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March 12, 2020___



Editor's note: We're sorry we're late! Technical difficulties delayed the send of some of our newsletters today. We appreciate your readership.


Today's Rundown


Featured Story

Was it something he said? Biotech CEO who met Trump this month exits without a word

Daniel Menichella started the month as CureVac CEO, one of the privileged few to discuss the coronavirus response with the U.S. president and kick-starting a vaccine trial against COVID-19.


Top Stories

How do you get acquired by Gilead? Forty Seven explains

Just before Christmas and, critically, after announcing some positive data, Forty Seven sat down at Gilead Sciences' HQ with its C-suite to talk M&A.

Harbour BioMed reels in $75M as proprietary pipeline hits clinic

Harbour BioMed has raised $75 million to continue moving multiple candidates through the clinic. The round, which Harbour described as a “series B+,” comes shortly after the antibody specialist took its first internally originated candidate into the clinic outside of greater China.

PDL Biopharma mulls a sale, pledges to dissolve by end of 2020

Back in December, PDL Biopharma decided to call it quits. The onetime antibody developer weighed options to “unlock the value of its portfolio,” and now, has arrived at a plan to completely liquidate the company and dissolve it by the end of the year. PDL’s board approved the plan in February.

Kymera marches protein-degrading drugs toward clinic with $102M raise

Kymera Therapeutics is plotting a big transition in 2020. After spending four years building the company around its protein degradation technology, it’s setting its sights on the clinic—and it’s just bagged $102 million to do so. The new capital will move up to three programs into the clinic in 2021.

Aldeyra halts trials, focuses on ocular assets to stretch runway

Aldeyra Therapeutics has halted clinical development of two systemic disease programs to stretch out its cash runway to the end of next year. The action is intended to enable Aldeyra keep pushing its ocular disease programs through late-phase development despite its falling cash reserves.

Bayer and MassBio teach startups regulatory ins and outs at new center

Bayer and the Massachusetts Biotechnology Council are this week opening a regulatory best practice center for start-up biotech and digital health companies. Their goal? Get new drug developers to start thinking about regulatory requirements earlier.

How Gilead's blood cancer med Zydelig might also address triple-negative breast cancer

Triple-negative breast cancer is hard to treat, because it lacks common markers for drugs to target. Now, instead of going after the tumors directly, a research team led by the University of Sussex has found a target in their surrounding environment and identified Gilead's FDA-approved blood cancer med Zydelig as a possible treatment.

FDA approves Roche HPV test add-on for identifying women with higher risk of cervical cancer

The FDA approved Roche’s diagnostic for triaging women whose primary cervical cancer screenings have tested positive for the human papillomavirus (HPV). The company’s CINtec PLUS Cytology test is designed to identify women with HPV infections who are most likely to develop cervical pre-cancers.


Enrollment Showcase

What's the value of an MBA to healthcare and the life sciences?


Prepare to step up in your career, build the expertise you need to reshape your organization, and explore opportunities worldwide.


Resources

[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.

[Whitepaper] Why BioPharma Co’s Leverage the Cloud to Gain Competitive Advantage


See why innovative BioPharma’s are partnering with Cloud Service Provider’s to design, manage and implement cloud strategies to smooth the path to FDA approval and enhance their competitive prowess. 

[Whitepaper] Create A More Compelling Program Development Dossier With Metabolomics


Metabolomics can help you streamline your drug development process by providing the framework to make a stronger, more confident, and more valuable case for a molecule in a shorter timeframe.

[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] The ROI of Document Delivery


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

[Whitepaper] Manufacturing Cytotoxic and Non-Cytotoxic


When different drug products are produced in shared facilities, potential for cross-contamination needs to be addressed.  Outsourcing to a CMO with experience in multiproduct facilities can be an option.

[Whitepaper] Measure the Right Things at the Right Time: Using A Metric Maturity Model to Optimize Performance Measurement


Ineffective measurement could mean wasting both time and money. This whitepaper showcases a custom-built Metric Maturity Model that helps illustrate and define the process for measuring the right things the right way.

[Whitepaper] Strategies for Improving Software Deployments and Business Processes Adoption Rates


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 by implementing the right methodology with a focus on behavior change.

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


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

[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] 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] 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.


Events