Bio Pharma Dive
JANUARY 27, 2023
The FDA gave the top-selling immunotherapy a broad label in adjuvant lung cancer despite mixed results in the main study supporting its application, taking one Wall Street analyst by surprise.
Pharmaceutical Technology
JANUARY 27, 2023
The European Union (EU) has granted approval for Daiichi Sankyo and AstraZeneca ’s Enhertu (trastuzumab deruxtecan) as monotherapy to treat unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer adult patients. Enhertu has been approved for patients who have previously received chemotherapy in the metastatic setting or who have seen disease recurrence during or in six months after adjuvant chemotherapy.
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Bio Pharma Dive
JANUARY 27, 2023
The trial is an important test of Carvykti’s potential for earlier use in multiple myeloma and found treatment helped extend progression-free survival over standard regimens.
Pharmaceutical Technology
JANUARY 27, 2023
The UK National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending the use of Kite’s axicabtagene ciloleucel (yescarta) to treat aggressive forms of lymphoma. The chimeric antigen receptor T-cell (CAR-T) therapy axicabtagene ciloleucel has been recommended for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL) in adult patients who have previously received two or more lines of systemic thera
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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
JANUARY 27, 2023
After a strategic review, the Celgene spinout said it won’t advance two experimental cancer therapies that use “natural killer” cells.
Pharmaceutical Technology
JANUARY 27, 2023
The FDA’s recent approval of TG Therapeutics’s Briumvi (ublituximab) against relapsing forms of multiple sclerosis (MS) is welcome news for the company after suffering a major setback in 2022 when the FDA extended its review of Briumvi by three months. However, Briumvi is unlikely to appeal to patients who are already receiving Genentech’s Ocrevus or Novartis’s Kesimpta.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
JANUARY 27, 2023
Every day it seems that there are headlines detailing mind-bogglingly large sums of government spending in various areas. And very rarely are these funds being directed towards the UK’s National Health Services (NHS). This raises the question: are these funds really being correctly allocated? An institution in decline For the last 75 years, the NHS has been free.
pharmaphorum
JANUARY 27, 2023
AstraZeneca’s revenue boost from COVID-19 therapy Evusheld looks set to be curbed early, as the FDA withdraws authorisation for the antibody on the grounds that it is ineffective against most subvariants now circulating in the US. Evusheld (tixagevimab and cilgavimab) was cleared by the FDA towards the end of 2021, becoming the first antibody to be authorised for prevention of COVID-19 infection, and it rapidly found use among people with compromised immune systems, such as cancer chemothe
Pharmaceutical Technology
JANUARY 27, 2023
Inflammatory bowel disease (IBD) refers to two autoimmune diseases that cause intestinal inflammation: Crohn’s disease (CD) and ulcerative colitis (UC), chronic inflammation that affects the colon (also known as the large intestine). Initially, UC manifests itself in the terminal part of the colon or the entire colon. The market for UC is filled with a number of different treatment options, and the pipeline is relatively strong.
NPR Health - Shots
JANUARY 27, 2023
The defendants allegedly took part in a scam that sold more than 7,600 fraudulent nursing degree diplomas from three Florida-based nursing schools, according to recently unsealed federal indictments. (Image credit: D.A.
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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
STAT News
JANUARY 27, 2023
When institutions in the United States and other high-income countries embark on collaborations to improve health or the delivery of health care in low-income countries, they do it with the best of intentions. But intentions aren’t good enough. Projects conducted by trainees at schools of medicine, public health, and other health disciplines in high-income countries can often make the problems they set out to address worse.
NPR Health - Shots
JANUARY 27, 2023
Policymakers have long grappled with how to handle experiments that might generate potentially dangerous viruses. Now, officials are considering whether oversight needs to be expanded.
Medical Xpress
JANUARY 27, 2023
Researchers at the Francis Crick Institute and King's College London have created a tool to predict the effects of different diets on both cancerous cells and healthy cells.
STAT News
JANUARY 27, 2023
LOS ANGELES – California cities are supposed to be cracking down on sales of flavored vapes, which are now illegal across the state. But even cities that have banned such vapes for years are unwilling — or unable — to police the sellers. STAT visited 24 vape shops earlier this month in Oxnard, Ventura, Pasadena, El Monte, Carson and West Hollywood — all of which have had bans on flavored vapes on the books for at least a year; most for two or more years.
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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.
pharmaphorum
JANUARY 27, 2023
The emergence of COVID-19 resulted in staffing challenges that have continued to have a sustained, negative impact on clinical trial workflows. In fact, 76% of healthcare professionals have recently cited feelings of burnout, leading to a turnover rate twice as high as before the pandemic and increased levels of vacant positions across clinical research sites.
STAT News
JANUARY 27, 2023
A panel of federal advisers voted unanimously Friday to advance a set of proposals to bolster government oversight of pathogen research that could make viruses more transmissible. The advisers, a collection of biosecurity, ethics and infectious disease experts, united to vote the set of proposals through with minor changes. But some of the scientists who attended the public meeting balked at language that they said could accidentally hinder relatively low-risk gain-of-function research, which ma
pharmaphorum
JANUARY 27, 2023
Late last year, pharmaphorum caught up with Dr Karen Mullen, chief medical officer and VP of clinical & medical affairs at global drug development consultancy Boyds. Having previously spoken with Dr Mullen three years ago when she was country medical director for the UK & Ireland at GSK – on the topic of patient centricity and embedding that focus within the core of a pharmaceutical company – our recent interview provided some interesting insights into the changing landscape of the indus
STAT News
JANUARY 27, 2023
After nearly a year of public silence and private speculation over Eric Lander’s next act, his return to the Broad Institute of MIT and Harvard is now official. Starting in February, the former White House science adviser will resume his position as a core institute member as well as his tenured faculty positions at MIT and Harvard. But the founding director will not be back at the helm of the Cambridge, Mass., biomedical research powerhouse, a role he held from 2003 to 2021, when he was
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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
JANUARY 27, 2023
Johnson & Johnson has been cleared to continue a lawsuit filed last year against drug benefit programme SaveOnSP, which claims it defrauded a payment assistance programme for patients out of “at least $100 million.” The complaint – originally filed in May 2022 in a New Jersey federal court – alleges that SaveOnSP took advantage of J&J’s Janssen CarePath programme, which covers eligible patients’ out-of-pocket expenses for 44 of its more expensive prescription drug
Medical Xpress
JANUARY 27, 2023
Brain stimulation, such as deep brain stimulation (DBS), is a powerful way to treat neurological and psychiatric disorders. While it has provided therapeutic benefit for sufferers of Parkinson's, Alzheimer's and addiction for more than a decade, its underlying neural mechanism is not yet fully understood.
pharmaphorum
JANUARY 27, 2023
As the legendary investor Warren Buffett once said, forecasts about the future usually tell you more about the forecaster than they do about the future. It’s wise advice from the “Sage of Omaha”; indeed, one highly respected financial newspaper began its 2023 predictions by conceding that it had been wrong on five major counts for 2022. Still, pretty much every business decision is based on some kind of forecast, or scenario; the alternative would be to do nothing, ever.
Medical Xpress
JANUARY 27, 2023
Turning a decades-old dogma on its head, new research from scientists at UC San Francisco and Stanford Medicine shows that the receptor for oxytocin, a hormone considered essential to forming social bonds, may not play the critical role that scientists have assigned to it for the past 30 years.
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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.
XTalks
JANUARY 27, 2023
Since 2018, annual US pharma industry advertising spending continues to register in at well over $6.5 billion. Pharma is the fourth-largest spender on TV ads in the country, after retail, financial & real estate and tech. While billions continue to be poured into pharma TV ads every year, total spending only rose by about one percent in 2022 compared to the previous year.
Medical Xpress
JANUARY 27, 2023
People hospitalized with COVID-19 may have an increased risk for heart damage, but not so much the type of inflammation previous research suggested, according to a new study.
STAT News
JANUARY 27, 2023
Legend Biotech said Friday that its CAR-T therapy Carvykti kept multiple myeloma patients’ cancer in check for longer than conventional therapy in a Phase 3 trial. Carvykti was approved last year, on the basis of an early trial that showed the cell therapy substantially diminished the number of cancer cells in 97% of patients, all of whom had already tried most of the other options available.
Medical Xpress
JANUARY 27, 2023
Anesthesiologists can play a role in reducing the greenhouse gas emissions that contribute to global warming by decreasing the amount of anesthetic gas provided during procedures without compromising patient care, suggests new research being presented at the American Society of Anesthesiologists' ADVANCE 2023, the Anesthesiology Business Event.
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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
JANUARY 27, 2023
Just outside St. Louis, a cemetery for children sits on a hill. A wooden, weather-worn sign welcomes mourners to "Baby Land." The gravediggers who made the special spot work quietly in the shadows.
XTalks
JANUARY 27, 2023
Nobelpharma America, a pharmaceutical and medical device company headquartered in Bethesda, Maryland, has launched an educational website called Face Forward. The website brings awareness for facial angiofibroma, an aspect of the rare genetic disease tuberous sclerosis complex (TSC). Face Forward brings the personal stories of affected individuals and their caregivers, which can help others with the same condition feel like they are not alone.
Drug Discovery World
JANUARY 27, 2023
The Winter 2022/2023 issue of Drug Discovery World Magazine is out now. Featuring a Therapeutic Spotlight on Oncology , the magazine is available to download free here and read for free on the DDW App. You can also request to receive a copy of the printed magazine here. Key features of the Winter issue include an overview of the drug discovery landscape in 2023, sector successes and challenges in the Scandinavian market, and how a drug sourced from the aerospace industry could offer treatments
Medical Xpress
JANUARY 27, 2023
Periodontitis, a gum disease, can lead to a litany of dental issues from bad breath to bleeding and lost teeth. Now, researchers at Hiroshima University have found that it could be connected to even more severe problems elsewhere in the body—the heart.
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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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