Sat.Nov 04, 2023 - Fri.Nov 10, 2023

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What if a CRISPR cure isn’t such an easy choice?

Bio Pharma Dive

A gene editing therapy developed by Vertex Pharmaceuticals and CRISPR Therapeutics can mute sickle cell disease’s most damaging symptoms. Yet treatment may not be as simple as its dramatic benefit makes it seem.

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Navigating the Challenges of Clinical Trial Design

BioSpace

Navigating the Challenges of Clinical Trial Design - read this article along with other careers information, tips and advice on BioSpace

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Bayer CEO Anderson says 'radical realignment' is underway

Fierce Pharma

In three years as the pharma chief at Roche, Bill Anderson executed a massive overhaul of the division, lopping off layers of management and recharting its course. | In three years as the pharma chief at Roche, Bill Anderson executed a massive overhaul of the division, lopping off layers of management and recharting its course. Now in his fifth month as CEO at struggling conglomerate Bayer, Anderson is focused on an even larger renovation, saying the company is on its way to a “radical realignme

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Travere Touts Phase III Kidney Disease Data for Filspari After Trial Failures

BioSpace

Following two late-stage failures, Travere Therapeutics has unveiled the results of two Phase III studies, attempting to regain Filspari’s footing in IgA nephropathy and focal segmental glomerulosclerosis.

Trials 112
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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100th patient joins ChariotMS trial for multiple sclerosis

Pharma Times

The trial is testing whether Mavenclad could benefit upper limb movement in MS patients - News - PharmaTimes

Trials 131
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Biogen says growth is coming, but won’t specify when

Bio Pharma Dive

CEO Chris Viehbacher said the company has “the elements to think about a return to topline growth.” Yet, that goal hinges on the successful commercialization of multiple new products.

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Professionals and Patients Offer Mixed Views on Retail Pharmacy Chains’ Enthusiasm About Trials

ACRP blog

As several retail pharmacy chains proclaim a rosy outlook for ongoing efforts to expand their services into the clinical trials arena in the wake of the pandemic, traditional study site personnel and patients interviewed on the topic offered more mixed and nuanced concerns about the prospects for near-term success for such ventures. “With retail pharmacies entering the clinical trial space, investigative sites are left with little information around how this move will affect them or their patien

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FDA approves Takeda’s Adzynma for rare blood clotting disorder

Pharmaceutical Technology

The US FDA has granted approval for Takeda’s Adzynma for congenital thrombotic thrombocytopenic purpura, a rare blood clotting disorder.

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Lilly weight loss drug approved by FDA

Bio Pharma Dive

The pharmaceutical company will sell the GLP-1 drug, branded as Zepbound, at a list price about 20% lower than Novo Nordisk's competing drug Wegovy.

Drugs 300
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There’s an Important Reason Disturbed Sleep Makes Everything Hurt More

AuroBlog - Aurous Healthcare Clinical Trials blog

Ever feel like everything hurts after not getting enough sleep? A new study reveals a neurotransmitter involved in the pain that sleep deprivation causes, indicating a potential new target for treatment. In sleep-deprived mouse models, the neurotransmitter N-arachidonoyl dopamine (NADA), an endocannabinoid, was reduced in one brain region linked to sensory processing and arousal.

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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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3 Considerations of the Patient Perspective from the 2023 Pain Therapeutics Summit

Worldwide Clinical Trials

Pain for chronic patients is not merely a condition they must manage but a social dynamic with various feelings and opinions. Its psychological impact is often understated, though it carries the same weight as pain’s physical effects. At this year’s annual Pain Therapeutics Summit , which took place in San Diego, CA, October 19 to 20th, I heard brilliant presentations on novel pain medication development, targeted discoveries, pain classifications, the NIH HEAL Initiative , trial designs, biomar

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Cloud in pharma: Q&A with GlobalData thematic analyst

Pharmaceutical Technology

GlobalData analyst Jemima Walker discusses key topics around cloud computing for the pharmaceutical industry.

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An obesity drug biotech gets buy-in from Eli Lilly, venture firms

Bio Pharma Dive

Startup OrsoBio raised $60 million in a Series A round co-led by Longitude Capital and Enavate Sciences, and joined by the pharma’s venture arm.

Drugs 286
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Huge Study Implicates Salt in Type 2 Diabetes, But Let’s Look At The Facts

AuroBlog - Aurous Healthcare Clinical Trials blog

When people think of foods related to type 2 diabetes, they often think of sugar (even though the evidence for that is still not clear). Now, a new study from the US points the finger at salt.

Research 208
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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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My Military Experience Was a Springboard to Career Success

Worldwide Clinical Trials

As someone who joined the military right after high school, I can say that it was one of the best decisions I ever made. My nearly perfect score on the Armed Services Vocational Aptitude Battery Test (ASVAB) qualified me for three positions, and I ended up taking the one that required a top-secret/SCI security clearance – as a Record Telecommunications Center Operator.

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AstraZeneca posts 16% drop in Q3 2023 profit after tax

Pharmaceutical Technology

AstraZeneca has posted a profit after tax of $1.37bn for Q3 2023 versus $1.64bn in the same quarter of the previous year, a decline of 16%.

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Biogen, Sage set price of postpartum depression pill at $15,900

Bio Pharma Dive

The price is below what some analysts had predicted and significantly less than $34,000 Sage initially set for its earlier postpartum infusion, Zulresso.

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FDA to Finally Outlaw Soda Ingredient Banned Around The World

AuroBlog - Aurous Healthcare Clinical Trials blog

An ingredient once commonly used in citrus-flavored sodas to keep the tangy taste mixed thoroughly through the beverage could finally be banned for good across the US.

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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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With FDA approval, Eli Lilly's weight-loss drug Zepbound arrives to challenge Novo Nordisk

Fierce Pharma

In the Big Pharma battle to treat obesity, Novo Nordisk sprinted to an early lead, but Eli Lilly is catching up quickly. | In the Big Pharma battle to treat obesity, Novo Nordisk sprinted to an early lead, but Eli Lilly is catching up quickly. Wednesday's FDA approval of Lilly's Zepbound to treat obesity closes the gap further. In addition, Lilly said it will charge 20% less than Novo for its obesity med in an attempt to provide increased access.

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Cell & gene therapy: the leading companies in rAAV production technology revealed

Pharmaceutical Technology

GlobalData uncovers the leading innovators in rAAV production technology for the pharmaceutical industry.

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Atara’s cell therapy approach to MS falls short in study

Bio Pharma Dive

Shares in the biotech tumbled by 75% as results from a Phase 2 trial showed more improvement in participants given a placebo.

Trials 278
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Millions of Women Feel Severe Pain From This Condition. Why Don’t We Talk About It?

AuroBlog - Aurous Healthcare Clinical Trials blog

Endometriosis causes physical, sexual and emotional pain. About 190 million people around the globe have endometriosis, including one in 10 American women, but there has historically been a deafening silence about the disease and the pervasive impact it can have on a person’s life.

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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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A guide to clinical trial phases [infographic]

Antidote

Before any new treatment or therapy is able to be used by the patient population, it must go through the process of a clinical trial — this is the case for any new prescription drug, but also true for over-the-counter medications, medical devices, and more.

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Mirati wins conditional UK approval for Krazati in NSCLC

Pharmaceutical Technology

Krazati received conditional marketing authorisation as a second-line treatment of KRAS-G12C mutated locally advanced or metastatic NSCLC.

Marketing 162
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Flagship expands into Asia-Pacific with new Singapore hub

Bio Pharma Dive

The biotech company creator hopes its new office will help its portfolio companies grow and strike partnerships in the region.

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NPP to tap international collaborations, enhancement of supply chain infrastructure to support pharma growth

AuroBlog - Aurous Healthcare Clinical Trials blog

In an effort to ensure a stable and cost-effective supply chain for active pharmaceutical ingredients (APIs) in the country, the Department of Pharmaceuticals (DoP) may look at tapping the potential of international collaborations for sourcing of raw materials and manufacturing of ingredients in the country.

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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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AbbVie, AstraZeneca, Boehringer and more face FTC's ire for 'improper' patent listings

Fierce Pharma

Pharma, you were warned. | Only two months after the Federal Trade Commission said it was eying a crackdown on improper patents listed by the FDA, the agency has filed challenges against more than 100 patents in the agency's Orange Book. The companies have 30 days to respond.

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AAO 2023: Apellis Pharmaceuticals reveals GALE extension study results for Syfovre

Pharmaceutical Technology

At AAO 2023, results were presented from the Phase III GALE trial, evaluating Apellis Pharmaceuticals’s Syfovre to treat geographic atrophy (GA).

Trials 147
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CAR-T biotech Cargo Therapeutics prices $281M IPO

Bio Pharma Dive

Cargo Therapeutics is the seventh oncology biotech to successfully price an IPO this year.

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TN DCA initiates action against use of diclofenac & aceclofenac in veterinary treatments to control death of vultures

AuroBlog - Aurous Healthcare Clinical Trials blog

The Tamil Nadu Drug Control Administration (TN DCA) has initiated action against the use of analgesic and anti-inflammatory drugs, diclofenac and aceclofenac, in veterinary treatments on account of sharp decline in vulture population in the forest areas of the state.

Drugs 157
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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.