Sat.Aug 29, 2020 - Fri.Sep 04, 2020

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After a rare win, a biotech details long-awaited results for its ALS drug

Bio Pharma Dive

Data published Wednesday describe what one study investigator deems a milestone in the fight against ALS, a deadly and progressive neurological disorder.

Drugs 363
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Medical Device Innovation Summit: India is poised to be a manufacturing hub for medical equipments and devices

Pharma Mirror

The first digital session of Medical Device Innovation Summit concludes on a positive note with industry leaders addressing burning topics to promote innovation in the medical equipment industry. From challenges like lack of regulatory systems to its new found potential of manufacturing indigenous products on a large scale, the summit successfully addressed discussions on new.

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Accelerated Authorizations Using Surrogate Endpoints: Takeaways from DIA 2020

Camargo

Sponsors and regulators use surrogate endpoints to predict the long-term benefits of drug products that. The post Accelerated Authorizations Using Surrogate Endpoints: Takeaways from DIA 2020 appeared first on Camargo.

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Bradykinin Hypothesis of COVID-19 Offers Hope for Already-Approved Drugs

BioSpace

A group of researchers at Oak Ridge National Lab used the Summit supercomputer, the second-fastest in the world, to analyze data on more than 40,000 genes from 17,000 genetic samples related to COVID-19.

Genetics 144
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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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AstraZeneca, vowing it won't cut corners, begins large US study of coronavirus vaccine

Bio Pharma Dive

Amid reports the U.S. might fast-track AstraZeneca and the University of Oxford's experimental shot, the company pledged to "follow the science.

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10 reasons why virtual collaboration and medical education will persist in the new normal

pharmaphorum

While the effects of COVID-19 have been devastating for many industries, its positive impact on accelerating the uptake of digital health technologies and virtual collaboration solutions is undeniable. This has been a long time coming and there are countless reasons why I believe virtual collaboration and medical education are here to stay, long after there is a vaccine for COVID-19 and physical distancing guidelines have been lifted. 1.

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Could Bee Venom Be the Key to Treating Triple-Negative Breast Cancer?

BioSpace

A study published in the journal npj Precision Oncology on Sept. 1 featured data that suggested honeybee venom can potentially destroy triple-negative breast cancer and HER2-enriched breast cancer cells.

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Healthcare workers likely to be first in line for coronavirus vaccination

Bio Pharma Dive

Initial vaccine supplies will be limited. Advisory groups, most recently that of the National Academies, are developing plans to figure out who should get access first.

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MHRA publishes guidance on medicine regulation after Brexit

pharmaphorum

The UK’s medicines regulator has published long-awaited guidance on regulation of medicines and medical devices as the UK approaches the end of its Brexit transition period at the end of the year. This would see the UK mirroring decisions made by the European Medicines Agency, while also laying out a process should companies wish to file for a separate approval in the UK.

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Immunotherapies could target aggressive pancreatic cancer, research indicates

Pharma Times

Scientists have discovered that hard-to-treat pancreatic cancer hijacks a key immune system response

Research 137
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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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AstraZeneca Expands Phase III COVID-19 Vaccine Trial into the U.S.

BioSpace

The U.S. expansion will recruit up to 30,000 adults over the age of 18 years from a broad range of racial, ethnic and geographic groups who are healthy or have stable underlying medical conditions.

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Akebia stumbles and clouds the prospects of anemia pills

Bio Pharma Dive

The biotech's drug was found to be less safe than an injectable anemia medicine in a Phase 3 trial, dimming its potential approval chances.

Medicine 294
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Mobio closes $1.8m seed fund to develop meditation app

pharmaphorum

Digital health firm Mobio Interactive has closed a $1.8 million seed fund to advance development of its meditation app Am Mindfulness. Mobio said that the app, known as Am for short, is the first and only meditation app to outperform placebo in randomised controlled trials. MI’s Seed raise was led by the Singapore-based Verge HealthTech Fund along with Atlas Asset Management , Creative Ventures and VC giant SOSV.

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Janssen disappointed with second NICE no for Spravato

Pharma Times

NICE has concerns with the evidence submitted but Janssen insists the nasal spray is a cost-effective use of NHS resources

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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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Bionano Genomics Acquisition Adds a CLIA-Certified Lab to its Novel Technology Platform

BioSpace

When Bionano Genomics acquired Lineagen, Inc. in August, the genomic analysis company gained the final piece it needed to provide comprehensive structural variation detection for researchers and drug developers and a reimbursement pathway for clinicians who want to use its technology to replace c.

Genome 135
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AbbVie wagers up to $2B on a Chinese biotech's cancer drug

Bio Pharma Dive

The licensing deal hands AbbVie exclusive rights to a drug that targets CD47, a protein which has caught the attention of other large drugmakers like Gilead and Celgene.

Drugs 262
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GSK opens £10m AI hub in London

pharmaphorum

GlaxoSmithKline is opening a £10 million artificial intelligence (AI) research hub in King’s Cross, London, according to a press report. The area is being reimagined as a life sciences and technology hub and is already home to the Francis Crick Institute biomedical research organisation. King’s Cross is also home to Google’s DeepMind artificial intelligence company, which has already been involved in life sciences projects such as using the technology to predict acute kidney injury.

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Medtronic Introduces New Minimed 770G For Type 1 Diabetes

XTalks

A leader in the medical device sphere, Medtronic plc announced the release of a US Food and Drug Administration (FDA) approved device called the MiniMed 770G hybrid closed loop system. This is an insulin pump system that offers the company’s most advanced SmartGuard technology. The MiniMed 770G features technology from the MiniMed 670G but with added benefits of smartphone connectivity and an expanded age indication to include children as young as two years old.

Insulin 98
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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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Lessons From Bergamo: Halting the Complement Cascade May Stop COVID-19 in Its Tracks

BioSpace

Treatments for COVID-19 may be focusing on at the wrong elements of the disease, according to physicians analyzing results from Bergamo, Italy, the epicenter of the pandemic in Europe.

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Catalent, seeing rising demand, to expand Indiana production plant

Bio Pharma Dive

The planned $50 million infusion is the third investment in Catalent's Bloomington facility in two years, reflecting the need for vial filling for biologic drugs and vaccines.

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Sanofi/Regeneron’s Kevzara fails again in serious COVID-19 cases

pharmaphorum

Sanofi has drawn another blank in its attempt to repurpose its IL-6 drug Kevzara to tackle the extreme immune reaction seen in serious cases of COVID-19. The French pharma and development partner Regeneron have been testing Kevzara (sarilumab) in patients severely or critically ill and hospitalised with COVID-19. In severe cases of COVID-19, patients suffer a “cytokine storm” where the immune system becomes overstimulated and attacks the body.

Trials 109
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NAFLD & NASH Clinical Trials: Viking Therapeutics Reports Positive Phase II Trial Data

XTalks

At the Digital International Liver Congress 2020, which was held virtually from August 27 – 29, 2020, Viking Therapeutics, Inc. presented promising results from a 12-week Phase II study of its small molecule compound VK2809 in patients with non-alcoholic fatty liver disease (NAFLD) and elevated low-density lipoprotein cholesterol (LDL-C). The release of the data was presented as the flagship event for the annual meeting of the European Association for the Study of the Liver (EASL).

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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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Moncef Slaoui Will Quit Operation Warp Speed if Politics Plays Role in Vaccine Approval

BioSpace

When Moncef Slaoui was tapped to helm Operation Warp Speed, he sought confirmation that politics would not play a role in driving certain treatments through an approval process without the proper supporting scientific data to back it up.

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Vir, GSK push coronavirus antibody drug straight into mid-stage tests

Bio Pharma Dive

The two companies, chasing rival treatments from Eli Lilly, Regeneron and more, aim to produce their first study results by the end of the year.

Antibody 277
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Highlight Therapeutics trials second-line melanoma combo after immunotherapy fails

pharmaphorum

Cancer immunotherapy has set new standards in care, with some impressive responses in those patients lucky enough to respond. But many patients still do not respond to therapies such as Merck & Co’s anti PD-1 therapy Keytruda (pembrolizumab), or go on to develop progressive disease, and pharma companies are looking for new second-line therapies.

Trials 108
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Battling Depression In A World Of Isolation: Tips For Managing COVID Depression

Olympian Clinical Research

Depression affects millions of Americans each year, significantly decreasing their quality of life while placing them at heightened risk of suicidal thoughts. The tough thing about depression is that the disease is wildly indiscriminate, affecting patients of every age, gender, and ethnicity. For patients that struggle with depression, the disease can have devastating impacts both mentally, physically, and emotionally.

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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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Former FDA Commissioner Questions Hahn’s COVID-19 Vaccine Fast-Track Statement

BioSpace

On Sunday, U.S. Food and Drug Administration Commissioner Stephen Hahn told the Financial Times that he would potentially fast-track a COVID-19 vaccine before clinical trials are done if it was “appropriate.

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Nestlé buys the rest of Aimmune, aiming to boost a struggling peanut allergy treatment

Bio Pharma Dive

The Swiss firm will take over the launch of Aimmune's Palforzia, sales of which have disappointed since its approval in January.

Allergies 277
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Sanofi and GSK begin clinical trials of coronavirus vaccine

pharmaphorum

Sanofi and GlaxoSmithKline have begun clinical trials of their coronavirus vaccine, as AstraZeneca expanded studies of its rival into Japan. The French pharma in April joined forces with the UK’s GSK to produce the vaccine, with Sanofi contributing an antigen that produces the immune reaction. Meanwhile GSK is producing the booster that reduces the amount of active ingredient necessary to produce an effect.

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Rapper Master P Launches Black-Owned Replacements for Aunt Jemima And Uncle Ben’s

XTalks

Master P has launched a line of “Uncle P” food products to offer consumers a Black-owned alternative to brands that use Black names and imagery, but don’t often give back to Black communities. The New Orleans rapper and serial entrepreneur told CNN that he had always assumed brands like Aunt Jemima and Uncle Ben’s were Black-owned. It wasn’t until recently, when some brands began to be phased out for perpetuating harmful racial stereotypes, that he learned about their problematic histori

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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.