To view this email as a web page, click here

   Home

Subscribe

Advertise

 

 

 

 

October 08, 2019___

Today's Rundown

Featured Story

Chasing AbbVie, Gilead files for approval of filgotinib in Japan

Gilead Sciences has filed for approval of JAK1 inhibitor filgotinib in Japan. The submission moves Gilead a step closer to selling the Galapagos-partnered drug to rheumatoid arthritis patients in the country. 

Top Stories

Chinese infectious disease biotech Ascletis nabs Novartis exec as CSO

After poaching an ex-Merck exec to run its R&D, Chinese biotech Ascletis has raided another U.S. Big Pharma for its new chief scientific officer.

Cygnal officially uncloaks with $65M and exoneural approach to cancer

When Roche veteran Pearl Huang landed at Cygnal Therapeutics in January, the company painted a broad picture of its exoneural approach to treating cancer. Now, as Flagship Pioneering officially launches Cygnal, the startup is filling in some details.

[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.

Novartis' Xolair follow-up banishes hives in 42% of patients with chronic hives

Two doses of Novartis’ new treatment for chronic hives cleared the skin of more patients than Xolair, its Roche-partnered asthma drug. The highest dose of the drug banished hives in 51% of patients, compared to 26% of patients taking Xolair.

Merck taps 4D pharma for bacterial vaccine R&D project

Merck has teamed up with 4D pharma to develop bacterial strains as vaccines. The deal gives Merck the chance to pick up three candidates against undisclosed indications for an upfront fee and up to $347.5 million (€316.2 million) in milestones.

Novartis takes on Regeneron, Roche blockbusters with Beovu approval

Novartis has its next big drug approval. The FDA on Tuesday approved wet AMD drug Beovu, which will go up against entrenched blockbusters Eylea from Regeneron and Lucentis from Roche. The drug has shown it can match up against Eylea's efficacy and bested the Regeneron drug on other measures.

Resources

[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] Advanced Analytical Approaches for Accelerated Development of Gene Therapy Products

Download the White Paper and learn how detailed characterization can guide successful development of gene therapy products.

[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] Fail Fast. Succeed Faster.

Slashing your R&D costs is easier than you think.

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

A global landscape study of funding trends and innovations.

[Whitepaper] Understanding Precision Medicine in Oncology

White paper providing an overview of precision medicine in oncology, as well as a look ahead at future developments and keys to success for pharmaceutical and diagnostics companies.

[Article] Why Market Leaders Outsource IT Requirements For A Competitive Edge

Find out how outsourcing your IT requirements enhances the bottom line while creating strategic advantage.

[Whitepaper] From Complex to Controlled: Advanced Data Management Strategies for Advanced Therapies

Developing a cell therapy, gene therapy, or personalized cancer vaccine? Modern data management makes a critical difference in operational and regulatory outcomes. This whitepaper will help your team leverage the latest data strategies for success.

[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