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August 30, 2018

Today's Rundown

Featured Story

Pfizer drops muscle-growth antibody after it misses phase 2 endpoint in DMD

Pfizer halted two ongoing phase 2 trials of its Duchenne muscular dystrophy drug domagrozumab after the main efficacy study failed to meet its primary endpoint after one year of treatment.

Top Stories

Sutro Biopharma eyes $75M IPO to push antibody-drug conjugates

On the heels of an $85 million private round, Sutro Biopharma has filed to raise up to $75 million in its IPO. The funding will support the clinical development of two antibody-drug conjugates being developed for blood cancers and solid tumors.

Sophiris eyes phase 3 after clearing patient death from its lead study

Sophiris Bio has completed its investigation into the death of a patient that halted additional dosing in a trial of its lead candidate topsalysin two months ago, finding its procedure for localized prostate cancer was unlikely to be the cause.

FDA starts pilot to help sponsors use novel trial designs

The FDA has initiated a pilot program to help drug developers use complex innovative trial designs. Sponsors accepted into the four-year pilot will meet twice with the FDA to discuss regulatory approaches to CID. 

Vertex taps Genomics for target discovery help, makes investment

Vertex has joined with Genomics to use genetics and machine learning to improve target discovery. The partnership will leverage a platform that collates and analyzes genotype-phenotype studies to uncover insights into the underpinnings of disease.

RegenXBio adds another CNS program to gene therapy plans

Fresh from its latest $175 million fundraising, gene therapy specialist RegenXBio has added another program to its pipeline, its third in neurodegenerative diseases.

Sequoia leads $7M seed round for T-cell player RootPath

RootPath has raised $7 million in seed funding to develop a T-cell therapy platform for cancer treatment that addresses the shortcomings of current technology.

Resources

[Webinar] Enabling precision medicine with Tableau and AWS

Inova is using the capabilities of Tableau on AWS to identify biomarkers for personalized treatment intended to improve health outcomes for children.

[Webinar] Build a holistic data management strategy for Life Sciences

Reltio and IQVIA provide holistic data management solutions for traditional pharma, emerging biotech, and consumer health companies, on AWS.

[Webinar] Safeguard your Life Sciences data with Druva and AWS

Life Sciences organizations are embracing cloud-based Master Data Management (MDM) to modernize the organization of critical data.

[Whitepaper] Evolving Approaches to Drug Value Assessment in Global Markets

The window of market exclusivity continues to narrow dramatically in the global marketplace. Given this demanding environment, your global market access team faces increasing urgency to get the value proposition right at the time of launch.

[Whitepaper] Getting to First-in-Human Clinical Trials: A Make-or-Break Milestone for Small Biopharmas

“Faster and better” has become the mantra for biopharmaceutical companies as they face intense pressure to get therapies to market faster. Quickly proving efficacy in first-in-human (FIH) trials is a make-or-break milestone for these cash-strapped companies whose hopes hinge upon one or two molecules. Read how CDMOs are responding to this pressure.

[Whitepaper] HOW TO POSITION YOUR PATIENT SUPPORT PROGRAM FOR SUCCESS

When was the last time your patient support program perfectly aligned with the patient journey, solving all the critical gaps in positioning your brand for success? Follow the 3-D approach to your solution design, and you will achieve a better outcome for your patients.

[Whitepaper] Avoid Enrollment Pitfalls: Find Your Best-fit Clinical Trial Sites

Selecting the right sites is the most crucial decision you’ll make in your next clinical trial, and the single most important factor to consider in selecting a site is whether or not it can meet its enrollment goals.

[Survey] Industry Report: Findings from the 2018 Unified Clinical Operations Survey

Industry Research: See new results from one of the industry's largest, global clinical operations surveys.

[Whitepaper] Building the Business Case for RIM Transformation

Ready to modernize your RIM environment? Secure buy-in with these tips.

[eLearning] BIOAVAILABILITY 101

Develop a basic understanding of principles and concepts of bioavailability of oral drugs.

Events

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