Tue.Oct 20, 2020

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Coronavirus vaccine trial leader Larry Corey on the tough FDA, policy decisions to come

Bio Pharma Dive

The co-leader of an NIH network of coronavirus prevention studies spoke with BioPharma Dive about the FDA's big vaccine meeting this week and what will come next.

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Pharma still doesn’t understand transparency

World of DTC Marketing

As development towards a COVID-19 vaccine continue so do the number of people who have said they won’t get vaccinated. The only way to get people on board with a vaccination is complete transparency about the product yet both J&J and Pfizer remain silent. Pausing clinical trials for any drug is normal when a participant gets sick. There has to be a complete investigation as to why the patient suffered ill effects including the possibility that he/she had a known or unknown health condi

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Merck, with more study data, builds case for pneumonia vaccine successor

Bio Pharma Dive

Results from two Phase 3 studies showed Merck's candidate to be similarly immunogenic as Pfizer's Prevnar 13, lending additional strength to Merck's plans to ask for U.S. approval.

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COVID-19 biologics will put huge pressure on large-scale bioprocessing networks

Pharma Mirror

Tightening of bio-manufacturing capacity expected to occur after 2024, whilst Europe forecast to equal North America in total capacity Amsterdam: The third part of the 2020 CPhI Annual Report – released during the second week of the CPhI Festival of Pharma (5-16 October, 2020) – predicts, that if approved, COVID vaccines and therapeutics will cause an impending biomanufacturing capacity.

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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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With approval in sight, Vifor expands deal for partner's anti-itch drug

Bio Pharma Dive

The company could pay as much as $440 million through a new licensing pact that gives it more commercial rights to a therapy developed by Cara Therapeutics.

Licensing 139
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CPhI Worldwide to return in 2021: Milan venue to play host to global pharma

Pharma Mirror

2021 will bring global pharma community back together in person to drive business growth CPhI Worldwide (31 August – 2 September 2021) will be held next year in Milan (Fiera Milano) for the first time in over a decade – following its postponement in 2020. The event returns at an apt moment, as the pharma industry in. The post CPhI Worldwide to return in 2021: Milan venue to play host to global pharma appeared first on Pharma Mirror Magazine.

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Report: AstraZeneca Could Resume U.S. Arm of COVID-19 Vaccine Study This Week

BioSpace

The U.S. arm of the trial has been paused for more than a month while the U.S. Food and Drug Administration investigates a serious illness that occurred in a patient who received the experimental treatment.

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UK government signs contract for COVID-19 challenge trial

pharmaphorum

The UK government has signed a contract to develop a controversial COVID-19 human challenge trial, where participants will be deliberately infected in a controlled environment with coronavirus to test whether a vaccine is effective. Contract research organisation (CRO) hVIVO, a subsidiary of Open Orphan, has signed the contract with the UK government to develop the trial model.

Trials 98
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Does classroom indoor environmental quality affect teaching and learning?

Scienmag

Credit: Dr. Brink What impact does a classroom’s indoor environment have on teaching, learning, and students’ academic achievement in colleges and universities? This is the question researchers set out to answer in their analysis of all relevant published studies. In the analysis published in Indoor Air, the team looked at indoor air, thermal, acoustic, and […].

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UK lines up first human challenge study for COVID-19

BioPharma Reporter

The UK is set to begin COVID-19 human challenge trials in January: aiming to increase understanding of coronavirus and speed up development of vaccine candidates.

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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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Declines in shellfish species on rocky seashores match climate-driven changes

Scienmag

Two decades of data from a study of Maine’s Swan’s Island document a slow and steady dwindling of mussels, barnacles, and snails Credit: Jonathan A. D. Fisher The waters of the Gulf of Maine are warming faster than oceans almost anywhere on Earth. And as the level of carbon dioxide rises in the atmosphere, it’s […].

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Purdue Pharma Agrees to $8 Billion DOJ Settlement Over Opioid Marketing Practices

BioSpace

The settlement stems from multi-year criminal and civil investigations into Purdue’s marketing practices related to its powerful prescription painkiller, OxyContin, which critics have argued facilitated the opioid epidemic.

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The effects of wildfires and spruce beetle outbreaks on forest temperatures

Scienmag

Credit: Dr. Carlson Results from a study published in the Journal of Biogeography indicate that wildfires may play a role in accelerating climate-driven species changes in mountain forests by compounding regional warming trends. The study examined temperatures within forests in a region of Colorado that has experienced wildfires and spruce beetle outbreaks within the last […].

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New patent for Salix Pharms drug XIFAXAN

Drug Patent Watch

Annual Drug Patent Expirations for XIFAXAN Xifaxan is a drug marketed by Salix Pharms and is included in two NDAs. It is available from two suppliers. There are twenty-six patents…. The post New patent for Salix Pharms drug XIFAXAN appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 84
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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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Rethinking the link between cannabinoids and learning

Scienmag

Credit: Illustration by Rita FĂ©lix, PhD. Cannabinoids have a strong influence on how our brains work and how we behave. Many people are only aware of the recreational aspect of cannabinoids. But in fact these molecules naturally exist in our brains where they participate in various intrinsic processes. Altered cannabinoid signalling, for instance due to […].

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FDA accepts review for ANGLE’s Parsortix system for metastatic breast cancer

Pharma Times

System captures and harvests intact circulating tumour cells for analysis

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Oncotarget: Sirolimus-eluting stents — opposite in vitro effects on the clonogenic cell potential

Scienmag

The cover for issue 31 of Oncotarget features Figure 4, ‘Concentration dose-response curves of sirolimus effect [55 nM-1 nM] on the number of cells per surviving colony in U2OS cell line after 2 weeks exposure,’ by Vasuri, et al. Credit: Correspondence to – Gianandrea Pasquinelli – gianandr.pasquinelli@unibo.it The cover for issue 31 of Oncotarget features […].

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COVID-19 response makes NZ an appealing trial destination

Outsourcing Pharma

A leader from a New Zealand-based CRO talks about the countryâs handling of the pandemic, and how their low rates are making sponsors take notice.

Trials 83
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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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Stronger promotion of natural pest control in association with BioProtection Global

Scienmag

CABI BioProtection Portal welcomes BioProtection Global as an associate Credit: CABI The CABI BioProtection Portal – the ground-breaking online bioprotection resource, available on four continents – has strengthened its ability to promote the worldwide adoption of natural pest control by welcoming BioProtection Global (BPG) as an Associate.

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Aimmune’s peanut allergy med moves toward EU approval

Pharma Times

CHMP grants Palforzia a positive opinion for the treatment of peanut allergic patients

Allergies 100
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Final two journals in the 2020 pilot program use Subscribe to Open to publish volumes OA

Scienmag

The Annual Review of Environment and Resources and the Annual Review of Nuclear and Particle Science have been converted from gated to open access Credit: Annual Reviews Nonprofit publisher Annual Reviews is pleased to announce that the 2020 volumes of the Annual Review of Environment and Resources ([link] and the Annual Review of Nuclear and […].

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WuXi AppTec: think ahead when dual-filing IND applications

Outsourcing Pharma

A leader from the company advises planning ahead when filing investigational new drug applications to avoid wasting time, work and money later.

Drugs 78
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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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Conversation about suicide prevention leads to safe gun storage

Scienmag

Credit: Forefront Suicide Prevention/University of Washington Talking to people at gun shows about suicide prevention and the risks of unsecured firearms can lead to safe weapons storage, according to a new study. The research by Forefront Suicide Prevention at the University of Washington, from visits to 18 gun shows and other community events around Washington […].

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Antibody Treatments, Though Promising, Will Be in Short Supply

NY Times

All the weak points of American health care — testing delays, communication breakdowns, inequity — are working against this potential treatment.

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Mechanism linking gum disease to heart disease, other inflammatory conditions discovered

Scienmag

Researchers at the University of Toronto have found first evidence that neutrophil immune cell activity is the missing link connecting periodontal disease with heart disease, cancer, and other inflammatory conditions Credit: Noah Fine (TORONTO, ON) Oct. 20, 2020 — The link between periodontal (gum) disease and other inflammatory conditions such as heart disease and diabetes […].

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New patent expiration for Covis Pharma drug OMNARIS

Drug Patent Watch

Annual Drug Patent Expirations for OMNARIS Omnaris is a drug marketed by Covis Pharma Bv and is included in one NDA. It is available from one supplier. There are three…. The post New patent expiration for Covis Pharma drug OMNARIS appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 64
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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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New risk model estimates likelihood of death or hospitalization from COVID-19

Scienmag

A model that can calculate a person’s risk of becoming infected and then seriously ill due to COVID-19 has been shown to accurately estimate risk during the first wave of the pandemic in England, in new research funded by the National Institute for Health Research (NIHR). The model, developed using routine anonymised data from more […].

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SparingVision Nabs €44.5 Million to Support Gene Therapy, Adds New CEO

BioSpace

Paris-based SparingVision, a genomic medicine company focused on ocular diseases, raised €44.5 million (approximately $52.2 million) in a financing round.

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A CNIO team describes how a virus can cause diabetes

Scienmag

Credit: CNIO It has recently been described that infection by some enteroviruses – a genus of viruses that commonly cause diseases of varying severity – could potentially trigger diabetes, although its direct effect ‘in vivo’ as well as its mechanism of action at the molecular level were unknown. Now, a team of researchers from the […].

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New patent for Amarin Pharms drug VASCEPA

Drug Patent Watch

Annual Drug Patent Expirations for VASCEPA Vascepa is a drug marketed by Amarin Pharms and is included in one NDA. It is available from two suppliers. There are fifty-six patents…. The post New patent for Amarin Pharms drug VASCEPA appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 59
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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.