Pharmaceutical Technology

DECEMBER 21, 2022

Moderna and the UK government have entered a ten-year strategic collaboration to build a messenger ribonucleic acid (mRNA) research, development and manufacturing facility in the country. The latest development comes after the parties announced an agreement in principle in June this year. This Moderna Innovation and Technology Centre (MITC) is expected to offer access to a locally produced future mRNA vaccine portfolio against respiratory viruses, subject to regulatory evaluation and licensure.

Gene Therapy 351

Gene Therapy Vaccination Vaccine Manufacturing 351

Bio Pharma Dive

DECEMBER 21, 2022

Lynparza’s authorization in first-line prostate cancer comes days after U.S. regulators delayed a decision on the same indication, a potential sign of the FDA’s concerns around PARP blockers.

Regulation 309

Regulation Drugs 309

AuroBlog - Aurous Healthcare Clinical Trials blog

DECEMBER 21, 2022

Scientists have found an extremely subtle twist in the genetics of aging cells, one that seems to make them increasingly less functional as time goes on. Researchers from Northwestern University have revealed animals like mice, rats, killifish, and even humans show a gradual imbalance of long and short genes in virtually every cell in their […].

Genetics 172

Genetics Gene Scientist Research 172

Bio Pharma Dive

DECEMBER 21, 2022

The pharma dosed the first patient in a Phase 2 study testing a treatment it hopes could compete with closely-watched weight-loss drugs from Lilly, Novo Nordisk and Amgen.

Drugs 294

Drugs 294

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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

Clinical Research

AuroBlog - Aurous Healthcare Clinical Trials blog

DECEMBER 21, 2022

The Union Ministry of Ayush’s ‘One Herb, One Standard’ policy mandates evaluation of drug standards and quality control in medicinal plants. In August this year, the Ministry of Ayush entered into a ‘One Herb, One Standard’ memorandum of understanding between the Pharmacopoeia Commission for Indian Medicine and Homoeopathy (PCIM&H) (Ministry of Ayush) and the Indian […].

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Medicine Drugs Clinical Trials Clinical Trials 134

Bio Pharma Dive

DECEMBER 21, 2022

Two months after signing a deal with Zymeworks, Jazz exercised an option for the drug after it showed potential in treating biliary tract cancer.

Drugs 148

Drugs 148

STAT News

DECEMBER 21, 2022

This is part of a series of snapshots from post-Roe America. H e loved peaches. He loved ice cream. He loved blueberry waffles, evenly gridded, which she’d pulled from the crinkly package in the freezer and popped in the toaster to eat on her way to work. L. knew all this from the way he moved, the way he made her sick. His name was Kai. He was due on December 18.

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Packaging Packaging 124

NPR Health - Shots

DECEMBER 21, 2022

A new report shows the pandemic and the overdose crisis helped push down the average life expectancy in the U.S. for a second year in a row.

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STAT News

DECEMBER 21, 2022

Even as the United States has made commitments to health as a human right and reversing health disparities and has invested significantly in orphan diseases, it continues to overlook sickle cell disease (SCD), the most common inherited blood disorder worldwide, which affects more than 100,000 Americans , most of whom are Black or Hispanic American. As hematologists who take care of people with sickle cell disease , it’s disheartening to see this condition receive only a fraction of the at

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NPR Health - Shots

DECEMBER 21, 2022

A health system charged a woman for a shoulder replacement she didn't need and hadn't received. She didn't receive the care, but she did receive the bill — and some medical records of a stranger.

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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

Clinical Trials

STAT News

DECEMBER 21, 2022

California authorities are seeking to revoke a license held by a CVS Health mail-order pharmacy unit for violating several state laws that govern shipments of various controlled substances — including prescription painkillers and ADHD medicines — directly to patients. In its complaint , the California Board of Pharmacy alleged that CVS Caremark — which runs a pharmacy benefit manager and a mail-order service — ignored several red flags that should have given the compa

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Licensing Licensing Pharmacy Medicine 105

NPR Health - Shots

DECEMBER 21, 2022

Teachers report security forces barging into classrooms and shouting at girls to go home, while the international community swiftly condems the Taliban's move.

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STAT News

DECEMBER 21, 2022

By the end of this year , the Environmental Protection Agency has promised to propose new national drinking water standards for PFOA and PFOS, two of the most studied pollutants among the thousands of compounds known as PFAS, or, more colloquially, “forever chemicals.” PFAS are man-made chemicals associated with nonstick pans and firefighting foams, but they are also used in things like cosmetics, paper straws and takeout containers, and waterproof fabrics.

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Cosmetics Containment 105

NPR Health - Shots

DECEMBER 21, 2022

Earlier this year, three activists who are opposed to COVID vaccines and standard treatment protocols for the illness were elected to the board of Sarasota Memorial Hospital.

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Vaccination Vaccine 121

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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.

Clinical Supply

STAT News

DECEMBER 21, 2022

An influential board of infectious disease physicians recommended Wednesday that hospitals and other health care facilities stop routinely screening asymptomatic patients for Covid-19, saying the potential risks of screenings now outweigh the benefits. The new guidelines from the Society for Healthcare Epidemiology of America’s board of directors may prove controversial.

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Fierce Pharma

DECEMBER 21, 2022

After overcoming vial issue, Gilead wins FDA approval for long-acting HIV injectable Sunlenca. zbecker. Wed, 12/21/2022 - 17:50.

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FDA Approval 119

STAT News

DECEMBER 21, 2022

Former Massachusetts Institute of Technology professor David Sabatini attempted to influence a legal investigation into complaints of gender bias and sexual harassment at his lab, according to what appears to be a copy of the investigation report,  leaked online Wednesday. The report further found his denials were not credible. Portions of the report had been leaked earlier.

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Medical Xpress

DECEMBER 21, 2022

Artificial intelligence (AI) is currently unable to pass one of the qualifying radiology examinations, suggesting that this promising technology is not yet ready to replace doctors, finds a study in the Christmas issue of The BMJ.

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Radiology Doctors Doctor 98

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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.

Clinical Trials

NPR Health - Shots

DECEMBER 21, 2022

The pandemic brought many small town health clinics to the brink. But health care providers say the crisis also led to more awareness of the health disparities that have long existed in rural America.

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STAT News

DECEMBER 21, 2022

H.T. Begay is a happy kid. He’s smiley, silly, and definitely trying to make you laugh. The four-year-old’s two neat braids of dark hair wave behind him as he runs amongst the dust, dogs, and sheep near his family’s ranch on their Navajo reservation in Arizona. On a table inside the family’s sweat lodge is a little altar.

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Gene Therapy Gene Trials 98

Medical Xpress

DECEMBER 21, 2022

Schulich School of Medicine & Dentistry researchers have shown that chronic exposure during adolescence to tetrahydrocannabinol (THC), the main psychoactive component of cannabis, may induce long-lasting memory impairments and increased anxiety levels. .

Medicine 98

Medicine Research 98

STAT News

DECEMBER 21, 2022

Good morning, everyone, and how are you today? We are doing just fine, thank you, courtesy of clear blue skies and a warming sun enveloping the Pharmalot campus. Moreover, the middle of the week has arrived, which means just a short stretch lies ahead until the weekend respite is here. We should note, however, that we are escaping soon for an extended break, so colleagues will be here the next two days.

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Marketing 98

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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.

Clinical Supply

Medical Xpress

DECEMBER 21, 2022

Using the CRISPR-Cas9 gene editing system, UT Southwestern researchers corrected mutations responsible for a common inherited heart condition called dilated cardiomyopathy (DCM) in human cells and a mouse model of the disease. Their findings, published in Science Translational Medicine, may one day provide hope to an estimated 1 in 250 people worldwide who suffer from this condition.

Gene Therapy 98

Gene Therapy Gene Editing Gene Research 98

STAT News

DECEMBER 21, 2022

Two veterans of the health care investing world — Art Cohen and Joe Healey — are planning to step back and sell their hedge fund to the fast-growing private equity firm Catalio Capital Management. Cohen and Healey’s firm, HealthCor Management, will be absorbed by Catalio in what three people with knowledge of the deal described as mainly a stock transaction.

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Medical Xpress

DECEMBER 21, 2022

Ten young children born without functioning immune systems and lacking the ability to fight infections are on track for healthier lives thanks to a new gene therapy treatment pioneered at UC San Francisco, reports a Dec. 22 study in the New England Journal of Medicine.

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Gene Therapy Gene Medicine Genetics 98

STAT News

DECEMBER 21, 2022

A Medicare program that allowed approved health systems to bill for hospital care delivered in people’s homes during the pandemic is on the cusp of a two-year extension, giving a boost to home care models many see as the future. Whether they become a long-term reality will depend on convincing policymakers and health care organizations that home health care delivers good outcomes in a financially viable way.

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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.

Clinical Trials

Medical Xpress

DECEMBER 21, 2022

In the largest-ever genetic study of dementia in people of African ancestry, VA researchers identified several genetic risks different from those seen in people of European ancestry.

Genetics 98

Genetics Research 98

pharmaphorum

DECEMBER 21, 2022

We know that the global healthcare sector is a contributor to the warming of our planet. It is responsible for 4.4% of annual carbon emissions; if the sector were a country, it would be the world’s fifth biggest global carbon emitter. 1. Recent research also found that, as of 2022, the sector had one of the lowest proportions of Net Zero targets of all industries.

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Life Science DNA Production Development 98

Medical Xpress

DECEMBER 21, 2022

Aerobics training is tied to improvement in self-reported anxiety, depression, and sleep quality among perimenopausal women, according to a study published online Nov. 24 in Frontiers in Psychiatry.

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Gerontology 98

BioSpace

DECEMBER 21, 2022

Merck entered into a license and collaboration agreement with Chinese company Kelun-Biotech to develop seven antibody-drug conjugates candidates against oncology targets.

Licensing 94

Licensing Licensing Antibody Development 94

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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.

Clinical Trials