The USFDA has approved Navidea Biopharmaceuticals’ Supplemental New Drug Application (sNDA) for the expanded use of Lymphoseek (technetium Tc 99m tilmanocept) Injection « New Drug Approvals

The USFDA has approved Navidea Biopharmaceuticals’ Supplemental New Drug Application (sNDA) for the expanded use of Lymphoseek (technetium Tc 99m tilmanocept) Injection « New Drug Approvals:



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The USFDA has approved Navidea Biopharmaceuticals’ Supplemental New Drug Application (sNDA) for the expanded use of Lymphoseek (technetium Tc 99m tilmanocept) Injection « New Drug Approvals

The USFDA has approved Navidea Biopharmaceuticals’ Supplemental New Drug Application (sNDA) for the expanded use of Lymphoseek (technetium Tc 99m tilmanocept) Injection « New Drug Approvals:



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Pharmaceutical co-crystals – are we there yet?

 

In the pharmaceutical arena it is agreed that co-crystals form a vital part of the solid-state toolbox, allowing the progression of novel compounds through the development pathway to patients and improving properties in older medicines. Sadly though, few co-crystals have made it to the market in the form of a new licensed product. This displays a disconnect between research effort and end product. For some time now it has been possible to determine the formation of co-crystals, by a variety of screening and analytical means; although it is recognised that there will always be phases that sit in the ‘greyer’ area of the salt-co-crystal continuum. It is also possible, with limitations, to predict the formation of co-crystals in silico via energetic and structural considerations. So what are the major hurdles and missing links, and what are the key structural properties we need to study to improve the success rate? This highlight hopes to address these.

http://pubs.rsc.org/en/Content/ArticleLanding/2014/CE/C4CE00127C?utm_medium=email&utm_campaign=pub-CE-vol-16-issue-26&utm_source=toc-alert#!divAbstract

Pharmaceutical co-crystals – are we there yet?

N. Blagden,^a   S. J. Coles^b and   D. J. Berry*^c  

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H

*Corresponding authors

^a School of Pharmacy, University of Lincoln, Brayford Pool, Lincolnshire, Lincoln, UK

^bChemistry, University of Southampton, Highfield, Southampton, UK

^cSchool of Medicine, Pharmacy and Health (Pharmacy), Durham University, Wolfson Building, F111, Queen's Campus, Stockton on Tees, UK
E-mail: d.J.berry@durham.ac.uk

CrystEngComm, 2014,16, 5753-5761

DOI: 10.1039/C4CE00127C

MS Drug RPC1063 Discovered at TSRI Is Safe and Effective in Phase II Study « New Drug Approvals

MS Drug RPC1063 Discovered at TSRI Is Safe and Effective in Phase II Study « New Drug Approvals:



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MS Drug RPC1063 Discovered at TSRI Is Safe and Effective in Phase II Study « New Drug Approvals

MS Drug RPC1063 Discovered at TSRI Is Safe and Effective in Phase II Study « New Drug Approvals:



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R&D productivity: Drug approvals don’t tell the whole story

R&D productivity: Drug approvals don’t tell the whole story

By Zachary Brennan, 28-May-2014

As the number of drug approvals declined between 2012 and 2013 by more than 30%, the value of new therapeutic agent approvals seems to indicate a stronger year than initially thought.

http://www.in-pharmatechnologist.com/Processing/R-D-productivity-Drug-approvals-don-t-tell-the-whole-story

New method for uncovering side effects before a drug hits the market

 

New method for uncovering side effects before a drug hits the market

 http://www.sciencedaily.com/releases/2013/01/130102140516.htm

Side effects are a major reason that drugs are taken off the market and a major reason why patients stop taking their medications, but scientists are now reporting the development of a new way to predict those adverse reactions ahead of time. The report on the method, which could save patients from severe side effects and save drug companies time and money, appears in ACS' Journal of Chemical Information and Modeling.

Yoshihiro Yamanishi and colleagues explain that drug side effects are a major health problem -- the fourth-leading cause of death in the U.S. -- which by some estimates claim 100,000 lives every year. Serious side effects are the main reason why existing drugs must be removed from the market and why pharmaceutical companies halt development of new drugs after investing millions of dollars. Current methods of testing for side effects are costly and inaccurate. That's why the scientists sought to develop a new computer-based approach to predicting possible side effects.