Prize for helping millions in crisis, talks about unprecedented challenges and dreams of a better future.
STAT News
OCTOBER 20, 2022
Your job can be hazardous to your health, according to a new report from the U.S. Surgeon General that highlights how the Covid-19 pandemic has revealed fractures in working Americans’ mental health and well-being. Released Thursday, the report cites workplace trends like quiet quitting and the Great Resignation as signals of the damage done to Americans by problems like endless hours, unpaid leave, and chronic stress.
BioPharma Reporter
OCTOBER 20, 2022
US gene therapy CDMO, Andelyn Biosciences, has opened a new GMP clinical and commercial manufacturing facility to support cell and gene therapy (CGT) development and manufacturing.
STAT News
OCTOBER 20, 2022
When the news came out last month that an experimental Alzheimer’s therapy succeeded in a clinical trial , it provided a rare boost of hope for the millions facing the condition. A select group of patients felt something more: lucky. In interviews, people who participated in the trial and their caregivers described a gratitude at somehow winding up in a study where the drug actually worked, against a backdrop of repeated failures to develop effective Alzheimer’s medications.
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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.
BioSpace
OCTOBER 20, 2022
A cover letter is an important part of any job application, but for scientists, it is especially important. Find tips for writing a scientist cover letter as well as an outline and examples in our guide.
STAT News
OCTOBER 20, 2022
Amid a push to widen access to medicines to poor countries, Novartis has reached an agreement to license one of its best-selling cancer treatments so that generic manufacturers can produce copies for distribution to 44 low- and middle-income nations. The deal with the Medicines Patent Pool, a public health organization backed by the United Nations, marks the first time that a voluntary licensing deal has been arranged for a cancer medication.
pharmaphorum
OCTOBER 20, 2022
Executing an effective commercial success strategy requires extensive planning and implementation within pharmaceutical companies that spans teams, functions, and geographies. Together, these groups compile vast amounts of data, including rich information on patient populations, target customers, and the competitive landscape. But after months of effort, in most cases, the usefulness of this data begins and ends in a static slide deck or spreadsheet.
STAT News
OCTOBER 20, 2022
The Inflation Reduction Act of 2022 mandates that Medicare-covered drug sales will be protected from price increases that exceed inflation, but the mechanics of this “inflation penalty” have generated some confusion. A top Medicare official recently noted that the per-pill value of the Medicare inflation penalty will be calculated based on average prices across both the Medicare and commercial markets, but the penalty will be paid only on prescriptions reimbursed by Medicare.
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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.
NPR Health - Shots
OCTOBER 20, 2022
The Richmond, Vt., water superintendent revealed in his resignation letter that fluoride levels have not been in the state-recommended range for over a decade — far longer than previously disclosed.
STAT News
OCTOBER 20, 2022
Three dozen institutional investors are urging the boards at several of the world’s largest pharmaceutical companies to establish concrete metrics for linking executive compensation with policies that widen access to medicines to low- and middle-income countries. In a series of letters, the investors asked the heads of board compensation committees to examine such steps as voluntary licensing agreements and technology transfer for generic production; supply chain performance for improving
BioSpace
OCTOBER 20, 2022
The FDA released guidelines Thursday in an attempt to clarify processes for assessing a drug candidate’s efficacy while examining several endpoints, simultaneously.
STAT News
OCTOBER 20, 2022
What happens when approved drugs turn out not to work? Is it OK to make SARS-CoV-2 hybrids? And are British tabloids reliable sources of science news? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. Lawyer and bioethicist Holly Fernandez Lynch joins us to explain a watershed test of the FDA’s authority to revoke drug approvals.
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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.
pharmaphorum
OCTOBER 20, 2022
In mid-October, our Web Editor Nicole Raleigh and Deep Dive Editor Eloise McLennan travelled to Nice for the Reuters Pharma event. This special episode includes a conversation recorded on-site with Nicole, Eloise, Virtual Science AI CEO Thomas Hughes, and VSAI VP of global patient affairs Geraldine Reilly. They discuss key takeaways from the event, major trends in the space, and the guests’ work at Virtual Science AI, using technology to help life sciences companies create virtual patient adviso
STAT News
OCTOBER 20, 2022
After years of stops and starts, a law was finally passed in Congress this summer to address the rising cost of prescription medicines. The Inflation Reduction Act allows the federal government to negotiate prices for some costly drugs, but only a small number that cost the government the most money. But those medicines can’t have any competing products on the market, and negotiations can’t begin until a small-molecule drug has been available for at least nine years and a biologic
Pharma Times
OCTOBER 20, 2022
Statistics show an average of 789 new malignant cancers diagnosed per day in 2020
STAT News
OCTOBER 20, 2022
Top of the morning to you. Another deliciously shiny day is unfolding over the Pharmalot campus, where the skies are blue and a cool breeze is circulating. Although there is much work to be done, please join us as we pause ever so briefly to relish the moment with a tasty cup of stimulation — our choice today is peppermint mocha. After all, life is short, so why not stop to appreciate, yes?
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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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