Biosimilars legislation approved in New Jersey

Wednesday, November 11, 2015

Legislation sponsored by Assembly Democrats of the New Jersey General Assembly (Pamela Lampitt, Daniel Benson, Shavonda Sumter, Nancy Pinkin, and Herb Conaway Jr., M.D.) to make it easier for consumers to obtain more cost-effective, “generic” versions of biological medicines used to treat conditions such as rheumatoid arthritis, anemia, psoriasis and various forms of cancer has been signed into law.

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Veeva launches RIM Solution for regulatory documents

Wednesday, November 4, 2015

Veeva Systems, a cloud-based software provider for the global life sciences industry, has launched Veeva Vault RIM, a next-generation regulatory information management (RIM) suite. Vault RIM unites submission documents, published dossiers, product registrations and health authority interactions into a single authoritative source for all regulatory information. The convergence of RIM capabilities in Veeva Vault’s regulatory product suite will align disconnected regulatory processes worldwide, dramatically improving life sciences companies’ speed, agility and compliance.

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E.U.’s Safe Harbor ruling hits global trials

Monday, October 26, 2015

Europe’s highest court has struck down an international agreement allowing companies to move digital information such as people’s Web search histories and social media updates between the E.U. and the U.S.
The decision could have an impact on global clinical trials and on U.S. pharmaceutical companies that are expanding to use international sites for that patient population.

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goBalto complies with European trial regulations

Wednesday, October 21, 2015

San Francisco-based goBalto, a provider of cloud-based clinical study startup solutions, has announced compliance with new European regulatory directives aimed at creating an environment that is favorable for conducting clinical trials across the European Union.

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Obama signs improved compensation bill for rare-disease clinical trial participants

Monday, October 19, 2015

Two hurdles were cleared for a relatively small number of clinical trial participants when President Barack Obama signed the Ensuring Access to Clinical Trials Act of 2015. The legislation enables individuals with rare diseases to receive up to $2,000 for participating in clinical trials without having that compensation counted as income when calculating eligibility.

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