Sat.Oct 31, 2020 - Fri.Nov 06, 2020

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The meeting that could change Alzheimer's treatment

Bio Pharma Dive

On Friday, a panel of experts and FDA staff will weigh in on a closely watched Alzheimer's drug from Biogen. Their feedback could affect how the disease is treated for years to come.

Drugs 363
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American health is in for a “world of hurt”

World of DTC Marketing

Cardiovascular disease deaths in the US have increased by nearly 17% since 2010, and are among the reasons that life expectancy in the U.S. is lower than in other high-income countries. The U.S. has also seen reversals in health improvements since 2010, partly due to increasing rates of obesity, high blood pressure, and high blood sugar. . We can’t ignore the poor shape of Americans.

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New study assessing antibiotics for COVID-19 sepsis

Pharma Times

It is hoped that findings from the NIHR-funded trial will help better inform treatment decisions

Trials 146
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MHRA looks to AI to hunt for COVID-19 vaccine side effects

pharmaphorum

The UK drugs regulator has awarded a £1.5 million tender to a software company for an artificial intelligence tool that will be used to process “the expected high volume of COVID-19 vaccine adverse drug reactions (ADRs).”. The tender awarded to Maidenhead, Berkshire-based GenPact UK aims to “ensure that no details from the ADRs…are missed” as the UK prepares to start rolling out COVID-19 vaccines – assuming their safety and efficacy is supported in late-stage trials.

Vaccine 145
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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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Allogene shares sink on early look at an 'off the shelf' CAR-T for myeloma

Bio Pharma Dive

Results the company will present at a medical meeting, while early, don't appear to meet the high bar set by rival CAR-T cell therapies from Bristol Myers Squibb and Johnson & Johnson.

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Why are healthcare companies so silent?

World of DTC Marketing

THE SKINNY : President Trump’s repeated assertions the United States is “rounding the turn” on the novel coronavirus are proving to be untrue as new cases surge in Midwest states. “We’re in for a whole lot of hurt. It’s not a good situation,” Anthony S. Fauci, the country’s leading infectious-disease expert, said in a wide-ranging interview late Friday.

Vaccine 188

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AI’s infiltration of pharma: How COVID-19 accelerated change

pharmaphorum

The pharmaceutical industry has sometimes been a laggard in terms of digital maturity, but the COVID-19 crisis has provided companies the impetus to rapidly implement the most cutting-edge technologies. At the heart of most of these digital advancements is AI and machine learning. With a collective sense of uncertainty, many are pinning their hopes on a vaccine and treatment, and sophisticated technology could help speed up the process of finding an effective medicine.

Nurses 132
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Bristol Myers bet pays off as psoriasis drug beats Amgen rival in study

Bio Pharma Dive

While full data were not disclosed, the trial's outcome signals competition for Amgen's Otezla, which Celgene was forced to divest last year as a result of its acquisition by Bristol Myers.

Drugs 344
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Misinformation and confusion: Online health seekers

World of DTC Marketing

THE SHORT : The confusion around the Presidential election, which is ongoing at the time of this post, has a lot of similarities with online health information. As social media becomes a bigger part of information gathering for health seekers they are often making bad treatment decisions based on what they read. According to Annual Review “in general, we do not have the cognitive capacity, motivation, or time to evaluate all the information that we encounter online.

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MHRA starts rolling review of AZ’s coronavirus vaccine

Pharma Times

British drugmaker confirmed review on Sunday

Vaccine 133
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Stage 4 Breast Cancer Treatment in Germany

Pharma Mirror

To date, breast cancer is one of the most dangerous diseases. Unfortunately, it is not always possible to diagnose it early due to the lack of modern equipment in many countries. Medical tourism is getting popular, and you can easily get stage 4 breast cancer treatment in Germany. Modern hospitals in Germany have the most. The post Stage 4 Breast Cancer Treatment in Germany appeared first on Pharma Mirror Magazine.

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Biogen surges as FDA reviewers appear supportive of Alzheimer's drug approval

Bio Pharma Dive

Documents made public ahead of a key advisory meeting Friday revealed an FDA more willing than expected to accept Biogen's controversial case for approval of aducanumab.

Drugs 338
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GW Pharma Hopes to Bring Its Second Cannabis-Based Drug to Market in the U.S.

BioSpace

GW Pharmaceuticals hopes to bring its cannabis-based treatment for multiple sclerosis spasticity to the United States.

Marketing 124
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Sanofi to buy Kiadis

Pharma Times

The move gives the French drug giant access to Kiadis' natural killer cell technology platform

Drugs 129
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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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How Hospital Emergency Rooms are Improving Care

Pharma Mirror

Accidents happen, people get sick, unexpected health issues pop up, problems occur when you least expect it – this is why there are emergency rooms and why millions of people go to them every year. Yet, visiting the emergency room can be very stressful and scary. You don’t know what is going to happen to. The post How Hospital Emergency Rooms are Improving Care appeared first on Pharma Mirror Magazine.

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Merck to pay almost $3B for VelosBio, broadening antibody cancer drug push

Bio Pharma Dive

Buying VelosBio is Merck's second investment in so-called antibody-drug conjugates since September, reflecting the drug class' fast turnaround.

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Three Biotechs Shutter Clinical Programs After Futility Analysis or Failed Trials

BioSpace

Three biopharma companies recently shuttered their clinical programs after either their compounds failed clinical trials or interim futility analysis suggested they were unlikely to meet their clinical endpoints. Here’s a look.

Trials 123
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AZ’s Forxiga wins EU approval for heart failure

Pharma Times

SGLT2 inhibitor approved for heart failure with reduced ejection fraction

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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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Ring 20: Could the rare disease get left behind by next-generation gene sequencing?

pharmaphorum

Ring Chromosome 20 Syndrome, or (R)20, is an ultra-rare form of epilepsy with a devastating impact – yet despite huge leaps forward in gene sequencing in recent years, diagnoses are going down instead of up. We spoke to Allison Watson, co-founder of Ring 20 Research and Support, about raising awareness, building the evidence base, and the importance of helping people through a pandemic despite limited funding.

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FDA gene therapy holdups suggest closer scrutiny by agency

Bio Pharma Dive

Requests for more data on manufacturing, clinical holds and a surprise rejection have led to questions of a tougher standard at the agency. Officials, however, point to a large and fast-advancing pipeline.

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Study: Biogen’s Lupus Drug Candidate Reduces Disease Activity Better Than Placebo

BioSpace

Additional findings from Biogen’s Phase II LILAC study, announced today, show the company’s lupus drug candidate BIIB059 is superior to placebo for reducing joint disease activity in patients with systemic lupus erythematosus.

Drugs 120
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NHS at a 'critical point' as COVID-19 cases climb

Pharma Times

NHS Confederation chief exec calls on public to support non-COVID services

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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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Australia makes COVID-19 vaccine supply agreements with Novavax and Pfizer

BioPharma Reporter

The Australian Government has inked an agreement with Novavax for 40 million COVID-19 vaccine doses; and with Pfizer/BioNTech for 10 million doses.

Vaccine 115
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Bluebird faces delay for sickle cell gene therapy as rivals inch closer

Bio Pharma Dive

The setback for Bluebird's LentiGlobin comes amid a string of manufacturing-related delays for gene therapy developers.

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Santhera Slashes Workforce in Half After Phase III DMD Failure

BioSpace

Santhera said the restructuring will allow the company to focus on the development of vamorolone, a first-in-class dissociative steroid with a novel mode of action that it gained the rights to from ReveraGen BioPharma.

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Be in the room: Turning patient engagement to patient centricity

pharmaphorum

After three brushes with cancer, Robert Weker understands the patient journey more than many – and he is determined to put that experience to good use. The avid blogger and passionate advocate retired from his R&D role four years ago to focus on his own health, and now works full time on making sure the patient voice is “in the room” when pharma companies make decisions.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Intouch & Athenex Oncology Talk AI at Frontiers Health Global Hybrid Conference

Intouch Solutions

What’s the best approach for investments in AI-based implementations? At this year's Frontiers Health conference, Intouch experts will discuss the 'what' and 'how'; we'll also hear a case study on creating an augmented-reality tool to help oncology HCPs empathize with patients undergoing chemotherapy, developed together with Athenex Oncology. The post Intouch & Athenex Oncology Talk AI at Frontiers Health Global Hybrid Conference appeared first on Intouch Solutions.

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Gene therapy for Duchenne muscular dystrophy: Nearing final tests

Bio Pharma Dive

Sarepta and Pfizer are advancing their experimental treatments into late-stage trials, while others are accelerating research in what's become one of gene therapy's most active fields.

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Opportunity Horizon – A Look at Recent Life Sciences Job Expansions

BioSpace

The life sciences industry is one of the fastest growing in the world. BioSpace provides a rundown of companies announcing facility and job expansions across the U.S. and beyond.

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Does my cough sound like COVID? There could be an app for that

pharmaphorum

It could be possible to detect whether someone has COVID-19 or not, just from the sound of their coughing. That’s the conclusion of testing of an artificial intelligence (AI) algorithm developed by the Massachusetts Institute of Technology (MIT), which was able to detect around 98% of cases of COVID-19 from a forced cough delivered down a cell phone – confirmed by coronavirus testing.

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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.