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Today's Rundown

Featured Story

Novartis targets Alexion's fiefdom after showing PNH patients can safely switch from Soliris

Novartis has presented midphase data showing paroxysmal nocturnal hemoglobinuria patients can safely transition from Alexion’s Soliris to its experimental oral candidate LNP023.

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Top Stories

Ionis strikes deal to buy back lipid disease spinout Akcea

Ionis Pharmaceuticals has struck a deal to buy its lipid disorder spinout Akcea Therapeutics. The deal will see Ionis pay around $500 million to acquire the 24% of Akcea that it doesn’t already own.

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The top 10 global R&D institutes

Many new drugs and diagnostics would never have seen the light of day if it wasn’t for academic and R&D institutes. Our top 10 are the most prolific when it comes to collabs and research pacts with the life sciences industry, with many big-name scientists and alumni working at biotech spin-outs from our leading institutes.

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ILC: Clinical failure or course correction? Gilead’s NASH programs could be both

2019 was not a good year for Gilead’s fatty liver programs. Its lead prospect did worse than placebo in not one, but two, phase 3 studies, while its combination treatments also fell short in phase 2. It’s not letting those efforts go to waste, though—in studies presented at this year’s virtual International Liver Congress, Gilead and partner PathAI suggest improvements to NASH drug development.

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ESC: Novartis' twice-yearly inclisiran cuts bad cholesterol by at least 30% in nearly all patients

Despite pandemic-related setbacks in its clinical program earlier this year, Novartis has continued to stack up favorable data for its cholesterol drug inclisiran—with a new analysis showing 99% of treated patients cut their LDL levels by 30% or more.

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Unum's CAR-T tech—and research team—lands at Czech biotech Sotio for $8.1M

It’s no secret that Unum Therapeutics has had a tough run—in March, the company cut more than half its staff and wound down its clinical work in a bid to shore up a preclinical CAR-T prospect. Now, that program, along with the technology behind it, has found a new home: Sotio, a Prague-based biotech developing multiple types of cancer treatments.

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ESC: MyoKardia's mavacamten boosts heart function in phase 3, teeing up 2021 filing

A phase 3 pivotal trial of MyoKardia's mavacamten has demonstrated that the first-in-class drug can perform as a disease-specific therapy for hypertrophic cardiomyopathy, or HCM, by preventing the thickened heart muscle associated with the disease from obstructing the flow of blood.

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ILC: GSK's antisense hep B hopeful hits positives in midstage test, rivaling RNA therapies

While the likes of Vir and J&J were highlighting their RNAi approaches to treating hepatitis B at the International Liver Congress this week, GlaxoSmithKline and Ionis quietly dropped their data using a rival MOA.

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Musk's Neuralink demos revamped brain-reading chip in live pigs

Elon Musk’s brain-burrowing Neuralink venture has debuted the latest version of its mind-reading chip, showing it can work in live animals.

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Cats point the way to potential COVID-19 remedies

University of Alberta scientists reported that a drug being developed by Anivive Lifesciences to treat feline infectious peritonitis prevented human coronaviruses from replicating in cell studies. They believe the drug should be rushed into human trials to treat patients with COVID-19, given that it has proven safe and effective in cats.

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Enrollment Showcase

Bioscience Certificate Pathways Advancing Knowledge, Skills, & Careers

Taught by experienced professionals, Biotility’s online short courses provide the knowledge and practical skills valued by the bioscience industry. Enhance your career through coursework in one of our certificate pathways, including Document Management, Operations Management, and Quality Management. Learn more.

Resources

Whitepaper: Accelerating the Development of Orphan Drugs for Rare Diseases

This white paper will discuss four principal CMC challenges for the developers of orphan drugs, and the potential solutions which are emerging. Download now >>

Case Study: QED Therapeutics accelerates launch of rare cancer drug into niche market with analytics-driven insights

In 2020, QED Therapeutics launched first-in-class infigratinib for cholangiocarcinoma (CCA). Learn how the launch team precisely identified and characterized eligible patients by taking an evidence-based approach to its commercial strategy.

Whitepaper: A Guide to Improving Your R&D Data Maturity

Life science R&D generates a LOT of data. Learn how to make sense of it and harness its potential with this step-by-step guide.

Whitepaper: How Broadening the Analysis of Compound Factors Allows for Predictive Solubility Solutions

Don’t oversimplify your solubility challenges.

Whitepaper: Reducing Site Workload for Better, Faster, Safer Clinical Trials

Download this free whitepaper to learn how to execute fast, high-quality clinical trials through eSource for studies that boost efficiency for both sponsors and sites.

Whitepaper: Learn How Collaboration (Not Competition) Will Bring Better Pediatric Medicines to Market

Drug developers and stakeholders must find ways to collaborate, rather than compete, as the RACE Act prompts the need for more pediatric research.

Whitepaper: Achieving a Successful Drug Product Technology Transfer

Get insights on key considerations for a successful tech transfer process for manufacturing a biologic drug product, including a case study on overcoming challenges in a process transfer for a sterile diluent.

Whitepaper: Avoid Fallout From Incompatibility Between Your API And Its Formulation

Download the whitepaper to learn more.

Webcast: DRUG ABUSE LIABILITY ASSESSMENT: Are you taking an integrated approach?

Two informative webcasts will present practical and methodological approaches to preclinical drug abuse liability assessment

Whitepaper: Top 7 Data Points from Medical Claim Forms to Drive Market Development

Traditionally, pharma companies use a combination of prescription data & internal sales reports to look for potential buyers. Such practice provides only a LIMITED VIEW without competitor information.

Whitepaper: New data models to gain insight on medication adherence

Download the whitepaper by Optum to see how novel data platforms can uncover hidden insights on medication adherence helping life sciences companies maximize product utilization.

Report: Decentralized Trials - Where Does the Industry Stand?

Patient-facing digital technologies are playing an important role in clinical trials for new drugs and medical devices, to the point where conducting virtual trials is becoming mainstream. But terms like remote trials, direct-to-patient trials, hybrid trials, decentralized trials, and more all add to the confusion of what makes a trial "virtual."

Whitepaper: Navigating the Changing Clinical Trial Landscape

The research conducted here is to help understand and solve the top challenges in clinical operations, to remove barriers that are slowing down our ability to bring new drugs to market as quickly as possible to patients waiting in need.

Whitepaper: Choosing the Best Sterile Dosage Form for Your Phase I Clinical Supply Needs

How to select the right dosage form for your Phase I clinical supply.

Whitepaper: Quality by Design: A Holistic Approach to Drug Development

Quality by Design (QbD) reduces risk within drug development, while bringing therapies to market quicker.

Executive Summary: Keys to a Successful Rapid Commercial Launch

Pharmaceutical and biotech companies are spending years developing drugs or promising new biologics, all with the hopes of saving or enhancing patients’ lives. It’s a “race to the finish” in some cases, and the quicker a company can get its product to patients, the better.

Whitepaper: More Powerful Analytics Capabilities

Case Study: Oncology-focused pharmaceutical company strengthens product launch by identifying hundreds of high-value physicians with Acorn AI.

eBook: Navigating the Insulin Affordability Act

Download the whitepaper for a solution designed to connect manufacturers, pharmacists, and patients. In this special guide, you will learn not just about the law but about the portal platform designed to change the entire process for all.

Whitepaper: Reducing the Complexity and Costs of Channel Planning and Logistics

Identifying opportunities to simplify channel strategies and business processes for biopharma companies, their customers and patients.

Whitepaper: The Art of Recognizing Clinical Supply Risk Factors

In a BioPharma Dive industry survey, planning and forecasting were identified as top concerns for trial sponsors. In response to this need, the CSM team at Catalent has developed a methodology for identifying, evaluating, and proactively managing the inherent risks involved in clinical trial supply chain management.

Case Study: Establishing Parameters for Success

Learn about a real-world example of how clinical supply management expertise was applied to overcome inventory challenges for a complex, global study.

Fact Sheet: Forecasting to Optimize Clinical Trial Supply Management

Whether a study is simple or highly complex, forecasting and simulation reports serve as data driven communication tools to help minimize risks and keep the study on track. Learn more about forecasting solutions for informed decision making and supporting contingency planning for clinical study.

eBook: Expecting the Unexpected: Strategies for Efficient Clinical Supply Management and Forecasting

Learn how to drive excellence within the forecasting process and utilize forecasting throughout the clinical study to better plan clinical supply budgets and project timelines. Explore how to identify potential supply-related issues before they can negatively impact your study.

Events