To view this email as a web page, click here

   Home

Subscribe

Advertise

 

 

 

 

February 12, 2020___

Today's Rundown

Featured Story

J&J allies with BARDA to accelerate coronavirus vaccine program

Johnson & Johnson has teamed up with the U.S. Biomedical Advanced Research and Development Authority (BARDA) to develop a vaccine against coronavirus. J&J is pooling money and resources with BARDA in an attempt to accelerate the progress of a vaccine candidate into phase 1 development.

Top Stories

Bayer moves 400 R&D jobs to CRO-run small molecules unit

Back in 2018, Bayer mulled outsourcing R&D as part of a greater restructuring. Now, the company is pulling the trigger on that plan, transferring 400 staffers to a “full-fledged research center” to be set up by Nuvisan, a German CRO, in Berlin. The deal is slated to close by the middle of this year.

ALX raises $105M for midphase trials of CD47 cancer drug

ALX Oncology has raised $105 million. The series C round will support phase 2 trials of CD47 myeloid checkpoint inhibitor ALX148 in combination with other anti-cancer therapies.

Ligand snags Roche-partnered drug in Icagen buyout

Ligand Pharmaceuticals has acquired a Roche-partnered program from Icagen. The deal comes a little more than one year after Roche and Icagen entered into a drug discovery pact aimed at neurological disorders.

Attacking pancreatic cancer with the help of the virus that causes foot-and-mouth disease in cows

Pancreatic cancer remains difficult to treat, with a five-year survival rate of around 10%. While looking for ways to tackle the deadly tumor, scientists at Queen Mary University of London, AstraZeneca and ADC Therapeutics identified an unexpected ally: the virus that causes foot-and-mouth disease in cows.

Calling vaccine makers: Moderna, NIH need a partner to produce their coronavirus shot

Moderna and the NIH put their coronavirus vaccine R&D into high gear. But the partners need a manufacturer, and no major pharma has stepped up. Why? Companies might not want to sacrifice capacity for their own profit-making vaccine prospects.

New startup uses fine retinal movements as a window into brain health

By measuring the minuscule motions of the human eye—and tracking the movements of the retina on a cellular level—a startup hopes to open new windows into a person’s neurological health.

Resources

[Whitepaper] Regulatory agencies provide insights and concerns for eConsent study

To conduct a successful trial, do you need to understand the global eConsent Regulatory landscape?

[Whitepaper] Computer Software Assurance: What You Need to Know About FDA’s Upcoming Guidance

Details on the FDA’s upcoming Computer System Validation guidance

[Whitepaper] Fusing Specifications and Design for Data Collection Casebooks with Veeva Vault EDC

Learn how data management teams at ICON, Bioforum, and Vertex Pharmaceuticals are creating the spec and casebook in a single step, reducing study build times and effort by over 50%.

[Whitepaper] Assessing the Financial Impact of Translational Pharmaceutics®

Tufts Center for the Study of Drug Development (CSDD) white paper sharing study results that indicate Quotient Sciences’ Translational Pharmaceutics® platform reduces development times by more than 12 months and lowers R&D costs by more than $100 million per approved new drug, compared to traditional multi-vendor development paradigms.

[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.

[Executive Summary] Clinical Supplies - Made to Order

Learn how recent innovations in demand-led supply and direct-to-patient distribution are converging to create a next-generation clinical supply chain that is flexible, lean and most importantly patient-centric.

[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.

[Q&A] Embarking Upon the Commercial Manufacturing Journey for a Biologic

In this Q&A, four Catalent Biologics experts share how scale-up, regulatory expectations, demand forecasting and process validation all play a role in the success of a biologic when embarking upon the commercial manufacturing journey.

Events