Sun.Nov 29, 2020

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COVID-19 studies should also focus on mucosal immunity, researchers argue

Scienmag

Credit: Douglas Levere/ University at Buffalo BUFFALO, N.Y. — Anyone who has undergone a nasal swab or saliva test for COVID-19 knows that the virus is most easily detected in the nose and mouth. That’s why, University at Buffalo researchers argue in a new paper, more COVID-19 studies should be devoted to how immunity emerges […].

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Clinical Catch-Up: November 23-27

BioSpace

As the U.S. went into its Thanksgiving holiday week, clinical trial news was quieter than usual, although there was a lot of important news on the COVID-19 vaccine front. Here’s a look.

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UofL researcher uses fruit for less toxic drug delivery

Scienmag

Suite of technologies now has commercial partner to bring them to market Credit: University of Louisville LOUISVILLE, Ky. — University of Louisville researchers have found a less toxic way to deliver medicines by using the natural lipids in plants, particularly grapefruit and ginger. The resulting intellectual property portfolio consisting of 12 patent families, invented by […].

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Sponsored | China’s Establishing Patent Linkage System More Favorable to Generic Drug Companies o.

BioSpace

The fourth Amendment of the China Patent Law has been deliberated and was passed on October 17, 2020. It will come into force on June 1, 2021. For the medical industry, China's proposed patent linkage system can be more favorable to generic drug companies than the U.S. system.

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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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Fast-moving gas flowing away from young star caused by icy comet vaporisation

Scienmag

Credit: Institute of Astronomy, University of Cambridge A unique stage of planetary system evolution has been imaged by astronomers, showing fast-moving carbon monoxide gas flowing away from a star system over 400 light years away, a discovery that provides an opportunity to study how our own solar system developed. Astronomers have detected fast-moving carbon monoxide […].

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FDA Action Alert: Y-mAbs, Vanda, Alnylam and BioCryst

The Pharma Data

grandbrothers/Shutterstock. The end of November and beginning of December is marked by several PDUFA dates at the U.S. Food and Drug Administration (FDA). Here’s a look. Y-mAbs Therapeutics Danyelza for Relapsed/Refractory High-Risk Neuroblastoma. Y-mAbs Therapeutics has a target action date of November 30 for its Biologics License Application (BLA) for Danyelza (naxitamab) for patients with relapsed/refractory high-risk neuroblastoma.

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Eisai and Wren Therapeutics Enter Into Research Collaboration Agreement for Drug Discovery for Synucleinopathies

The Pharma Data

Nov. 30, 2020 07:00 UTC. TOKYO & CAMBRIDGE, England–( BUSINESS WIRE )– Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Wren Therapeutics Ltd. (Headquarters: Cambridge, UK, “Wren”) today announced that the companies have entered into an exclusive research collaboration agreement aiming to advance the discovery of novel small molecules that target ?

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Measuring broken hearts: divorce has negative effects on physical and mental health

Scienmag

Study measures effects immediately after divorce and is the first to show that higher conflict levels predict worse mental health regardless of other factors Going through a divorce is extremely challenging and previous research has highlighted the adverse effects that it can have on divorcees. A recent study in open-access journal Frontiers in Psychology is […].

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Drugmakers Tap New Cell and Gene Therapies Through Acquisitions

The Pharma Data

It seems like every week another large biopharmaceutical company announces a new relationship with a cell and gene therapy (CGT)-focused company, if not an outright acquisition — often for stunning amounts. Source link.

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Vivoryon Therapeutics N.V.: Vivoryon Therapeutics AG Announces Conversion into Vivoryon Therapeutics N.V.

BioTech 365

DGAP-News: Vivoryon Therapeutics AG / Key word(s): Corporate Action 30.11.2020 / 07:00 The issuer is solely responsible for the content of this announcement. Vivoryon Therapeutics AG Announces Conversion into Vivoryon Therapeutics N.V.

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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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BioNTech and Fosun Pharma Begin Phase 2 COVID-19 Vaccine Trial in China

The Pharma Data

German drugmaker BioNTech and China’s Fosun Pharmaceutical Group have announced that the Pfizer/BioNTech COVID-19 vaccine candidate, BNT162b2, will be evaluated in a phase 2 study in China, building on an agreement the companies signed in March. Source link.

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Insights on the Iris Recognition Market 2020-2024: COVID-19 Analysis, Drivers, Restraints, Opportunities, and Threats – Technavio

BioTech 365

Insights on the Iris Recognition Market 2020-2024: COVID-19 Analysis, Drivers, Restraints, Opportunities, and Threats – Technavio Insights on the Iris Recognition Market 2020-2024: COVID-19 Analysis, Drivers, Restraints, Opportunities, and Threats – Technavio LONDON–(BUSINESS WIRE)–#GlobalIrisRecognitionMarket–The iris recognition market is expected to … Continue reading →

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AstraZeneca Likely to Start New Global COVID-19 Vaccine Trial to Verify Effectiveness | 2020-11-29

The Pharma Data

AstraZeneca’s COVID-19 vaccine candidate is facing another potential delay as the company plans to undertake a new global clinical trial to confirm the vaccine’s 90 percent efficacy based on a one-and-a-half-dose regimen. The additional trial of AZD1222 would seek to settle questions about the efficacy results that the company announced last Monday after a fortuitous dosing error revealed that a one-and-a-half-dose was significantly more effective than a double dose.

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PharmaSGP publishes Q3 Interim Statement 2020

BioTech 365

DGAP-News: PharmaSGP Holding SE / Key word(s): Quarterly / Interim Statement 30.11.2020 / 07:30 The issuer is solely responsible for the content of this announcement. PharmaSGP publishes Q3 Interim Statement 2020 – Group revenues raised by 6.2% to € 48.

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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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Later School Start Time, Fewer Migraines for Teens?

The Pharma Data

SUNDAY, Nov. 29, 2020 — Later school start times for teenagers might help those who struggle with migraines, a new study suggests. Starting school later in the morning could reduce the number of migraines each month for these students, the researchers said. The delayed start would be a nod to teens’ later-to-bed, later-to-rise body clocks. “Evidence suggests that there is a relationship between sleep and migraine,” said first author Dr.

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Sorrento to Participate in the 32nd Piper Sandler Healthcare Investor Conference

BioTech 365

Sorrento to Participate in the 32nd Piper Sandler Healthcare Investor Conference Sorrento to Participate in the 32nd Piper Sandler Healthcare Investor Conference SAN DIEGO, Nov. 29, 2020 (GLOBE NEWSWIRE) — Sorrento Therapeutics, Inc.

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Rhythm Receives FDA Approval for IMCIVREE in Certain Patients with Obesity

The Pharma Data

The FDA approval was based on results from the largest studies conducted to date in obesity associated with POMC, PCSK1 or LEPR deficiency. Source link.

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Telix Pharmaceuticals Limited Acquires TheraPharm GmbH, Broadening Reach to Hematologic Cancers and Transplant Medicine

BioTech 365

Telix Pharmaceuticals Limited Acquires TheraPharm GmbH, Broadening Reach to Hematologic Cancers and Transplant Medicine Telix Pharmaceuticals Limited Acquires TheraPharm GmbH, Broadening Reach to Hematologic Cancers and Transplant Medicine MELBOURNE, Australia and BAAR, Switzerland, Nov.

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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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HOOKIPA Announces Positive Phase 2 Interim Safety, Immunogenicity, and Efficacy Data for its Cytomegalovirus Vaccine Candidate HB-101

The Pharma Data

Early interim data show Cytomegalovirus (CMV)-negative kidney transplant recipients vaccinated with three doses of HB-101 had reduced incidence of CMV viremia, reduced antiviral use and no CMV disease. Observed CMV-neutralizing antibody responses and tolerability profile are consistent with previous interim results. CMV can cause severe complications in kidney transplant recipients including organ rejection and death. NEW YORK and VIENNA, Austria, Nov. 30, 2020 (GLOBE NEW

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Philips Patient Management Solution keeps patients safe and personalizes care during COVID-19 at leading U.S. medical centers

BioTech 365

Philips Patient Management Solution keeps patients safe and personalizes care during COVID-19 at leading U.S. medical centers Philips Patient Management Solution keeps patients safe and personalizes care during COVID-19 at leading U.S.

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Agilent Announces Launch of Global Biomarker Pathologist Training Program

The Pharma Data

Biomarker testing has profoundly influenced the practice of both pathology and oncology today. Targeted therapies have seen more than 30% increase from 2019, and more than 50% of targeted therapies currently in clinical trials are being co-developed with a predictive biomarker [1][2]. The Agilent Biomarker Pathologist Training Program will enable pathologists to gain confidence with scoring methodologies to enable the pursuit of the right treatment for patients. “We are excited to successf

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TeraRecon Awarded Landmark Patent for Diagnostic Imaging Clinical Reporting with AI

BioTech 365

TeraRecon Awarded Landmark Patent for Diagnostic Imaging Clinical Reporting with AI TeraRecon Awarded Landmark Patent for Diagnostic Imaging Clinical Reporting with AI New allowance includes continuous synchronization of AI findings between the image interpretation viewer, physician, and diagnostic report DURHAM, … 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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Sorrento to Participate in the 32nd Piper Sandler Healthcare Investor Conference

The Pharma Data

SAN DIEGO, Nov. 29, 2020 (GLOBE NEWSWIRE) — Sorrento Therapeutics, Inc. (NASDAQ: SRNE, “Sorrento”), is pleased to announce that Dr. Henry Ji, Chairman and CEO, will be participating in the Piper Sandler 32nd Annual Virtual Healthcare Conference. A pre-recorded presentation is made available to participants and the public, in addition to 1 on 1 virtual meetings with selected investors taking place between 11/30/20 and 12/03/20.

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Moderna Announces Amendment to Current Supply Agreement with United Kingdom Government for an Additional 2 Million Doses of mRNA Vaccine Against COVID-19 (mRNA-1273)

BioTech 365

Moderna Announces Amendment to Current Supply Agreement with United Kingdom Government for an Additional 2 Million Doses of mRNA Vaccine Against COVID-19 (mRNA-1273) Moderna Announces Amendment to Current Supply Agreement with United Kingdom Government for an Additional 2 Million Doses … Continue reading →

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Ascentage Pharma Enters into an Agreement with University of Michigan to obtain an exclusive license for a MDM2 Degrader using PROTAC Technology

The Pharma Data

SUZHOU, China and ROCKVILLE, Md. , Nov. 29, 2020 /PRNewswire/ — Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, today announced it has entered into an agreement with the University of Michigan , through which the company may obtain the exclusive global rights to a MDM2 protein degrader developed using the Proteolysis-Targeting Chimeras (PROTACs) techn

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GE Healthcare Expands AI, Digital and Imaging Solutions at #RSNA2020, Helping Shape Future of Healthcare in the COVID Era

BioTech 365

GE Healthcare Expands AI, Digital and Imaging Solutions at #RSNA2020, Helping Shape Future of Healthcare in the COVID Era GE Healthcare Expands AI, Digital and Imaging Solutions at #RSNA2020, Helping Shape Future of Healthcare in the COVID Era CHICAGO–(BUSINESS WIRE)–GE … 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.

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Gannex Appoints Former Takeda Head of Liver Disease Clinical Development Melissa Palmer, MD as Chief Medical Officer

The Pharma Data

SHANGHAI , Nov. 29 , 2020 /PRNewswire/ — Gannex, a wholly owned company of Ascletis Pharma Inc. (HKEX:1672) and fully dedicated to the R&D and commercialization of new drugs in the field of NASH, announced today that Melissa Palmer , MD, an internationally renowned Hepatologist, will join the Company as Chief Medical Officer, effective December 1, 2020.

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Which pharmaceutical drugs have the most drug patents in Denmark?

Drug Patent Watch

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

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Telix Pharmaceuticals Limited Acquires TheraPharm GmbH, Broadening Reach to Hematologic Cancers and Transplant Medicine

The Pharma Data

MELBOURNE, Australia and BAAR, Switzerland, Nov. 29, 2020 (GLOBE NEWSWIRE) — Telix Pharmaceuticals Limited (ASX: TLX, ‘Telix’, the ‘Company’) announces it has entered into an agreement with Scintec Diagnostics GmbH (‘Scintec’) to acquire TheraPharm GmbH (‘TheraPharm’), a Swiss-German biotechnology company developing innovative diagnostic and therapeutic solutions in the field of hematology.

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Top Emerging Therapies To Watch Out for in the Retinal Vein Occlusion Market

Delveinsight

Recent years started witnessing the emergence of novel treatment approaches that have been keeping the Retinal vein occlusion market in a hyped-up state. Looking at the potential of the pipeline therapies they hold once approved, pharmaceutical companies are charting out a seemingly exciting course in the market. Therapies such as dexamethasone drug delivery system and vascular endothelial growth factor inhibitors have already pierced deeper into the market.

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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.