Fri.Feb 23, 2024

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The latest c-level appointments in drug discovery

Drug Discovery World

Despite December usually being a slower time for recruitment, there has been a high number of senior moves within the drug discovery sector over the last three months. Shorla Oncology has appointed Rayna Sethi Herman as Chief Commercial Officer. Herman leaves a role as CCO at EVERSANA, and brings more than 30 years of expertise in commercialisation.

Drugs 148
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Isoliquiritigenin attenuates neuroinflammation after subarachnoid hemorrhage through inhibition of NF??B?mediated NLRP3 inflammasome activation

Chemical Biology and Drug Design

In the present work, we report that isoliquiritigenin, a bioactive component of licorice roots, attenuates neuroinflammation of a mice model with subarachnoid hemorrhage through inhibition of NF-κB-mediated NLRP3 inflammasome activation. This work suggests that isoliquiritigenin may ameliorate neurological injury of the patients with subarachnoid hemorrhage, as a kind of adjuvant therapy.

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This week in drug discovery (19-23 February) 

Drug Discovery World

News round-up for 19-23 February by DDW Digital Content Editor Diana Spencer. In a breakthrough for advanced therapies, this week saw the FDA approve the first ever cell therapy for solid tumour cancers, but there were other significant developments in the cell and gene therapy space. The top stories: Insulin independence without immunosuppression Preclinical data has demonstrated insulin independence following transplantation of hypoimmune (HIP) allogeneic primary islet cells without immunosupp

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Barriers against Antarctic ice melt disappearing at the double

Science Daily: Pharmacology News

Undersea anchors of ice that help prevent Antarctica's land ice from slipping into the ocean are shrinking at more than twice the rate compared with 50 years ago, research shows. More than a third of these frozen moorings, known as pinning points, have decreased in size since the turn of the century, experts say. Further deterioration of pinning points, which hold in place the floating ice sheets that fortify Antarctica's land ice, would accelerate the continent's contribution to rising sea leve

Research 120
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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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Combination therapy reduced risk of lung cancer progression by 38%

Drug Discovery World

The US Food and Drug Administration (FDA) has approved AstraZeneca’s osimertinib (Tagrisso) as a treatment for locally advanced or metastatic non-small cell lung cancer (la/mNSCLC). It is approved in combination with platinum-based chemotherapy for patients with la/mNSCLC whose tumours have EGFR exon 19 deletions or exon 21 L858R mutations. Efficacy was evaluated in the Phase III trial FLAURA2 in 557 patients with EGFR exon 19 deletion or exon 21 L858R mutation-positive la/mNSCLC and no prior sy

Therapies 130
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Florida Surgeon General Defies CDC Guidance Amid School Measles Outbreak

Drugs.com

FRIDAY, Feb. 23, 2024 -- Amid an outbreak of measles at a Florida elementary school, the state's surgeon general has defied federal health guidance and told parents it's up to them whether they want to keep their unvaccinated child home to avoid.

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1 in 3 Trans Masculine People Taking Testosterone Can Still Ovulate: Study

Drugs.com

FRIDAY, Feb. 23, 2024 -- A third of trans masculine people who have undergone testosterone therapy and have stopped menstruating are still ovulating, a new study suggests.That means they remain at risk for an unwanted pregnancy, despite the absence.

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BioMarin preaches patience amid slow sales for hemophilia gene therapy

BioPharma Drive: Drug Pricing

The company earned only $3.5 million last year from its Roctavian treatment, far below the $50 million to $150 million range it had forecast eight months ago.

Therapies 123
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Poll Shows Strong Support Among Black Voters for Menthols Ban

Drugs.com

FRIDAY, Feb. 23, 2024 -- Black voters support a ban on menthol cigarettes by a wide margin, refuting claims that such a ban would be strongly opposed by Black Americans, a new survey shows.Black voters support by a 37-point margin the menthol ban.

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Four Keys to Success for Retail and Specialty-Lite Hub Services

Drug Channels

Today’s guest post comes from Nicole Grycan, VP of Commercialization at Phil, Inc. Nicole discusses how hubs can improve access and adherence. She outlines four success factors for manufacturers that use a digital hub partner. To learn more, register for Phil's upcoming webinar: Improving Access, Coverage, and GTN with a Digital Hub. Read on for Nicole’s insights.

Drugs 98
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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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How to Keep the 'Ozempic Effect' Going: Exercise

Drugs.com

FRIDAY, Feb. 23, 2024 -- An open question for weight-loss drugs like Ozempic, Wegovy and Zepbound has been whether folks will keep the pounds off when they stop taking them.Regular exercise could be the key to quitting the drugs without regaining.

Drugs 111
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J&J secures EMA backing for earlier CAR-T use in multiple myeloma

BioPharma Drive: Drug Pricing

European drug regulators recommended clearing J&J and Legend Biotech's Carvykti for use as early as after first relapse, potentially giving the therapy an advantage over Bristol Myers’ Abecma.

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Will Your Knee Replacement Need a Second Surgery?

Drugs.com

FRIDAY, Feb. 23, 2024 -- Increasingly, knee replacement surgeries are requiring follow-up operations when post-op complications arise.Now, new research from the University of Texas Southwestern is illuminating whether you might fall into a.

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Almodóvar receives NIH grant to study pulmonary hypertension in HIV patients

SCIENMAG: Medicine & Health

Across the globe, more than 39 million people are living with the Human Immunodeficiency Virus (HIV), the virus that causes AIDS, including more than 1.3 million new HIV diagnoses last year.

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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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School Lockdown Drills Help Students Feel Safer: Study

Drugs.com

FRIDAY, Feb. 23, 2024 -- Lockdown drills have become a shudder-inducing part of American life, preparing kids to lie low and keep quiet if a gunman chooses to roam their school.But a new study finds these drills help children who’ve been exposed.

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New patent expiration for Baudax drug ANJESO

Drug Patent Watch

Annual Drug Patent Expirations for ANJESO Anjeso is a drug marketed by Baudax and is included in one NDA. There are seven patents protecting this drug. Drug patent litigation for… The post New patent expiration for Baudax drug ANJESO appeared first on DrugPatentWatch - Make Better Decisions.

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AI Outperforms Eye Docs in Managing Glaucoma

Drugs.com

FRIDAY, Feb. 23, 2024 (HealthDay news) -- Artificial intelligence can match and even outperform human eye doctors in diagnosing and treating glaucoma, a new study finds.The GPT-4 system from OpenAI did as well or better than ophthalmologists in.

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New patent for Kaleo Inc drug AUVI-Q

Drug Patent Watch

Annual Drug Patent Expirations for AUVI-Q Auvi-q is a drug marketed by Kaleo Inc and is included in one NDA. It is available from three suppliers. There are twenty-four patents… The post New patent for Kaleo Inc drug AUVI-Q appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 59
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Microplastics Found in Human Placentas

Drugs.com

FRIDAY, Feb. 23, 2024 -- Microscopic bits of plastic have been found lodged in tissues in much of the human body, and new research shows they are also infiltrating the placenta.All samples of placental tissue take from 62 women were shown to.

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New patent for Allergan drug AVYCAZ

Drug Patent Watch

Annual Drug Patent Expirations for AVYCAZ Avycaz is a drug marketed by Allergan and is included in one NDA. It is available from one supplier. There are seven patents protecting… The post New patent for Allergan drug AVYCAZ appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 59
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Young Workers' Injuries Rise After Recreational Marijuana Sales Made Legal

Drugs.com

FRIDAY, Feb. 23, 2024 -- After states legalize the sale of weed for recreational use, on-the-job injuries rise among younger workers, new research shows.U.S. Bureau of Labor statistics for 2006 through 2020 show that legal “recreational marijuana.

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Overdue EMA reflection paper on drug dosing in obesity introduces more questions than answers

Agency IQ

BY CHELSEY MCINTYRE, PHARMD Although the prevalence of overweight and obesity in Europe exceeds 50%, the EMA does not currently offer guidance to sponsors on investigating the effects of obesity during drug development. Last week, the agency finalized a reflection paper that has been available only in draft form for the past six years. The paper reaffirms the importance of obesity to drug disposition but offers little in the way of recommendations and guidance to sponsors.

Drugs 59
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Is a 'Universal' Snake Venom Antidote Near?

Drugs.com

FRIDAY, Feb. 23, 2024 -- A “universal” antivenom can block the lethal toxins in the venoms of a wide variety of poisonous snakes found in Africa, Asia and Australia, researchers report.The antibody protected mice from the normally deadly venom.

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EPA poised to strengthen chemical facility risk management program regulations

Agency IQ

BY WALKER LIVINGSTON, ESQ The Office of Information and Regulatory Affairs (OIRA) has completed its review of the Safer Communities by Chemical Accident Prevention rule that would amend some of the agency’s risk management program procedures for facilities to focus on protecting vulnerable communities. Under Section 112(r) of the Clean Air Act, the EPA must publish regulations and guidance regarding chemical accident protection at facilities nationwide.

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Food-Focused Toddlers at Higher Risk for Eating Disorders as Teens

Drugs.com

FRIDAY, Feb. 23, 2024 -- Toddlers who are really into their food might have a higher risk of developing an eating disorder once they enter adolescence, a new study shows.Kids ages 4 and 5 with a strong urge to eat when teased with tasty food appear.

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Workshop addresses oncology dose optimization across full span of development

Agency IQ

BY CHELSEY MCINTYRE, PHARMD , KARI OAKES In a series of broad-ranging, frank discussions, attendees at a joint FDA-American Association of Cancer Research (AACR) workshop worked through opportunities and challenges for dose optimization across the span of cancer drug development activities. On the first day, discussants looked at how to tackle first-in human trials, weighed the importance of the maximum tolerated dose, and looked at the evolving concept of the clinical utility index.

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The Evolution of Digital Patient Portals: Enhancing Healthcare Access and Engagement

Vial

In 2022, the global market value of patient portals within the clinical research and healthcare industries was estimated to be US $2.9 billion and is expected to climb at a compound annual growth rate (CAGR) of 19.44% between 2023 and 2030. A number of factors are contributing to this increase in popularity of digital patient portals, including the surge in telemedicine needs following the COVID-19 pandemic, technological advances enabling better integration of mobile-based health platforms, as

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Spurred by NRDC report, California senator proposes state ban on PFAS

Agency IQ

BY WALKER LIVINGSTON, ESQ California state Sen. NANCY SKINNER has updated a bill she introduced in early January 2024 to ban the sale of intentionally added PFAS in the state after 2030. Although the bill may receive state support, the actual implementation of the ban, if passed, would be a herculean task. Fill out the form to read the full article.

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Healthy Engagement in Autism Research Dialogue (HEARD)

Broad Institute

Healthy Engagement in Autism Research Dialogue (HEARD) By Rose Circeo February 23, 2024 Breadcrumb Home Healthy Engagement in Autism Research Dialogue (HEARD) There are currently a number of sensitive issues and concerns related to research, language usage and treatment of autistic individuals. This has led to disagreement and contention between groups within the autism community.

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Revised guidance on Covid-19 symptom assessment incorporates new knowledge, adds flexibility

Agency IQ

BY RACHEL COE, MSC This week, the FDA revised its guidance on assessing symptoms in outpatients in clinical trials for products intended to treat or prevent Covid-19. This update – the first since its initial publication in almost four years – reflects the significant gains in knowledge that have occurred in that timeframe. With this publication, the FDA has only one remaining Covid-19-related guidance document that still awaits revisions.

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Designing for All: The Power of a User-Centric Approach in Universal Design

Perficient: Drug Development

Universal design is not just about creating accessible spaces; it’s about crafting experiences that cater to the diverse needs of individuals. At the heart of this philosophy lies a user-centric approach—one that places the preferences, abilities, and feedback of users at the forefront of the design process. This blog post explores the transformative impact of adopting a user-centric approach in the pursuit of universal design.

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Formal FDA Meetings for Sponsors or Applications of PDUDA Products

thought leadership

Discover the different types of formal FDA meetings for sponsors and applications including what to expect at each of these FDA meeting types.

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Analysis Chemical Thank You Spurred by NRDC report, California senator proposes state ban on PFAS

Agency IQ

Spurred by NRDC report, California senator proposes state ban on PFAS California state Sen. NANCY SKINNER has updated a bill she introduced in early January 2024 to ban the sale of intentionally added PFAS in the state after 2030. Although the bill may receive state support, the actual implementation of the ban, if passed, would be a herculean task.

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Which pharmaceutical companies have the most drug patents in Mexico?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most patents in Mexico. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is… The post Which pharmaceutical companies have the most drug patents in Mexico? appeared first on DrugPatentWatch - Make Better Decisions.