Sun.Nov 01, 2020

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Why are healthcare companies so silent?

World of DTC Marketing

THE SKINNY : President Trump’s repeated assertions the United States is “rounding the turn” on the novel coronavirus are proving to be untrue as new cases surge in Midwest states. “We’re in for a whole lot of hurt. It’s not a good situation,” Anthony S. Fauci, the country’s leading infectious-disease expert, said in a wide-ranging interview late Friday.

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How Hospital Emergency Rooms are Improving Care

Pharma Mirror

Accidents happen, people get sick, unexpected health issues pop up, problems occur when you least expect it – this is why there are emergency rooms and why millions of people go to them every year. Yet, visiting the emergency room can be very stressful and scary. You don’t know what is going to happen to. The post How Hospital Emergency Rooms are Improving Care appeared first on Pharma Mirror Magazine.

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Santhera Slashes Workforce in Half After Phase III DMD Failure

BioSpace

Santhera said the restructuring will allow the company to focus on the development of vamorolone, a first-in-class dissociative steroid with a novel mode of action that it gained the rights to from ReveraGen BioPharma.

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Outcomes of Contact Tracing in San Francisco, California—Test and Trace During Shelter-in-Place

JAMA Internal Medicine

This case series evaluates case investigation and contact tracing outcomes in San Francisco, California, during shelter-in-place restrictions during the COVID-19 pandemic.

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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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Algernon Pharmaceuticals Gets Go-Ahead for Phase 3 COVID-19 Study | 2020-11-02

The Pharma Data

Vancouver-based Algernon Pharmaceuticals plans to conduct a late-stage study to evaluate an orally delivered drug, NP-120 (ifenprodil), as a COVID-19 treatment. The drug was originally developed in the 1990s by Sanofi to treat peripheral circulatory disorders and it is still used in generic form in Japan. Participants in the phase 3 study will receive either standard of care, standard of care plus ifenprodil 60 mg or standard of care plus ifenprodil 120 mg.

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Sanofi Picks Up Kiadis and Its Immuno-Oncology Assets for $359 Million

BioSpace

Kiadis has three compounds in the clinic: K-NK002 in Phase II for HSCT in blood cancer; K-NK003 for relapsed or refractory acute myeloid leukemia (AML); K-NK-ID101 for COVID-19.

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More Trending

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Study: CureVac’s COVID-19 Vaccine Produces Immune Responses in Healthy Volunteers

BioSpace

Newly announced results of a Phase I dose-escalation study show CureVac’s COVID-19 vaccine candidate, CVnCoV, generates noticeable immune responses in healthy volunteers.

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Misuse and Neologisms in Clinical Communication

JAMA Internal Medicine

This essay discusses the prevalence of medical jargon and how clinicians can consciously avoid jargon and work to improve communication with patients and their families.

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Clinical Catch-Up: October 26-30

BioSpace

It was a particularly busy week for announcements about clinical trials, both related to COVID-19 and everything else. Here’s a look.

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Lidocaine patch for BACK PAIN – treatment review

Druggist

Lidocaine patch (brand name: Versatis medicated plaster) is a prescription-only medication, which has limited licensed use in the UK. Lidocaine patch offers a different approach to pain management as compared to standard analgesic drugs. In this post, I will review the use of lidocaine patch for back pain. The main points covered: What is lidocaine patch?

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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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Regeneron Hits Pause on LUMINA-1 Trial Due to Concerns with Garetosmab

BioSpace

Regeneron announced on Friday that it is pausing dosing of garetosmab (REGN2477), an investigational therapy, in the Phase I LUMINA-1 trial.

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Mission Therapeutics Appoints Dr Suhail Nurbhai as Chief Medical Officer

The Pharma Data

Nov. 2, 2020 08:00 UTC. CAMBRIDGE, England–( BUSINESS WIRE )– Mission Therapeutics (“Mission”), a drug discovery and development company focused on selectively inhibiting deubiquitylating enzymes (DUBs), has appointed Dr Suhail Nurbhai as Chief Medical Officer (CMO) with immediate effect. This press release features multimedia. View the full release here: [link].

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Perceptive Advisors Close on $1.1 Billion Credit Fund for Life Sciences Investments

BioSpace

The fund had an original target of $750 million, but was so enticing to investors that it hit its $1.1 billion hard cap.

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BD Receives Order from Dutch Ministry of Health for More than Nine Million 15-minute COVID-19 Antigen Tests

The Pharma Data

The first shipment of 1.2 million SARS-CoV-2 Assays for use on the BD Veritor Plus System to be delivered in The Netherlands by mid-November. THE HAGUE, NETHERLANDS and FRANKLIN LAKES, N.J. , Nov. 2, 2020 /PRNewswire/ — BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced the receipt of an order from the Dutch Ministry of Health for 9.2 million of its rapid, point-of-care, SARS-CoV-2 antigen tests for use on the BD Veritor Plus System

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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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Icosavax Turns VLP Tech to COVID-19 Vaccine, with $16.5 Million in New Financing

BioSpace

BioSpace caught up with Icosavax CEO Adam Simpson to discuss its new vaccine candidate, IVX-411.

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Regeneron Halts Enrollment of Severe Patients in COVID-19 Antibody Trial Following Possible Safety Signal | 2020-10-30

The Pharma Data

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators … and what their competitors are up to. Don’t waste your time on unending, unproductive online searches for news stories, reports and opinion; let DID’s experienced in-house editorial team do the work for you.

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PerkinElmer Expands Horizons with $383 Million CRISPR Tech Acquisition

BioSpace

Horizon Discovery Group brings new gene editing and gene modulation tools to PerkinElmer’s expanding life sciences portfolio.

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PwC Pharma & Life Sciences Webinar: Keep up to date with regulatory developments

Pharma Business Blog

Dear pharma & life sciences colleagues, As a tax/regulatory specialist within a pharmaceutical & life sciences company, you face complex sector-specific challenges each and every day. You have to do more with fewer resources and find efficient and pragmatic solutions in line with rapidly changing local legislation. Exchange and information are the current best practices in your industry which can support and inspire you in your daily business.

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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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Finality, finally:  Adir and Servier Canada Inc. confirm their perindopril win

Pharma in Brief

The 14 year perindopril litigation in Canada is over, with Adir and Servier Canada Inc. (collectively “ Servier ”) emerging victorious against Apotex Inc. and Apotex Pharmachem Inc. (collectively “ Apotex ”). The end was marked by the Supreme Court of Canada’s dismissal of Apotex’s application for leave to appeal a decision requiring it to disgorge its profits associated with infringement of Servier’s patent.

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Researchers discover mechanism that allows SINEUPs to amplify protein production

Scienmag

Scientists from an international group led by the RIKEN Center for Integrative Medical Sciences and Yokohama City University have discovered that a pair of proteins play a key role in allowing an important type of functional non-coding RNA, known as SINEUPs, to act to promote their target messenger RNA.SINEUPs are a recently discovered type of […].

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Hansa Biopharma Nomination Committee formed – Nov 02, 2020

The Pharma Data

LUND, Sweden , Nov. 2, 2020 /PRNewswire/ — Hansa Biopharma today announced that the Nomination Committee has been formed in accordance with the principles adopted by the Annual General Meeting (AGM) on June 23, 2020 and has the following composition: Natalie Berner representing Redmile Group. Thomas Olausson. Jannis Kitsakis representing AP4. Ulf Wiinberg, Chairman of the Board. The Chairman of the Board shall also summon the first meeting of the Nomination Co

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Neurosurgeons and malpractice suits

Scienmag

CHARLOTTESVILLE, VA (NOVEMBER 1, 2020). We live in a litigious world. With respect to medicine, this manifests in medical malpractice suits. Patients sue doctors for unexpected adverse outcomes. One field prone to litigation is neurosurgery, which “treats acute pathology and refractory pain.” Patient’s dissatisfaction with the outcomes of neurosurgical procedures sometimes shifts over into the […].

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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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Walgreens Boots Alliance and McKesson Complete the Formation of German Wholesale Joint Venture

The Pharma Data

Nov. 2, 2020 08:00 UTC. DEERFIELD, Ill. & IRVING, Texas–( BUSINESS WIRE )– Walgreens Boots Alliance (Nasdaq: WBA) and McKesson Corporation (NYSE: MCK) today announced the completion of their previously announced agreement to create a joint venture combining their respective pharmaceutical wholesale businesses in Germany, Alliance Healthcare Deutschland (AHD) and GEHE Pharma Handel (GEHE).

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Biomarker combination predicts kidney injury in critically ill children

Scienmag

Researchers at the University of Liverpool have identified a unique method of identifying the early signs of a potentially serious condition known as Acute Kidney Injury (AKI). The condition occurs commonly in critically ill children admitted to paediatric intensive care units often because of reduced blood supply to the kidneys (for example due to dehydration […].

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InnoCare Announces Clearance by the US FDA of Phase II Clinical Trial Using orelabrutinib for the Treatment of Multiple Sclerosis

The Pharma Data

Nov. 2, 2020 07:59 UTC. BEIJING–( BUSINESS WIRE )– InnoCare Pharma (HKEX: 09969), a clinical-stage biopharmaceutical company, announced today the Investigational New Drug (IND) clearance of its Bruton’s tyrosine kinase (BTK) inhibitor orelabrutinib by the US Food and Drug Administration (FDA) for starting phase II clinical investigations in multiple sclerosis (MS) in the United States.

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Intelligent cameras enhance human perception

Scienmag

FAU team develops cost-efficient and high-resolution multi-spectral camera Intelligent cameras are the next milestone in image and video processing A team of researchers at the Chair of Multimedia Communications and Signal Processing at Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU) has developed an intelligent camera that achieves not only high spatial and temporal but also spectral resolution.

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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.

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Telix Pharmaceuticals and China Grand Pharma Announce Strategic Licence and Commercial Partnership for Greater China Market

The Pharma Data

MELBOURNE, Australia and HONG KONG, Nov. 02, 2020 (GLOBE NEWSWIRE) — Telix Pharmaceuticals Limited (ASX: TLX, ‘Telix’, the ‘Company’) announces it has entered into a strategic licence and commercial partnership with China Grand Pharmaceutical and Healthcare Holdings Limited (‘China Grand Pharma’) for Telix’s portfolio of Molecularly-Targeted Radiation (‘MTR’) products.

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Masimo Announces Limited Market Release of Radius VSM™

BioTech 365

Versatile, Wearable Continuous Monitoring Solution Provides Masimo SET® Pulse Oximetry, Proprietary Noninvasive Blood Pressure, Body Temperature, Respiration Rate, and Electrocardiography NEUCHATEL, Switzerland–(BUSINESS WIRE)–Masimo (NASDAQ: MASI) announced today that Radius VSM™, a wearable, tetherless vital signs monitor, has received CE marking … Continue reading →

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Tiziana Announces Initiation of Clinical Trial with Covid-19 Patients in Brazil with Nasally Administered Foralumab, a Fully Human Anti-CD3 Monoclonal Antibody

The Pharma Data

Highly innovative first-in-class study for treating COVID-19 disease with nasally administered drug. Trial facilitated with coll a boration of Harvard Medical School and one of the world’s top Neurologist, Dr. Howard Weiner. Patent for p otentially revolutionary n asally a dministered d elivery system already filed. Clinical Data Expected by End of Year. Tiziana Life Sciences plc. (“Tiziana” or the “Company”).

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Dicerna Announces Updated Phase 1 Data on RG6346 Investigational Treatment for Chronic Hepatitis B Virus to be Presented in Late-Breaking Session at AASLD’s The Liver Meeting® Digital Experience™ 2020

BioTech 365

LEXINGTON, Mass.–(BUSINESS WIRE)–Dicerna Pharmaceuticals, Inc.

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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.