Bio Pharma Dive
NOVEMBER 28, 2022
Shares of the New York-based biotech rose by a third Monday morning, as fresh clinical trial results showed its drug AXS-05 both delayed and prevented the recurrence of Alzheimer’s agitation.
Pharmaceutical Technology
NOVEMBER 28, 2022
C4X Discovery (C4XD) and AstraZeneca have entered an exclusive global licensing agreement worth up to $402m to develop oral therapy to treat inflammatory and respiratory ailments. The deal has been signed to develop the C4X NRF2 Activator programme for these ailments. Under the agreement, AstraZeneca will be responsible for the development and marketing of oral therapy for inflammatory and respiratory diseases with a key focus on chronic obstructive pulmonary disease (COPD).
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Bio Pharma Dive
NOVEMBER 28, 2022
Whether economic times are good, bad or somewhere in between, life science companies benefit from a holistic, centralized approach, including technological, financial, operational and regulatory considerations for GtN management and predictability of GtN rates.
Pharmaceutical Technology
NOVEMBER 28, 2022
The UK Government has announced funds worth $24.17m (£20m) to conduct research for developing new obesity therapies and technologies. These therapies and digital tools have been demonstrated to aid people in shedding 20% of their weight. Every year, obesity costs a staggering $7.2bn (£6bn) to the UK National Health Service (NHS), and by 2050, the figure is expected to increase to more than $11.7bn (£9.7bn) per year.
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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
NOVEMBER 28, 2022
The company will cut its R&D workforce by 75% and discontinue development of its experimental lung cancer drug poziotinib.
NPR Health - Shots
NOVEMBER 28, 2022
The bottom base of some Green Sprouts products can break off, exposing a solder dot that contains the toxic metal, a federal regulator said. No injuries have been reported from such incidents. (Image credit: U.S.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
STAT News
NOVEMBER 28, 2022
Eisai’s announcement that lecanemab, its antibody drug for Alzheimer’s disease that targets the buildup of amyloid protein in the brain, modestly slowed cognitive decline in a Phase 3 trial offers hope to people with Alzheimer’s disease. But what I’ll be looking for in the final data — which have not yet been presented or published — is whether the brain shrinkage seen in the Phase 2 trial remains.
Bio Pharma Dive
NOVEMBER 28, 2022
See how the effective use of CMC expertise helped guide a biopharma company’s development of a CGT product.
STAT News
NOVEMBER 28, 2022
Late on a Friday, I sit reviewing some of my patients’ old medical records instead of heading home to be with my family. I’ll likely be doing it next Friday, and the one after that. This wasn’t my idea. The health system I work for discovered that some patients for whom CT scans were ordered never got them over the ensuing two to three years.
Bio Pharma Dive
NOVEMBER 28, 2022
The agency will decide on an accelerated approval of Sarepta’s treatment by May 29, months before results are expected from a potentially confirmatory Phase 3 trial.
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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
NPR Health - Shots
NOVEMBER 28, 2022
Some doctors and medical practices voluntarily give rebates on a bill if an injury occurs during a procedure, while others will not, a medical ethicist says. Here's how patients can respond.
Bio Pharma Dive
NOVEMBER 28, 2022
The company, one of several developing a drug for treatment-resistant hypertension, had pulled off one of 2022’s top performing biotech IPOs prior to the results.
STAT News
NOVEMBER 28, 2022
The World Health Organization said Monday it will phase out the name of the disease monkeypox over the next year, replacing it with the term mpox. The decision follows widespread calls for changing the name since the current international outbreak of the disease was first detected last May. The name of the disease and even the virus itself has been deemed by many to exacerbate the stigma attached to the infection — a sentiment the WHO referenced in the statement it issued announcing the c
Bio Pharma Dive
NOVEMBER 28, 2022
The longtime pharma critic is set to become chair of the HELP Committee, a post that holds significant power in directing congressional efforts on healthcare issues.
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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.
Medical Xpress
NOVEMBER 28, 2022
Eating a plant-based diet rich in healthy plant foods—such as whole grains, vegetables, and legumes—and low in unhealthy plant foods—including refined grains, fruit juices, and added sugars—is associated with a lower risk of colorectal cancer in men. The findings are published in the open access journal BMC Medicine.
pharmaphorum
NOVEMBER 28, 2022
According to a report by the Office of Health Economics (OHE), commissioned by the Association of the British Pharmaceutical Industry (ABPI), immediate action must be taken by governments, health systems, and companies to secure the era of green pharmaceuticals. ‘Supporting the era of green pharmaceuticals in the UK’ highlights that, while Britain can play a leading role in the sustainability agenda for pharmaceuticals, action must also be taken on a global scale to ensure impact.
NPR Health - Shots
NOVEMBER 28, 2022
"Removing 'monkey' removes the stigma that monkeypox comes with," an expert tells NPR. But he questions why the World Health Organization will wait a year for the change to take full effect.
STAT News
NOVEMBER 28, 2022
When Jacob Becraft addressed a bustling party of a hundred-plus employees, friends, and investors at his startup’s lab last month, he credited messenger RNA for bringing everyone back together in one room. His remarks carried a double meaning. Yes, the mRNA vaccines had allowed the large group to gather in person — not a mask in sight.
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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.
pharmaphorum
NOVEMBER 28, 2022
With COP27 concluding in November, Ben Hargreaves takes a look at what efforts pharma companies are making to limit their environmental impact. The past eight years are set to be the eight warmest on record. The rate of sea level rise has doubled since 1993; the past two and half years alone represent 10% of the overall rise in sea level since records began 30 years ago.
STAT News
NOVEMBER 28, 2022
A hotly contested provision of a federal law designed to speed copycat drugs to market and foster competition saved Medicare $1.5 billion from 2015 to 2020 — or nearly 5% of the $30.2 billion spent by the health care program — on just five medicines during that period, according to a new analysis. The provision is known as skinny labeling , which refers to a move by a company that seeks regulatory approval to market a generic or biosimilar medicine for a specific use, but not for o
Medical Xpress
NOVEMBER 28, 2022
A new study led by UB researchers shows that wasteosomes—structures that act as containers for brain waste products—indicate a malfunction of the glymphatic system, a recently discovered system that is an important brain-cleaning mechanism.
STAT News
NOVEMBER 28, 2022
A drug developed by Axsome Therapeutics significantly reduced a common side effect of Alzheimer’s disease — agitation — the company announced Monday. The therapy, AXS-05, met its primary goal of delaying time to relapse and preventing patients from relapsing. Patients taking the drug had a 3.6-fold lower risk of relapse overall, compared to placebo.
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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.
pharmaphorum
NOVEMBER 28, 2022
Anthropy 2022 brought climate change to industry in Cornwall in (a very wet and windy) early November, settling cosily into the truly eco-minded environs of the Eden Project and firing up fervent and necessary conversations on sustainability, accessibility, and action plans. Amidst all this, Adelphi Group’s CEO Stuart Cooper found a moment to sit with pharmaphorum web editor Nicole Raleigh and discuss just how exciting it was to bring to vibrant and discursive life the ethos of Anthropy – a unit
STAT News
NOVEMBER 28, 2022
“Living With” explores the contours of life with chronic illness, from the prelude to diagnosis to new patterns of living, to wrestling with big questions about illness and health. A little under 10 years ago, Leigh Krauss was almost done with her schooling to become a physical therapist. A former guard on the women’s basketball team at Trinity College in Hartford, Conn., she had always been active and healthy.
Antidote
NOVEMBER 28, 2022
Osteoporosis and osteoarthritis (OA) are conditions with different causes and symptoms, but because people are often diagnosed with both, the terms are frequently used interchangeably.
Medical Xpress
NOVEMBER 28, 2022
Using MRI data from the largest long-term study of brain development and child health in the United States, researchers have found that higher weight and body mass index (BMI) in pre-adolescence are associated with poor brain health. The findings are being presented today at the annual meeting of the Radiological Society of North America (RSNA).
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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.
NPR Health - Shots
NOVEMBER 28, 2022
A power outage at a Houston water plant caused low water pressure across the city. Houston Mayor Sylvester Turner said he believes the water is safe, but is waiting on confirmation from the state. (Image credit: David J.
Medical Xpress
NOVEMBER 28, 2022
The human microbiome has been a hot topic over the last decade, with research pointing to disrupted bacterial communities as culprits for a host of maladies including irritable bowel syndrome, eczema, and autoimmune diseases. Most studies have focused on the microbiome within the human gut, but there is growing recognition that another oft-ignored bacterial community deserves equal attention—that found in the vagina.
STAT News
NOVEMBER 28, 2022
BEIJING — Chinese authorities eased some anti-virus rules but affirmed their severe “zero Covid” strategy Monday after protesters demanded President Xi Jinping resign in the biggest show of opposition to the ruling Communist Party in decades. The government made no comment on the protests or the criticism of Xi, but the decision to ease at least some of the restrictions appeared to be aimed at quelling anger.
Medical Xpress
NOVEMBER 28, 2022
Pregnant women living in U.S. states where cannabis is legal must be screened for the drug, for the health of both mother and baby. This is the claim of scientists who in a new national study have found that these individuals are far more likely to use the substance.
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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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