Sat.Aug 26, 2023 - Fri.Sep 01, 2023

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Sanofi appoints a venture investor to R&D head as executive team expands

Bio Pharma Dive

Houman Ashrafian, currently a scientific advisor at SV Health Investors, will fill the role left by John Reed, who oversaw the transformation of research and development during his five years at Sanofi.

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Clinical trials: How AI can help providers stay TMF inspection-ready

Pharmaceutical Technology

The clinical trials industry is facing a number of hurdles, but AI and digitalisation are being heralded as key to overcoming them, particularly when it comes to preparing for inspections and audits

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Does Drinking Lots of Water Help You Lose Weight? An Expert Explains.

AuroBlog - Aurous Healthcare Clinical Trials blog

It’s often claimed that if you’re trying to lose weight, one of the things you should do each day is drink plenty of water – with some internet advice even suggesting this should be as much as a gallon (about 4.5 liters).

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August 31, 2023: FDA’s Robert Califf and Coauthors Assert More Is Needed to Achieve Learning Health Care

Rethinking Clinical Trials

In an article published this month in the American Journal of Bioethics , FDA Commissioner Robert Califf and coauthors suggest that—despite the potential of embedded pragmatic research to generate information to improve clinical practice and public health policy—it is still relatively uncommon in US healthcare. “Simply stated, what we are currently doing does not work, and in the face of declining health status we lack answers to critical questions about what we should be doing in health care an

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Bristol Myers gets key FDA approval for bone marrow disease drug

Bio Pharma Dive

A broadened clearance for Reblozyl in myelodysplastic syndromes should help Bristol Myers offset the looming loss of revenue from top-selling medicines set to soon lose market exclusivity.

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Signal: Novo Nordisk market cap higher than Danish GDP due to obesity drugs

Pharmaceutical Technology

Novo Nordisk's obesity drugs are driving Danish growth as well as record profits as the company becomes second-most valuable in Europe.

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More Trending

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Breaking Free from Addiction: Exploring Online Suboxone Clinics in San Antonio, TX

Pharma Mirror

San Antonio’s online suboxone clinics serve as lifesavers for individuals fighting opioid addiction. Offering advanced treatments and personalized care, these online clinics light the dark tunnel of addiction recovery. This post delves into how these clinics aid in patients’ transformative journeys. Understanding the Role of Suboxone in Opioid Addiction Treatment Suboxone is a potent weapon in our arsenal against opioid addiction, primarily utilized in Medication-Assisted Treatment (

Drugs 130
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Sage, reeling from depression drug decision, to lay off 40% of workforce

Bio Pharma Dive

Two founding executives are leaving Sage alongside a major restructuring announced weeks after the FDA approved the medicine, Zurzuvae, for much narrower use than the company had hoped.

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Otsuka Pharmaceutical agrees to buy Mindset Pharma

Pharmaceutical Technology

Otsuka Pharmaceutical has signed a definitive arrangement agreement to acquire Mindset Pharma, in an all-cash deal worth C$80m ($59.1m).

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Amazing Brain Implant Gives a Voice to People Who Couldn’t Speak For Years

AuroBlog - Aurous Healthcare Clinical Trials blog

There’s new hope for people who have lost their ability to speak. In two separate cases, scientists have successfully used brain implants and machine learning to give patients back their voice after theirs was taken; one by a stroke, the other a result of amyotrophic lateral sclerosis (ALS).

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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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Merging mind and machine: Augmented intelligence and the limits of AI in medical communications

Pharma Mirror

The integration of artificial intelligence (AI) tools across medical communications is proving to be a transformative development, ushering in increased efficiencies and innovation across the healthcare industry. by Matt Lewis, Global Chief Artificial and Augmented Intelligence Officer at Inizio Medical, an Inizio company A subset of AI, augmented intelligence, refers to the synergy between AI, machine learning, and natural language processing (NLP) technologies to complement human intelligence

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Roche claims study success for targeted drug in early lung cancer

Bio Pharma Dive

The Swiss pharma said, without details, that it observed “unprecedented” results that could make Alecensa the first treatment specifically available after surgery for ALK-positive lung tumors.

Drugs 268
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The changing of the guard is expected in the Crohn’s disease marketplace

Pharmaceutical Technology

As per GlobalData, AbbVie has remained the Crohn’s disease market leader over the last five years, with Humira sales of $2.7bn in 2022 in 8MM.

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Groundbreaking Stem Cell Therapy Can Repair Vision After Eye Injury

AuroBlog - Aurous Healthcare Clinical Trials blog

Four patients with severe chemical burns to one eye have shown early positive results in a phase 1 clinical trial of a therapy based on their own stem cells. Even without further treatment, two of the patients reported significant improvements in their vision after a year of follow-up, according to a team of US researchers.

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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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Pharmaceutical Equipment Manufacturer Unveils Custom Wash Rack Services 

Pharma Mirror

North Charleston, SC: Pharmaceutical sterilization and cleaning equipment manufacturer Belimed Life Science, North Charleston, SC, has unveiled custom wash rack design and manufacturing services. A key option offered with the company’s automated cleaning and disinfecting wash systems, the custom wash rack services were developed to help pharmaceutical and nutritional product manufacturers ensure complete cleaning and disinfection of laboratory glassware, tableting tools, containers, valves

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Medicare names first 10 drugs for price negotiations

Bio Pharma Dive

The list includes the top-selling blood thinners Eliquis and Xarelto, as well as the arthritis drug Enbrel and heart failure medicine Entresto.

Drugs 294
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Specialised Therapeutics partners with Treeway to license ALS drug

Pharmaceutical Technology

Specialised Therapeutics has entered into a licensing agreement with Treeway for TW001, designed for treating amyotrophic lateral sclerosis.

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A Mediterranean Lifestyle Really Can Help You Live Longer, Study Shows

AuroBlog - Aurous Healthcare Clinical Trials blog

Rich in fruits, vegetables, whole grains, and fish, the Mediterranean diet has long been linked with improving health. In fact, living a Mediterranean lifestyle in general could be the ticket to a longer, healthier life.

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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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August 30, 2023: NIH Pragmatic Trials Collaboratory Welcomes New Demonstration Project: I CAN DO Surgical ACP

Rethinking Clinical Trials

We are excited to welcome I CAN DO Surgical ACP (Improving Completion, Accuracy, and Dissemination of Surgical Advanced Care Planning) to our portfolio of innovative Demonstration Projects. This project is supported within the NIH Pragmatic Trials Collaboratory by a grant from the National Institute on Aging (NIA). Despite advance care planning (ACP) being incorporated into national quality metrics and society guidelines for surgical care for older adults, effective integration of ACP into the p

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FTC pulls back on legal challenge to Amgen’s $28B bid for Horizon

Bio Pharma Dive

Urged by a judge, the antitrust regulator said it wants to start discussions “regarding the proper resolution of this matter” — a potential prelude to a settlement.

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Biostax and Immgenuity to expedite HIV immunotherapies development

Pharmaceutical Technology

Biostax and Immgenuity have entered into an agreement to expedite the development of new immunotherapeutics to treat HIV and other diseases.

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CDSCO declares three drug samples as spurious, 51 as NSQ during July

AuroBlog - Aurous Healthcare Clinical Trials blog

The Central Drugs Standard Control Organisation (CDSCO) has declared three drug samples it tested in the month of July as spurious and another 51 samples as Not of Standard Quality (NSQ). It added that two drug samples tested as not of standard quality during June were also alerted by the manufacturer as spurious.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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Amid shortage, FDA clears several generics of Takeda's popular ADHD drug Vyvanse

Fierce Pharma

After 16 years on the market, Takeda's blockbuster attention-deficit/hyperactivity disorder (ADHD) med Vyvanse has finally reached its patent cliff. | After 16 years on the market, Takeda's blockbuster ADHD med Vyvanse has finally reached its patent cliff. And the FDA's approval of several generics comes amid a U.S. shortage of the drug.

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Superluminal draws RA Capital, Nvidia as investors in GPCR drug hunt

Bio Pharma Dive

GPCRs, a ubiquitous family of proteins that are prime drug targets, have drawn the interest of companies like Structure Therapeutics, Septerna and now Superluminal Medicines.

Drugs 246
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Novo Nordisk acquires Embark and lead asset metabolic programme

Pharmaceutical Technology

Novo Nordisk has acquired Embark Biotech and its lead asset targeting obesity and other cardiometabolic diseases.

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India’s success story in pediatric vaccination program should be further replicated in adult vaccination: Experts

AuroBlog - Aurous Healthcare Clinical Trials blog

India’s success story in pediatric vaccination programme should be further replicated in the form of adult vaccination programme, experts recommended on the occasion of the 2nd edition of the India Vaccine Leaders Conclave (IVLC) held between August 22 and August 23, 2023 under the theme “Building Resilient Vaccine Ecosystems” in Mumbai.

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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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Amgen's $28B Horizon buyout cleared for takeoff after FTC, states settle

Fierce Pharma

After months of legal wrangling, Amgen is free to go forward with its $27.8 billion buyout of Horizon Therapeutics. | Friday, the U.S. Federal Trade Commission (FTC) said it reached a proposed consent order with Amgen to address “the potential competitive harm” that could result from the merger deal. Now, Amgen is free to go forward with its $28 billion buyout.

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FTC allows Amgen’s $28B deal for Horizon to go through, with conditions

Bio Pharma Dive

The settlement between Amgen and the FTC may reassure those in the industry who feared a more activist regulator would gum up dealmaking.

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FDA grants priority review for Zealand Pharma’s dasiglucagon

Pharmaceutical Technology

The US FDA has granted priority review for Zealand Pharma’s dasiglucagon for hypoglycemia in the infants with congenital hyperinsulinism.

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Industry sees push for Ayurveda signals shift towards scientifically validated nutraceuticals

AuroBlog - Aurous Healthcare Clinical Trials blog

The push for Ayurveda, herbal remedies, and nutraceuticals to bridge nutritional gaps reflects a growing interest in holistic health and natural approaches to wellness. In India, healthcare sector has evolved considerably post Covid-19 and there is an increased emphasis on nutraceuticals which have emerged as the way forward.

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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.