Tue.Aug 25, 2020

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Sarepta, after two dramatic approvals, gets an FDA review for next Duchenne drug

Bio Pharma Dive

Sarepta's first two medicines were both cleared in controversial fashion. Will its third attempt go more smoothly?

Medicine 293
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Bayer strikes $98m deal with digital health firm One Drop

pharmaphorum

Bayer has taken a further stake in New York-based One Drop to support its plans to become a digital health business by developing new integrated care services for patients. The German pharmaceutical company will work with One Drop on digital health products that span multiple therapeutic areas, with Bayer citing oncology, cardiovascular diseases and women’s health as potential targets.

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AstraZeneca's coronavirus antibody drug cocktail begins human tests as rivals slip

Bio Pharma Dive

The British pharma has started a Phase 1 trial amidst reports that competing programs from Regeneron and Eli Lilly haven't met their projected timelines.

Antibody 201
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Virtual Trials and Technology Enablement

Cloudbyz

A virtual clinical trial, also known as a decentralized clinical trial, is comparatively a new method of conducting clinical trials virtually. In a true sense, a virtual clinical trial has no physical interaction during the entire process. Technology plays a major role in a virtual clinical trial. Different patient-facing technologies like wearables, electronic monitoring apps, online social engagement platforms, etc. are used extensively during a remote clinical trial.

Trials 77
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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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New data lead Ovid, Takeda to push seizure drug into final testing

Bio Pharma Dive

The partner companies found that, when tested in two types of rare epilepsy, their drug seems to perform better in one. But they see a path forward in both.

Drugs 141
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FDA Q&A: Your Pharmaceutical Manufacturing Inspection Questions Answered

XTalks

Business as usual is anything but in the COVID-19 era, but as the pharmaceutical and clinical trials industries adjust, the US Food and Drug Administration (FDA) has received an influx of questions regarding site inspections and manufacturing-related queries. To help address these concerns, the FDA has released a new guidance document with a Q&A for the industry.

More Trending

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Behind the scenes of the new ABPI Code of Practice

pharmaphorum

For over 60 years the ABPI Code of Practice has been key to the UK industry’s self-regulation, and now, as pharma is experiencing its most intense period of change in decades, a new update seeks to bring the Code in line with the modern sector. With the new Code now in its consultation stage, we spoke to ABPI president Haseeb Ahmad to find out more about the key changes.

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Lack of Customer Loyalty Troubles Food Delivery Services

XTalks

Everyone is fighting for a bigger piece of the food delivery service pie, and it doesn’t stop at simply delivering meals from restaurants. Now, food delivery services are incorporating new options, including delivering groceries from convenience stores and supermarkets. DoorDash, the largest US third-party delivery company for restaurants, has launched a new grocery service in an increasingly crowded market dominated by Instacart and Amazon Fresh.

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WHF partners with AZ to reduce burden of CV disease

Pharma Times

New initiatives will raise public awareness of the burden of heart failure to boost prevention, diagnosis and treatment

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Bavarian Nordic’s freeze-dried smallpox vaccine clears clinical test

BioPharma Reporter

Phase 3 trial of Bavarian Nordicâs freeze-dried smallpox vaccine hits primary endpoint, teeing biotech up to fulfill $299 million government contract.

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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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Three-dimensional quantum Hall effect and global picture of edge states in Weyl semimetals

Scienmag

Credit: International Center for Quantum Materials, Peking University Since Von Klitzing discovered the quantum Hall effect in a two-dimensional electron gas system in 1980, there has been theoretical work discussing how to quantize the Hall conductance in a three-dimensional system. In a three-dimensional system, electrons form Landau levels in the directions perpendicular to the magnetic […].

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Eversana partners on migraine treatment launch

Outsourcing Pharma

The company is joining with Zosano Pharma to aid the commercialization and distribution of Qtrypta, a transdermal migraine treatment candidate.

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A case for botanical gardens to lead in global plant crisis

Scienmag

New call for funding, advocacy for botanical gardens to lead efforts to avert plant extinction Credit: © The Morton Arboretum LISLE, Ill. (August 25) – The world is experiencing a sixth global mass extinction event, and a new paper advocates that botanical gardens are uniquely positioned to preserve the world’s plant diversity. In a paper […].

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Thread Research lands $50m infusion for decentralized trial tech

Outsourcing Pharma

The clinical research tech provider has received a capital commitment from healthcare industry investors to advance its decentralized trial solutions.

Trials 77
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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 tool for identifying endangered corals could aid conservation efforts

Scienmag

Credit: Iliana Baums, Penn State Coral conservation efforts could get a boost from a newly developed genotyping “chip”–the first of its kind for corals. The chip allows researchers to genetically identify corals and the symbiotic algae that live within the coral’s cells, a vital step for establishing and maintaining genetic diversity in reef restoration efforts. […].

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Original-Research: Epigenomics AG (von First Berlin Equity Research GmbH)

BioTech 365

Original-Research: Epigenomics AG - von First Berlin Equity Research GmbH Einstufung von First Berlin Equity Research GmbH zu Epigenomics AG Unternehmen: Epigenomics AG ISIN: DE000A11QW50 Anlass der Studie: Update Empfehlung: Kaufen seit: 25.08.

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How effective does a COVID-19 vaccine need to be to stop the pandemic?

Scienmag

This question as well as coronavirus-related discrimination, population vulnerability, anxiety, and depression are explored in recent articles in the American Journal of Preventive Medicine Credit: PHICOR Ann Arbor, August 25, 2020 – The American Journal of Preventive Medicine, published by Elsevier, is committed to publishing the most robust, evidence-based research and commentary on COVID-19 as […].

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Moderna scaling up ex-US COVID-19 vaccine capacity as EU deal nears

BioPharma Reporter

The European Commission concludes exploratory discussions with Moderna about deal for up to 160 million doses of COVID-19 vaccine.

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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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Enzyme prisons

Scienmag

Credit: Charlotte Konrad, MDC There are up to a hundred different receptors on the surface of each cell in the human body. The cell uses these receptors to receive extracellular signals, which it then transmits to its interior. Such signals arrive at the cell in various forms, including as sensory perceptions, neurotransmitters like dopamine, or […].

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WHF partners with AZ to reduce burden of CV disease

The Pharma Data

New initiatives will raise public awareness of the burden of heart failure to boost prevention, diagnosis and treatment. AstraZeneca is partnering with the World Heart Federation (WHF) to progress global action to prevent, control and reduce the burden of cardiovascular (CV) disease and its associated risks and complications. The move follows findings of The Heart Failure Gap Review , which revealed that over half (55%) of the general public were unable to identify a definition

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Researchers introduce new theory to calculate emissions liability

Scienmag

Credit: Michigan Tech A comparison of the results for conventional point source pollution and bottleneck carbon emissions sources shows that oil and natural gas pipelines are far more important than simple point-source emissions calculations would indicate. It also shifts the emissions liability towards the East Coast from the Midwest. Most surprisingly, the study found that […].

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Clinical research cut 87% at peak of pandemic

The Pharma Data

The model suggests that just 13% of full-time academics would have been available to carry out research during the height of the pandemic. At the peak of the COVID-19 pandemic, clinical research capacity may have been slashed by up to 87% in England, according to a new study led by UCL academics. The research, published on PLOS One , estimated that at a population infection rate of 10% – at the peak in April, for over a month – less than 400 of the 3,200 (13%) full-time clinica

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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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Working While Retired: What You Need to Know About Social Security

Triage Cancer

There are many reasons to continue or go back to work after you have retired: it can generate extra income, fulfill purpose, add structure to your day, create opportunities for socializing with coworkers, and sharpen valuable skills. Working can add to both your daily routine and to your retirement savings. However, the rules about working while receiving Social Security retirement benefits can be confusing.

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Bristol Myers Squibb Provides Update on Phase 3 IDHENTIFY Trial in Patients with Relapsed or Refractory Acute Myeloid Leukemia

The Pharma Data

PRINCETON, N.J.–( BUSINESS WIRE )– Bristol Myers Squibb (NYSE:BMY) today announced that the Phase 3 IDHENTIFY study evaluating IDHIFA ®. (enasidenib) plus best supportive care (BSC) versus conventional care regimens, which include best supportive care (BSC) only, azacitidine plus BSC, low-dose cytarabine plus BSC or intermediate-dose cytarabine plus BSC, did not meet the primary endpoint of overall survival (OS) in patients with relapsed or refractory acute myeloid leukemia (R/R AML)

Trials 52
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Veeva report highlights study start-up challenges

Outsourcing Pharma

The company has released a report revealing how clinical trial professionals are handling start-up, before and after COVID-19 first impacted the industry.

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Clinical Trial Budget Negotiations: A View from Each Side

Forte Research Systems®

Site recruitment is key to a clinical trial's success. This blog explores the impact budget negotiations has on study startup.

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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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Hydroxychloroquine reduces in-hospital COVID-19 mortality

Scienmag

An observational multi-center study, coordinated by the I.R.C.C.S. Neuromed, with the participation of 33 Italian hospitals, shows that the risk of death is 30% lower for coronavirus patients treated with hydroxychloroquine An Italian observational study contributes to the ongoing debate regarding the use of hydroxychloroquine in the current pandemic.

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4 Can’t-Miss Sessions at 2020 Virtual Fall Onsemble Conference

Forte Research Systems®

Our 2020 Virtual Fall Onsemble Conference is October 6-9. Thinking of attending? Check out these 4 can't-miss sessions.

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Rates of e-cigarette and marijuana use not associated with vaping-related lung injuries

Scienmag

Higher rates of e-cigarette and marijuana use in U.S. states did not result in more e-cigarette or vaping-related lung injuries (known as EVALI), a new study from the Yale School of Public Health finds. Published in the journal Addiction, the study estimates the relationship between states’ total reported EVALI cases per capita as of January […].

Drugs 42
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Global Ischemia Reperfusion Injury Therapeutics Market to Surpass US$ 2,290.1 Million by 2027, Says Coherent Market Insights (CMI)

BioTech 365

SEATTLE–(BUSINESS WIRE)–#HeartInjury–According to Coherent Market Insights, the global ischemia reperfusion injury therapeutics market is estimated to be valued at US$ 1,582.3 million by end of 2020 and is expected to exhibit a CAGR of 5.4% during the forecast period (2020-2027).

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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.