ASPET

APRIL 19, 2024

One cannot survive without regularly urinating and defecating. People with neurological injury (spinal cord injury, traumatic brain injury, stroke) or disease (multiple sclerosis, Parkinson's disease, spina bifida) and many elderly are unable to voluntarily initiate voiding. The great majority of them require bladder catheters to void urine and "manual bowel programs" with digital rectal stimulation and manual extraction to void stool.

Therapies 100

Therapies Hospitals Disease Drugs 100

Science Daily: Pharmacology News

APRIL 19, 2024

Analysis of mooring observations and hydrographic data suggest the Atlantic Meridional Overturning Circulation deep water limb in the North Atlantic has weakened. Two decades of continual observations provide a greater understanding of the Earth's climate regulating system.

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Regulations 124

Drugs.com

APRIL 19, 2024

FRIDAY, April 19, 2024 -- The right diet may be the best medicine for easing the painful symptoms of irritable bowel syndrome (IBS), new research shows. In the study, two different eating plans beat standard medications in treating the debilitating.

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Research 116

BioPharma Drive: Drug Pricing

APRIL 19, 2024

The new label for Alecensa makes it the first targeted treatment available after surgery for people with ALK-positive lung tumors, who are at high risk for brain metastases.

FDA 114

FDA Treatment Drugs 114

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

Treatment

Drugs.com

APRIL 19, 2024

FRIDAY, April 19, 2024 -- An early marker of multiple sclerosis could help doctors figure out who will eventually fall prey to the degenerative nerve disease, a new study says.In one in 10 cases of MS, the body begins producing a distinctive set of.

Doctors 115

Doctors Disease 115

Drug Target Review

APRIL 19, 2024

Can you tell us about your journey in the field of STEM and the challenges you encountered along the way? In the STEM area, I was born as a physicist, which was – among many other things – the inception of looking at the world from many different points of view to get the big picture without losing the fascination with mystery. This eventually translated into looking at my life from many points of view, without fear of change, which opened many opportunities.

Molecular Biology 111

Molecular Biology Research Pharmaceuticals Small Molecule 111

Collaborative Drug

APRIL 19, 2024

Tokyo, Japan, April 17, 2024 — In a significant move to bolster CDD Vault’s presence in the Japanese market, Collaborative Drug Discovery (CDD) is excited to announce the appointment of Mr. Yasushi Hamagashira as the new Head of Sales and Marketing for Japan. Bringing on board a wealth of experience and expertise, Mr. Hamagashira is set to play a pivotal role in CDD’s strategic expansion and deepening of client engagements in Japan.

Marketing 106

Marketing Drugs 106

Drugs.com

APRIL 19, 2024

FRIDAY, April 19, 2024 -- The dangerous heart rhythm disorder known as atrial fibrillation is mainly known for increasing people’s risk of stroke.But people with A-Fib actually have a much higher risk of developing heart failure than suffering a.

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111

Collaborative Drug

APRIL 19, 2024

Moderna Embracing Data & AI to Transform Drug Discovery. Are US Scientists Leaving Academia? Can Viagra Support Alzheimer’s Prevention?

Drugs 89

Drugs 89

Drugs.com

APRIL 19, 2024

FRIDAY, April 19, 2024 -- A head-to-head trial of obese, pre-diabetic people who ate the same amount of daily calories -- with one group following a fasting schedule and the other eating freely -- found no difference in weight loss or other health.

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Trials 105

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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

BioPharma Drive: Drug Pricing

APRIL 19, 2024

The agreement may help Alvotech capitalize on a recent policy shift by CVS that has driven major market share declines for AbbVie’s blockbuster drug.

Biosimilars 75

Biosimilars Marketing Drugs 75

Drugs.com

APRIL 19, 2024

FRIDAY, April 19, 2024 -- An immune-compromised man with a year-and-a-half-long COVID infection served as a breeding ground for dozens of coronavirus mutations, a new study discovered.

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Virus 105

Collaborative Drug

APRIL 19, 2024

Celebrating 20 Years of Pioneering Drug Discovery and Collaboration: CDD User Group Meeting

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Drugs 95

Drugs.com

APRIL 19, 2024

FRIDAY, April 19, 2024 -- All expecting mothers should get a blood test for syphilis three times during pregnancy, new guidance issued by the American College of Obstetricians and Gynecologists recommends.The practice advisory calls on doctors to.

Doctors 105

Doctors 105

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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

Agency IQ

APRIL 19, 2024

BY LAURA DIANGELO, MPH On April 14, FDA announced that its Center for Drug Evaluation and Research (CDER) is launching a new clinical trial innovation hub, the CDER Center for Clinical Trial Innovation (C3TI). The announcement includes a scope of projects for the initiative, with a particular focus on pragmatic trial elements, Bayesian analyses and selective safety data collection methods.

Clinical Trials 64

Clinical Trials Trials FDA Research 64

Drugs.com

APRIL 19, 2024

FRIDAY, April 19, 2024 -- Black and Hispanic patients with Alzheimer’s disease are greatly underrepresented in clinical trials, even though they’re more likely to get dementia than whites.However, racial discrimination may not be driving this.

Clinical Trials 104

Clinical Trials Trials Disease 104

Agency IQ

APRIL 19, 2024

BY WALKER LIVINGSTON, ESQ This week, the EPA published an update to its interim guidance on the available disposal and destruction technologies for PFAS-containing materials. This guidance provides valuable insight into the agency’s views on currently available technologies, as well as its plans to evaluate emerging technologies and address existing research gaps.

Research 59

Research 59

Drugs.com

APRIL 19, 2024

FRIDAY, April 19, 2024 -- A British study finds that beyond the physical pain and turmoil of an mpox diagnosis, many of the mostly gay and bisexual men infected during the 2022 outbreak faced stigma, homophobia and shame. Mpox is spread largely.

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101

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Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

Clinical Trials

Agency IQ

APRIL 19, 2024

BY AMANDA CONTI Last week, FDA’s Oncologic Drugs Advisory Committee (ODAC) voted unanimously in favor of using minimal residual disease (MRD) as an accelerated approval endpoint for multiple myeloma. Committee discussions noted the potential for earlier readout and faster completion of studies, with an expectation that the FDA will ultimately require follow-through with confirmatory trials.

FDA 59

FDA Disease Trials Drugs 59

Drugs.com

APRIL 19, 2024

MONDAY, April 22, 2024 -- Women who smoke and become pregnant may worry that the weight gain that comes with quitting might bring its own harms to themselves or their baby.However, a new study confirms the health benefits of quitting smoking still.

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59

Agency IQ

APRIL 19, 2024

BY KIRSTEN MESSMER, PHD, RAC The EMA has published a draft revision to its 2006 guideline on product development quality considerations for inhaled and nasal products. The revised document contains significant changes that reflect both scientific progress in the field and the experience gained from product applications and scientific advice sessions.

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Production 59

Drug Patent Watch

APRIL 19, 2024

Annual Drug Patent Expirations for XHANCE Xhance is a drug marketed by Optinose Us Inc and is included in one NDA. It is available from one supplier.

Drugs 59

Drugs Marketing 59

Agency IQ

APRIL 19, 2024

BY SCOTT STEPHENS, MPA The Health and Safety Executive (HSE) has launched a call for evidence to invite stakeholders to provide information on the UK REACH Annex XV dossier. The British regulator is currently working on a proposal to restrict per- and polyfluoroalkyl substances in firefighting foams. The U.K.’s official withdrawal from the European Union on February 1, 2020, started a year-long transition period.

Regulations 59

Regulations 59

Drug Patent Watch

APRIL 19, 2024

Annual Drug Patent Expirations for EVRYSDI Evrysdi is a drug marketed by Genentech Inc and is included in one NDA. It is available from one supplier.

Drugs 59

Drugs Marketing 59

Crucial Data Solutions

APRIL 19, 2024

The landscape of clinical research is undergoing a rapid digital transformation. Data can be collected in ways not imagined just. The post Build Better Studies Faster: 3 Advantages of Mobile eClinical Platforms appeared first on Crucial Data Solutions.

Clinical Research 52

Clinical Research Research Trials 52

Perficient: Drug Development

APRIL 19, 2024

Total Cost of Ownership (TCO) is a financial estimate that helps consumers and enterprise managers determine direct and indirect costs of a product or system. It goes beyond the initial purchase price to consider other costs involved in procurement, operations, and maintenance over the system’s life. In the B2B market, understanding TCO is crucial as it impacts the return on investment and ultimately the bottom line.

Marketing 52

Marketing Production Research 52

Fierce BioTech

APRIL 19, 2024

Designing Patient-Centered Endpoint in Rare Disease Trials Moving beyond standard endpoints in rare disease clinical trials has never been more crucial. In this ebook, we discuss 5 areas of meaningful, patient centered assessment that drive impactful results and are reshaping the landscape of rare disease research and improving the lives of patients. jpiatt Fri, 04/19/2024 - 13:20 To make every rare disease trial count, we design patient-centric, relevant strategies for sponsors and caregivers t

Trials 40

Trials Disease Clinical Trials Research 40

Agency IQ

APRIL 19, 2024

Meet C3TI, FDA’s new clinical trial innovation hub On April 14, FDA announced that its Center for Drug Evaluation and Research (CDER) is launching a new clinical trial innovation hub, the CDER Center for Clinical Trial Innovation (C3TI). The announcement includes a scope of projects for the initiative, with a particular focus on pragmatic trial elements, Bayesian analyses and selective safety data collection methods.

Clinical Trials 40

Clinical Trials Trials Science FDA 40

Drug Patent Watch

APRIL 19, 2024

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Drugs 78

Drugs Marketing 78

Agency IQ

APRIL 19, 2024

In updated PFAS disposal and destruction guidance, EPA evaluates existing and emerging technologies This week, the EPA published an update to its interim guidance on the available disposal and destruction technologies for PFAS-containing materials. This guidance provides valuable insight into the agency’s views on currently available technologies, as well as its plans to evaluate emerging technologies and address existing research gaps.

Treatment 40

Treatment Regulations Production Research 40

Drugs.com

APRIL 19, 2024

MONDAY, April 22, 2024 -- Women hoping to get pregnant sometimes wonder if there’s anything they can do to make it easier to conceive.Those questions might take on an added edge if a couple has been having unprotected sex for at least a year with.

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64

Agency IQ

APRIL 19, 2024

FDA advisors endorse minimal residual disease (MRD) as accelerated approval endpoint for multiple myeloma Last week, FDA’s Oncologic Drugs Advisory Committee (ODAC) voted unanimously in favor of using minimal residual disease (MRD) as an accelerated approval endpoint for multiple myeloma. Committee discussions noted the potential for earlier readout and faster completion of studies, with an expectation that the FDA will ultimately require follow-through with confirmatory trials.

FDA 40

FDA Disease Trials Clinical Trials 40

Agency IQ

APRIL 19, 2024

Draft guideline modernizes EMA recommendations on quality of inhaled, nasal products The EMA has published a draft revision to its 2006 guideline on product development quality considerations for inhaled and nasal products. The revised document contains significant changes that reflect both scientific progress in the field and the experience gained from product applications and scientific advice sessions.

Production 40

Production Pharmaceuticals Regulations Drugs 40