Sat.Sep 19, 2020 - Fri.Sep 25, 2020

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Merck matches Roche in search for next cancer immunotherapy

Bio Pharma Dive

The maker of Keytruda unveiled data for three experimental cancer drugs, including results for an anti-TIGIT therapy that compare favorably to those for a similar medicine being developed by Roche.

Medicine 345
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The Themes of The World Pharmacists Day 2010-2020

Pharma Mirror

Pharmacists are healthcare professionals who have enough knowledge about the effective uses of medications. World Pharmacist Day is celebrated on 25th September every year since 2010 on the day FIP (International Pharmaceutical Federation) started their journey. FIP encourages pharmacists to celebrate this day to promote and support the role of the pharmacist in the whole.

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Switching to DrugPatentWatch

Drug Patent Watch

Don’t wait until the end of the year to start looking for alternatives to your existing business intelligence providers. DrugPatentWatch can help you replace or supplement your current solutions with:…. The post Switching to DrugPatentWatch appeared first on DrugPatentWatch - Make Better Decisions.

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Innovate UK funding for new precision cancer treatment technology

pharmaphorum

Sixfold Bioscience and Medicines Discovery Catapult awarded Innovate UK grant to pursue ground-breaking project. Sixfold Bioscience in partnership with Medicines Discovery Catapult, has been given the green light, through the award of an Innovate UK Smart Grant to test a pioneering system designed to deliver drugs directly to cancerous cells, without impacting the healthy cells around it.

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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 Eli Lilly data, another drug emerges to stop breast cancers from returning

Bio Pharma Dive

The highly anticipated results could signal a change in how some patients with the most common form of breast cancer are treated — and drive up the costs of care.

Drugs 352
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Sanofi & GSK sign deal to supply EU with 300 million COVID-19 vaccine doses

BioPharma Reporter

Sanofi and GSK will provide the EU with up to 300 million doses of their COVID-19 vaccine candidate, with the agreement suppporting scale-up of manufacturing capabilities in several European countries.

More Trending

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Vertical pharma: How sector convergence can erase digital health siloes

pharmaphorum

Life science companies must evolve and find new ways of working that erase the lines between industries and sub-sectors if they are to adapt to the digitalised world. That’s according to the team at Sweden’s Sahlgrenska Science Park, who are getting ready to host a virtual event looking at how the specialisation of digital expertise is driving a trend of sector convergence that pharma is only just cottoning on to.

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FDA sets back Novartis plans to expand use of SMA gene therapy

Bio Pharma Dive

The agency has asked Novartis to run a new study of the Zolgensma formulation that Novartis aims to bring to older patients with spinal muscular atrophy.

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Novavax Begin Phase III Study of COVID-19 Vaccine Candidate in the U.K.

BioSpace

The late-stage study is part of an agreement struck between the company and the U.K. government last month that includes providing 60 million doses of the vaccine, should it be approved.

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Deep learning helps explore the structural and strategic bases of autism?

Scienmag

Credit: KAIST and IEEE Spectrum (Image usage restrictions: News organizations may use or redistribute this image, with proper attribution, as part of news coverage of this paper only.) Psychiatrists typically diagnose autism spectrum disorders (ASD) by observing a person’s behavior and by leaning on the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), widely considered […].

Engineer 121
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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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Could a COVID-19 breath test help UK out of lockdown?

pharmaphorum

A potential COVID-19 breath test has been unveiled in the UK, as the country desperately searches for alternatives to crippling lockdown measures to prevent the disease from spreading. The breath test has been developed by Integumen in collaboration with Modern Water, Avacta and Aptamer Group, which had been working on test that identifies the SARS-CoV-2 coronavirus in waste water.

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Blueprint's bet on itself pays off with rare disease drug data

Bio Pharma Dive

Study data show Blueprint's first approved cancer drug, Ayvakit, could also work to treat a rare disease, a result that sent the company's shares higher.

Drugs 281
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Evergreen Theragnostics Breaks Ground on Radiopharmaceutical Factory

BioSpace

The new facility will be 14,000 square feet and is designed from start to finish to meet global current Good Manufacturing Practice (cGMP) standards for radiopharmaceutical manufacturing.

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Controlling ultrastrong light-matter coupling at room temperature

Scienmag

Credit: Illustration: Denis Baranov, Chalmers University of Technology Physicists at Chalmers University of Technology in Sweden, together with colleagues in Russia and Poland, have managed to achieve ultrastrong coupling between light and matter at room temperature. The discovery is of importance for fundamental research and might pave the way for advances within, for example, light […].

Research 116
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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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MindMed aims for Nasdaq listing after Compass’ magic mushroom-fuelled IPO

pharmaphorum

Compass Pathways and its potential magic mushroom depression drug went public last week – and now psychedelic therapy firm Mind Medicine is aiming to follow suit by up-listing its shares on the Nasdaq. UK-based Compass has a patented synthetic version of psilocybin, the active ingredient in magic mushrooms, and raised around $127.5 million with its IPO on Friday and shares are still significantly above their launch price of $17.

Medicine 134
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AC Immune drug fails in blow to another Alzheimer's hypothesis

Bio Pharma Dive

Negative results for the experimental drug semorinemab dents a theory that Alzheimer's disease may be caused by tangles of the protein tau in the brain.

Drugs 285
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FDA Plans New, More Stringent Guidance for COVID-19 Vaccine EUA

BioSpace

Although the updated guidance has largely remained under wraps, sources who spoke to The Washington Post hinted that the new rules would make it more difficult for an EUA to be granted to a vaccine ahead of Nov. 3, the day of the U.S. elections.

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Fitbit Wins Another Approval for AFib App

XTalks

The San Francisco-based tech giant, Fitbit, has received clearance from the US Food and Drug Administration (FDA) and the Conformité Européenne (CE) in the European Union for its electrocardiogram (ECG) app. The application is used to assess heart rhythm for atrial fibrillation (AFib). AFib is an irregular heartbeat, known as arrhythmia, that can lead to blood clots, stroke, heart failure and other heart-related complications.

Gene 107
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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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Amazon bolsters Alexa’s health credentials with Sharecare deal

pharmaphorum

Amazon’s Alexa device can already field health and medical questions, but the library of responses has now been bulked up thanks to a partnership with digital health company Sharecare. The new deal adds more than 80,000 questions and answers to the repertoire of the Alexa virtual assistant, which provides information, entertainment and advice to users on voice command via devices such as Amazon’s Echo smart speakers.

Pharmacy 131
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Regeneron forges ahead in lung cancer, but will need more to unseat Merck

Bio Pharma Dive

The biotech's immunotherapy Libtayo looks headed for approval in lung cancer, but surpassing the bar set by Merck's Keytruda remains a challenge.

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Progentec’s Novel Blood Test Predicts Lupus Flares Up to 12 Weeks Before They Occur

BioSpace

Progentec Diagnostics, Inc. just launched a novel blood test to determine the likelihood that a patient with systemic lupus erythematosus (commonly known as both SLE and lupus) will experience an immunologic disease flare during the coming 12 weeks.

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Why viral vector manufacturing capacity is constrained

BioPharma Reporter

Viral vector production capacity has become increasingly constrained in recent years due to increases in the therapies in development, the dosages given and the patient populations targeted. COVID-19 is exacerbating the situation.

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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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Cognoa preps FDA filing for digital autism diagnostic

pharmaphorum

An artificial intelligence-powered diagnostic for autism spectrum disorder (ASD), developed by Cognoa, has met all its objectives in a pivotal trial and will be filed for approval with the FDA. The ASD diagnostic app is designed to serve as a tool that can be used by paediatricians in primary care to detect autism traits early on and start treatment sooner.

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AstraZeneca turns to Samsung Biologics to help fuel Asia drugs push

Bio Pharma Dive

The British drugmaker struck a manufacturing deal with Samsung to expand its ability to supply drugs to the Asia Pacific region, an area that's been key to its recent growth.

Drugs 246
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Gilead Settles Kickback Claims with U.S. Government for $97 Million

BioSpace

The company allegedly used a foundation as a conduit to pay the copays of Medicare patients who were taking Letairis, Gilead’s pulmonary arterial hypertension drug.

Drugs 121
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Roles and Responsibilities of a Clinical Research Coordinator

Forte Research Systems®

Clinical Research Coordinators are tasked with many responsibilities throughout the day. Learn more about how to balance each role and responsibility effectively.

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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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New study reveals patients’ changing needs during COVID-19

pharmaphorum

New research from The Patients Association, supported through sponsorship provided by Novo Nordisk and ENGINE MHP, looks at how more than 950 patients experienced the COVID-19 pandemic, with an emphasis on managing and accessing care and their experiences of treatment and services more broadly. Here, Patients Association CEO Rachel Power and ENGINE MHP director Jonathon Sheppard explore some of the findings – such as major disruptions to the relationships between patients and the health and care

Engineer 114
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Amgen's KRAS drug can shrink tumors for months, but new data leave room for improvement

Bio Pharma Dive

Study results unveiled Sunday, if replicated later this year, could be strong enough to garner an approval for Amgen's sotorasib, the first KRAS-blocking drug to get this far.

Drugs 249
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Lumen Bioscience Receives $4 Million Grant to Develop COVID-19 GI Therapies

BioSpace

Lumen Bioscience was awarded a $4 million grant by the U.S. Army Medical Research and Development Command to develop a rapid, scalable and inexpensive biologic drug cocktail to treat gastrointestinal infection in COVID-19 patients.

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New patent for Corcept Therap drug KORLYM

Drug Patent Watch

Annual Drug Patent Expirations for KORLYM Korlym is a drug marketed by Corcept Therap and is included in one NDA. There are thirteen patents protecting this drug and one Paragraph…. The post New patent for Corcept Therap drug KORLYM appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 98
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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.