News, views and contacts from the global Drugdevelopment industry
26 October 2016
Industry News

Gilead reports results from Phase 3 studies of switching to Descovy-based regimens from Truvada-based regimens
Gilead Sciences has reported 96-week data from a Phase 3 study and 48-week data from two Phase 3b studies analysing the safety and efficacy of switching virologically suppressed HIV-1 infected patients from regimens containing Truvada to regimens containing Descovy.

Faron begins enrolment for Phase III trial of Traumakine to treat respiratory disease in Japan
Faron Pharmaceuticals has reported that its Japanese licensing partner Maruishi Pharmaceutical has recruited the first patient in the Phase III pivotal clinical trial for the treatment of acute respiratory distress syndrome (ARDS) with FP-1201-lyo (also known as Traumakine) within the country.

Two studies confirm positive benefit-risk profile of XARELTO in treating VTE
Janssen Pharmaceuticals and its development partner Bayer announced results of two new real-world studies, which confirmed the positive benefit-risk profile of XARELTO (rivaroxaban) in treating venous thromboembolism (VTE), or blood clots, and minimising the risk of recurrence.

Boston Biomedical begins Phase III CanStem303C study of napabucasin to treat colorectal cancer
Boston Biomedical has dosed the first patient in CanStem303C, a new global Phase III study investigating napabucasin in combination with standard of care (FOLFIRI) in patients with previously treated metastatic colorectal carcinoma (mCRC).

Press Releases

Biovian to Present at Bio-Europe in Germany
Biovian has announced it will be present at the biotechnology partnering Conference Bio-Europe in Cologne, Germany.

Malvern to Demonstrate New Nanoparticle-Size and Concentration Measurer in Webinar
Malvern has announced it will be demonstrating the NanoSight NS3000, which uses Nanoparticle Tracking Analysis (NTA) to measure nanoparticles and concentrates.

Drug Labeling Types
Understanding the various types of drug product labeling is an essential component of maintaining labeling compliance. Our most recent paper describes the different types of Drug Labeling and includes reference to the regulatory basis for each.

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.

White Papers

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

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

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...

From Gene to Finished Vial
Biovian is a one-stop-shop in GMP contract manufacturing of biopharmaceuticals, covering services from early development to finished...

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...

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