Sun.Nov 14, 2021

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COVID Update: U.S. Exceeds 400 Million Vaccine Doses and Waning Efficacy

BioSpace

Between the numerous COVID-19 vaccines and several new antiviral drugs, it would appear that the tools to end the COVID-19 pandemic are within reach. Here’s a look at some of the top stories.

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New patent expiration for Novartis drug AMTURNIDE

Drug Patent Watch

Annual Drug Patent Expirations for AMTURNIDE Amturnide is a drug marketed by Novartis and is included in one NDA. There are two patents protecting this drug. This drug has one…. The post New patent expiration for Novartis drug AMTURNIDE appeared first on DrugPatentWatch - Make Better Decisions.

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Merck’s Anti-Cholesterol Drug Threatens Esperion, Other PCSK9 Inhibitor Makers

BioSpace

PCSK9 inhibitors have had trouble gaining tracking in the marketplace. Since about 2015, a number of companies have received approval for these drugs but struggled with sales.

Drugs 101
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Survey finds Americans still plan to be cautious during holiday celebrations

Scienmag

COLUMBUS, Ohio – With the holiday season here, and COVID-19 vaccines rolling out to millions of American children 5-11 years old, celebrations could look a little different this year compared to the scaled back or cancelled holiday plans in 2020. While experts say small gatherings for those who are vaccinated can be safe for the […].

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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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PhaseBio Reversal Agent Continues to Show Promise in Phase III

BioSpace

If bentracimab continues to yield the desired results through the rest of the Phase III study, PhaseBio will be on track to file a Biologics License Application in mid-2022.

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Atrial fibrillation and death are more common during the first year after breast cancer diagnosis

Scienmag

Women are significantly more likely to develop an abnormal and often rapid heart rhythm in the first year after being diagnosed with breast cancer than women without cancer, according to research published in the European Heart Journal. Credit: Credit European Heart Journal Women are significantly more likely to develop an abnormal and often rapid heart […].

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Mouse cell studies show that correcting DNA disorganization could aid diagnosis and treatment of rare inherited diseases

Scienmag

In a study with lab-grown mouse cells, Johns Hopkins Medicine researchers say they have found that a protein that helps form a structural network under the surface of the cell’s “command center” — its nucleus — is key to ensuring that DNA inside it remains orderly. The new experiments distinguish the role of the protein, […].

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Aulos’ Selective Antibody Surmounts Limits of Existing IL-2 Therapeutics, Mimetics

BioSpace

The investigational drug directs a patient’s own IL-2 toward immune activation while simultaneously preventing IL-2’s immune suppression activities.

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J&J finally decides to dismantle its diversified business model

pharmaphorum

After decades of a diversified healthcare business model, Johnson & Johnson has announced it plans to split off its consumer health division from its pharma and medical device operations. The move would create a new consumer health company within 18 to 24 months, according to J&J, which said it would unlock “significant value” whilst allowing the company to focus on its faster-growing prescriptionmedicine and medical device business.

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Seniors Bear Burden of Biogen’s Alzheimer’s Drug in Medicare Price Hike

BioSpace

Thanks partly to Biogen's pricey new Alzheimer's drug, Medicare enrollees will be burdened with higher monthly premiums for their Part B coverage.

Drugs 97
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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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Roche ranked as one of the top three most sustainable healthcare companies in the Dow Jones Sustainability Indices for the thirteenth year running

The Pharma Data

The ranking acknowledges Roche’s commitment to sustainability as an integral part of its business strategy Roche performed particularly well in Operational Eco-Efficiency, Environmental and Social Reporting. Roche (SIX: RO, ROG; OTCQX: RHHBY) has again been recognised as one of the most sustainable companies in the Pharmaceuticals index of the Dow Jones Sustainability Indices (DJSI).

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Flagship's Noubar Afeyan Aims to Answer Science’s ‘What if’ Questions

BioSpace

Flagship Pioneering Founder and CEO Noubar Afeyan has been behind the launch of dozens of companies, some of which, such as Moderna, have become a household name across the globe.

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“The Name’s Bond. James Bond.”: DOJ Requires Companies to Identify All Responsible Individuals

FDA Law Blog

By Anne K. Walsh & JP Ellison — It may be just a coincidence that DOJ released its latest policy pronouncement at the same time as the final “Daniel Craig as James Bond” movie. But like James Bond, companies in the crosshairs of a government investigation have No Time to Die, as they answer to shareholders and fight for corporate survival. In an October 28, 2021 Memorandum issued by Deputy Attorney General Lisa Monaco, DOJ announced that it is reverting to and reinforcing the Individual Ac

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Clinical Catch-Up: November 8-12

BioSpace

It was another busy week for clinical trial news. Here’s a look.

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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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New patent for Amarin Pharms drug VASCEPA

Drug Patent Watch

Annual Drug Patent Expirations for VASCEPA Vascepa is a drug marketed by Amarin Pharms and is included in one NDA. It is available from two suppliers. There are sixty-four patents…. The post New patent for Amarin Pharms drug VASCEPA appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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Association of Social Support With Functional Outcomes in Older Adults Who Live Alone

JAMA Internal Medicine

This cohort study assesses whether identifiable support buffers the vulnerability of a health shock in older adults who live alone.

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New patent for Glaxo Grp drug BREO ELLIPTA

Drug Patent Watch

Annual Drug Patent Expirations for BREO+ELLIPTA Breo Ellipta is a drug marketed by Glaxo Grp Ltd and is included in one NDA. It is available from two suppliers. There are…. The post New patent for Glaxo Grp drug BREO ELLIPTA appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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Valbiotis Announces Positive Preclinical Results for TOTUM•070 in Hypercholesterolemia, Selected and Presented at the American Heart Association (AHA) Annual Meeting

BioTech 365

Valbiotis Announces Positive Preclinical Results for TOTUM•070 in Hypercholesterolemia, Selected and Presented at the American Heart Association (AHA) Annual Meeting Valbiotis Announces Positive Preclinical Results for TOTUM•070 in Hypercholesterolemia, Selected and Presented at the American Heart Association (AHA) Annual Meeting … Continue reading →

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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 expiration for APIL drug ASACOL HD

Drug Patent Watch

Annual Drug Patent Expirations for ASACOL+HD Asacol Hd is a drug marketed by Apil and is included in one NDA. It is available from two suppliers. There are three patents…. The post New patent expiration for APIL drug ASACOL HD appeared first on DrugPatentWatch - Make Better Decisions.

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AIBODY Introduces World’s First Digital Human Organism at MEDICA 2021

BioTech 365

AIBODY Introduces World’s First Digital Human Organism at MEDICA 2021 AIBODY Introduces World’s First Digital Human Organism at MEDICA 2021 Cloud-based Platform Offers Lifelike, Immersive Simulations for Medical Education, Training, Research LONDON–(BUSINESS WIRE)–AIBODY, the world’s first Physiology-as-a-Service platform, today unveiled … Continue reading →

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New patent for Redhill drug TALICIA

Drug Patent Watch

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

Drugs 52
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New Study Finds That Use of Masimo SedLine® PSi and DSA May Significantly Reduce Postoperative Delirium

BioTech 365

New Study Finds That Use of Masimo SedLine® PSi and DSA May Significantly Reduce Postoperative Delirium New Study Finds That Use of Masimo SedLine® PSi and DSA May Significantly Reduce Postoperative Delirium NEUCHATEL, Switzerland–(BUSINESS WIRE)–Masimo (NASDAQ: MASI) today announced the … Continue reading →

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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.

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New patent for Abbvie Inc drug VENCLEXTA

Drug Patent Watch

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

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NOXXON Announces Convocation of an Extraordinary General Meeting of Shareholders

BioTech 365

NOXXON Announces Convocation of an Extraordinary General Meeting of Shareholders NOXXON Announces Convocation of an Extraordinary General Meeting of Shareholders Appointment of Bryan Jennings to the Board of Directors through the binding nomination of the Supervisory Board BERLIN–(BUSINESS WIRE)–Regulatory News: … Continue reading →

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New patent for Fresenius Kabi drug LEVOTHYROXINE SODIUM

Drug Patent Watch

Annual Drug Patent Expirations for LEVOTHYROXINE+SODIUM Levothyroxine Sodium is a drug marketed by Teva Pharms Usa Inc, Dr Reddys, Fresenius Kabi Usa, Maia Pharms Inc, Par Sterile Products, Piramal Critical,…. The post New patent for Fresenius Kabi drug LEVOTHYROXINE SODIUM appeared first on DrugPatentWatch - Make Better Decisions.

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Biophytis announces US centers to restart recruitment for the COVA phase 2-3 study with Sarconeos (BIO101) in COVID-19

BioTech 365

Biophytis / Key word(s): Miscellaneous Biophytis announces US centers to restart recruitment for the COVA phase 2-3 study with Sarconeos (BIO101) in COVID-19 15-Nov-2021 / 08:00 CET/CEST Biophytis announces US centers to restart recruitment for the COVA phase 2-3 study … Continue reading →

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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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New patent for Gilead Sciences drug EPCLUSA

Drug Patent Watch

Annual Drug Patent Expirations for EPCLUSA Epclusa is a drug marketed by Gilead Sciences Inc and is included in two NDAs. It is available from one supplier. There are fifteen…. The post New patent for Gilead Sciences drug EPCLUSA appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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89bio Presents New Data from Phase 1b/2a NASH Study Showing BIO89-100 Reduces Spleen Volume 

BioTech 365

89bio Presents New Data from Phase 1b/2a NASH Study Showing BIO89-100 Reduces Spleen Volume 89bio Presents New Data from Phase 1b/2a NASH Study Showing BIO89-100 Reduces Spleen Volume New sub-analysis presented at The Liver Meeting® 2021 shows treatment with BIO89-100 … Continue reading →

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Drug Patent Expirations for the Week of November 14, 2021

Drug Patent Watch

ASACOL HD (mesalamine) Apil Patent: 9,089,492 Expiration: Nov 15, 2021 See More … For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs, contact admin@DrugPatentWatch.com or…. The post Drug Patent Expirations for the Week of November 14, 2021 appeared first on DrugPatentWatch - Make Better Decisions.

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Late Breaking Presentation at American Heart Association Annual Meeting of Landmark Phase 3 Trial of Rexlemestrocel-L in Chronic Heart Failure

BioTech 365

Late Breaking Presentation at American Heart Association Annual Meeting of Landmark Phase 3 Trial of Rexlemestrocel-L in Chronic Heart Failure Late Breaking Presentation at American Heart Association Annual Meeting of Landmark Phase 3 Trial of Rexlemestrocel-L in Chronic Heart Failure … Continue reading →

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.