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FDA accepts for priority review Bristol-Myers’ sBLA for Opdivo for urothelial carcinoma use

Oct 24, 2016
The US Food and Drug Administration (FDA) has accepted for priority review Bristol-Myers Squibb's supplemental biologics license application (sBLA) for Opdivo (nivolumab) in previously…
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Virtus sues FDA for clearing potassium chloride market of competition

Oct 17, 2016
Virtus Pharmaceuticals has filed a lawsuit against the US Food and Drug Administration (FDA) and Department of Health and Human Services (HHS), seeking to prevent a monopoly, and…
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VBL Therapeutics unveils plans to build new manufacturing facility in Israel

Oct 14, 2016
VBL Therapeutics has entered in to a long-term lease contract for a new stand-alone facility in Modiin, Israel. The site will house VBL's local biological drugs manufacturing facility,…
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IBM’s Watson Helps Employees Tackle Cancer

Oct 12, 2016
IBM announced that many IBM U.S. employees fighting cancer will be able to tap into Watson for insights into their cancer treatment as well as potential clinical trial options. Through…
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Nexus BioPharma signs deal with TransChem for kinase inhibition technology

Oct 11, 2016
Nexus BioPharma has signed an agreement to license TransChem's transition state chemistry technology for kinase inhibition. Kinases are enzymes that regulate essential cellular…
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Codexis Completes Transfer of CodeEvolver Technology to Merck

Oct 6, 2016
Codexis has completed the second and final phase in the transfer of its CodeEvolver protein engineering platform technology to Merck, known as MSD outside the US and Canada, under a…
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Pilgrim Introduces OOS Management Software to Support Pharmaceutical Manufacturing

Oct 4, 2016
Pilgrim Quality Solutions announced the validated release of Smart Solve Out Of Specification Management (OOS) Management. Pilgrim’s out-of-specification software drives consistent OOS…
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Depomed gets favorable patent ruling in US for NUCYNTA ANDAs

Oct 3, 2016
Judge Claire C. Cecchi of the United States District Court for the District of New Jersey has ruled in favor of Depomed in the company's patent litigation against all three filers of…
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Bayer and DelSiTech Partner to Develop Innovative Drug Delivery Technology for Ophthalmology

Sep 30, 2016
Bayer and DelSiTech Ltd., a Finnish drug delivery technology and drug development company, have signed a Collaboration and Technology Licence Agreement for the worldwide application of…
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Pharmaron enters into non-binding heads of terms with MSD over Hoddesdon UK site

Sep 26, 2016
Pharmaron has entered into a non-binding Heads of Terms (HoTs) with Merck Sharp & Dohme Limited (MSD) for the sale of the Hoddesdon UK site which includes MSD’s process development…
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Industry Reports

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