Sun.Jan 31, 2021

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As Virus Variants Spread, ‘No One Is Safe Until Everyone Is Safe’

NY Times

Rich countries are cornering the market on coronavirus vaccines, leaving poorer regions as potential breeding grounds for variants, like one found in South Africa, that could make vaccines less effective.

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Solving complex physics problems at lightning speed

Scienmag

Credit: Illustration: Andreas Ekström and Yen Strandqvist/Chalmers University of Technology A calculation so complex that it takes twenty years to complete on a powerful desktop computer can now be done in one hour on a regular laptop. Physicist Andreas Ekström at Chalmers University of Technology, together with international research colleagues, has designed a new method […].

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Time to Benefit of Statins for the Primary Prevention of Cardiovascular Events

JAMA Internal Medicine

This meta-analysis assesses randomized clinical trials of statins to determine the time to benefit for prevention of a first major adverse cardiovascular event in adults aged 50 to 75 years.

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Just add mushrooms: Making meals more nutritious

Scienmag

Understanding the nutritional impact of adding a serving of mushrooms on usual intakes and population nutrient adequacy using NHANES 2011-2016 data Credit: Mushroom Council February 1, 2021 – Researchers have identified another good reason to eat more mushrooms. New research , published in Food Science & Nutrition (January 2021) found that adding a mushroom serving […].

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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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Gilead and Gritstone Ink $785 Million+ Deal to Develop HIV Cure

BioSpace

Gilead Sciences has inked a collaboration, option and license deal with Gritstone Oncology to create a vaccine-based immunotherapy as a cure for HIV.

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The past, present, and possible future of the United Nations Environmental Program

Scienmag

Credit: The MIT Press The United Nations Environmental Programme (UNEP) was founded in 1972 as a nimble, fast, and flexible entity at the core of the UN system–a subsidiary body rather than a specialized agency. It was intended to be the world’s environmental conscience, an anchor institution that established norms and researched policy, leaving it […].

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Association of Physical Activity Intensity With Mortality

JAMA Internal Medicine

This cohort study uses data from the National Health Interview Survey to examine the association of the proportion of vigorous physical activity to total physical activity with all-cause mortality, cardiovascular disease mortality, and cancer mortality.

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Concert Pharmaceuticals Switches Focus After Schizophrenia Drug Falls Flat

BioSpace

Concert Pharmaceuticals said its Phase II clinical trial for its adjunctive schizophrenia treatment, CTP-692, did not meet the primary endpoint or other secondary endpoints, causing the company to halt development of the drug.

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Larger panel finds more gene mutations, treatment targets for leukemia

Scienmag

Credit: Kim Ratliff, Augusta University Photographer AUGUSTA, Ga. (Feb. 1, 2020) – A gene panel that looks for about 10 times the number of cancer-causing genes as panels currently used to diagnose and fine tune treatment for a variety of cancers is effective at identifying problematic genes in the most common leukemia, investigators report. The […].

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Merck's Keytruda Proves Better Alone in Combination Trial With BMS' Yervoy

BioSpace

Adding Yervoy to the therapy did not improve overall survival (OS) or progression-free survival (PFS) but did add toxicity to Keytruda monotherapy.

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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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Evotec CSO Cord Dohrmann Appointed to German Council of Science and Humanities

The Pharma Data

HAMBURG, GERMANY / ACCESSWIRE / February 1, 2021 / Evotec (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) today announced that Dr Cord Dohrmann has been appointed to the German Council of Science and Humanities (German: “Wissenschaftsrat”) for a term of three years. He is appointed by the Federal President Frank-Walter Steinmeier on the joint recommendation of the German Federal Government and the governments of the German states.

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Clover Bio Dumps GSK Adjuvant Technology, Will Take Dynavax to Vaccine Dance

BioSpace

China’s Clover Biopharmaceuticals is spurning GlaxoSmithKline’s adjuvant vaccine technology in favor of one created by California-based Dynavax Technologies.

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Premier Central New Jersey Group of Oncology Care Providers Forms Astera Cancer Care, Joins OneOncology

The Pharma Data

EAST BRUNSWICK , N.J. and NASHVILLE, Tenn. , Feb. 1, 2021 /PRNewswire/ — A group of 37 medical and radiation oncologists, along with a robust staff of cancer care providers, led by Drs. Bruno S. Fang and Edward J. Licitra , who currently comprise the “Central Jersey Division” of Regional Cancer Care Associates (RCCA), are forming Astera Cancer Care, an independent and physician-owned multi-specialty community oncology practice serving 12,000 new patients annually in Central New

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FDA Action Alert: Adamas, Mallinckrodt and Merck

BioSpace

February is kicking off with a number of PDUFA dates for the U.S. FDA as well as a cancer advisory committee meeting. 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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Virios Therapeutics, Inc. Announces Research Collaboration to Explore Role of HSV-1 in Irritable Bowel Syndrome

The Pharma Data

Feb. 1, 2021 12:05 UTC. ATLANTA–( BUSINESS WIRE )– Virios Therapeutics, Inc. (Nasdaq: VIRI), a biotechnology company focused on advancing novel antiviral therapies to treat diseases associated with a viral triggered abnormal immune response, announced today that it is entering a collaboration with Dr. Michael Camilleri of the Mayo Clinic to explore the role of antiviral therapy in managing Irritable Bowel Syndrome (IBS).

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Illumina Partners with Sequoia Capital for its 3rd Life Science Incubator, This One in China

BioSpace

Illumina, the world’s leading DNA sequencing and array-based technologies company, is partnering with Sequoia Capital China, an investment firm, to launch a life sciences incubator in China. It is dubbed the Sequoia Capital China Intelligent Healthcare Genomics Incubator, Powered by Illumina.

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Cardiovascular Systems, Inc. Announces Partnership With Chansu Vascular Techologies, LLC to Develop New Drug-Coated Balloon Technology

The Pharma Data

Feb. 1, 2021 12:00 UTC. ST. PAUL, Minn.–( BUSINESS WIRE )– Cardiovascular Systems, Inc. (CSI ® ) (NASDAQ: CSII) announced today that it has partnered with Chansu Vascular Technologies, LLC (CVT) to develop novel peripheral and coronary everolimus drug-coated balloons (DCBs). This partnership brings together CSI’s leadership in the treatment of calcified arterial lesions with Dr.

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Horizon Therapeutics Augments Rare Disease Portfolio with Viela Bio Buy

BioSpace

Shares of Viela Bio skyrocketed more than 52% in premarket trading after Ireland’s Horizon Therapeutics announced it was acquiring the company in a $3.05 billion deal.

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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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Indication Bioscience Granted First Patent for Statin Plus Cannabidiol (CBD) Combination

The Pharma Data

Feb. 1, 2021 12:16 UTC. Issuance of U.S. Patent US10835501B2 Begins Development of Indication BioSciences’ Intellectual Patent Portfolio for statin plus cannabinoid combination therapies. SILVERTHORNE, Colo.–( BUSINESS WIRE )– Indication BioScience, an early-stage pharmaceutical development company focused on identifying, developing, and commercializing innovative therapies to address unmet needs in cardiovascular health, today announced that the United States Patent and Trademark Of

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Cellino Raises $16 Million Seed Round for AI-Guided Cell Therapies

BioSpace

The round was led by The Engine, a venture capital firm born at Massachusetts Institute of Technology, and Khosla Ventures and joined by Humboldt Fund and 8VC.

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Nevro to Present at Citi’s 2021 Healthcare Services, Medtech, Tools, & HCIT Virtual Conference

The Pharma Data

. REDWOOD CITY, Calif. , Feb. 1, 2021 /PRNewswire/ — Nevro Corp (NYSE: NVRO), a global medical device company that is providing innovative, evidence-based solutions for the treatment of chronic pain, today announced that D. Keith Grossman , Nevro’s Chairman, CEO and President, will present at Citi’s 2021 Healthcare Services, Medtech, Tools, & HCIT Virtual Conference on Thursday, February 25, 2021 at 1:30 pm Eastern Time / 10:30 am Pacific Time. &#

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Invisalign Plano TX Orthodontics Dentist Updates Clear Aligners Invisible Braces

BioTech 365

Invisalign Plano TX Orthodontics Dentist Updates Clear Aligners Invisible Braces Invisalign Plano TX Orthodontics Dentist Updates Clear Aligners Invisible Braces Plano TX: Dental Renaissance’s Dr Kari Blankenship announces updated cosmetic dentist services including Invisalign clear aligners invisible braces for teeth … 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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Illumina and Sequoia Capital China Partner to Launch Genomics Incubator in China

The Pharma Data

Feb. 1, 2021 00:00 UTC. SAN DIEGO–( BUSINESS WIRE )– January 31, 2021— Illumina, Inc. (NASDAQ: ILMN), the global leader in DNA sequencing and array-based technologies, and Sequoia Capital China , a leading investment firm, today announced a collaboration to catalyze the startup ecosystem in China with the launch of the Sequoia Capital China Intelligent Healthcare Genomics Incubator, Powered by Illumina.

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Clinical Catch-Up: January 25-29

BioSpace

It was a busy week for clinical trial news. Read on for more information.

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GN Hearing: New ReSound Key Essential Hearing Aids Give More People Around the World Access to Great Hearing Care

The Pharma Data

Feb. 1, 2021 08:00 UTC. BALLERUP, Denmark–( BUSINESS WIRE )– GN Hearing , the global leader in hearing aid innovation, today unveils ReSound Key, a full essential hearing aid line-up that provides greater access to proven and award-winning hearing technology worldwide. Based on an advanced chip platform and GN’s Organic Hearing philosophy, ReSound Key promises clear, natural sound quality.

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Poor Performance of Masks Secured Using Ear Loops

JAMA Internal Medicine

To the Editor The Original Investigation by Sickbert-Bennett and colleagues provides much-needed data to help ensure that health care professionals caring for patients with respiratory viral illness are provided with an effective mask for respiratory protection. Importantly, their results may also provide insights that could guide future design of masks, especially in terms of how they are held in place on the user’s face.

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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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Clover Biopharmaceuticals Announces Publication of Phase 1 Clinical Trial Data for its Adjuvanted COVID-19 Vaccine Candidates in The Lancet

The Pharma Data

Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immune responses in a phase 1 trial. Clover plans to initiate a global phase 2/3 trial in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021. CHENGDU, China , Feb. 1, 2021 /PRNewswire/ — Clover Biopharmaceuticals (Clover), a global clinical-stage biotechnology company committed to developing tra

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Takeda Completes Sale of TachoSil® to Corza Health

BioTech 365

Takeda Completes Sale of TachoSil® to Corza Health Takeda Completes Sale of TachoSil® to Corza Health OSAKA, Japan–(BUSINESS WIRE)–Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that it has completed the previously announced sale of TachoSil® Fibrin Sealant Patch (“TachoSil®”) … Continue reading →

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Clover and Dynavax Announce Planned Global Phase 2/3 Efficacy Trial of Adjuvanted COVID-19 Vaccine Candidate

The Pharma Data

Clover plans to initiate a global Phase 2/3 efficacy trial of its protein-based S-Trimer COVID-19 vaccine candidate adjuvanted with Dynavax’s CpG 1018 plus alum in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021. The Coalition for Epidemic Preparedness Innovations (CEPI) continues to support Clover’s COVID-19 vaccine candidate and will fund its development through licensure. EMERYVILLE, Calif. and CHENGDU, China

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Bayer Receives Approval in the UK for Xarelto®? (rivaroxaban) to Treat Children With Venous Thromboembolism (VTE) and to Prevent VTE Recurrence

BioTech 365

Bayer Receives Approval in the UK for Xarelto®? (rivaroxaban) to Treat Children With Venous Thromboembolism (VTE) and to Prevent VTE Recurrence Bayer Receives Approval in the UK for Xarelto®?

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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.