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October 22, 2019___

Today's Rundown

Featured Story

Biogen resurrects aducanumab, arguing expanded data set supports FDA filing in Alzheimer's 

Biogen is planning to file for FDA approval of its failed Alzheimer’s disease drug aducanumab. The drug flunked a futility analysis in March, but Biogen resurrected it after factoring in data generated after the cutoff for the interim assessment.

Top Stories

Novartis' asthma drug fails in phase 3, raising doubts about Gossamer's prospects

Novartis’ asthma prospect fevipiprant has failed to improve lung function in two phase 3 trials. The negative top-line data deal a big blow to the prospects of a drug analysts tipped to achieve blockbuster sales if it cleared phase 3.

Bayer backs off running Casebia JV as CRISPR Tx takes over management

Three years after Bayer and gene-editing biotech CRISPR Therapeutics joined forces to launch and run Casebia Therapeutics, the German Pharma is now handing over the full reins of running the biotech to CRISPR.

[Sponsored] Advancing Site-Sponsor Relationships

Clinical trials involve massive complexity and, often, systems that lack consistency and discipline. With a new perspective to an old problem, WCG coordinates the execution of six proven strategies to dramatically and consistently bring clinical studies to launch faster and at a lower cost.

Takeda picks up Cour's celiac treatment, promising $420M in biobucks

Cour Pharma unveiled data from a phase 2a study showing that its treatment cut levels of inflammation-promoting cytokines and protected the gut against damage in patients with celiac disease. Based on the results, Takeda pulled the trigger on a global license for the program.

Intrepida Bio uncloaks with $9.5M and anti-BAG3 cancer programs from Italy

Intrepida Bio launched with $9.5 million from Sofinnova and Canaan Partners to develop anti-BAG3 programs for the treatment of cancer. The funding will support IND-enabling studies for antibodies that target a pathway that is hijacked by tumors to create an environment that promotes their growth and thwarts attacks from the immune system.

Vertex lands blockbuster triple combo nod for CF drug Trikafta—5 months early

The triple combo era in cystic fibrosis (CF) is here thanks to Vertex Pharmceuticals' new OK. Five months ahead of schedule, the FDA green-lighted Trikafta for the treatment of CF patients over the age of 12 with either one or two copies of the delF508 CFTR gene mutation.

Resources

[Article] 8 Compelling Reasons Why Businesses Need To Be In The Cloud Now!

Companies that don’t have a cloud strategy are at a competitive disadvantage. Why? The cloud has a measurable impact on business.

[Whitepaper] The Next Generation of Trial Master File Systems

Simplified filing, improved oversight, audit readiness: is your eTMF system delivering best-in-class benefits?

[Whitepaper] Implementing On-Dose Authentication Technologies for Solid Dose Drug Products

Learn about how you better manage product authentication and battle drug counterfeiting with innovative solutions.

[Whitepaper] Cortellis Q2 2019 M&A report

Download this report for full details of Life sciences M&As in the second quarter of 2019 with notes and trends.

[Whitepaper] SOAR™ Model Manages Data From Source to Submission

Find out how it leverages real-world data and novel IntElligo Research Stack™ technology to help researchers battle rising costs, cumbersome processes, and stagnant participation — bridging the gap between research and care.

[Whitepaper] Successful Clinical Trials in the Era of Genetics-based Medicine

Download this complimentary guide paper that explores key strategies for a successful genetics-informed clinical trial.

[Whitepaper] Best Practices for Incorporating Real World Imaging Data into RWE Programs

The time has finally come when medical imaging can be effectively utilized into the RWE process. Read the whitepaper on the best practices for incorporating Real World Imaging.™

[Whitepaper] Synthesizing Success: Six Principles for Getting Pharmaceutical Development Right from the Start

Is your API development on track?

[Whitepaper] Webinar Benchmarks Report for Life Sciences 2019

Compare digital program performance and audience engagement among your life sciences peers.

[Webinar] Clinically Integrated Networks: A Growing Disruptor in American Healthcare

Clinically Integrated Networks are vehicles for powerful IDNs to extend their influence into the physician sector and play a key role for IDNs trying to pave a path to becoming a self-contained healthcare ecosystem.

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

A global landscape study of funding trends and innovations.

[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