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April 24, 2020___

Today's Rundown

Featured Story

Did Gilead's remdesivir flop a Chinese trial? Analysts beg to differ

The World Health Organization accidentally revealed data from a study in China showing that the treatment neither improved patients’ condition nor tamped down on the amount of virus in their blood, the Financial Times reported, calling the trial a “flop.” But was it really a flop?

Top Stories

Sanofi culls pipeline dud, still looking to out-license unwanted later-stage meds

Sanofi is culling a Regeneron-partnered med and still looking for partners for two unwanted pipeline candidates as the Big Pharma continues to reshuffle its R&D priorities.

ORIC pulls off upsized $120M Wall Street debut to bankroll cancer resistance pipeline

ORIC Pharma is the latest biotech to go public since the World Health Organization declared COVID-19 a pandemic. The cancer biotech priced its IPO at the top end of its range, raking in $120 million and eclipsing its $86 million goal.

GSK posts middling data from PD-1 Tesaro buyout drug

GlaxoSmithKline has posted some updated though underwhelming and “clinically meaningful” data from a PD-1 inhibitor it got via its $5 billion Tesaro buyout.

Takeda licenses ProThera plasma drug for use in inflammatory conditions

Takeda has allied with ProThera Biologics to develop a plasma-derived inter-alpha inhibitor proteins (IAIP) therapy for use in acute inflammatory conditions. The deal advances Takeda’s efforts to extract value from the plasma-derived therapy unit it acquired in its $62 billion takeover of Shire. 

Healing the heart by returning it to its infancy

Researchers at UT Southwestern Medical Center discovered that a protein called calcineurin plays a key role in blocking the ability of heart muscle to regenerate after the first week of life. The finding could be used to develop treatments that reverse this process, offering new strategies for repairing hearts damaged by heart attacks, high blood pressure, viruses and more, they said.

Medtronic details COVID-19 impacts, with 60% drop in U.S. sales

As hospitals redirect resources toward COVID-19 and patients put off less-urgent medical procedures and trips to the doctor, Medtronic has seen serious impacts on its bottom line—including a 60% drop in weekly revenue from the U.S., where the medtech giant does most of its business.

FiercePharmaAsia—Gilead's remdesivir trial flop; India's reduced production; Samsung's Herceptin copy

A leaked document suggested Gilead's remdesivir fell short in a Chinese trial in severe COVID-19 patients. A key pharma manufacturing hub in India is suffering from lower capacity due to a local lockdown. Samsung Bioepis has launched its Herceptin biosimilar in the U.S. at a 15% discount. And more.

Chutes & Ladders—Silverback names Synthorx vet Shawver to CEO post

Silverback nabs Synthorx vet Shawver as CEO; PTC brings Klein aboard as CDO; deposed BARDA chief Bright calls out Trump administration.

Resources

[Magazine] Perspective: the patient edition

Report: Think you’re patient-centric? Think again. Find out how patients really feel about patient-centricity. Learn what they would like to experience along with tools and tips for maximising patient engagement across the product life cycle¬ – from clinical trials to service design and creative campaigns.

[GUIDE] Managing Clinical Trial Patient & Site Engagement During COVID-19

Leverage strategic solutions to respond to immediate challenges to patient and site engagement from COVID-19, and learn to maximize the FDA guidance on the conduct of clinical trials during a pandemic.

[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] Successful BYOD in Any Phase

This white paper includes a Phase III case study and discusses BYOD advantages and misconceptions, regulatory, copyright, and equivalency considerations.

[Whitepaper] A Fast Way to Curb Your R&D Spend: Make Failure a Strategy

Turn your drug failures into competitive advantage.

[Whitepaper] Payers’ Perspectives on Digital Therapeutics In-Depth Interviews Reveal What Manufacturers Can Expect

How will US payers evaluate and manage digital therapeutics? Get insights and recommendations on successful market access considerations.

[Whitepaper] Data Integration and the R&D Organization

Despite advances in content aggregation and search, silos still limit the free flow of data and analytics. So, what can be done, and how can you get more value from the data you already have?

[Webinar] Model-Based Approach to Design Bispecific Modalities in Early Discovery

Learn how we used a tiered model-based approach of a bispecific antibody to appropriately cover multiple antigen pairs to help teams with informed antibody design, prioritization of experiments, and triaging of challenging antigen pairs

[Whitepaper] Digital Twins: Creating Digital Operations Today to Deliver Business Value Tomorrow

This whitepaper highlights the challenges of implementing the right digital twin strategy while providing key use cases in the manufacturing domain for which a digital twin is extremely useful and several examples of technology trends that will shape the future.

[Guide] Pandemic Survival Guide --- IT Solutions for Business Continuity

To survive in these challenging conditions, companies need to promptly address business continuity issues - especially the remote delivery of data and voice solutions. See how Outer Edge can help.

[Whitepaper] Ensuring the Greatest Return From Your Poorly Soluble Molecule

Poorly soluble molecules hindering your workflow?

[On Demand] Tufts-eClinical Solutions Data & Analytics Survey Results

Key findings from the 2019 Life Sciences Data & Analytics Survey conducted by the Tufts Center for the Study of Drug Development will be unveiled during this live webinar led by industry expert and study lead, Ken Getz, Director of Sponsored Programs and Associate Professor.

[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.

[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.

[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.

[Executive Summary] Strategies for Flexible Manufacturing

This whitepaper discusses the benefits of end-to-end solutions and share case studies on how flexible manufacturing strategies can accommodate the changing landscape of pharmaceutical products and help bring a drug to market.

[Presentation] Flexible Manufacturing Strategies

Get expert insights on strategies to implement flexible manufacturing and different technologies that are easily scalable and reproducible.

[Executive Summary] Overcoming Manufacturing Challenges for Accelerated Drug Development

Regardless of the assigned FDA expedited approval designation and approach, the key action items should be: the assurance of a detail-oriented plan and the adaption of a “forward-thinking” approach that will assist in any future challenges and opportunities for growth of each project.

[Case Study] Precision Analytics for Product Launch and Growth

Pharma launch teams spend significant resources on data and analytics with limited ROI. Read this case study to learn how a Life Sciences company identified two times more patients best suited for therapy, using Clarify’s deep and longitudinal patient and HCP insights. 

Events