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News, views and contacts from the global Drugdevelopment industry
28 September 2016
Industry News

Corvus reports positive pre-clinical and preliminary biomarker data from Phase I/Ib trial of CPI-444
US-based clinical-stage biopharmaceutical company Corvus has reported positive pre-clinical and preliminary biomarker data from its ongoing Phase I/Ib trial of CPI-444, both as a single agent and combined with Genentech’s Tecentriq (atezolizumab) to treat cancer.

Faraday begins first-in-human Phase I trial of FDY-5301 as elemental reducing agent
US-based biopharmaceutical company Faraday has initiated its first in-human Phase I clinical trial of FDY-5301 as an elemental reducing agent (ERA).

Syros begins Phase II clinical trial of SY-1425 to treat AML and MDS
US-based Syros Pharmaceuticals has initiated its Phase II clinical trial of SY-1425 by dosing the first patient suffering from relapsed or refractory acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS).

Tocagen begins enrolment in Phase Ib trial of Toca 511 and Toca FC to treat metastatic cancers
US-based clinical-stage, cancer-selective immunotherapy company Tocagen has enrolled the first patient in its Phase Ib Toca 6 study of Toca 511 (vocimagene amiretrorepvec) combined with Toca FC (extended-release 5-fluorocytosine) to treat metastatic cancers.

Press Releases

Is a Consultant Required to Review a Quality Management System (QMS) or Submit a 510(k) Application?
Is it your first time submitting a 510(k) application for a class II medical device? Are you thinking you have a Quality Management System (QMS) in place and experience with drug submissions, so this should be easy?

Biovian's CEO will be Available for Discussions at Three Events in Europe
Biovian will be present at Nordic Life Science Days, BioTalk, and Bio-Europe.

Measuring Zeta Potential for Product Stability and Performance
Cosmetics, paints, inks, paper, drug delivery, personal care, food or intra-lipid emulsions are made up of multi component chemistries. Most products go through a stage where different phases co-exist such as emulsions, suspensions or dispersions and as such require a specific amount of stability in order to meet expected performance criteria.

Six Must-Read Scenarios for FDA Consulting
FDA consulting from the perspective of a regulatory strategist: there exists a space between potential Rx-to-OTC drug candidates, medical devices and nonprescription drugs that is ripe for further drug and device development.

Morphologi G3-ID Used by FDA to Approve a New Nasal Spray
Key data for the approval of a nasal spray containing mometasone furoate has been obtained by the Food and Drug Administration (FDA) through the use of Malvern's Morphologi G3-ID system.

White Papers

Using FlexyCUBE in Risk and Quality Analysis
In the first reaction step, an acid is added with constant thermal reduction (TR) control and stirrer...

Stability Analysis of Proteins for the Biopharmaceutical Industry
The biggest class of biopharmaceuticals on the market is monoclonal antibodies (mAb) and their specific binding nature provides an opportunity to use them to modulate...

Using Differential Scanning Calorimetry in Lipid Bilayer Membranes to Characterise Thermotropic Phase Transitions
Proteins and other constituents are bound or incorporated into cell membrane surface bilayers formed by...

Validated Metal Analysis
Four commonly utilized carbohydrates for ptotein stabilization are Sucrose, Trehalose, Mannitol, and...

Benefits of Trehalose
Products such as monoclonal antibodies (mAb), fusion proteins, peptides, vaccines, antibody drug conjugulates (ADC) and stem cells benefit from the stabilising effects of...

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