Sat.Nov 04, 2023 - Fri.Nov 10, 2023

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Biopharma Has No Choice But To Comply With Price Controls

Forbes: Drug Truths

Medicare will save money but there will be fewer new medicines.

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Drug halves alcohol consumption to aid alcohol dependence

Drug Discovery World

Kinnov Therapeutics’ Phase II study for its lead compound KT-110 has shown that the treatment can halve alcohol consumption amongst heavy drinkers in three months. The trial showed that KT-110 has superior efficacy in significantly reducing alcohol consumption in heavy drinkers by 26 to 30 grams (2.6-3 drinks) per day compared to the placebo. This increased to 50 grams (five drinks) per day compared to the baseline measure at the start of treatment.

Drugs 265
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What if a CRISPR cure isn’t such an easy choice?

BioPharma Drive: Drug Pricing

A gene editing therapy developed by Vertex Pharmaceuticals and CRISPR Therapeutics can mute sickle cell disease’s most damaging symptoms. Yet treatment may not be as simple as its dramatic benefit makes it seem.

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A guide to clinical trial phases [infographic]

Antidote

Before any new treatment or therapy is able to be used by the patient population, it must go through the process of a clinical trial — this is the case for any new prescription drug, but also true for over-the-counter medications, medical devices, and more.

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How Machine Learning Drives Clinical Trial Efficiency

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.

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Designing cities for 21st-century weather

Science Daily: Pharmacology News

Researchers have investigated how changes in urban land and population will affect future populations' exposures to weather extremes under climate conditions at the end of the 21st century. They used a data-driven model to predict how urban areas across the country will grow by 2100, and found that how a city is laid out or organized spatially has the potential to reduce population exposures to future weather extremes.

Research 120
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Decoding diseases: The AI renaissance in clinical trials

Drug Discovery World

Deepika Khedekar , Associate Centralized Clinical Lead at IQVIA, explains how artificial intelligence could make clinical trials more accurate, accessible and standardised. Over 19 million 1 hearts succumb to cardiovascular disease yearly, while around 10 million 2 lives are claimed by cancer every year. To put this scale into perspective, these numbers surpass the combined population of the Netherlands, Hong Kong, and Singapore.

More Trending

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Bloodborne Pathogen Exposures Continue in Operating Room Settings

NIOSH Science Blog: Drugs

Despite legislation and improved technology, data from Massachusetts hospitals show that sharps injuries have increased in the operating room (OR) [1]. These injuries place healthcare workers at risk of exposure to bloodborne pathogens (BBPs). There is an urgent need to renew efforts to protect healthcare workers inside the operating room. The Massachusetts data highlight a gap and the need to establish a national surveillance program that would help hospitals develop further measures to prevent

Hospitals 114
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Lilly weight loss drug approved by FDA

BioPharma Drive: Drug Pricing

The pharmaceutical company will sell the GLP-1 drug, branded as Zepbound, at a list price about 20% lower than Novo Nordisk's competing drug Wegovy.

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Targeting advances in immunotherapies

Drug Discovery World

DDW Editor Reece Armstrong speaks to Christian Leisner , Chief Executive Officer of antibody therapeutics’ developer CDR-Life about methods to increase access to antigens and improving immunotherapy treatments. RA: Why are existing immunotherapies restricted to certain patient populations? CL: Immunotherapies, principally anti-PD-1/-L1 checkpoint inhibitors, have shown therapeutic benefit in improving the prognosis of patients but only in a select handful of solid cancers.

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Establishing a Composable Roadmap

Perficient: Drug Development

It’s no secret: the digital world is moving to composable. Moving from the traditional monolithic CMS model to composable does allow you to pick and choose “best in breed” products, but it can lead to confusion and uncertainty. How do you determine what the ideal mix is? When do you start to migrate to these tools? Here are three steps to establish a composable roadmap in your organization.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

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.

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Blood Clot Risk From Contraceptive Pills Ends Soon After Women Stop Taking Them

Drugs.com

FRIDAY, Nov. 10, 2023 -- Women and their doctors have long known that taking birth control pills can elevate the risk for a blood clot. Now, some good news: That added risk will disappear within a few weeks of stopping an oral contraceptive, a new.

Doctors 111
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The power of combinations in blood cancers

Drug Target Review

Advances in research and development and the utilisation of combination treatment strategies are revolutionising the haematology care landscape, but more must be done to address patients’ individual needs. There are more than 150 identified types of leukaemia’s, lymphomas and myelomas 1 and given that each blood cancer is unique, their heterogenous nature makes them some of the most challenging cancers to treat. 2 To redefine standards of care in haematology and close gaps to improve

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Podcast: In conversation with Isaac Klein, CSO of Dewpoint Therapeutics

Drug Discovery World

In the In Conversation With series, a part of the free DDW podcast, DDW speaks with members of the drug discovery industry about their work and how it helps turn science into business. In this episode, Megan Thomas is in conversation with Isaac Klein, Chief Scientific Officer of Dewpoint Therapeutics. Klein is a physician-scientist and medical oncologist.

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Maximizing Intellectual Property Value in the Biomedical Sector: A Case Study on Rucaparib Patents

Drug Patent Watch

A paper titled “Analysis of Strategy for Extending Patent Protection of Rucaparib” by Zhifeng Wang. discusses the strategies employed by pharmaceutical companies to extend the patent protection period of the… The post Maximizing Intellectual Property Value in the Biomedical Sector: A Case Study on Rucaparib Patents appeared first on DrugPatentWatch - Make Better Decisions.

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

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

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#ScienceSaturday: November 4, 2023

KIF1A

#ScienceSaturday posts share exciting scientific developments and educational resources with the KAND community. Each week, Dr. Dylan Verden of KIF1A.ORG summarizes newly published KIF1A-related research and highlights progress in rare disease research and therapeutic development. KIF1A-Related Research The epithelial Na + channel UNC-8 promotes an endocytic mechanism that recycles presynaptic components to new boutons in remodeling neurons Glossary : Synapses: The region where two neurons commu

Treatment 111
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Low-intensity fires reduce wildfire risk by 60%, according to study by Columbia and Stanford researchers

Science Daily: Pharmacology News

High-intensity, often catastrophic, wildfires have become increasingly frequent across the Western U.S. Researchers quantified the value of managed low-intensity burning to dramatically reduce the risk of such fires for years at a time.

Research 109
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Molecular photoswitch improves visual acuity in retinitis pigmentosa

Drug Discovery World

Topline results from a Phase I/II clinical trial have shown that Kiora’s light-restoring small molecule KIO-301 has the potential to meaningfully improve vision in patients with retinitis pigmentosa (RP). The results of the ABACUS study for Kiora’s intravitreal (IVT) molecular photoswitch were presented at the American Academy of Ophthalmology annual conference by Russell Van Gelder, Professor and Chair, Department of Ophthalmology, University of Washington, School of Medicine.

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An obesity drug biotech gets buy-in from Eli Lilly, venture firms

BioPharma Drive: Drug Pricing

Startup OrsoBio raised $60 million in a Series A round co-led by Longitude Capital and Enavate Sciences, and joined by the pharma’s venture arm.

Science 117
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Wegovy, Ozempic Probably Won't Harm Vision in People With Diabetes, Study Finds

Drugs.com

THURSDAY, Nov. 9, 2023 (HealthDay) -- There's good news for people with diabetes who are turning to drugs like Ozempic and Wegovy to treat their disease and lose weight: The drugs probably will not harm their vision. Semaglutide (the generic name.

Disease 105
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Using Rapid Development Environment in AEM as a Cloud Service

Perficient: Drug Development

There’s a new type of environment known as a Rapid Development Environment (RDE) with Adobe’s Cloud Service. This environment was specifically made with developers in mind to accelerate code deployments and other development activities in Cloud Service. We’ve had a chance to use the RDE to better understand its capabilities, strengths, and gaps. Pipelines in an AEMaaCS program are often executing and busy during high development activity, which is one of the main reasons for using an RDE.

Packaging 105
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This week in drug discovery (6-10 November) 

Drug Discovery World

News round-up for 6-10 November by DDW Digital Content Editor Diana Spencer. With the first DDW Turning Science into Business Summit taking place next week on the theme of Cancer Research, this dynamic area of drug discovery is my round-up focus again. Most significantly, this week has seen the UK approval of a new indication for anastrozole in the prevention of breast cancer and a number of significant findings in the field of immunotherapy announced at SITC 2023.

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New patent expiration for APIL drug ACTONEL

Drug Patent Watch

Annual Drug Patent Expirations for ACTONEL Actonel is a drug marketed by Apil and Warner Chilcott and is included in two NDAs. It is available from two suppliers. There are… The post New patent expiration for APIL drug ACTONEL appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 105
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Majority of Workers at America's Nursing Homes Unvaccinated Against Flu, COVID

Drugs.com

THURSDAY, Nov. 9, 2023 -- Health care workers at America’s nursing homes are woefully under-vaccinated for both flu and COVID-19, threatening their own health and that of the frail elderly patients under their care, a new report.

Nurses 105
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How to use Google to stay up to date with your medical condition

Antidote

The medical research industry is fast-moving. Despite the fact that the average clinical trial lasts about 10 years , new discoveries are happening all the time. However, keeping up with new developments can be a challenge.

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Latest advances in immunotherapy from SITC 2023

Drug Discovery World

The Society for Immunotherapy of Cancer’s (SITC) 38th Annual Meeting (SITC 2023) took place on 1-5 November 2023, at San Diego Convention Center in San Diego, US. CAN-2409 in non-metastatic pancreatic cancer Candel Therapeutics reported on initial positive interim data from its Phase II clinical trial of CAN-2409 that showed notable improvements in patients with borderline resectable pancreatic ductal adenorcarcinoma (PDAC).

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Lots of FDA Guidance, But Few Drug Manufacturing “Remote Interactive Evaluations” (We Would Call Them “Virtual Inspections”)

FDA Law Blog: Biosimilars

By Douglas B. Farquhar & Richard A. Lewis, Senior Regulatory Device & Biologics Expert — We were preparing this blogpost about FDA’s draft guidance on “Remote Interactive Evaluations” when we learned something. A phone call to FDA requested information about the number of Remote Interactive Evaluations (RIEs) that FDA has performed at drug manufacturing facilities since it announced in April 2021 that it would start using them as an alternative to on-site inspections.

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Marijuana Use Could Raise Odds for Heart Attack, Heart Failure

Drugs.com

MONDAY, Nov. 6, 2023 -- People who regularly smoke medical marijuana may be increasing their risk for a heart attack, heart failure or stroke, new research suggests. One study found that cannabis use among older patients increases the risk of heart.

Research 105
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Biogen, Sage set price of postpartum depression pill at $15,900

BioPharma Drive: Drug Pricing

The price is below what some analysts had predicted and significantly less than $34,000 Sage initially set for its earlier postpartum infusion, Zulresso.

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How to solve biological mysteries

Drug Discovery World

In the In Conversation With series, a part of the free DDW podcast, DDW speaks with members of the drug discovery industry about their work and how it helps turn science into business. In this episode, Megan Thomas is in conversation with Isaac Klein, Chief Scientific Officer of Dewpoint Therapeutics. Klein is a physician-scientist and medical oncologist.

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Greenland's glacier retreat rate has doubled over past two decades

Science Daily: Pharmacology News

A new study documents how Greenland's peripheral glaciers have changed from 1890 to 2022. Using satellite images and a unique archive of historical aerial photos, researchers documented changes in the lengths of more than 1,000 of the country's glaciers over the past 130 years. Although glaciers in Greenland have experienced retreat throughout the last century, the rate of their retreat has rapidly accelerated over the last two decades.

Research 108
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More U.S. Children Enter Foster Care in States With Abortion Restrictions

Drugs.com

TUESDAY, Nov. 7, 2023 -- When states have restrictive abortion laws in place, more children end up in foster care, new research finds. This happened even before the U.S. Supreme Court overturned Roe v. Wade in June 2022, the investigators.

Research 105
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The future of technology in pharmaceutical manufacturing

Fierce BioTech

In this interview, Charles Chase, PhD, the VP and Technical Business Development at Asymchem, a technology-focused pharmaceutical manufacturing company, discusses the significant impact of RNA vacc | Diversifying manufacturing and investing into emerging technologies improves cost effectiveness, reproducibility, and environmentally friendly processes.

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Phase I clinical trial validates qEEG biomarker in CNS disorders

Drug Discovery World

Gate Neurosciences has announced positive topline quantitative EEG (qEEG) biomarker and safety results from its Phase I multiple ascending dose study of apimostinel in healthy volunteers. The results demonstrated a dose-dependent increase in qEEG pharmacodynamic biomarkers of NMDA receptor target activation from baseline, compared with subjects who received placebo.

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A step closer to injection-free diabetes care: Innovation in insulin-producing cells

Science Daily: Pharmacology News

A team has developed a new step to improve the process for creating insulin-producing pancreatic cells from a patient's own stem cells, bringing the prospect of injection-free treatment closer for people with diabetes.

Treatment 107