Today's Rundown Bayer cuts with one hand, adds cancer R&D jobs in Kendall Square with the other Zogenix data blunder trips up its FDA filing for epilepsy drug Fintepla Roivant-backed Merck Serono spinout hits phase 3 diabetes goal; NDA on the horizon [Sponsored] The Power to Pivot: Using Dedicated Onsite Resources to Adapt Recruitment Practices in a Shifting Landscape Synlogic finds a new CSO in ex-Janssen gastroenterology chief Frequency shows early positive results for small-molecule hearing loss therapy Featured Story | | | Tuesday, April 9, 2019 German pharma Bayer is looking to boost its research presence in the life science hub Kendall Square amid a 12,000 global job cull. |
|
|
| This week's sponsor is Deloitte. | | | Deloitte's 2019 Life Sciences accounting and financial reporting update
Insights on new accounting standards and more
A year of major change for life sciences companies is underway. Deloitte's latest update on life sciences financial reporting explains what accounting departments need to know to keep up in a rapidly evolving environment. Download the full report here. |
Top Stories Tuesday, April 9, 2019 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. Tuesday, April 9, 2019 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. Monday, April 8, 2019 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. Tuesday, April 9, 2019 Synlogic has recruited a new chief scientific officer: Scott Plevy, M.D., who headed up gastroenterology and interleukin-23 research at Janssen. Tuesday, April 9, 2019 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. | This week's sponsor is ExL Events. | | | |
Resources Sponsored by: Strativity Every life sciences firm talks about patient-centricity, but are you doing what it takes to deliver? Sponsored by: Data MATRIX | 3:00 AM EDT / 9:00 AM EDT / 2:00 PM EDT 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. Sponsored by: USDM Life Sciences The year’s biggest compliance and technology trends in life sciences. Learn about the latest trends impacting the biotech, medical device and pharmaceutical industries. Sponsored by: Eurofins Discovery Learn how to utilize allosteric modulation to maximize its full potential in drug discovery programs. Download this white paper to learn more. Sponsored by: BioAnalytix, Inc. 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. Sponsored by: PointCross Life Sciences 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. Sponsored by: Unchained Labs Download this whitepaper to learn more! Sponsored by: Patheon, part of Thermo Fisher Scientific Is Flow Chemistry right for your API Development? Sponsored by: Veradigm 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. Sponsored by: Outer Edge Technology 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. Sponsored by: AlphaSense 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. Sponsored by: InterSystems Analytics using patients’ real-time longitudinal laboratory results, and claims data, yielded higher value information and new revenue streams for TriCore reference laboratories. Sponsored by: InterSystems Whitepaper on leveraging normalized real-world patient data to streamline clinical trials, reduce delays and lower costs. Sponsored by: Biotech Primer 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. BioBasics: Biotech For The Non-Scientist May 8-9, 2019 | New York, NY Drug Development Immersion May 16-17, 2019 | Boston, MA 2019 BIO International Convention June 3-6, 2019 | Philadelphia, PA FierceBiotech Executive Breakfast at BIO 2019 – Getting Real: The Changing Tide on Real-World Evidence in Drug Development June 5, 2019 | Philadelphia, PA Drug Development Boot Camp® 2019 November 20-21, 2019 | Boston, MA | Register and start preparing Today! | 