Bio Pharma Dive
MARCH 23, 2023
The two companies gained billions of dollars in market value after their antibody drug succeeded against a disease that’s been difficult to treat with biologic medicines.
Pharmaceutical Technology
MARCH 23, 2023
Biohaven has purchased the exclusive global rights for oral, brain-penetrant dual Tyrosine Kinase 2 (TYK2)/Janus Kinase 1 (JAK1) inhibitor, BHV-8000 (previously TLL-041), which treats immune-mediated brain disorders , from Hangzhou Highlightll Pharmaceutical. The deal gives Biohaven global rights for the development of BHV-8000, excluding regions of China.
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Bio Pharma Dive
MARCH 23, 2023
Nearly one year after Clay Siegall’s arrest and resignation from Seagen, the executive has been named CEO of Morphimmune, a small cancer biotech.
Pharmaceutical Technology
MARCH 23, 2023
Pfizer recently announced an agreement to acquire Seagen, a biotech company based in the US with four marketed oncology therapeutic agents and a rich pipeline. The deal, expected to be completed by the end of 2023, will see Pfizer pay $229 per Seagen share in cash for a total of $43bn, the largest deal for the sector in the past three years. Seagen specialises in developing antibody-drug conjugates (ADCs) which will complement Pfizer’s oncology portfolio.
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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
MARCH 23, 2023
The biotech plans to use Generation Bio’s nonviral delivery technology to get nucleic acid-based therapies to immune cells and into the liver.
Pharmaceutical Technology
MARCH 23, 2023
This week, the Medicines and Healthcare products Regulatory Agency (MHRA) is introducing major changes to clinical trial regulation in the UK with expedited timelines at several stages. The MHRA hopes this new framework “will remove obstacles to innovation” and “streamline the regulation of clinical trials” amongst other things. These changes come following a public consultation with the Healthcare Research Authority, to which a government response was published on March 21.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
MARCH 23, 2023
The biotech initial public offering (IPO) market saw a 79% decline in the number of completed IPOs from 2021 to 2022 in the US; however, this comes after the IPO boom in 2020 and 2021, according to GlobalData’s Pharma Intelligence Center Deals Database. An initial public offering is a process in which a private company sells its shares on the stock exchange to become public.
Bio Pharma Dive
MARCH 23, 2023
Rezzayo is the first new treatment for candidemia and invasive candidiasis to win FDA approval in years.
Pharmaceutical Technology
MARCH 23, 2023
China’s National Medical Products Administration (NMPA) has granted emergency use authorisation (EUA) for CSPC Pharmaceutical Group’s messenger RNA (mRNA) vaccine, SYS6006, to treat Covid-19. With this regulatory approval, CSPC Pharmaceutical is claimed to be the first company to receive approval for providing an mRNA vaccine in the country. The latest authorisation from the Chinese health authority comes as cases of Covid-19 decline after a recent surge.
STAT News
MARCH 23, 2023
On Thursday, the Centers for Disease Control and Prevention announced another increase in the prevalence of autism among children. In a pair of new reports — one focused on 8-year-olds and one on 4-year-olds — the CDC found that 1 out of every 36 children has autism. This is a significant increase from the 2021 estimate of 1 in 44 , which was a big jump from 1 in 110 in 2006.
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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
Pharmaceutical Technology
MARCH 23, 2023
At the European Crohn´s and Colitis Organisation (ECCO) 2023 meeting, Prometheus Bioscience presented results from its Phase IIa APOLLO-CD clinical trial of PRA023 in Crohn’s disease (CD). The presentation highlighted the efficacy and safety of PRA023, an anti-TL1A asset, in a small sample size (N=50) of CD patients. The findings indicated the potential for PRA023 as a therapy in CD.
Medical Xpress
MARCH 23, 2023
Muscle is able to regenerate through a process that involves multiple steps and players, including the immune system. As our organism ages, the muscles lose the capacity to regenerate.
STAT News
MARCH 23, 2023
Early in the Covid-19 pandemic, new diagnoses of tuberculosis dropped like a stone in the United States. Data released Thursday by the Centers for Disease Control and Prevention suggest the pandemic effect has pretty much worn off; TB is nearly back to pre-2020 levels. “We’re getting … close to where we were pre-pandemic; not quite back yet with increases in cases in the last two years,” Philip LoBue, director of the CDC’s division of tuberculosis elimination,
NPR Health - Shots
MARCH 23, 2023
The state will ban most gender-affirming surgeries and hormone replacement therapies for transgender people under 18 with a new bill signed into law by Gov. Brian Kemp.
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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
MARCH 23, 2023
Researchers should focus on age, not weight, to capture the greatest number of people in all racial and ethnic groups with prediabetes and diabetes, recommends a new Northwestern Medicine study.
NPR Health - Shots
MARCH 23, 2023
Part of a national trend, medical residents at Penn Medicine in Philadelphia push to form a union to demand better working conditions and higher wages. Child care is an important issue for many.
Medical Xpress
MARCH 23, 2023
Coffee lovers—and their doctors—have long wondered whether a jolt of java can affect the heart. New research published Wednesday finds that drinking caffeinated coffee did not significantly affect one kind of heart hiccup that can feel like a skipped beat.
NPR Health - Shots
MARCH 23, 2023
A total of 295 types of drugs — everything from sedatives to children's flu medicine — were in short supply in 2022, according to a new report from the U.S. Senate Committee on Homeland Security.
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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
MARCH 23, 2023
Millions of diabetes cases may be missed under the current U.S. screening guidelines, especially among Asian Americans, according to a new study. A better way to test for the condition would be to leave body weight out of it, the researchers suggest. Current guidelines from the U.S. Preventive Services Task Force recommend screening adults ages 35-70 who are considered overweight or obese (having a body mass index over 25).
Medical Xpress
MARCH 23, 2023
More magnesium in our daily diet leads to better brain health as we age, according to scientists from the Neuroimaging and Brain Lab at The Australian National University (ANU).
STAT News
MARCH 23, 2023
Directly observed therapy — where a health professional watches someone take a medication — has been the standard of care for tuberculosis treatment in the United States since 2016. Now DOT, as it’s called, has an approved video alternative. The Centers for Disease Control and Prevention announced Thursday it was updating its guidance to include video DOT or vDOT, saying there is enough evidence to show it is at least as effective as the in-person version.
Medical Xpress
MARCH 23, 2023
Exercise has many benefits—strengthening muscles and bones, preventing disease and extending lifespan. It is also known to change the composition and activity of the trillions of microbes in our guts known as the microbiome.
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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.
STAT News
MARCH 23, 2023
After 40 years at the helm of nonprofit Boston Health Care for the Homeless Program, Jim O’Connell likes to remind himself — and his colleagues — that they’re not saving the world. Yes, the program has a longtime reputation for building bridges between unhoused people and clinicians at Mass General, building sufficient trust to convince “rough sleepers” to be treated in the streets or visit the hospital.
Medical Xpress
MARCH 23, 2023
Using artificial intelligence, researchers have discovered how to screen for genetic mutations in cancerous brain tumors in under 90 seconds—and possibly streamline the diagnosis and treatment of gliomas, a study suggests.
STAT News
MARCH 23, 2023
In a defeat for Johnson & Johnson, the Indian patent office has rejected its bid to extend a monopoly on a crucial tuberculosis treatment, opening the door to lower-cost generic alternatives needed in low- and middle-income countries. The health care giant sought to extend patent protection on bedaquiline, also known as Sirturo, after the primary patent expires in India in July.
Medical Xpress
MARCH 23, 2023
A new Series published in The Lancet describes how, although commercial entities can contribute positively to health and society, the products and practices of some commercial actors are responsible for escalating rates of avoidable ill health, planetary damage, and social and health inequity. Authors make key recommendations to ensure that contemporary capitalism is compatible with good population health.
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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.
ACRP blog
MARCH 23, 2023
Generating evidence by integrating research into patient care Clinical trials are increasingly using longitudinal evidence generation, where repeated measurements are taken over time from the same set of patients. This is leading to changes in expectations of how research sites carry out trials. “During the COVID-19 pandemic, we’ve seen therapies reaching the market more quickly in areas such as rare diseases, cancer, and Alzheimer’s disease,” says Brad Hirsch, MD, Head of Product & Implemen
Medical Xpress
MARCH 23, 2023
The most comprehensive state-by-state analysis of the impacts of COVID-19 across the U.S., published today in The Lancet, reveals the underlying reasons why the pandemic has played out in vastly different ways across the country.
STAT News
MARCH 23, 2023
ST. LOUIS — Anesthesiologist and former U.S. surgeon general Jerome Adams has emerged as a leading voice on public health and issues of equity in medicine from his new position as executive director of health equity initiatives at Purdue University, in his home state of Indiana. He recently was a keynote speaker at the Association for Health Care Journalists annual meeting in St.
Medical Xpress
MARCH 23, 2023
New research led by investigators at Massachusetts General Hospital (MGH), a founding member of Mass General Brigham (MGB), found that males but not females born to mothers with SARS‐CoV‐2 infection during pregnancy were more likely to receive a neurodevelopmental diagnosis in the first 12 months after delivery. The findings are published in JAMA Network Open.
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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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