Eisai gives first glimpse into Alzheimer’s drug launch
Bio Pharma Dive
FEBRUARY 6, 2023
In the month since its U.S. approval, Leqembi has had its first sale, its first prescription written and its first administration to a patient.
Mon.Feb 06, 2023
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Feinstein Institutes researchers discover new protein for sepsis treatment
Pharmaceutical Technology
FEBRUARY 6, 2023
Researchers at the Feinstein Institutes for Medical Research have discovered a new protein that can be a potential therapeutic target for lethal sepsis. Led by Feinstein Institutes researcher Haichao Wang, the new study focuses on detecting protein mediators that might contribute to uncontrolled immune responses to lethal infections. It explores the monoclonal antibody detection that may work against procathepsin-L (pCTS-L), a pro-inflammatory protein mediator, as the potential remedy.
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Astellas switches CEOs amid plans to pursue ‘aggressive’ growth
Bio Pharma Dive
FEBRUARY 6, 2023
Naoki Okamura, currently Astellas’ chief strategy officer, will replace current CEO Kenji Yasukawa as the company attempts to “further accelerate growth.
Qurient partners with TB Alliance to develop telacebec
Pharmaceutical Technology
FEBRUARY 6, 2023
South Korean biotechnology company Qurient has entered a licence agreement with TB Alliance for the development and commercialisation of telacebec (Q203). Under the deal, TB Alliance will have the exclusive global license to develop and market telacebec except in Russia, South Korea, and the Commonwealth of Independent States (CIS) countries. The first-in-class orally available investigational drug, Telacebec blocks Mycobacterium tuberculosis growth by inhibiting cytochrome bc1 complex.
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
Idorsia shares sink on ‘unexpected’ failure of drug study
Bio Pharma Dive
FEBRUARY 6, 2023
The Actelion spinout’s drug clazosentan, which is approved for use in Japan, didn’t significantly outperform a placebo in a Phase 3 study of patients with a particular type of stroke.
To Share or Not to Share Failed Genetic Screening Results with Patients
Worldwide Clinical Trials
FEBRUARY 6, 2023
When using genetic screening to identify clinical trial volunteers, a sponsor’s obligations for further testing and disclosure of results to patients and families are unclear, especially when the results have no impact on medical management. Guidance in this area is much needed. At Worldwide, this topic arises frequently in discussion with rare disease sponsors.
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February 6, 2023: Grand Rounds Podcast Now Available, Featuring Dr. Emily Largent on Ethical Considerations When Vulnerable Populations are Subjects in Pragmatic Clinical Trials
Rethinking Clinical Trials
FEBRUARY 6, 2023
In the latest episode of the NIH Collaboratory Grand Rounds podcast , Dr. Emily Largent and Dr. Stephanie Morain continue their discussion about the ethical considerations for vulnerable populations participating in pragmatic clinical trials. The full January 13 Grand Rounds webinar with Dr. Largent is also available. The post February 6, 2023: Grand Rounds Podcast Now Available, Featuring Dr.
Family caregivers of people with long COVID bear an extra burden
NPR Health - Shots
FEBRUARY 6, 2023
When a case of COVID-19 morphs into the mysterious, chronic condition known as long COVID, the specialists, appointments, medications and daily need for family care can overwhelm everyone involved.
Opinion: Mindstrong’s demise and the future of mental health care
STAT News
FEBRUARY 6, 2023
One of the shinier entrants to have emerged in the world of mental health startups abruptly announced last week it would wind down, right in the middle of an ongoing crisis in mental health care. Mindstrong, which had raised a total of $160 million from a who’s-who of blue-chip investors, and was led for a while by a former National Institute of Mental Health director, simply couldn’t find a way to make money delivering the low-cost, high-quality care it had promised.
Hundreds of ready-to-eat foods are recalled over possible listeria contamination
NPR Health - Shots
FEBRUARY 6, 2023
The foods are sold under dozens of different brand names, but all recalled products say Fresh Creative Cuisine on the bottom of the label. The recall affects items sold in nine East Coast states.
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
February 6, 2023: Postdoctoral Fellowship Available in Ethics and Regulatory Aspects of Pragmatic Trials
Rethinking Clinical Trials
FEBRUARY 6, 2023
The Johns Hopkins Berman Institute of Bioethics is accepting applications for its 2023-2024 Postdoctoral Fellowship in the Ethics and Regulatory Aspects of Pragmatic Clinical Trials. From the announcement: The Johns Hopkins Berman Institute of Bioethics invites applications for a Postdoctoral Fellowship in the Ethics and Regulatory Aspects of Pragmatic Clinical Trials.
After ‘losing my life’ caring for a sick partner, a professor examines the U.S. caregiver crisis
STAT News
FEBRUARY 6, 2023
“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. Laura Mauldin was immersed in Deaf culture from childhood — but she’s not deaf. She went to a school that happened to educate many deaf children, and so she grew up learning American Sign Language.
Podcast January 25, 2023: Ethical Considerations When Vulnerable Populations are Subjects in Pragmatic Clinical Trials (Emily A. Largent, JD, PhD, RN)
Rethinking Clinical Trials
FEBRUARY 6, 2023
This podcast continues the discussion with Dr. Emily Largent as she discusses ethical considerations for vulnerable populations participating in pragmatic clinical trials. Click on the recording below to listen to the podcast. NIH Pragmatic Trials Collaboratory · Podcast 43: Ethical Considerations for Vulnerable Populations in Pragmatic Clinical Trials Want to hear more?
‘They were his best shot. And they failed to help’: Why did EMS workers neglect Tyre Nichols?
STAT News
FEBRUARY 6, 2023
By the time medics arrived, Tyre Nichols was sitting on the ground, handcuffed and propped against a police car. The 29-year-old’s face was bloody and he was groaning in pain. On Jan. 7, after pulling Nichols over for a traffic stop, Memphis police officers had tased him, pepper-sprayed him, punched him, kicked him in the head, and beaten him with a baton.
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.
How the 'construction site' of long term memory gets built in the brain
Medical Xpress
FEBRUARY 6, 2023
Think of a new longer-term memory as a construction site inside the brain. The brain's neurons restructure themselves and build or demolish connections with other neurons to store the memory for retrieval when needed.
Pfizer’s 2023 pipeline: ‘We potentially will have the largest number of new product and indication launches that we’ve ever had in such a short period of time’
BioPharma Reporter
FEBRUARY 6, 2023
Pfizer currently has an unprecedented number of anticipated launches, says its CEO: with the company expecting to have 19 new products or indications in the market in the next 18 months.
Opinion: Covid convalescent plasma: the ‘little engine that could’
STAT News
FEBRUARY 6, 2023
The FDA’s withdrawal of its authorization for Evusheld , a monoclonal antibody therapy used to prevent and treat Covid-19, leaves no monoclonals available for this purpose. Another monoclonal, bebtelovimab, used to treat Covid-19, was withdrawn late last November. The FDA pulled its approval for these therapies because they were no longer effective against the newer SARS-CoV-2 variants circulating in the United States.
Researchers discover that a change in brain function contributes to obesity
Medical Xpress
FEBRUARY 6, 2023
University of Calgary researchers find diet-induced obesity is linked to a functional change in the brain. The study published in Nature Neuroscience finds that in obese mice there is a reduction in function of the brain's brake signal located in the lateral orbitofrontal cortex. This region of the brain is involved in decision making about rewards and whether action should be taken to get rewards.
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.
Opinion: How technology can help solve mental health care’s biggest barrier
STAT News
FEBRUARY 6, 2023
From telehealth and TikTok to artificial intelligence and virtual reality, the mental health care industry is embracing technology — but it’s making many clinicians uneasy. From concerns about the ethics of mental health influencers to the inaccuracy of mental health advice on TikTok and to complaints about teens misdiagnosing themselves , many experts are uncomfortable about the role technology is playing in mental health support.
Overlooked tau-RNA interaction may play key role in dementia
Medical Xpress
FEBRUARY 6, 2023
Sometimes in science, "Eureka!" moments happen with surprisingly little effort. Sometimes they take years or decades to emerge. Such was the case with Brian Kraemer's research team and their recent study of the protein tau and its impact on dementia diseases.
STAT+: Pharmalittle: AbbVie to lift $2B cap on deals as Humira rivals appear; India to spend $80M to bolster regulatory system
STAT News
FEBRUARY 6, 2023
Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because that oh-so-familiar routine of online meetings, conferences and deadlines has predictably returned. But what can you do? The world, such as it is, keeps spinning. So to give it a nudge in a useful direction, we are firing up the coffee kettle to brew another cup of stimulation.
Playing golf may be just as healthy or better than Nordic walking for older people
Medical Xpress
FEBRUARY 6, 2023
Older adults may gain more health benefits from playing golf than participating in regular or Nordic walking, suggests a study published online in the journal BMJ Open Sport & Exercise Medicine.
Accelerating Clinical Supply Through Integrated Drug Development
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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.
Patient’s race and method of dialysis are linked to higher risk of blood infection
STAT News
FEBRUARY 6, 2023
Hispanic, Latino, and non-Hispanic Black Americans on dialysis for end-stage kidney disease have a higher risk of developing life-threatening bloodstream infections, a new report says. And those racial and ethnic disparities are deepened by another risk factor: how the patient received hemodialysis. Going through a central venous catheter straight into major veins was linked to higher rates of infection than less invasive routes.
Vitamin D supplementation may lower diabetes risk for the more than 10 million adults with prediabetes
Medical Xpress
FEBRUARY 6, 2023
A review of clinical trials has found that higher vitamin D intake was associated with a 15 percent decreased likelihood for developing type 2 diabetes in adults with prediabetes. The review is published in Annals of Internal Medicine.
STAT+: Eisai reports first U.S. sales of newly approved treatment for Alzheimer’s disease
STAT News
FEBRUARY 6, 2023
Japanese drugmaker Eisai reported Monday the first U.S. sales of Leqembi, its treatment for Alzheimer’s disease, although exact numbers were not provided and people taking the drug appear to be paying out of pocket because insurance coverage has not yet been established. The first U.S. sales of Leqembi were recorded on Jan. 18, Eisai said Monday during its presentation of financial results for the fiscal third quarter that ended on Dec. 31.
New immunotherapy holds promise for ovarian cancer
Medical Xpress
FEBRUARY 6, 2023
CAR T-cell therapy, a certain kind of cancer treatment in which the immune system's T cells are programmed to attack tumor cells, is effective in mice with ovarian cancer, according to a study published in The Journal for ImmunoTherapy of Cancer. The researchers, who work at Karolinska Institutet, hope that the discovery will pave the way for a clinical trial to see how effective the treatment is for women with the disease.
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.
STAT+: Boston biotech internship program aims to increase diversity through expansion
STAT News
FEBRUARY 6, 2023
When Betelihem Alemayehu moved with her parents from the countryside of Ethiopia to Boston nearly a decade ago, she didn’t know how to ride the T, she couldn’t speak English, and she could never have guessed that one day she’d be employed in one of the city’s cutting-edge industries. Alemayehu, now 22, works in lab operations at Vedanta Biosciences, a Cambridge biotech startup that’s unraveling the mysteries of the human microbiome to create drugs from helpful
Jesduvroq (daprodustat) is FDA Approved for Anemia due to Chronic Kidney Disease
XTalks
FEBRUARY 6, 2023
GlaxoSmithKline LLC (GSK) recently announced that the US Food and Drug Administration (FDA) approved Jesduvroq (daprodustat), a new once-a-day oral treatment for anemia due to chronic kidney disease (CKD). The approval is currently only for adult patients who have been undergoing dialysis for at least four months. Jesduvroq is the first FDA-approved oral treatment for anemia caused by CKD for adults on dialysis, as other FDA-approved treatments for this condition are injected under the skin or i
STAT+: FDA grants priority review for Sage’s rapid-acting treatment for depression
STAT News
FEBRUARY 6, 2023
Sage Therapeutics said Monday that U.S. regulators accepted a marketing application for its rapid-acting antidepressant and granted it priority review with a decision date set for early August. The Food and Drug Administration will assess the efficacy and safety of the Sage drug, a once-daily pill called zuranolone, for the treatment of people with major depressive disorder and postpartum depression.
Many patients receive too little rehab therapy following stroke, study finds
Medical Xpress
FEBRUARY 6, 2023
Many patients don't receive much rehabilitation therapy following a stroke, despite strong evidence that higher amounts can reduce long-term disability, according to a new UCLA-led study that tracked over 500 patients across 28 acute care hospitals in their first year following a stroke.
The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric
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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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