Bio Pharma Dive
JANUARY 5, 2023
A regimen involving the Swiss biotech’s electrical field-based treatment extended lives in a late-stage trial. But data comparing the medical device to standard chemotherapy is less persuasive.
Pharmaceutical Technology
JANUARY 5, 2023
Capsida Biotherapeutics and Eli Lilly and Company ’s wholly owned subsidiary Prevail Therapeutics have announced a partnership for the development of non-invasive gene therapies for central nervous system (CNS) diseases. Under the multi-year strategic partnership, Prevail will detect and advance capsids, which are clinically translatable, along with its cargo to develop the transformative genetic medicines by using Capsida’s novel adeno-associated virus (AAV) engineering platform.
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Bio Pharma Dive
JANUARY 5, 2023
The IPO, which one estimate said could raise as much as $5 billion, is likely to be one of the largest new stock offerings in recent years.
Pharmaceutical Technology
JANUARY 5, 2023
Alpha Healthcare Acquisition Corp. III (ALPA) has executed a definitive merger agreement with Phase II-stage biotechnology platform company Carmell Therapeutics. Once the deal closes, ALPA will be renamed Carmell Therapeutics Corporation, the combined company that is expected to receive nearly $154m in gross proceeds. ALPA chairman and CEO Rajiv Shukla and Carmell CEO Randy Hubbell will serve as chairman and CEO of the combined company, respectively.
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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 5, 2023
Singhal, who took over R&D leadership on an interim basis from Al Sandrock, will lead Biogen’s development work while the company searches for a new research chief.
STAT News
JANUARY 5, 2023
SAN DIEGO — Fate Therapeutics, a biotech upstart with big ambitions to use cell-based therapies to treat autoimmune diseases and cancer, is now planning to cut back on both jobs and experimental drugs after an early end to a deal with Janssen. The setback, announced Thursday, will cut the company’s size to 220 workers by the end of the first quarter of this year.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
NPR Health - Shots
JANUARY 5, 2023
Changes by the FDA mean patients won't have to schedule in-person exams to get a prescription. That opens the door for more pharmacies to provide the medication. But not everyone will have access.
Medical Xpress
JANUARY 5, 2023
Young children sometimes believe that the moon is following them, or that they can reach out and touch it. It appears to be much closer than is proportional to its true distance. As we move about our daily lives, we tend to think that we navigate space in a linear way. But Salk scientists have discovered that time spent exploring an environment causes neural representations to grow in surprising ways.
NPR Health - Shots
JANUARY 5, 2023
Hunching over screens takes a toll. Movement researchers say you can prevent pain from accumulating by taking quick breaks for movement. Here are 5 exercises to try that take a minute or less.
Medical Xpress
JANUARY 5, 2023
Researchers at Baylor College of Medicine have found more evidence that dry fasting (fasting without food or liquid intake) from dawn to dusk can play an important role in overall health. In a new study published in Metabolism Open, researchers found that fasting from dawn to dusk for four weeks has an anti-atherosclerotic, anti-inflammatory and anti-tumorigenic effect on the proteins in a type of immune cell called a peripheral blood mononuclear cell (PBMC).
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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 5, 2023
As 2023 begins, health care providers in the United States must make health records more easily available or risk losing Medicare funding under the 21st Century Cures Act. While this is a win for patients, providers, and researchers, the legislation’s failure to include dental care ignores the crucial link between oral health and overall health.
Medical Xpress
JANUARY 5, 2023
Women that experience recent intimate partner violence (IPV) are three times more likely to contract HIV, according to a new study led by McGill University researchers. In regions like Sub-Saharan Africa, women face an intersecting epidemic of intimate partner violence and HIV.
STAT News
JANUARY 5, 2023
ANNECY, FRANCE — At first blush, the deal was hailed as a breakthrough. Last fall, Novartis agreed to license a best-selling cancer drug so that generic companies could make copies for distribution to 44 low- and middle-income nations, marking the first time a voluntary license was arranged for a cancer medicine. Until then, such deals typically involved drugs for infectious diseases, such as HIV and hepatitis C.
Medical Xpress
JANUARY 5, 2023
A new study by Burke Neurological Institute (BNI), Weill Cornell Medicine, finds that activation of MAP2K signaling by genetic engineering or non-invasive repetitive transcranial magnetic stimulation (rTMS) promotes corticospinal tract (CST) axon sprouting and functional regeneration after spinal cord injury (SCI) in mice.
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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.
STAT News
JANUARY 5, 2023
More than a year after Al Sandrock was pushed out as Biogen’s R&D chief, the company has set permanent plans to replace him into motion. Biogen announced Thursday that it will be splitting the head of R&D role into two, with Priya Singhal being named as the new head of development. The company has initiated a search for a new research chief, it said in a press release.
Medical Xpress
JANUARY 5, 2023
Multiple sclerosis patients do not have the same bacteria in their intestines as healthy people. There are also differences in the composition and function of the bacteria in the intestines of multiple sclerosis patients, depending on whether their illness is active, and whether they are in treatment. This is the result of a major study of intestinal bacteria in multiple sclerosis patients and healthy control subjects, which was recently published in the journal Genome Medicine.
STAT News
JANUARY 5, 2023
For only the second time since launching nearly two years ago, the AMR Action Fund has made another investment in a fledgling European biotech company as it tries to underwrite efforts to develop badly needed medicines for combating antibiotic resistance. In its latest move, the fund is providing $7.5 million to BioVersys, which is developing an antibiotic to combat a type of bacteria that affects people with compromised immune systems and is increasingly responsible for infections in hospitaliz
Medical Xpress
JANUARY 5, 2023
Talking, smiling, eating together—these are all social activities that are inherent to the human experience. But for some head and neck cancer survivors, they are dreaded tasks. These survivors can go through disfiguring surgeries and radiation treatments to their tongues, jaws, voice boxes, necks and faces that radically affect their appearances and their control over facial muscles.
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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.
STAT News
JANUARY 5, 2023
What does 2023 have in store for biotech? How can the FDA win back trust? And who came up with “XBB.1.5”? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. First, we delve into a sweeping congressional investigation into the FDA’s approval of the last treatment for Alzheimer’s disease and what it means for the next one.
BioPharma Reporter
JANUARY 5, 2023
AstraZeneca and Sanofi said their Biologics License Application (BLA) for nirsevimab has been accepted for review by the US Food and Drug Administration (FDA).
Medical Xpress
JANUARY 5, 2023
What it means to be conscious is more than just a philosophical question. Researchers continue to investigate how conscious experience arises from the electrochemical activity of the human brain. The answer has important implications for the way brain health is understood—from coma, wherein a person is alive but unable to move or respond to his or her environment, to surgical anesthesia, to the altered thought processes of schizophrenia.
STAT News
JANUARY 5, 2023
Good morning, everyone, and how are you today? We are doing just fine, thank you, despite a thick fog enveloping the Pharmalot grounds. After all, as the Morning Mayor taught us: “Every new day should be unwrapped like a precious gift.” So while you tug on the ribbon, we will fire up our coffee kettle to brew another cup of stimulation.
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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 5, 2023
Engaging in self-harming behaviors without the intention to die, or non-suicidal self-injury (NSSI), increases dramatically in the transition from childhood to adolescence and continues to grow throughout the teenage years. Although engagement in NSSI is often associated with emotional reactivity and may occur in response to distressing social experiences, some youth are more likely than others to carry out self-injury.
pharmaphorum
JANUARY 5, 2023
Biotech Moderna, Inc. and OriCiro Genomics K.K. have announced they have entered into a definitive agreement for Moderna to acquire OriCiro at a cost of $85 million. The deal marks 10-year-old Moderna’s first acquisition. The company develops mRNA therapeutics and vaccines , and the move will enable it to utilise the synthetic biology and enzyme tech of 2018-founded Japanese company OriCiro, which develops cell-free DNA synthesis and amplification technologies, and thereby expand Moderna’s portf
Medical Xpress
JANUARY 5, 2023
Cardiac arrest (or sudden cardiac arrest as it is more formally known) is a medical emergency. It happens when an event, usually an electrical disturbance, quickly and unexpectedly causes your heart to stop working. It's not the same as a heart attack, and is called sudden because it seems to happen without warning.
Pharma Times
JANUARY 5, 2023
Agreement covers cell-based studies, with an additional option to further develop screening activities
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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 5, 2023
A patient-centered text message-based platform can enhance self-efficacy of symptom management for patients with interstitial cystitis/bladder pain syndrome (IC/BPS), according to a study published online Dec. 15 in NeuroUrology and Urodynamics.
NPR Health - Shots
JANUARY 5, 2023
Last month, Walgreens finalized a settlement with state and local governments to resolve opioid abuse lawsuits. Despite the legal charge, the company beat Wall Street forecasts.
Medical Xpress
JANUARY 5, 2023
Of the nearly 4 million births each year in the United States, roughly 50,000 are marked by life-threatening complications, and up to 900 result in maternal death during delivery. One major, often life-threatening complication is placenta accreta spectrum (PAS), which poses a threat to both the mother and the baby. Currently, PAS cases are identified by ultrasounds, MRIs, and predictive confounding conditions—but these methods leave between 33% and 50% of PAS cases undetected prior to delivery.
pharmaphorum
JANUARY 5, 2023
For most people, the name “JP Morgan” means bankers and investors. But for the pharma sector, it means meetings all over town in San Francisco and presentations by anybody who’s anybody in pharma, life sciences, and, increasingly, digital health. Back in the Golden City after a few years of COVID-enforced virtuality, JPM Week is more than just the exclusive closed-door conference it’s named for – it also includes a smattering of satellite events and, of course, thousands of one-on-one meetings b
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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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