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Pharmaceutical Commerce
OCTOBER 28, 2022
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With new startup, immunotherapy pioneer Lieping Chen tries to turn ‘cold’ tumors ‘hot’
Bio Pharma Dive
OCTOBER 25, 2022
Chen, who discovered the cancer-protecting protein PD-L1, will work closely with startup Normunity to find targets that can help the immune system reach ‘cold’ tumors.
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Cloud robotics labs are accelerating drug discovery and development
Pharmaceutical Technology
OCTOBER 28, 2022
Drug discovery and development is an incredibly expensive and time-consuming process, taking between 12 and 18 years, and costing on average between $2 billion and $3 billion. Considering the low chances of success, with only 10% of drug candidates making it into clinical development, pharma companies must prevent the increased erosion of profit margins.
6 Operational Considerations You Need To Know for Psychedelic Trials
Worldwide Clinical Trials
OCTOBER 26, 2022
Bringing a psychedelic into a clinical trial setting is complex and requires a thorough operational approach to ensure the study’s success. Having worked in psychedelic research since the advent of industry-sponsored trials, Worldwide Clinical Trials has amassed the expertise needed to execute these studies successfully, recently sharing insights in a webinar titled “ Demystifying Complex Operations in Psychedelic Research ,” available on-demand now.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
Something Toxic Flourishes in Your Brain After Too Much Hard Work
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 24, 2022
A long day in the office can leave you empty of energy and overcome with desire for TV and a takeaway. But you’ve been sitting down all day. So why do you feel as tired as your friends who have physical jobs? Struggling through your list of essential tasks feels ever more grueling as the […].
Gilead, fueled by latest approval, sees CAR-T sales take off
Bio Pharma Dive
OCTOBER 28, 2022
After a slow start, Gilead’s CAR-T business is growing fast, enabling it to pull ahead of rival cell therapy developers like Bristol Myers Squibb and Johnson & Johnson.
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Dispensing Pharmacy Packaging Machines: COVID-19 Impact
Pharma Mirror
OCTOBER 22, 2022
Finding a reliable supply of bar-coded, unit-dose pharmaceuticals remains difficult despite measures to improve patient safety. The ability to repackage and bar code drugs to the unit of usage is becoming increasingly necessary in health-system pharmacies. Benefits for pharmacies that invest in a high-throughput unit dose packing machine include improved productivity and management of bar-coded medicine stock.
Feeling Stressed Before You Get COVID May Increase Your Odds of Developing Long COVID
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 26, 2022
Millions of people are now suffering from long COVID, which presents with a staggering array of possible symptoms that can linger for months, or even years. To provide more answers to this frustratingly relentless condition, researchers have tested an association between mental stresses and long COVID. These stressors include depression, anxiety, and types of distress […].
AstraZeneca extends run of trial successes with breast cancer drug results
Bio Pharma Dive
OCTOBER 26, 2022
On the heels of a major approval for Enhertu, the pharma reported positive results for two experimental drugs in settings where rival medicines from Roche and Sanofi recently failed.
BioMed X and Sanofi partner to leverage AI for drug development
Pharmaceutical Technology
OCTOBER 25, 2022
BioMed X has entered a research partnership with Sanofi to leverage artificial intelligence (AI) for drug development. Under the joint research project, a new research team will be set up at the BioMed X Institute in Heidelberg, Germany. This team will focus on creating a versatile computational platform that can precisely forecast the first-in-class drug candidates’ efficacy in virtual patient groups.
The New Age of Decentralized Clinical Trials
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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
Bridging the Translational Gap between Alzheimer’s Advances and Patients
BioSpace
OCTOBER 26, 2022
With diagnostics for Alzheimer's already approved and therapeutics in late-stage clinical trials, the next hurdle is to translate these advances into clinical practice. The Davos Alzheimer's Collaborative is working on it.
Scientists Grow Fully Functioning Hair Follicles in New Lab First
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 25, 2022
We can add functional mouse hair follicles to body parts that scientists have successfully grown in the lab, outside the body. Using cells obtained from embryonic mice, for the first time researchers were able to produce hair follicle organoids – small, simple versions of an organ – that grew hair. Moreover, they were able to […].
AstraZeneca’s persistence pays off with Imjudo approval
Bio Pharma Dive
OCTOBER 24, 2022
After failing multiple studies, the company’s immunotherapy tremelimumab is cleared to treat liver cancer as part of a regimen that could challenge a similar drug combination from Bristol Myers Squibb.
Vaxcyte trains its sight on a lucrative market with pneumococcal vaccine
Pharmaceutical Technology
OCTOBER 28, 2022
On 24 October, American vaccine developer Vaxcyte shared positive topline data from a Phase I/II study of its multivalent conjugate pneumococcal vaccine VAX-24 , bringing the 24-valent pneumococcal jab one step closer to market. The vaccine demonstrated a similar safety profile to Pfizer’s marketed 20-serotype shot Prevnar 20 at all assessed doses, and showed non-inferior efficacy.
How Machine Learning Drives Clinical Trial Efficiency
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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.
Omicron keeps finding new evolutionary tricks to outsmart our immunity
NPR Health - Shots
OCTOBER 25, 2022
SARS-CoV-2 is evolving "rapidly," spawning one new variant after another. But omicron continues to dominate, raising new questions about how evolution of the virus is headed.
Does Faking a Smile Make You Happier? The Latest Findings Are In
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 27, 2022
Does faking a smile make you feel happier? That question has been debated since famed naturalist Charles Darwin published a book on the subject in 1872. “The free expression by outward signs of an emotion intensifies it… Even the simulation of an emotion tends to arouse it in our minds,” Darwin wrote. Popular culture has […].
An unusual alliance opens a gene and cell therapy hub outside Boston
Bio Pharma Dive
OCTOBER 27, 2022
Landmark Bio, armed with $75 million and a wide range of backers, is the latest company to emerge with plans to open a “bottleneck” slowing development of the complex medicines.
Pharma’s ESG goals need to underscore push for health equity
Pharmaceutical Technology
OCTOBER 26, 2022
Over recent years, many pharmaceutical companies have taken up environment, social and governance (ESG) targets in order to prioritize sustainability whilst boosting their external public relations. On October 6, in a GlobalData webinar, experts tried to answer the question ‘ Is Pharma at an ESG turning point?’ , revealing a multitude of diverse strategies for pharmaceutical companies to remain conscious of their global impacts.
What the FDA's New Dosage Guidance Means for the Future of Clinical Research
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.
With hospitalizations ticking up, flu season appears off to an early start
STAT News
OCTOBER 28, 2022
There are increasing signs that flu season is off to a very early start in parts of the United States, with the cumulative hospitalization rate higher than it has been at this point in the fall for more than a decade, the Centers for Disease Control and Prevention reported Friday. In its weekly FluView report , the CDC estimated that there have already been 880,000 influenza illnesses, 6,900 flu hospitalizations, and 360 deaths caused by flu this season, which started at the beginning of October
Indian Ayurveda propels growth with strong industry norms & high herb quality claims: Dr. Rangesh Paramesh
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 27, 2022
Indian Ayurveda propels its growth supported by the industry guidelines of Good Agricultural and Collection Practice (GACP), Good Clinical Practice (GCP), Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP), said Dr. Rangesh Paramesh, director – Intellectual Property, Himalaya Wellness Company. Delving on the topic ‘Key Drivers Determining the Future of the Ayurvedic Drug and […].
Myovant agrees to sell after buyer ups price
Bio Pharma Dive
OCTOBER 24, 2022
Sumitomo Pharma, a Japanese drug company that already owns 52% of Myovant, is now offering to buy all the remaining shares for $27 apiece in a deal that values the biotech at $2.9 billion.
AI medtech platform is aiming to tackle drug-resistant pathogens
Pharmaceutical Technology
OCTOBER 27, 2022
Belfast startup AMPLY has raised £900,000 to develop a range of new products that hopes to tackle multi-drug resistent pathogens using its artificial intelligence (AI) drug discovery platform. It hopes to ensure new strains of antibiotics can still tackle global threat diseases, despite antimicrobial resistance. Antimicrobial resistance is when bacteria and viruses become resistant to medication, making previous treatments ineffective.
Roles and Responsibilities of Specialized Clinical Supply Experts
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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+: Death of patient in closely watched Alzheimer’s trial raises concern about risk for some groups
STAT News
OCTOBER 28, 2022
The experimental Alzheimer’s drug lecanemab, hailed after it slowed patients’ cognitive decline in a clinical trial, may have contributed to the death in June of a patient in the study, STAT has learned. One investigator on the study flagged the death, noting it came after the patient experienced bleeding in the brain, and concluded it was related to the drug, according to documents obtained by STAT.
Govt Siddha doctors in Kerala form new association to promote Siddha dispensaries in rural areas
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 25, 2022
The Siddha medical practitioners working under the Kerala ISM department and assigned with various Central and state government projects have joined hands to form an organisation of government Siddha medical officers on the lines of the Kerala Government Ayurveda Medical Officers Association. The new organisation of Siddha medical officers will be known as ‘Kerala Government […].
For Biogen investors, company’s outlook rests on next Alzheimer’s drug
Bio Pharma Dive
OCTOBER 25, 2022
The company’s latest earnings presentation saw analysts press for more details about the Alzheimer’s drug it’s developing with Eisai — and how the partners plan to avoid some of the pitfalls experienced with Aduhelm.
BMS reports 3% decline in total revenues in Q3 2022
Pharmaceutical Technology
OCTOBER 26, 2022
Bristol Myers Squibb (BMS) has reported a 3% decline in total revenues to $11.2bn in the third quarter (Q2) of 2022 as against $11.6bn in the year-ago quarter. The decline in Q3 revenue was driven by the latest LOE products, chiefly Revlimid, and impacts from foreign exchange. In-line products, namely Eliquis and Opdivo, as well as the latest product portfolio including Opdualag, Abecma and Reblozyl partially offset the decline in revenues.
The New Age of Decentralized Clinical Trials
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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.
Most teens who start puberty suppression continue gender-affirming care, study finds
NPR Health - Shots
OCTOBER 26, 2022
A new study from a Dutch clinic found that 98% of transgender adolescents who received puberty suppression treatment went on to continue gender-affirming treatment.
Pharma exports report 6.86% growth in September
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 26, 2022
Pharmaceutical export during the month of September has registered a 6.86 per cent growth as compared to the same month of previous year. The first six months of the fiscal year has also registered a growth of 6.04 per cent compared to the same period of previous year, with a significant improvement from the growth […].
GSK, dialing back cell therapy work, ends deals with Lyell and Adaptimmune
Bio Pharma Dive
OCTOBER 25, 2022
The British drugmaker terminated the two alliances following disappointing results this year for a once highly touted cell-based treatment for solid tumors.
Quality by design with a focus on biosimilars
Pharmaceutical Technology
OCTOBER 28, 2022
Quality by design (QbD) is a concept introduced into the pharmaceutical regulatory lexicon in 2005. It aims to ensure the quality of medicines by employing statistical, analytical, and risk-management methodology in the design, development, and manufacturing processes of medicines. Part of this is ensuring that all sources of variability affecting a process are identified, explained and managed by appropriate measures so that the finished medicine consistently meets its predefined characteristic
Deliver Fast, Flexible Clinical Trial Insights with Spotfire
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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.
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