Drug Discovery World

APRIL 20, 2023

Dr Paula Moran, Dr Kiri Granger, Dr J Mark Treherne , and Dr Jenny Barnett explore the effects of long Covid-19 symptoms and what the opportunities are for drug developers working to treat post-Covid-19 cognitive impairment. We are amidst a shift of focus from dealing with the acute impacts of the Covid-19 pandemic to tackling the ‘long Covid-19’ symptoms that may now represent greater future challenges for healthcare systems and patient quality of life.

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Development Drugs Clinical Trials Clinical Trials 98

Bio Pharma Dive

APRIL 16, 2023

The pharma has struck the sector’s second-largest buyout this year, announcing a deal for the developer of an inflammatory bowel disease treatment that’s shown promise in testing.

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Development 319

Pharmaceutical Technology

APRIL 17, 2023

Merck has signed a definitive agreement to buy clinical-stage biotechnology firm Prometheus Biosciences for $10.8bn, strengthening its immunology pipeline. The company will buy all of Prometheus Biosciences’ outstanding shares for $200 a share through a subsidiary. Prometheus Biosciences uses precision medicine to discover, develop and commercialise new therapeutic and companion diagnostic products to treat immune-mediated diseases.

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Medical Xpress

APRIL 21, 2023

Wake Forest Institute for Regenerative Medicine (WFIRM) scientists have created a promising injectable cell therapy to treat osteoarthritis that both reduces inflammation and also regenerates articular cartilage.

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Scientist Medicine 145

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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

Clinical Research

STAT News

APRIL 21, 2023

A medical student spoke emotionally about grappling with a diagnosis his classes told him little about. A young queer man took one test, got a different result on the next, and is now saving up the money needed for the most advanced diagnostics, which insurers rarely cover. A young woman tested positive, got little guidance from her doctor and found information on government sites that she interpreted as pushing abstinence.

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Doctors Doctor Research 145

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.

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Drugs 300

NPR Health - Shots

APRIL 19, 2023

Millions of Americans suffer from long COVID, which can have debilitating physical effects, including fatigue and difficulty breathing. Yet many patients feel abandoned, as federal aid winds down.

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Medical Xpress

APRIL 17, 2023

Magnetic resonance imaging (MRI) is how we visualize soft, watery tissue that is hard to image with X-rays. But while an MRI provides good enough resolution to spot a brain tumor, it needs to be a lot sharper to visualize microscopic details within the brain that reveal its organization.

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Bio Pharma Dive

APRIL 16, 2023

Data presented at AACR suggest a personalized shot made with messenger RNA may amplify the effects of a widely prescribed cancer immunotherapy.

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RNA 341

Pharmaceutical Technology

APRIL 21, 2023

Incyte has received marketing authorisation from the European Commission for Opzelura (ruxolitinib) cream 15mg/g to treat non-segmental vitiligo with facial involvement in adults and in adolescents aged 12 years and above. Opzelura is the first and only approved treatment across the European Union (EU) aimed at achieving repigmentation in the targeted patients.

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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

Clinical Trials

NPR Health - Shots

APRIL 20, 2023

The U.S. desperately needs more Black and Hispanic doctors, research shows. But financial pressures and discrimination can keep young people from even applying to med school.

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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.

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Research 145

Bio Pharma Dive

APRIL 20, 2023

The company, which previously raised $32 million in Series A funding, joins a growing list of new startups working to develop targeted radiation treatments.

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Research Development 291

Pharmaceutical Technology

APRIL 21, 2023

The US Food and Drug Administration (FDA) has pushed quizartinib’s Prescription Drug User Fee Act (PDUFA) date in newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML) for the review of updates of Risk Evaluation and Mitigation Strategies (REMS) included in the application. The PDUFA date was extended by three months to July 24, based on an April 20 company announcement.

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Branding Drugs Medicine Trials 246

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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.

Clinical Trials

NPR Health - Shots

APRIL 18, 2023

Boys born to mothers who got COVID-19 while pregnant seem to have a higher risk of subtle developmental delays, including those associated with autism spectrum disorder.

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Development 145

Medical Xpress

APRIL 17, 2023

Putting on your workout clothes and getting to the gym can feel like a slog at first. Eventually, you might get in the habit of going to the gym and readily pop over to your Zumba class or for a run on the treadmill. A new study from social scientists at Caltech now shows how long it takes to form the gym habit: an average of about six months.

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Scientist 145

Bio Pharma Dive

APRIL 17, 2023

The buyout of Prometheus highlights pharmaceutical companies’ intense interest in medicines targeting inflammatory diseases, according to analysts.

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Medicine 286

Pharmaceutical Technology

APRIL 20, 2023

Chinese firm Hasten Biopharmaceutic has raised $315m for business development of its pipeline assets in a financing round co-led by Singapore-based CBC Group and Abu Dhabi sovereign wealth fund Mubadala Investment, The funding round was supported by additional institutional investors. Hasten will also use the proceeds from the round to fund future acquisitions.

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Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

Clinical Research

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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Research 142

Medical Xpress

APRIL 18, 2023

Effective management of depression through psychological therapy is associated with a lower likelihood of heart disease and stroke, according to research published today in European Heart Journal.

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Research 138

Bio Pharma Dive

APRIL 18, 2023

The acquisition gives GSK a competitor to a similar drug being developed by Merck for the condition, which the companies estimate affects millions of people in the U.S.

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Drugs Development 265

Pharmaceutical Technology

APRIL 20, 2023

European life sciences venture capital firm Forbion has raised €1.35bn ($1.47bn) across its two new funds. The latest fundraising brings the total funds managed by the company to €3bn ($3.28bn). The Forbion Ventures Fund VI and the Forbion Growth Opportunities Fund II both exceeded their original target sizes. The Forbion Ventures Fund VI’s final close reached the hard cap of €750m ($821.76m), while the Forbion Growth Opportunities Fund II secured €600m ($657.41m).

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Life Science Marketing Development 246

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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.

Clinical Supply

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.

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Scientist Genetic Disease Genetics Research 136

NPR Health - Shots

APRIL 18, 2023

Anthony Comstock pushed Congress to crack down on what he saw as harmful vices, such as pornography and contraception. An 1873 law named for him has appeared in recent court battles over abortion.

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Bio Pharma Dive

APRIL 21, 2023

The company has chosen to stop an extension portion of a key study after an external group of advisers reviewed the data available and concluded further treatment with the drug was unwarranted.

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Drugs 241

Pharmaceutical Technology

APRIL 18, 2023

IntelGenx Corp announced that the US Food and Drug Administration (FDA) has approved the company’s Rizafilm VersaFilm new drug application (NDA) for the treatment of acute migraine. The approval was based on successful results from a bioequivalence study comparing Rizafilm to Merck and Co’s Maxalt-MTL and the European reference Maxalt-Lingua. Rizaport and Maxalt are different formulations of Rizatriptan benzoate.

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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.

Clinical Trials

Medical Xpress

APRIL 15, 2023

A major UK study has discovered that the disturbed sleep patterns in patients hospitalized with COVID-19 was likely to be a driver of breathlessness.

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NPR Health - Shots

APRIL 18, 2023

Maria Caprigno was one of the youngest people in the U.S. to get the surgery. As parents and doctors grapple with the obesity treatment for teens, Caprigno cites the long-term benefits.

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Doctors Doctor 132

Bio Pharma Dive

APRIL 21, 2023

With cash running low and a search for a buyer underway, GenSight wants advice from regulators on the type of data that would support an approval.

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Gene Therapy Gene Regulation 256

Pharmaceutical Technology

APRIL 17, 2023

NKGen Biotech, a clinical-stage natural killer (NK) cell therapy firm, has signed a definitive agreement to combine its business operations with Graf Acquisition. NKGen Biotech will become a publicly traded company, while Graf will be rebranded as NKGen Biotech. Graf is also anticipated to be listed on the New York Stock Exchange, NYSE American and Nasdaq under the ticker symbol ‘NKGN’.

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Gene Therapy Gene Clinical Development Development 246

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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.

Clinical Trials