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February 24, 2020___

Today's Rundown

Featured Story

Top 10 biotech IPOs in 2019

The big question at the start of 2019 was whether the IPO window would stay open for biotech companies, particularly those seeking to pull off ever-larger IPOs at increasingly earlier stages of development. The short answer is yes—kind of.

Top Stories

GSK gives Clover adjuvant for vaccine against 'indispensable' COVID-19 protein

GlaxoSmithKline has struck a deal to provide its pandemic adjuvant to Clover Biopharmaceuticals for use in a COVID-19 vaccine candidate. Clover is one of a clutch of organizations working to tackle COVID-19 by targeting a protein the novel coronavirus needs to enter host cells.

NGM’s NASH drug cuts liver fat, inflammation, scarring in phase 2, shares surge

Last fall, NGM Bio unveiled data from a small group of patients showing its NASH drug cut liver fat in a phase 2 study. Now, the company is reporting results for all 78 patients in the study, showing the treatment beat placebo at reversing liver scarring and inflammation, as well as reducing liver fat buildup.

[Sponsored] Executive Interviews at J.P. Morgan 2020

FierceBiotech sits down with some of the most informative industry leaders at JPM 2020.

Kadmon drops detailed look at cGVHD data; analysts see 'underappreciated potential'

Kadmon has posted positive and more detailed data out of its so-called ROCKstar pivotal trial of KD025 in chronic graft-versus-host disease.

Grifols buys antibiotic assets from bankrupt partner Aradigm

Grifols has struck a deal to buy assets from bankrupt antibiotic developer Aradigm. The agreement sees Grifols waive a $32 million debt and pay $3 million in cash to take full ownership of three assets.

Repurposing Astellas' and Novartis' leukemia drugs in resistant lung cancer

University of Toronto researchers used a live-cell-based screening system to identify drugs that can enter cells and target EGFR mutations in lung cancer. In so doing, they discovered that Astellas’ Xospata and Novartis’ Rydapt, both approved to treat leukemia, may be useful in treating lung cancer patients who have developed resistance to EGFR inhibitors.

Sophia Genetics taps ex-Foundation Medicine CEO as chairman

The former CEO of the molecular testing company Foundation Medicine, Troy Cox, has been named chairman of the Swiss big data firm Sophia Genetics after serving on its board of directors for less than a year.

Esperion scores FDA nod for cholesterol-buster Nexletol

Esperion has had a rocky road to approval for its LDL-cholesterol-lowering drug Nexletol after a late-stage trial in 2018 threatened to derail its quest. But after backing its drug up with strong safety data, Esperion has the green light to go to market. 

Resources

[Whitepaper] Navigating Today’s Healthcare Transformation: The Evolution of Payers

Read about the innovative ways payers are making smart moves in the healthcare game.

[Whitepaper] One-step Specs and Design 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%.

[Video] FierceBiotech Sits Down With H1

Biopharma companies don't want to go to market with a product no one knows about. H1 has homed in on the often time-consuming research and engagement phases that companies must ace for a successful launch, said Ariel Katz, co-founder of H1.

[Whitepaper] The ROI of Document Delivery

3 ways you may be overspending on scientific literature access, and how to fix them.

[Whitepaper] Successful BYOD in Any Phase

Download this free white paper to learn how a BYOD ePRO approach is beneficial to your trial.

[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.

[Video] FierceBiotech Sits Down With Accenture

Kevin Julian, senior managing director of Accenture’s life sciences practice, recently sat down with FierceBiotech to discuss market trends and Accenture’s new technology platform, INTIENT. 

[Whitepaper] Science-based Training Ensures 90%+ Adoption Rates for Software Deployments and Business Processes

Mediocre adoption rates aren’t due to poorly designed software or lazy users. They’re the result of how skills are trained. Achieve high adoption rates for Veeva, Workday, Microstrategy or any software platform by implementing the right methodology with a focus on behavior change.

[Whitepaper] Achieving Differentiation in the Complex Oncology Market

White paper describing how a biopharma company can successfully differentiate an oncology product when the clinical profile alone is not enough to get the job done.

[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?

[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