Pharma R&D Today

Growth, recognition, results—and an important partnership

Posted on January 17th, 2019 by admin

Here at Sigilon Therapeutics, we have had a very exciting period of growth recently, including receiving an Advanced Therapy Medicinal Product (ATMP) designation from the European Medicines Agency, adding two new members to our leadership team and initiating a collaboration with Eli Lilly in type 1 diabetes. Continue reading “Growth, recognition, results—and an important partnership” »

Government Shutdown Means New Drugs May Have to Wait – But Safety Monitoring Will Continue

Posted on January 17th, 2019 by Xuanyan Xu

The partial shutdown of the U.S. government, which began just before the Christmas holiday, has been especially terrible for hundreds of thousands of federal employees who are either furloughed or working without pay. Continue reading “Government Shutdown Means New Drugs May Have to Wait – But Safety Monitoring Will Continue” »

Avoiding Pitfalls and Costly Mistakes in Early Stage R&D

Posted on January 17th, 2019 by admin

Pharma R&D costs continue to rise rapidly. A well-known Tufts study estimated the average pre-tax cost per new approved prescription drug (including failures and capital costs) was nearly $2.6 billion in 2013. However, the creation of novel approved drugs has not kept up with investment over the past two decades. Continue reading “Avoiding Pitfalls and Costly Mistakes in Early Stage R&D” »

FDA Announces Plans to Improve Approvals Process for Medical Devices

Posted on January 15th, 2019 by Xuanyan Xu

In the pharmaceutical industry, safety protocols are rigorous. Clinical trials, a lengthy and intense part of the drug development process, are deemed absolutely crucial to ensuring the safety and efficacy of new drugs and therapies. There are also many regulations designed to make certain that high standards are maintained during the various trial phases.

Continue reading “FDA Announces Plans to Improve Approvals Process for Medical Devices” »

Pharma and Biotech Firms Gather at the 37th Annual J.P. Morgan Healthcare Conference

Posted on January 15th, 2019 by admin

2019 marks the 37^th year of the J.P. Morgan Healthcare Conference, which has come to be one of the premiere annual events for companies involved in all aspects of the industry, from biotech start-ups to large healthcare service providers. Continue reading “Pharma and Biotech Firms Gather at the 37th Annual J.P. Morgan Healthcare Conference” »

Emulating start-up success with purpose-built data tools

Posted on December 12th, 2018 by admin

Innovation used to be almost solely accredited to Big Pharma, but many of the more established businesses in the industry are finding that their rate of discovery is slowing as they try to find answers to some the industry’s biggest problems, such as antibiotic resistance. Continue reading “Emulating start-up success with purpose-built data tools” »

About this Blog

The Elsevier Pharma R&D blog provides insight and opinion on topics related to pharmaceutical research and development, namely: big data, target identification, new drug discovery, drug safety monitoring, risk mitigation and regulatory compliance. We serve the community of chemists, scientists, drug safety specialists, educators and students interested in pharmaceutical R&D.

Editor’s note: The views and opinions expressed are those of the author and do not necessarily reflect the views of Elsevier,  its affiliates and sponsors or its parent company, Reed Elsevier.