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December 12, 2019___

Today's Rundown

Featured Story

Gilead's Kite files for FDA approval of second CAR-T therapy

Gilead’s Kite has filed for FDA approval of its second CAR-T cell therapy. Kite hopes to win approval for KTE-X19 in mantle cell lymphoma on the strength of midphase results linking it to a 67% complete response rate.

Top Stories

Compass guides magic mushroom drug through early safety test

A synthetic form of the active ingredient in magic mushrooms has cleared an early-phase trial. The drug, Compass Pathways’ COMP360, came through the placebo-controlled phase 1 without setting off any safety alarms, setting the stage for further tests in treatment-resistant depression. 

Pyxis Oncology nabs Pfizer spin-off founder as new CEO

Pfizer’s 2017 spin-out company SpringWorks has lost president and founder Lara Sullivan, M.D. who has moved over to Pyxis Oncology as its new chief and director.

Canaan Partners promotes Julie Grant to general partner

Julie Grant came to life sciences because she was hospitalized a lot as a child. She is the fourth woman to join Canaan’s ranks of general partners. She joins Maha Ibrahim, who focuses on technology investments, and Nina Kjellson and Wende Hutton, who both focus on healthcare.

Almirall taps Iktos for AI drug discovery work

Almirall is enlisting Iktos to speed up drug design for its discovery programs. Under the deal, the pair will use Iktos’ AI technology to design new compounds that tick multiple drug criteria boxes. Almirall is not disclosing the number of programs the duo is working on, nor is it sharing which disease areas they target.

By turning stem cells into brain cells, Aspen Neuroscience hopes to rewind the progress of Parkinson's disease

The idea of a cell therapy for Parkinson’s disease starts out simple: By replacing lost neurons with new dopamine producers, researchers hope to renew the brain’s connection to the body’s muscles and improve a person’s overall motor function. But in the brain, everything becomes more complicated.

Repurposing Pfizer's heart rhythm drug Tikosyn to treat PAH

Pfizer’s Tikosyn (dofetilide) has been available since 1999 to treat patients with irregular heartbeats. Now, years after the drug has gone generic, scientists at Georgetown University have found a potential new use for it—treating pulmonary arterial hypertension.

ESMO I-O: Keytruda shines among KRAS-mutated patients in Merck's latest lung cancer analysis

With all the buzz about KRAS these days, Merck’s been fielding its fair share of questions about whether lung cancer patients with KRAS mutations respond as well to Keytruda as other previously untreated patients do. So the New Jersey drugmaker set out to answer them.

Resources

[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.

[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] 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] 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.

[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