Sun.Nov 12, 2023

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First look at Verve study data offer base editing ‘proof of principle’

Bio Pharma Dive

Early clinical trial results are the first for a base editing treatment and show Verve’s therapy can substantially lower cholesterol levels by editing the genes of liver cells.

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FDA Approves Powerful New Drug to Counter Obesity Epidemic

AuroBlog - Aurous Healthcare Clinical Trials blog

The US Food and Drug Administration (FDA) on Wednesday announced it had approved Eli Lilly’s highly anticipated weight loss drug Zepbound, the latest entrant in a field of powerful – and lucrative – new obesity medicines.

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Companies Devise New Ways to Smuggle Drugs Across the Blood-Brain Barrier

BioSpace

To protect the central nervous system, the blood-brain barrier bars entry to around 98% of molecules—but approaches like Roche’s trontinemab could spell new hope in Alzheimer’s and beyond.

Drugs 110
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AI-Driven Strategies: Pharma’s Answer to Patent Expirations

Drug Patent Watch

In a recent article in Pharmaceutical Executive, Alan Kalton, Senior Vice President of Commercial Strategy at Aktana, sheds light on the critical challenges facing pharmaceutical companies as they confront impending… The post AI-Driven Strategies: Pharma’s Answer to Patent Expirations appeared first on DrugPatentWatch - Make Better Decisions.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Widening Gender Gap in Life Expectancy in the US

JAMA Internal Medicine

This cross-sectional study systematically examines the contributions of COVID-19 and other underlying causes of death to the widened gender life expectancy gap from 2010 to 2021.

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Novo Builds Wegovy’s Cardio Case with Much-Anticipated Data Drop

BioSpace

Novo Nordisk posted new data at AHA 2023 showing that its blockbuster weight loss drug could cut the risk of major cardiovascular events—including heart attack—across patient subgroups.

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More Trending

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Harnessing Social Media for Clinical Trial Recruitment

BioSpace

Harnessing Social Media for Clinical Trial Recruitment - read this article along with other careers information, tips and advice on BioSpace

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Need for AI Vigilance to Safeguard Health Care

JAMA Internal Medicine

This study examines whether artificial intelligence (AI) models can be manipulated for the generation of targeted health disinformation regarding vaccines and vaping.

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Verve’s Gene Editor Cuts Cholesterol in First-in-Human HeFH Trial

BioSpace

When given at potentially therapeutic doses, Verve’s base editor led to strong reductions in LDL cholesterol and PCSK9 levels in patients with heterozygous familial hypercholesterolemia.

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Spielberg’s Secret

JAMA Internal Medicine

This essay describes how a podcast inspired a physician’s new approach to complimenting patients and colleagues and the benefits gained.

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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FDA Action Alert: Pacira, CorMedix, Aldeyra and More

BioSpace

Over the next two weeks, the FDA is set to decide on New Drug Applications from Pacira, CorMedix and Aldeyra and hold an advisory committee meeting for two overdue confirmatory trials from Acrotech.

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AHA: Wegovy improves survival in outcomes trial

pharmaphorum

AHA: Wegovy improves survival in outcomes trial Phil.

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Lilly Notches Second Cholesterol Win with RNA Silencer

BioSpace

At its highest dose level of 608 mg, lepodisiran reduced lipoprotein(a) levels by a median of 94% after 48 weeks.

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New tentative approval for Rising drug acetylcysteine

Drug Patent Watch

Acetylcysteine is the generic ingredient in seven branded drugs marketed by Cumberland Pharms, Aspen, Eugia Pharma, Exela Pharma, Fresenius Kabi Usa, Indoco, Rising, Sagent Pharms Inc, Steriscience, Zydus Pharms, Alvogen,… The post New tentative approval for Rising drug acetylcysteine appeared first on DrugPatentWatch - Make Better Decisions.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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

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Aclaris’ Stock Crashes after Lead Asset Fails Mid-Stage Trial

BioSpace

Pennsylvania-based Aclaris Therapeutics will stop development of zunsemetinib after it failed to meet the primary endpoint in a Phase II study for rheumatoid arthritis.

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New patent expiration for Bayer Hlthcare drug SKYLA

Drug Patent Watch

Annual Drug Patent Expirations for SKYLA Skyla is a drug marketed by Bayer Hlthcare and is included in one NDA. It is available from one supplier. There are six patents… The post New patent expiration for Bayer Hlthcare drug SKYLA appeared first on DrugPatentWatch - Make Better Decisions.

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Novartis Enters into Deal with Legend Biotech for $100 Million Upfront

BioSpace

After success with J&J, Legend strikes another license agreement, this one with Swiss pharma Novartis around CAR-T therapies.

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New patent expiration for Bayer Hlthcare drug KYLEENA

Drug Patent Watch

Annual Drug Patent Expirations for KYLEENA Kyleena is a drug marketed by Bayer Hlthcare and is included in one NDA. It is available from one supplier. There are six patents… The post New patent expiration for Bayer Hlthcare drug KYLEENA appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 59
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The New Age of Decentralized Clinical Trials

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.

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Lilly, UCB-Backed ViaNautis Scores $25M for Genetic Nanomedicines

BioSpace

The UK-based nanomedicine biotech, previously known as SomaServe, has closed its Series A with some significant biopharma names attached.

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Drug Patent Expirations for the Week of November 12, 2023

Drug Patent Watch

AMRIX (cyclobenzaprine hydrochloride) Teva pharms intl Patent: 7,829,121 Expiration: Nov 14, 2023 See More … For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs, contact… The post Drug Patent Expirations for the Week of November 12, 2023 appeared first on DrugPatentWatch - Make Better Decisions.

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Cell & Gene Therapy Space Gears Up for First CRISPR Approval

BioSpace

As Vertex and CRISPR Therapeutics await the monumental potential approval of exa-cel, bluebird bio, Iovance and Rocket Pharmaceuticals wait patiently in the wings.

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Remembrance Day

Client Pharma

In honour of those who served and sacrificed, we pledge to keep their memory alive with gratitude and reverence. hashtag#RemembranceDay2023 hashtag#RemembranceDay hashtag#LestWeForget The post Remembrance Day appeared first on ClientPharma.

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Roles and Responsibilities of Specialized Clinical Supply Experts

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.

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Test New Investigational Hearing Devices and Get Paid

Trialfacts

Contents About the Study Why Participate? Your Rights Who Can Participate? More Study Details About the Research Center: Location Research Center: Sonova USA, Inc. Location: Sonova USA, Inc., 47257 Fremont Blvd, Fremont, CA 94538, United States Lead Researcher: Dr. Grace Gardner IRB Committee: This study has been reviewed and approved by the WCG Institutional Review Board About the Study Did you know that approximately 1 in 7 people living in the United States have hearing loss?

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Drug pricing: PMPRB releases scoping paper to consult on new Guidelines

Pharma in Brief

The Patented Medicine Prices Review Board ( PMPRB ) has released a scoping paper on themes and questions to develop new price review Guidelines. The scoping paper also includes information on how stakeholders can participate in the consultation. The deadline for written submissions addressing the scoping paper is December 20, 2023. Background The PMPRB has not had a full set of Guidelines since July 1, 2022, when amendments to the Patented Medicines Regulations came into force implementing a

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I Am Worried I Have Sciatica—What Do I Need to Know?

JAMA Internal Medicine

This JAMA Internal Medicine Patient Page reviews sciatica, its symptoms, and treatment options for those who have it.

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Which pharmaceutical companies have the most drug patents in Croatia?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most patents in Croatia. 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 Croatia? appeared first on DrugPatentWatch - Make Better Decisions.

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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.