Sun.Apr 16, 2023

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Merck to buy inflammatory disease drugmaker Prometheus for $10.8B

Bio Pharma Dive

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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The improbable fame of a hijab-wearing teen rapper from a poor neighborhood in Mumbai

NPR Health - Shots

First Saniya wrote poems. Then she began rapping. Now she appears on TV and YouTube and before big crowds, spreading her message about justice. Her father the rickshaw driver is her chauffeur.

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Moderna, Merck data support claim of cancer vaccine’s promise

Bio Pharma Dive

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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Out-of-staters flocking to places where abortions are easier to get

NPR Health - Shots

States with strong abortion rights protections are seeing many more abortion seekers, mostly from neighboring states with abortion restrictions.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Adding new vaccine type to leading immunotherapy dramatically reduced melanoma recurrence

Medical Xpress

The combination of an experimental mRNA vaccine with an immunotherapy reduced the likelihood of melanoma recurring or causing death by 44% when compared to immunotherapy alone, a new clinical trial shows.

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Reformulated: New Takes on Parkinson’s Disease Treatments

BioSpace

Reformulated: New Takes on Parkinson’s Disease Treatments 4/17/2023

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When Oral Therapy Can Replace Intravenous Antibiotics

JAMA Internal Medicine

This essay describes a physician-patient’s experience with unchanged practice patterns despite the publication of new data challenging those patterns.

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Lung cancer outcomes significantly improved with immunotherapy-based treatment given before and after surgery

Medical Xpress

A regimen of pre-surgical immunotherapy and chemotherapy followed by post-surgical immunotherapy significantly improved event-free survival (EFS) and pathologic complete response (pCR) rates compared to chemotherapy alone for patients with operable non-small cell lung cancer (NSCLC), according to Phase III trial results presented today by researchers from The University of Texas MD Anderson Cancer Center at the American Association for Cancer Research (AACR) Annual Meeting 2023.

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Novel Estimates of Mortality Associated With Poverty in the US

JAMA Internal Medicine

This cohort study estimated association between poverty and mortality and quantified the proportion and number of deaths associated with poverty.

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Scientists identify compounds that reduce the harmful side effects of antibiotics on gut bacteria

Medical Xpress

Antibiotics help to fight bacterial infections, but they can also harm the helpful microbes living in the gut, which can have long-lasting health consequences.

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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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Abortion Pill to Remain Available After Supreme Court Stays Lower Court Ruling

BioSpace

Abortion Pill to Remain Available After Supreme Court Stays Lower Court Ruling 4/17/2023

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Detailed guidance on natural pacemaker method published today

Medical Xpress

An international consensus statement on the safest and most effective way to implant a pacing system that mimics the heart's normal function is published today in EP Europace, a journal of the European Society of Cardiology (ESC). The document is being launched at the EHRA Conduction System Pacing (CSP) Summit and will be discussed during EHRA 2023, a scientific congress of the ESC.

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AACR Weekend Roundup: Roche, AstraZeneca, Moderna, Merck and Affimed

BioSpace

AACR Weekend Roundup: Roche, AstraZeneca, Moderna, Merck and Affimed 4/17/2023

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Strep A infections among children surged in France across 2022, after nearly two-years of COVID-related low case numbers

Medical Xpress

New research from France shows that infections cause by Group A Streptococcus (GAS) fell by 80% as the first COVID lockdown took effect in March 2020 and stayed at low levels until March 2022, from which point they increased by 18% a month to rise well above pre-COVID levels.

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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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Sponsored: In mRNA Production, You Get Out What You Put In

BioSpace

Sponsored: In mRNA Production, You Get Out What You Put In 4/17/2023

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UK nurses prepared to strike until Christmas: union leader

Medical Xpress

Nurses in Britain are prepared to strike until Christmas if they cannot reach a deal with the government on pay, the leader of the country's main nursing union said on Sunday.

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New patent for Bayer Healthcare drug NUBEQA

Drug Patent Watch

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

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10 Reasons Why Your Site Needs a CTMS and Payments Solution for Clinical Trials

Cloudbyz

Clinical trials are complex and expensive endeavors that require meticulous planning, coordination, and execution. The success of a clinical trial depends on various factors, including effective communication, timely data collection and analysis, and accurate financial management. Clinical Trial Management Systems (CTMS) and payments solutions are software platforms designed to streamline the management and administration of clinical trials.

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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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New patent for Janssen Pharms drug INVOKAMET

Drug Patent Watch

Annual Drug Patent Expirations for INVOKAMET Invokamet is a drug marketed by Janssen Pharms and is included in two NDAs. It is available from one supplier. There are five patents… The post New patent for Janssen Pharms drug INVOKAMET appeared first on DrugPatentWatch - Make Better Decisions.

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Saving Costs and Improving Efficiency in Clinical Trials During Economic Recession: The Benefits of a Unified Management Platform

Cloudbyz

Clinical trials are crucial in advancing medical research and finding new treatments and cures for various diseases. However, the process of managing clinical trials is complex and time-consuming, requiring significant financial and human resources. The economic recession has had a significant impact on healthcare organizations, making it imperative to find ways to reduce costs while maintaining the quality of research.

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New patent for Nevakar Injectables drug NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE

Drug Patent Watch

Annual Drug Patent Expirations for NOREPINEPHRINE+BITARTRATE+IN+0.9%25+SODIUM+CHLORIDE Norepinephrine Bitartrate In 0.9% Sodium Chloride is a drug marketed by Inforlife and Nevakar Injectables and is included in two NDAs. It is available… The post New patent for Nevakar Injectables drug NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE appeared first on DrugPatentWatch - Make Better Decisions.

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Choosing the Best CTMS: A Guide to Selecting the Right Solution for Your Clinical Trials

Cloudbyz

Clinical trial management systems (CTMS) are software solutions designed to help manage clinical trials. They provide a range of tools for study management, including tracking patient recruitment, monitoring data, and managing study budgets. Choosing the right CTMS can be a challenging task, as there are many different solutions available. Here are some criteria to consider when choosing the top CTMS: Functionality and Features The first criteria to consider when choosing a CTMS is the functiona

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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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Personalised mRNA cancer vaccine prolongs survival in melanoma

Drug Discovery World

Personalised mRNA-based cancer vaccine mRNA-4157/V940, in combination with the immune checkpoint inhibitor pembrolizumab (Keytruda) improved recurrence-free survival (RFS) compared with pembrolizumab alone in patients with high-risk melanoma. The clinical benefit was observed regardless of the tumour mutational burden (TMB) status, according to results from the Phase IIb KEYNOTE-942 clinical trial presented at the AACR Annual Meeting 2023, held April 14-19.

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Top 2023 Neurodegenerative Readouts

BioSpace

Top 2023 Neurodegenerative Readouts 4/17/2023

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Results revealed for ‘practice-changing’ combination liver cancer therapy

Drug Discovery World

Adjuvant therapy with atezolizumab (Tecentriq) and bevacizumab (Avastin) increased recurrence-free survival of patients with hepatocellular carcinoma (HCC) following surgical resection or ablation, according to the results from a Phase III trial. The results of the IMbrave050 clinical trial were presented at the AACR Annual Meeting 2023, held April 14-19.

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10 Biopharma Companies Hiring AI/ML Talent Now

BioSpace

10 Biopharma Companies Hiring AI/ML Talent Now 4/17/2023

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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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Therapy represents ‘new treatment paradigm’ for non-small cell lung cancer

Drug Discovery World

Patients with treatment-naïve resectable non-small cell lung cancer (NSCLC) who received neoadjuvant durvalumab (Imfinzi) plus chemotherapy and adjuvant durvalumab monotherapy had improved event-free survival (EFS) and pathological complete response (pCR) compared with those who received neoadjuvant chemotherapy alone. The results from the Phase III placebo-controlled AEGEAN clinical trial were presented at the AACR Annual Meeting 2023, held April 14-19.

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Merck Leans into Immunology with $10.8B Prometheus Buy

BioSpace

Merck Leans into Immunology with $10.

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Adding an immune checkpoint inhibitor improved survival in rare cancer

Drug Discovery World

The addition of pembrolizumab (Keytruda) to gemcitabine and cisplatin improved overall survival in patients with untreated metastatic or unresectable biliary tract cancer, according to results from the Phase III KEYNOTE-966 clinical trial. The results were presented at the AACR Annual Meeting 2023, held April 14-19 and published in The Lancet. Biliary tract cancers are rare malignancies arising in the gallbladder, bile ducts, and the ampulla of Vater and are associated with poor patient outcomes

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Drug Patent Expirations for the Week of April 16, 2023

Drug Patent Watch

TESTIM (testosterone) Auxilium pharms llc Patent: 7,608,610 Expiration: Apr 21, 2023 See More … For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs, contact admin@DrugPatentWatch.com… The post Drug Patent Expirations for the Week of April 16, 2023 appeared first on DrugPatentWatch - Make Better Decisions.

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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.