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April 09, 2019

Today's Rundown

Featured Story

Bayer cuts with one hand, adds cancer R&D jobs in Kendall Square with the other

German pharma Bayer is looking to boost its research presence in the life science hub Kendall Square amid a 12,000 global job cull.

Top Stories

Zogenix data blunder trips up its FDA filing for epilepsy drug Fintepla

Last July, Zogenix was riding high on positive phase 3 data for Fintepla, its treatment for Dravet syndrome, a rare form of childhood epilepsy. Not so Monday, when the FDA turned back its new drug application because it included the wrong data.

Roivant-backed Merck Serono spinout hits phase 3 diabetes goal; NDA on the horizon

Poxel, a biotech spun out of Germany’s Merck and based in France, and Japanese partner Sumitomo Dainippon Pharma have announced positive data from their late-stage diabetes study in Japan. The pair has been studying imeglimin, a new type of drug which the partners say is the first clinical candidate in a new chemical class of oral agents called Glimins, which targets mitochondrial bioenergetics.

[Sponsored] The Power to Pivot: Using Dedicated Onsite Resources to Adapt Recruitment Practices in a Shifting Landscape

Increasingly complex trials place a burden on study sites, exacerbating already-troubling recruitment and enrollment issues. Strategically placed Enrollment Assistants can ease that burden, making sites more agile and offering patients personalized attention that leads to conversion and retention.

Synlogic finds a new CSO in ex-Janssen gastroenterology chief

Synlogic has recruited a new chief scientific officer: Scott Plevy, M.D., who headed up gastroenterology and interleukin-23 research at Janssen.

Frequency shows early positive results for small-molecule hearing loss therapy

Concert goers, rejoice: An early safety study of Frequency Therapeutics’ hearing loss drug treatment has cleared its first hurdles while showing some signs of hearing improvement in certain patients.

Resources

[Whitepaper] Redefining Your Value to Win Empowered Patients: Six Steps to Success

Every life sciences firm talks about patient-centricity, but are you doing what it takes to deliver?

[Webinar] Doing Trials in Russia? Disrupt the market barriers through eClinical

How to cut a study budget by 4 times? How to process CRFs 3 times faster? What made a CRO switch from a US vendor to Data MATRIX? In 45 minutes, we will dissolve myths about entering the market.

[Whitepaper] Key Life Sciences Trends, 2019 and Beyond

The year’s biggest compliance and technology trends in life sciences. Learn about the latest trends impacting the biotech, medical device and pharmaceutical industries.

[Whitepaper] The New World of Allosteric Modulation: Another Shot on Goal

Learn how to utilize allosteric modulation to maximize its full potential in drug discovery programs. Download this white paper to learn more.

[Whitepaper] Advanced HDX-MS and Native-MS for Improved Biologic Candidate Selection and Development

Discussion of the potential for improving biologic drug development success through earlier, strategic application of advanced mass spectrometry, because currently, with most biologic drugs, including gene therapies, failures are realized in late-stage development, after substantial investment has been made in a candidate.

[Whitepaper] Workbench for Biomarker and Translational Research

Clinical trials and biomarker data from patients when unified, harmonized, and made searchable; is a rich, reliable and controlled resource for research. This paper sets out the requirements for a Translational and Biomarker Research Workbench for scientists using the experiences from use of Xbiom™ at BioPharma.

[Whitepaper] Meet Our Uncle: 12 Protein Stability Applications on One Platform

Download this whitepaper to learn more!

[Whitepaper] Flow Chemistry For Modern API Development & Manufacturing

Is Flow Chemistry right for your API Development?

[Whitepaper] Systolic Heart Failure: Real-World Study Using Electronic Health Records

Real-World case study by Veradigm suggests that new medications specifically approved for the treatment of systolic heart failure may be underutilized despite being important advances in patient care.

[Article] Are you ready for 2008 Microsoft SQL and Windows Servers end of life?

Software end of life puts you at risk for data breaches, business disruption and liability. Support for Microsoft SQL Server 2008/2008 R2 and Windows Server 2008/2008 R2 ends on July 9, 2019 and January 14, 2020, respectively. Learn how you can turn these risks into a strategic business advantage.

[Whitepaper] Better Market Intelligence With Smart Search

From new regulations to drug pricing and the latest M&A deals, learn how AI is making it easier for competitive intelligence to uncover the insights they need to stay ahead of the curve.

[Case Study] TriCore Reference Laboratories Transforms to Clinical Lab 2.0 Model

Analytics using patients’ real-time longitudinal laboratory results, and claims data, yielded higher value information and new revenue streams for TriCore reference laboratories.

[Whitepaper] Accelerating Clinical Trials through Access to Real-World Patient Data

Whitepaper on leveraging normalized real-world patient data to streamline clinical trials, reduce delays and lower costs.

[eBook] 2018 Weekly Compendium

The Biopharma industry is moving at lightning speed and it can be a challenge to keep pace. Here at Biotech Primer we spend hours each week researching, writing, and editing original content for the Biotech Primer WEEKLY with one goal in mind: to help everyone better understand the latest science and technology driving today’s healthcare industry.

Events