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December 04, 2019___

Today's Rundown

Featured Story

Pfizer Ventures helps gamma delta player ImCheck to $53M round

Pfizer Ventures has co-led a $53 million (€48 million) series B investment in ImCheck, a developer of antibodies focused on gamma delta T cells. ImCheck will use the money to move its lead candidate into the clinic in patients with solid and hematological cancers.

Top Stories

Deerfield unveils Civetta with $53M to tackle propeller proteins in cancer

Civetta Therapeutics is launching with tech from the Broad Institute and Dana-Farber Cancer Institute, as well as $53 million to develop drugs targeting beta-propeller proteins. Naturally, the company’s first focus will be cancer, but the approach could be useful in other areas, such as neurodegenerative disease.

Rapt edges into Asia with Hanmi I-O deal worth up to $118M

Rapt Therapeutics is gaining a development partner and a foothold in Asia through a partnership potentially worth $118 million. The biotech is handing Hanmi the rights to its lead cancer program in South Korea and greater China in exchange for $10 million upfront and the promise of millions more in milestones.

[Sponsored] Thwarting Subjectivity in Clinical Trials

A clinical trial is a measurement system, but too often, we fail to calibrate the most significant of measurement instruments: trial participants.

Omeros hits endpoint in pivotal stem cell transplant study

A pivotal trial of Omeros’ narsoplimab in hematopoietic stem cell transplant patients has hit its primary endpoint. Omeros expects to use the data to win FDA approval, although secrecy around the design of the trial means there remains scope for skepticism about the results.

Biostage's regenerative esophagus implant placed on FDA hold ahead of clinical tests

Biostage’s lab-grown replacement esophagus candidate has been placed on a clinical hold by the FDA as the company works to field questions from the agency before beginning initial human testing.

Enrollment Showcase

Webinar, Dec. 3 | Precision Medicine Insights: Patient Safety

University of Florida precision medicine leaders highlight current knowledge and trends to advance the future of health care in this new webinar series. Register today.

Resources

[Whitepaper] Q2 2019 Life Sciences M&A notes and trends

Get your copy of the Q2 2019 Life Sciences M&A notes and trends to understand the mergers and acquisitions (M&A) activity in the life sciences sector which drove 136 new M&A deals and provides a forward look to 2020 activity ahead.

[Whitepaper] What You Need to Know to Avoid Costly Delays in Your API Scale-Up

Are you facing costly delays in your API scale-up?

[Whitepaper] Innovative Funding Models for Treatment of Cancer and Other High-Cost Chronic Noncommunicable Diseases

This global landscape study identifies and assesses innovative funding models for cancer and other high-cost chronic NCDs across Africa, Asia, Europe, Latin America and Middle East. The study aims to enable readers to better understand the possibilities that innovative funding models bring to bridge the current and future funding gap, while stressing the key success factors that enable sustainability and success such as stakeholder collaboration.

[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.

[Whitepaper] Modernizing clinical trials with Amazon Web Services (AWS)

From IoT to data management to high-performance computing and machine learning, leading life sciences organizations are using Amazon Web Services (AWS) to develop scalable, global, predictable, and secure solutions to modernize clinical trials while mitigating risks

[Whitepaper] Why Companies Leverage the Cloud to Smooth the Path to FDA Approval

See why visionaries outsource the design and management of the infrastructure allowing their scientists to innovate.

[Whitepaper] Medical Affairs 2025 Excellence in the Era of Precision Medicine

Medical Affairs 2025 brings together leading perspectives from AstraZeneca, Bristol-Myers Squibb, Merck, Lilly, and other innovative life sciences organizations on key challenges impacting medical affairs and a roadmap for success in the coming decade.

[Whitepaper] The State of Real-World Evidence in Biopharma

This whitepaper provides a snapshot of where the biopharma industry is now, where it's heading, and how companies are allocating their resources to adapt & grow.

[Whitepaper] IBM Clinical Development: Key solutions for more efficient clinical research

IBM’s highlighted solutions reside in a security-rich cloud environment—home for capturing, managing and analyzing clinical study data with control, accuracy and confidence. These solutions lay the groundwork for further integration with IBM® Watson® cognitive technology.

[Whitepaper] How Big is the US Market for Medical Devices and Technologies?

Inpatient View and Outpatient View are powered by robust data assets and use sophisticated projection methodologies to help ensure accuracy of reporting.

[Whitepaper] The importance of early key opinion leader outreach in the biologics and biosimilars marketplace

Acknowledging various stakeholder networks, as well as recognizing variances within the regulatory environment, we believe, is essential for companies looking to uncover the right decision-makers in support of biologics or biosimilars. Learn more.

[Whitepaper] 5 Best Practices for Marketing Medical Devices

Discover solutions to the most common challenges faced by medical device companies.

[Whitepaper] The Impact of Step-Therapy Policies on Patients

Download this complimentary paper that explores the practice of step therapy and its impact on key stakeholders in the US healthcare system.

[Whitepaper] How to succeed by failing faster

This white paper examines the skyrocketing cost of drug development and provides step-by-step guidance for executing a successful fail fast strategy.

[Case Study] Clinical Supply Management

Download the case study to learn about the clinical supply management tools that helped a small sized pharma company during phase III of a multi-arm oncology study.

[Video] Demand Led Services and Clinical Supply Efficiency

Watch a short video on demand led supply model. It is designed to meet the needs of patients, clinical sites, clinical team and sponsors and results in shorter lead time, less waste, less stock out risk and no booklet labels.

[eBook] Strategies for Efficient Clinical Supply Management and Forecasting

Download the eBook to explore a proactive approach for clinical supply management.

Events