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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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.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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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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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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AstraZeneca, Under Fire for Vaccine Safety, Releases Trial Blueprints

NY Times

Experts are concerned that the company has not been more forthcoming about two participants who became seriously ill after getting its experimental vaccine.

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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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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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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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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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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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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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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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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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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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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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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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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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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 123
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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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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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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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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 115
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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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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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ALX Oncology Pairs Lead Asset with Keytruda in HNSCC Study

BioSpace

ALX Oncology will partner with pharma giant Merck to evaluate a combination of its CD47 inhibitor with Keytruda as a potential treatment for patients with Head & Neck Squamous Cell Carcinoma.

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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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Life in phase III: How effective data management can support NHS Trusts to hit their targets

pharmaphorum

Although life for the general public is (slowly) starting to edge back towards normality, healthcare providers are still on a heightened state of alert. In the UK, the 1 August step down from EPRR incident level four may have meant we’re no longer in a state of national incident, but at a regional level NHS Trusts and private sector providers are still very much working flat out to manage and contain COVID-19 and its associated fallout.

Doctors 110
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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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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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4 Things You Might Overlook When Applying for Jobs

BioSpace

Often times, you can fall into a trap of seeing a particular title, skimming a listing, and firing off an application.

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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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UK university strikes e-prescribing partnership with Better

pharmaphorum

A UK university has struck a partnership with medical technology firm Better that aims to give nursing and pharmacy students a better insight into e-prescribing. Liverpool John Moores University is to use Better’s OPENeP electronic prescribing and medicines administration software to teach the students about modern prescribing practices. OPENeP is designed as a stand-alone product that allows electronic patient record systems to be integrated with medication-related decision support systems.

Pharmacy 109
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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.