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April 10, 2020___

Today's Rundown

Featured Story

BioCryst starts COVID-19 trial of broad-spectrum antiviral

BioCryst Pharmaceuticals has begun enrolling COVID-19 patients in a clinical trial of its antiviral drug galidesivir. The trial builds on in vitro evidence that the adenosine nucleoside analog is effective against pathogens including the MERS and SARS coronaviruses. 

Top Stories

Arix cuts costs, changes leadership team to hunker down

Arix Bioscience has overhauled its leadership to help it hunker down and survive the current turmoil. Naseem Amin, formerly of Biogen and Genzyme, is stepping up to the executive chairman position to lead the biotech investor through a potentially tricky period.

CalciMedica moves inflammation-targeting COVID-19 drug into phase 2

The FDA green-lighted a clinical trial for CalciMedica’s CRAC channel inhibitor in patients with severe pneumonia caused by COVID-19. The drug, CM4620-IE, is designed to settle down an overactive immune system to reduce inflammation, CalciMedica Chief Medical Officer Sudarshan Hebbar, M.D., told FierceBiotech.

Cancer biotech Oncoceutics loses CEO, chair and co-founder

Oncoceutics’ chairman and CEO Wolfgang Oster has abruptly left the biotech, leaving COO Lee Schalop, M.D., as its new leader.

China's CanSino Bio advances COVID-19 vaccine into phase 2 on preliminary safety data

In the global race to develop an effective vaccine to protect people against the novel coronavirus, China’s CanSino Bio has leapt ahead. The biotech has started enrollment activities of a phase 2 trial testing its recombinant shot, Ad5-nCoV, in healthy volunteers in the city of Wuhan.

U.S. government issues $1.1B in ventilator contracts to Philips, GM

The U.S. federal government has tapped Philips to manufacture hospital ventilators for critical COVID-19 care, with the company planning to double its production by May—while the automaker General Motors has been contracted to deliver 30,000 by the end of August.

EuroBiotech Report—AZ, GSK in COVID-19, $8B funding call, CRUK cuts and Evotec

In this week's EuroBiotech Report, AstraZeneca, GSK share COVID-19 updates, Wellcome sounds alarm on panedmic funding and Evotec. 

FiercePharmaAsia—Takeda-CSL coronavirus tie-up; Qiming's $1B VC fund; Fujifilm's Avigan COVID-19 trial

Takeda has partnered with CSL Behring and others to focus on a single, unbranded plasma-based COVID-19 therapy. China's Qiming Venture, backer of CanSino and Zai Lab, has raised $1.1 billion in VC fund. Fujifilm will test Avigan in a U.S. COVID-19 phase 2 trial. And more.

Chutes & Ladders—Immunomedics taps Ipsen exec Semerjian as CEO

Ipsen vet Semerjian joins Immunomedics as CEO; von Moltke joins Seres as CMO; Fierce 15 winner Aravive taps McIntyre as CEO.

Resources

[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.

[eBook] 9 Ways to Enhance Healthcare Customer Experiences

Download this e-book to learn 9 ways to enhance the customer experience within healthcare marketing.

[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