Thu.Oct 08, 2020

article thumbnail

Moderna says it won't enforce coronavirus vaccine patents during pandemic

Bio Pharma Dive

The biotech, a frontrunner in the coronavirus vaccine race, said it won't tie up resources defending the intellectual property covering its experimental shot as long as the pandemic continues.

article thumbnail

“Get the First Inch Right”: Oncology Combination Product First-in-class Treatment Success Story

Camargo

Throughout the life-cycle of a drug development program, sponsors are confronted with a range of key questions. They must decide on the correct…. Regulatory pathway, FDA center, Key Opinion Leaders (KOLs), Target Product Profile (TPP) inclusions, Data to rely on, Studies to conduct, Indication and patient population, Commercial strategy, and much more.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Pharmacquired: Splashy deals belie a shallow pool of heart drugs left to acquire

Bio Pharma Dive

Recent deals for MyoKardia and The Medicines Co. may be hard to follow, since venture investors and big pharma acquirers have largely ignored cardiovascular drugs.

Drugs 361
article thumbnail

Clinical trials have ‘much work to do’ in boosting diversity

Outsourcing Pharma

A veteran with more than 20 years of experience talks about the vitality of recruiting an inclusive patient population, and the perils of falling short.

article thumbnail

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

article thumbnail

Regeneron follows Lilly in asking for emergency approval of COVID-19 antibody drug

Bio Pharma Dive

The two antibody treatments are now being reviewed by the FDA, although limited supply could mean their impact won't be felt for months, even if they are cleared for use.

Antibody 300
article thumbnail

Pharma’s response to COVID: GSK

pharmaphorum

A few months into the pandemic, the world is now moving beyond managing the crisis, with more focus on addressing the collateral damages and shaping the future. As part of a new series looking at how pharma has responded to the pandemic, Neale Belson, SVP UK & Ireland and general manager for the UK at GSK, tells us that it is “absolutely critical” to do this with the pace and out-of-the box thinking of the past months.

More Trending

article thumbnail

Trump’s Covid Treatments Were Tested in Cells Derived From Fetal Tissue

NY Times

The “cell lines” used to develop monoclonal antibodies, as well as remdesivir and vaccines, began with fetal tissue decades ago.

Antibody 126
article thumbnail

EU stocks up on coronavirus vaccine, drug supplies with J&J, Gilead deals

Bio Pharma Dive

Agreements with J&J and Gilead will help the EU catch up with the U.S. and the U.K. in securing advance stores of in-demand treatments.

article thumbnail

Lansoprazole vs Omeprazole: differences and similarities

Druggist

In today’s post, I will contrast the two most popular proton pump inhibitors (PPIs) prescribed in the UK. Not only lansoprazole and omeprazole are the two most common PPI, but they are also one of the most popular prescribed drugs in the UK. I will review the essential facts to highlight the similarity and difference between each medication. Lansoprazole vs omeprazole – post summary: Lansoprazole vs omeprazole: drug classification Lansoprazole vs omeprazole: mechanism of action Lansoprazol

article thumbnail

Bigfinite Rebrands as Aizon and Expands AI Expertise

XTalks

Bigfinite, Inc., an industry-leading AI and machine learning company that caters to the pharma and biotech sectors, recently announced that it has changed its corporate name to Aizon as of October 5, 2020. According to a press release from the company, the change “highlights Aizon’s expertise in providing cutting-edge artificial intelligence (AI) and machine learning (ML) capabilities and reflects the expansion of the company mission to serve additional regulated industries including animal heal

article thumbnail

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.

article thumbnail

Lilly asks FDA for emergency clearance for COVID-19 antibody therapy

pharmaphorum

Eli Lilly has asked the FDA for an Emergency Use Authorization for its COVID-19 antibody therapy, after announcing new efficacy data from an ongoing trial. It’s been a big week for this class of therapies – Regeneron’s antibody cocktail was famously used to treat president Donald Trump’s illness and GlaxoSmithKline is expanding research into its rival.

article thumbnail

Study describes COVID-19 transmission pattern

Scienmag

Model developed by Brazilian researchers predicts spatial and temporal evolution of epidemic diseases and can help plan more effective social isolation programs with less socio-economic impact. Credit: Airton Deppman By José Tadeu Arantes | Agência FAPESP – The most widely used model to describe the epidemic evolution of a disease over time is called SIR, […].

article thumbnail

ABPI calls on UK government to create non-COVID clinical research strategy

Pharma Times

New report finds UK is leading on early-stage clinical trials but needs strategy to restart non-COVID research

article thumbnail

Johnson & Johnson to supply EU with up to 400 million COVID-19 vaccine doses

BioPharma Reporter

A contract between the EU and Janssen Pharmaceutica NV will see Janssen supply 200 million doses of a COVID-19 vaccine, with the potential for an additional 200 million doses.

article thumbnail

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.

article thumbnail

Development of cost-efficient electrocatalyst for hydrogen production

Scienmag

Development of a highly efficient and durable electrocatalyst for water electrolysis that will lead to cost-efficient hydrogen production. Trace amounts of titanium doping on low-cost molybdenum phosphide resulting in modified electronic structure with gr Credit: Korea Institue of Science and Technology(KIST) The key to promoting the hydrogen economy represented by hydrogen vehicles is to produce […].

article thumbnail

Gilead inks supply agreement with the European Commission for remdesivir

Pharma Times

New agreement allows countries in the EU, EEA and the UK to purchase drug

Drugs 129
article thumbnail

UK early years sector needs new strategy to recruit and support male staff, says study

Scienmag

The UK’s early years sector — staffed 96% by women and facing a longstanding recruitment crisis – needs a radical new strategy to gender-diversify its workforce, according to a new report by Lancaster University, published today Credit: GenderEYE project The UK’s early years sector – staffed 96% by women and facing a longstanding recruitment crisis […].

92
article thumbnail

4 Biotech IPOs this Week: Kronos, Shattuck, Spruce and Aziyo

BioSpace

It’s been a fairly busy week for biotech initial public offerings (IPOs) with four announcing their list pricing. Here’s a look.

111
111
article thumbnail

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.

article thumbnail

Bacterial cellulose degradation system could give boost to biofuels production

Scienmag

Credit: NINS/IMS Efforts to find ways to break down cellulose, the tough stuff that makes up plant cell walls, faster and more productively has long been a goal of industrial researchers. When plants are processed into biofuels or other biomass applications, cellulose has to be degraded into simpler sugar molecules first, and this step can […].

article thumbnail

EU Faces Remdesivir Shortages Amidst Sharp Spikes in New COVID-19 Cases

BioSpace

Supplies of remdesivir are running out across Europe, leading to rationing and reliance on the generic drug, dexamethasone. The UK rationed its supplies of remdesivir Tuesday in the face of rising demands.

article thumbnail

Oncotarget: Exosomes secreted under hypoxia enhance stemness in Ewing’s sarcoma

Scienmag

The cover for issue 40 of Oncotarget features Figure 5, ‘miR-210 silences the proapoptosis member CASP8AP2,’ by Kling, et al. which reported that hypoxic Ewing’s sarcoma cells release exosomes that promote sphere formation, a stem-like phenotype, in EWS Credit: Correspondence to – Shantaram S. Joshi – ssjoshi@unmc.edu The cover for issue 40 of Oncotarget features […].

article thumbnail

Global Trial Launches to Test Remdesivir with hIVIG in COVID-19

BioSpace

The U.S. National Institutes of Health (NIH) is launching a clinical trial of a combination of Gilead Sciences’ antiviral drug remdesivir (Vitrakvy) and hyperimmune intravenous immunoglobulin (hIVIG).

Trials 100
article thumbnail

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.

article thumbnail

Juan Enriquez’s “Right/Wrong”

Scienmag

New book analyzes how technology transforms our ethics Credit: The MIT PRESS, 2020. “This book will make you uncomfortable and it will make you think,” writes John Palfrey, President of the John D. and Catherine T. MacArthur Foundation, of Juan Enriquez’s Right/Wrong: How Technology Transforms Our Ethics (on sale 10/13/20 from The MIT PRESS).

Sales 84
article thumbnail

With a Global Focus, Seattle Genetics Rebrands as Seagen

BioSpace

Despite the change of corporate name, the company said it will maintain its focus on the pursuit of developing novel therapies for solid tumors and blood-related cancers.

article thumbnail

New drug carrier systems

Scienmag

University of Delaware researchers advance drug delivery systems to treat connective tissue disorders Credit: Graphic illustration by Jeffrey C. Chase University of Delaware Professor Kristi Kiick is leading collaborative research to create new drug delivery systems with the potential to improve treatment for diseases that affect connective tissues, such as osteoarthritis or rheumatoid arthritis, which […].

article thumbnail

First-ever Patient Partnership Index Conference takes place

Pharma Times

Senior leaders from patient organisations and the pharma industry came together to discuss best practice in patient partnerships

80
article thumbnail

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.

article thumbnail

2020 Neukom Awards honors complex stories in complex times

Scienmag

Winners peer into imagined worlds with real consequences Credit: Turnbull photo credit: Anju Manandhar; Chiang photo credit: Alan Berner. HANOVER, N.H. — Dartmouth’s Neukom Institute is proud to announce the winners of the 2020 Neukom Institute Literary Arts Awards for speculative fiction: 2020 Neukom Institute Literary Arts Award for Speculative Fiction (Debut) Cadwell Turnbull, The […].

article thumbnail

Clinical trial volume, variety drive data solutions

Outsourcing Pharma

eClinical, a provider of clinical data service solutions, has seen an increase in interest in clinical data platform and other digital products.

article thumbnail

Drug combination proves effective in rare peripheral nerve sheath tumours

Scienmag

Research in cancer cells and mice has ‘immediate translational implications’ Malignant tumours of the peripheral nerve are rare but aggressive and very difficult to treat successfully. Now, researchers in the US have shown that a combination of two types of anti-cancer drugs, MEK and SHP2 inhibitors, is effective in targeting the mechanism that drives the […].

Drugs 81
article thumbnail

BARDA and Locus in tie-up to tackle UTIs with phages

BioPharma Reporter

Locus Biosciences has signed a contract with the Biomedical Advanced Research and Development Authority (BARDA), to co-fund development of LBP-EC01, a CRISPR Cas3-enhanced bacteriophage (crPhage) that targets E. coli bacteria causing recurrent urinary tract infections (UTIs).

article thumbnail

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.