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Weekly Round Up
25 September 2016
Latest Companies

Pharmaceutical Development Group - Pharmaceutical Consultant and FDA Regulatory Strategist

SYSTAG Systems Technik - Automation Systems for Small-Molecule Drug and API Development

Pfanstiehl - Injectable and HPLE Carbohydrates for Protein Stabilisation and Optimisation

Softigel - Contract Development Services and Drug Delivery Systems

Kemwell - Pharmaceutical Contract Development, Manufacturing, Packaging and Distribution

Press Releases

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.

BioOutsource's new Website is Live Featuring Cellca's Cell Line and Upstream Process Development Services
International supplier for the biopharmaceutical industry Sartorius Stedim Biotech (SSB) has announced that its subsidiary BioOutsource has launched an updated website to showcase Sartorius Stedim Cellca's cell line and upstream process development services for the biopharmaceutical industry.

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...

Features

August's top stories: Gradalis' Phase I breast cancer trial, Biothera and Merck conducted combination cancer immunotherapy trials
Gradalis dosed the first patient in its pilot Phase I trial of a combination of Vigil Engineered Autologous Tumour Cells (EATCs) and durvalumab to treat advanced breast cancer, and Biothera collaborated with Merck to expand the ongoing clinical programme of Merck’s KEYTRUDA and Biothera’s Imprime PGG. Drugdevelopment-technology.com wraps up the key headlines from August 2016.

Pharma Technology Focus – Issue 50
In this issue: Maximising investment by cancer megafunds, positive clinical trials for an antibody to treat lupus, how copper can be used to tackle obesity, whether day and night should influence our drug regimes, a device to soak up excess drugs and more.

July's top stories: GBT's Phase II1 trial GBT440, Merck's Phase III trial ONCEMRK of Isentress
Global Blood Therapeutics (GBT) began the Phase IIa trial (GBT440-007) of GBT440 in adolescents with sickle cell disease (SCD), and Merck reported positive results from its ongoing Phase III pivotal trial ONCEMRK of Isentress (raltegravir) to treat adults with HIV-1 infection. Drugdevelopment-technology.com wraps up the key headlines from July 2016.

June's top stories: Bayer reported positive results of RESORCE trial, TapImmune initiated Phase II trial of TPIV 200
Bayer reported positive results from the Phase III RESORCE trial of Stivarga (regorafenib) tablets to treat unresectable hepatocellular carcinoma, and TapImmune initiated its Phase II trial of cancer vaccine TPIV 200. Drugdevelopment-technology.com wraps up the key headlines from June 2016.

May's top stories: ProMedica began human stem cell trial, Cerulean dosed in Phase l/ll combination trial
ProMedica and Stemedica planned to begin a human stem cell trial for traumatic brain injury and Cerulean dosed its first patient in a Phase l/ll combination trial of CRLX101 and lynparza. Drugdevelopment-technology.com wraps up the key headlines from May 2016.

Projects

Afluria Quadrivalent for Prevention of Infection from Influenza Virus
Afluria Quadrivalent is an inactivated influenza vaccine developed by Seqirus, which is developed to provide active immunisation against the disease.

GLS-5700 DNA Vaccine for Prevention of Infection from Zika Virus
GLS-5700 is a synthetic vaccine being developed by Inovio Pharmaceuticals and GeneOne Life Sciences to prevent and treat infections caused by the Zika virus.

Adlyxin (lixisenatide) for the Treatment of Type 2 Diabetes
Adlyxin (lixisenatide) is an injectable solution developed by Sanofi for the treatment of type 2 diabetes in adults.

Spritam (levetiracetam) for the Treatment of Epilepsy
Spritam (levetiracetam) is an adjunctive therapy indicated for the treatment of seizures in patients with epilepsy, the fourth most common neurological disorder affecting people of all age groups.

Sivextro for Treatment of Acute Bacterial Skin and Skin Structure Infections
Sivextro (tedizolid phosphate) is an oxazolidinone class antibacterial drug indicated for treatment of adult patients infected with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible gram-positive bacteria.


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