Bio Pharma Dive
JANUARY 3, 2023
By the end of June, highly anticipated study results are expected in Alzheimer’s, obesity and Huntington’s disease, while a pair of high-priced acquisitions could be put to the test.
Pharmaceutical Technology
JANUARY 3, 2023
Alligator Bioscience and Orion are initiating the second programme of their immuno-oncology research collaboration and licence agreement. The second programme involves the development of a new bispecific antibody with potential applications in solid tumours using Alligator’s Ruby platform. As part of the expanded collaboration, Alligator and Orion will provide validated monospecific binders for each target, respectively.
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Bio Pharma Dive
JANUARY 3, 2023
Analysts noted hundreds of wholesale price increases, including dozens by Pfizer. Many checked in around 5%, roughly in line with hikes taken in recent years.
STAT News
JANUARY 3, 2023
A diverse and inclusive workforce benefits science and research. But unless it includes people living with a disability — the largest minority group in the U.S. and around the world — research will never be fully representative and science will not reach its full potential. Although 27% of U.S. adults live with a disability, only 10% of science, engineering, and health doctorate holders, and less than 2% of researchers funded by the National Institutes of Health, report having a di
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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 3, 2023
The agency’s main review office cleared 37 new medicines last year, its lowest total since 2016 and well below 2021’s mark of 50.
NPR Health - Shots
JANUARY 3, 2023
It involves the impact of a specific force to the chest at a specific moment in the cardiac cycle. One cardiologist told NPR that what happened to Hamlin was likely "a perfect storm of events.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
NPR Health - Shots
JANUARY 3, 2023
The cases of accidental ingestion of cannabis candies and baked goods among small children increased 1,375% in five years, according to a study in the journal Pediatrics.
STAT News
JANUARY 3, 2023
The number of people in the United States hospitalized with Covid-19 is about to surpass the figure reached during this summer’s spike, federal data show , as a confluence of factors — from the continued evolution of the coronavirus to holiday gatherings — drives transmission. Notably, the number of people hospitalized with Covid — roughly 40,000 — is still far below the winter waves of 2020-2021 and 2021-2022 (the wave driven by the original Omicron variant) a
NPR Health - Shots
JANUARY 3, 2023
The Food and Drug Administration on Tuesday finalized a rule change that broadens availability of abortion pills to many more pharmacies, including large chains and mail-order companies. (Image credit: Allen G.
ACRP blog
JANUARY 3, 2023
Four strategies to address the next frontier of a patient-centric approach. During the COVID-19 pandemic, sponsors and research institutions adapted to new approaches to clinical trials, deploying technology and other tools such as remote monitoring, telemedicine, and home healthcare visits, which has helped to accelerate the evolution 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
NPR Health - Shots
JANUARY 3, 2023
There are many more drinking options this Dry January if you like the taste of alcoholic drinks but don't like the effects of alcohol.
Fierce Pharma
JANUARY 3, 2023
COVID-19 tracker: AstraZeneca workers who were fired for refusing vaccine file lawsuit. kdunleavy. Tue, 01/03/2023 - 10:31.
pharmaphorum
JANUARY 3, 2023
Encouraged by new data, Newron Pharmaceuticals has said it will start a registration study of would-be blockbuster evenamide in treatment-resistant schizophrenia (TRS) later this year. The Italian biopharma said it had decided to press ahead with the new study after assessing results from 100 patients with TRS in open-label studies who received the glutamate modulator drug as an add-on to their current therapy for more than six months.
Medical Xpress
JANUARY 3, 2023
For many people, keeping a healthy body weight can be a challenge. According to the Centers for Disease Control and Prevention, among adults 20 years old and over, the prevalence of obesity is 42% in the U.S. Obesity-related conditions, including heart disease, stroke, type 2 diabetes and certain types of cancer are among the leading causes of preventable, premature death.
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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 3, 2023
Research advises against aggressive cancer treatment at the end-of-life stages of the disease. At the same time, the pharmaceutical industry is creating a greater number of oncology treatments that could provide breakthroughs for patients where none previously existed. Ben Hargreaves examines why there is no easy answer to the question of when palliative care is the right option for patients.
STAT News
JANUARY 3, 2023
If rebates had been required for price hikes on most of the nearly 100 medicines covered by Medicare during a recent three-year period, the U.S. government program would have saved $3.7 billion, or 3% of the total spending on so-called Part B medicines, a new analysis found. More specifically, 70 of the 93 top-selling drugs covered by the Medicare Part B program – which are typically pricier medicines that are administered by physicians or in hospitals – between 2018 and 2020 would
Medical Xpress
JANUARY 3, 2023
The number of young kids, especially toddlers, who accidentally ate marijuana-laced treats rose sharply over five years as pot became legal in more places in the U.S., according to a study published Tuesday.
STAT News
JANUARY 3, 2023
Over the past three years, many Americans learned more about epidemiology than they ever knew before. From Covid-19 to mpox to polio, a new generation of citizen scientists is now joining trained professionals in analyzing public health data, forecasting trends, and making personal decisions based on the latest outbreak patterns. But professionals and everyday observers alike are running up against one of the most significant problems in the world of health care data science: the available infor
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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.
Medical Xpress
JANUARY 3, 2023
A common fatty acid found in the Western diet breaks down into compounds that contribute to increased temperature and pain—but not itch—sensitivity in psoriatic lesions. The finding could lead to better understanding of how lipids communicate with sensory neurons, and potentially to improved pain and sensitivity treatments for psoriasis patients.
STAT News
JANUARY 3, 2023
As inflation-weary shoppers try to make ends meet, many are turning to a modern twist on the layaway plan: buy now, pay later. But while platforms like Afterpay and Affirm were originally built to take the sting out of online shopping, these new financing options are beginning to creep into the world of health care. “Buy now, pay later is a small fraction of the health space, but it is exploding,” said Jay Zagorksy, an economist at the Questrom School of Business at Boston Universi
Medical Xpress
JANUARY 3, 2023
Being on parental leave is protective against poorer mental health particularly among mothers, with evidence of this beneficial effect continuing in later life, according to a systematic review in The Lancet Public Health.
STAT News
JANUARY 3, 2023
A House investigation released last week unearthed a trove of documents that shed new light on the polarizing approval and disastrous rollout of Aduhelm, the first new drug for Alzheimer’s disease in two decades. But crucial questions remain for the Food and Drug Administration, Biogen, and the future of treating Alzheimer’s disease. The FDA has not made clear just what it has changed since the Aduhelm debacle, and the revelations about its inner workings — and the blow to i
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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.
Medical Xpress
JANUARY 3, 2023
A study of children and adolescents who received a COVID-19 vaccination following multisystem inflammatory syndrome (MIS-C) found that there were no reports of serious complications including myocarditis or MIS-C reoccurrence. About half of participants experienced mild and typical reactions, including arm soreness and fatigue. The study demonstrates that it is safe to get a vaccine after having MIS-C.
STAT News
JANUARY 3, 2023
Paying people to participate in medical research has been proposed as a way to narrow racial and ethnic gaps in who signs up for clinical trials and other research studies. But a new study finds that if the amount is too small, it could have the opposite effect. Offering $100 to participate in a Covid-19 study enticed affluent and white people while doing little to increase the participation of people from low-income or non-white households.
Antidote
JANUARY 3, 2023
Before becoming available to patients, every medication, therapy, and intervention must undergo a rigorous approval process: the clinical trial. Clinical trials are divided into phases that are aimed at testing the safety and efficacy of every potential new treatment before it is able to enter the market.
STAT News
JANUARY 3, 2023
For almost three years, hospitals and health insurers have been riding the waves of the Covid-19 pandemic. Even though they can better predict what lies ahead in 2023, there remain several big unknowns. STAT’s business reporters will be paying attention to three trends in particular: the end of the public health emergency, how hospital price hikes will affect people’s paychecks, and Medicare Advantage’s explosive growth.
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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.
Medical Xpress
JANUARY 3, 2023
New results from a USC-led study reveal that 3 percent of all children have elevated sensory traits that seemingly worsen as they grow from infants/toddlers into school-aged children. Of those fitting the profile of this so-called "Elevated–All Worsening" group, 82 percent were diagnosed with autism or showed elevated autistic traits by the time they reached 3-6 years old.
STAT News
JANUARY 3, 2023
BEIJING — The Chinese government sharply criticized COVID-19 testing requirements imposed on passengers from China and threatened countermeasures against countries involved, which include the U.S. and several European nations. “We believe that the entry restrictions adopted by some countries targeting China lack scientific basis, and some excessive practices are even more unacceptable,” Foreign Ministry spokesperson Mao Ning said at a daily briefing Tuesday.
Medical Xpress
JANUARY 3, 2023
One of the most popular new year's resolutions is to exercise more. Many of us set ambitious goals requiring a big, regular commitment, but then abandon them because they're too much to fit in. Plans to exercise more in the new year are often broken within a month.
STAT News
JANUARY 3, 2023
Here is STAT’s biotech scorecard, our regular ledger of stock-moving biotech events, for the first quarter: Last year, a novel combination pill developed by Karuna Therapeutics reduced psychosis and related symptoms experienced by patients with schizophrenia, achieving the main goals of a late-stage clinical trial. This quarter, the company hopes to follow up those positive results with the readout of a second, Phase 3 study.
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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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