Sat.Oct 21, 2023 - Fri.Oct 27, 2023

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Leveraging real-world evidence with analytics: 3 essential components to capture a 360-degree view of your patient population

Bio Pharma Dive

Three essential components to create impactful real-world evidence with a 360-degree patient journey.

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FDA cracks down on off-label drug use messaging

Pharmaceutical Technology

The FDA released a draft guidance giving firms recommendations on provider-directed communication for off-label drug use.

Drugs 245
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Pharma dips toe into tech adoption, but is it deep enough?

pharmaphorum

Pharma dips toe into tech adoption, but is it deep enough? Mike.

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Bristol Myers says new drugs sales will grow more slowly

Bio Pharma Dive

Company shares fell Thursday as the company adjusted its medium-term guidance for sales of new products like Reblozyl, Camzyos and Abecma.

Sales 169
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Pear Therapeutics: a lesson for future DTx developers

Pharmaceutical Technology

Pear Therapeutics was a pioneer in developing DTx for neurological conditions traditionally treated by evidence-based behavioural or psychological management strategies.

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The longitudinal history of medicines innovation: Part One

pharmaphorum

The longitudinal history of medicines innovation: Part One Mike.

Medicine 115

More Trending

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What Challenges Is the Vaccine Industry Facing When Dealing with the Flu and COVID-19?

XTalks

Fall marks the beginning of the “flu season,” the period during the year when influenza (flu) viruses are in increased circulation and cause illness at higher rates than usual. The season also marks the increased circulation of other respiratory viruses, including SARS-CoV-2, which causes COVID-19, and respiratory syncytial virus (RSV). In the US, the flu or respiratory virus season typically begins in the fall and peaks in the winter, usually between December and February, but it can last as la

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5 things to look for in a marketing analytics partner

Bio Pharma Dive

Effective marketing measurement requires objectivity, connected data, transparency, a track record of innovation and a proven ability to execute.

Marketing 269
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October 25, 2023: In This Friday’s PCT Grand Rounds, Krumholz Presents PaxLC Trial of Paxlovid for Long COVID

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, Harlan Krumholz of Yale University will present “Digital, Decentralized and Democratized: Lessons From the Yale PaxLC Trial.” The Grand Rounds session will be held on Friday, October 27, 2023, at 1:00 pm eastern. The PaxLC Trial is a decentralized study of Paxlovid in adult participants with long COVID.

Trials 268
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ADDF announces speech database to identify biomarkers for Alzheimer’s

Pharmaceutical Technology

SpeechDx will contain recorded voice samples and other data, which will be used to develop algorithms for creating new speech biomarkers.

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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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New Link Between Fungal Organisms And Severe COVID Discovered

AuroBlog - Aurous Healthcare Clinical Trials blog

Many tiny organisms including bacteria, fungi and viruses normally live on our bodies, and even inside us. These are called the microbiome. The large number of these organisms living in the gastrointestinal tract are collectively known as the gut microbiome.

Bacteria 206
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Vertex gearing up for launch as sickle cell therapy review advances

Bio Pharma Dive

Executives at the biotech say they’re trying to get ahead of the payer and production challenges that will face their gene editing treatment exa-cel, which is now under FDA review.

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Amgen Lays Off 350 Employees Following $27.8B Horizon Acquisition

BioSpace

In its most recent round of layoffs this year, the California-based biopharma company is letting go of 350 former Horizon Therapeutics staff whose roles overlap with existing positions at Amgen.

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UK NICE recommends use of AbbVie’s Parkinson’s treatment 

Pharmaceutical Technology

The UK NICE has recommended the use of AbbVie’s foslevodopa–foscarbidopa (Produodopa) for the treatment of advanced Parkinson’s disease.

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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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Adults With ADHD at Greater Risk of Dementia, Study Shows

AuroBlog - Aurous Healthcare Clinical Trials blog

Adults diagnosed with attention-deficit/hyperactivity disorder ( ADHD) are almost three times more likely to go on to develop dementia, according to a new study that looked at 109,218 adults with and without the condition over a period of 17 years. The researchers, from institutions in Israel and the US, found that 13.

Research 184
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Bristol Myers’ neuroscience research head explains the big pharma’s return to brain drugs

Bio Pharma Dive

In a wide-ranging interview, Bristol Myers’ Ken Rhodes talked biomarkers, diseases of interest and why the company is far from done with neuroscience-focused deals.

Research 306
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NASH on the Cusp: An Emerging Market Opportunity

BioSpace

The non-alcoholic steatohepatitis space is still a “big mystery,” analysts tell BioSpace, but its connection to weight loss could provide an additional opportunity for contenders.

Marketing 127
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How gene therapies can transform sickle cell disease treatment

Pharmaceutical Technology

The potential for using gene therapies to treat sickle cell disease is high, but their durability and high price point invite scrutiny.

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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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The Brain Cells That Give You Motion Sickness May Have Been Identified

AuroBlog - Aurous Healthcare Clinical Trials blog

If the idea of driving down a winding road makes you feel queasy, spare a thought for the mice employed in a new study, which sought to pinpoint the brain cells responsible for motion sickness.

Research 175
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Pfizer wins FDA approval of new meningococcal vaccine

Bio Pharma Dive

The clearance of the pentavalent shot Penbraya adds to Pfizer’s infectious disease portfolio as it adjusts to slumping COVID-19 vaccine sales.

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Takeda Reports $770M Write-Down, Cuts Profit Forecast by 71% for FY2023

BioSpace

Attributing losses to exchange rate and pipeline impairment losses, the Japanese biopharma dropped its reported net profit forecast of 142 billion yen ($945.1 million) to 93 billion yen ($618.8 million).

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European Commission bolsters defences against critical medicine shortages

Pharmaceutical Technology

The EC announced new initiatives to tackle critical medicine shortages in winter, introducing more flexibility to strengthen supplies.

Medicine 246
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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ICMR invites proposals to establish Ayush-ICMR Advanced Centre for Integrative Health Research at AIIMS

AuroBlog - Aurous Healthcare Clinical Trials blog

The Indian Council of Medical Research (ICMR) has invited proposals to establish Ayush-ICMR Advanced Centre for Integrative Health Research (AI-ACIHR) at the All India Institute of Medical Sciences (AIIMS) under Extramural Programme. This is following a Memorandum of Agreement (MoA) signed between the Union Ministry of Ayush and the ICMR at an inter-ministerial level.

Research 159
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Sanofi to divest consumer unit, joining pharma industry shift

Bio Pharma Dive

The restructuring came as the French company forecast an earnings drop in 2024, prompting a stock selloff that erased about $20 billion in market value.

Marketing 293
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Lilly’s Ulcerative Colitis Therapy Mirikizumab Finally Snags FDA Approval

BioSpace

Following an FDA rejection and a previous discontinuation in psoriasis, Eli Lilly’s anti-IL-23 antibody has finally won an approval in ulcerative colitis, joining a crowded inflammatory bowel disease market.

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Annovis looks to advance pivotal Alzheimer’s and Parkinson’s drug studies

Pharmaceutical Technology

The AD and PD drug aims to reduce the level of neurotoxic proteins, thereby improving information flow across the axonal transport

Drugs 246
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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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NABH releases first edition of NABH Certification standards for stroke care centres

AuroBlog - Aurous Healthcare Clinical Trials blog

The National Accreditation Board for Hospitals and Healthcare Providers (NABH) has released the first edition of NABH Certification standards for stroke care centres. It has urged all the centres across the country to apply for accreditation depending on the self-assessment of the standards.

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OrbiMed raises $4.3B in new funds for startup investing

Bio Pharma Dive

The money will be spread across three investment funds and comes at a time when investment into biotech remains shakier than in years past.

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Araclon’s Alzheimer’s Vaccine Shows Clean Safety Profile in Phase II Analysis

BioSpace

While the trial was designed to test safety and not efficacy, patients treated with Araclon Biotech’s experimental ABvac40 vaccine saw a 38% drop in disease progression compared to placebo.

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Pfizer and BioNTech post early win for combination Covid-19/flu vaccine 

Pharmaceutical Technology

A pivotal Phase III trial will be initiated in the coming months to further evaluate the lead formulations of the combination vaccine.

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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.