Bio Pharma Dive
APRIL 19, 2023
A study abstract inadvertently posted online showed J&J and Legend’s therapy, Carvykti, reduced the risk of disease progression or death by more than 70% over standard drugs.
Pharmaceutical Technology
APRIL 19, 2023
GSK has signed an agreement to buy Canadian late-stage biopharmaceutical company BELLUS Health for $2bn (£1.6bn). GSK will buy all the outstanding shares in BELLUS for $14.75 per share in cash. GSK expects that the BELLUS Health acquisition will boost its speciality medicines and respiratory pipeline. The company will gain access to BELLUS’s investigational, twice-daily oral P2X3 receptor antagonist, camlipixant, to treat refractory chronic cough (RCC).
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Bio Pharma Dive
APRIL 19, 2023
Forbion and Gilde Healthcare raised a combined $2 billion across their respective funds to invest in emerging biotech and life sciences companies.
Rethinking Clinical Trials
APRIL 19, 2023
In this Friday’s PCT Grand Rounds, Amit Garg of Western University’s Schulich School of Medicine & Dentistry will present “Personalised Cooler Dialysate for Patients Receiving Maintenance Haemodialysis (MyTEMP): A Pragmatic, Cluster-Randomised Trial.” The Grand Rounds session will be held on Friday, April 21, 2023, at 1:00 pm eastern.
Bio Pharma Dive
APRIL 19, 2023
An administrative stay of a Texas district court ruling will remain in place through Friday, pushing out a Supreme Court decision in the closely watched case over the drug mifepristone.
Pharmaceutical Technology
APRIL 19, 2023
Everest Medicines has signed a memorandum of understanding with Shanghai Pharma subsidiary SPH Keyuan Xinhua Pharmaceutical (SPH Kyuan) to support the import and channel distribution of XERAVA (eravacycline) in China. The collaboration will leverage SPH Kyuan’s drug import capabilities and distribution network, along with an improved logistics system.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
APRIL 19, 2023
Johnson & Johnson (J&J) has reported a 5.6% increase in sales to $24.75bn in the first quarter (Q1) of 2023, up from $23.4bn during the corresponding quarter of 2022. The company reported a net earnings loss of $68m, down by 101.3% from $5.15bn in Q1 2022. A one-time charge related to claims that the company’s talc-based products cause cancer led to a basic loss per share of $0.03.
Medical Xpress
APRIL 19, 2023
A University of Rhode Island researcher has led a study that confirms a direct link between certain chemicals in drinking water and human obesity—specifically that increased PFAS content in blood promotes weight gain and makes it harder to keep a lower body weight after weight loss.
Pharmaceutical Technology
APRIL 19, 2023
Bayer has announced that it will shift the focus of its drug research away from women’s health to four core therapeutic areas: oncology, cardiovascular, neurology and rare diseases/immunology. This news comes after the refinement of Bayer’s early innovation framework, where it had decided to concentrate on the therapeutic areas with the best opportunities for delivering differentiated, high-value breakthrough medicines to patients.
STAT News
APRIL 19, 2023
For many years, there’s been considerable debate about the best age for women to initiate breast cancer screening.The U.S. Preventive Services Task Force recommends that women start getting screenings around age 50, while groups such as the American Cancer Society recommend screenings begin at an earlier age. Now a large new study suggests that if Black women begin screening for breast cancer at age 42, that could help lower racial disparities in breast cancer deaths.
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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
APRIL 19, 2023
Neuronascent plans to start a potential Phase II trial of its neurorestorative agent NNI-362 in Parkinson’s disease in H1 2024, said CEO Judith Kelleher-Andersson in an interview with P harmaceutical Technology. While the Clarksville, US-based company completed a Phase Ia study in healthy participants to eventually develop the drug for Alzheimer’s disease, it is likely that the company will now focus on Parkinson’s disease in its Phase II study first, said Kelleher-Andersson.
STAT News
APRIL 19, 2023
University of Michigan pediatric neurologist Vivian Cheung made a name for herself studying rare genetic diseases, and in 2008 — when she was on the faculty at the University of Pennsylvania — was hired as a Howard Hughes Medical Institute investigator, an honor for which she received $1 million a year over the next 12 years to further her research.
Pharmaceutical Technology
APRIL 19, 2023
MedX Health Corporation has announced a Memorandum of Understanding for the launch of a pilot project with PharmaChoice Canada to expand its teledermatology screening services. The pilot will be tested across locations in British Columbia, Ontario, Nova Scotia and, Newfoundland. PharmaChoice, which has more than 1,000 independent pharmacy owners and operators under its brand, will run MedX’s technology at 20 locations across the four provinces over a three-month assessment period.
NPR Health - Shots
APRIL 19, 2023
When a town loses its grocery store, it also lose a local source of healthy food and a place for neighbors to gather and connect. But some communities are finding innovative ways to keep shops open.
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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
Pharmaceutical Technology
APRIL 19, 2023
The US Food and Drug Administration (FDA) has accepted Arcutis Biotherapeutics ’ new drug application (NDA) for roflumilast foam 0.3% to treat patients aged nine years and above with seborrheic dermatitis. The regulator has set 16 December 2023 as a prescription drug user fee act (PDUFA) target action date for the decision on the application. Roflumilast foam is an investigational, potent and selective phosphodiesterase type 4 (PDE4) inhibitor.
Medical Xpress
APRIL 19, 2023
High consumption of sugar-sweetened beverages (SSBs) was associated with an elevated risk of premature death and incidence of cardiovascular disease (CVD) among people with type 2 diabetes, according to a new study led by researchers at Harvard T.H. Chan School of Public Health. Drinking beverages like coffee, tea, low-fat cow's milk, and plain water was associated with lower risk of dying prematurely.
NPR Health - Shots
APRIL 19, 2023
COVID-19 disrupted health care across the globe. causing the biggest drop in childhood vaccination rates in decades. UNICEF's latest estimates find that nearly 50 million children entirely missed out.
Fierce Pharma
APRIL 19, 2023
Goodbye, original COVID-19 vaccines: FDA updates shot guidance, pulls monovalent authorizations zbecker Wed, 04/19/2023 - 11:04
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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
APRIL 19, 2023
Studies have shown that consuming alcohol during pregnancy can alter the brain and behavioral development of gestating offspring. Currently, the Centers for Disease Control and Prevention advises against maternal alcohol consumption during pregnancy and state that there is no known safe level of consumption. What are the consequences, however, of mothers consuming alcohol while breastfeeding?
STAT News
APRIL 19, 2023
An expert panel that advises the Centers for Disease Control and Prevention on vaccination policy informally endorsed a plan Wednesday to offer an additional Covid-19 booster shot to people 65 and older as well as people who are immunocompromised, and to simplify the Covid vaccine schedule. The Advisory Committee on Immunization Practices was not asked to vote on the changes , announced Tuesday by the Food and Drug Administration.
NPR Health - Shots
APRIL 19, 2023
The announcement kicks the can down the road on what the high court will do for another few days. Mifepristone is used in about half of all abortions nationwide.
Medical Xpress
APRIL 19, 2023
Like many neurodegenerative diseases, Parkinson's disease (PD) is a thief that hacks into human operating systems and corrupts their cognitive hard drives until they can no longer control their movements or perform activities of daily living.
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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.
NPR Health - Shots
APRIL 19, 2023
If a pregnant person is struggling with mental health and considering suicide, several states' laws, including Florida's, specifically say the "life of the mother" exception does not apply to them.
STAT News
APRIL 19, 2023
The U.S. Supreme Court on Wednesday extended a stay on limits to a federally approved abortion drug, giving the panel two more days to consider a case that could determine whether the widely used medication can remain on the market. The stay, now in place until the end of Friday, was due to end at midnight amid an unprecedented case testing the Food and Drug Administration’s authority to approve and regulate drugs.
NPR Health - Shots
APRIL 19, 2023
GenBioPro, which makes a generic form of mifepristone, is suing the FDA seeking to preserve access to the drug amidst ongoing federal litigation.
STAT News
APRIL 19, 2023
The Food and Drug Administration’s latest plan to study whether opioids are effective as a chronic pain treatment is facing significant resistance from addiction and pain care experts. A planned clinical trial, doctors and researchers argued on Wednesday, would not yield significant new information about whether opioids are effective as long-term treatments for chronic pain.
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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
APRIL 19, 2023
Scientists at Trinity College Dublin today announced a significant development toward a new therapeutic treatment of glaucoma.
STAT News
APRIL 19, 2023
Just one week after the season finale of the HBO show “The Last of Us,” about a zombie apocalypse caused by a fungal infection, the Centers for Disease Control and Prevention issued a warning about Candida auris spreading in U.S. health care facilities. Twenty-seven states and Washington, D.C. have reported cases of the deadly fungal infection that often doesn’t respond to common antifungal drugs, with southern Nevada emerging as a hotspot of infections.
Medical Xpress
APRIL 19, 2023
The human body naturally produces opioid-like substances, such as endorphins, that block the perception of pain and increase the feeling of well-being. Similarly, opioid drugs, including morphine or fentanyl, are widely used for alleviating severe pain. However, their use is associated with a high risk of dependence and addiction, and their excessive misuse causes more than 350,000 annual deaths worldwide.
STAT News
APRIL 19, 2023
The calamity of March 2020 arrived two years later for pediatric units. In the fall of 2022, a tidal wave of respiratory viral illnesses sent children to emergency rooms in droves when enterovirus, respiratory syncytial virus (RSV), and influenza peaked in close succession, bombarding young children who had remained mostly unexposed to these viruses during the most acute years of the Covid pandemic.
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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.
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