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22 September 2017
WEEKLY UPDATE
Digital Magazine
Latest Companies

Pharmaceutical Development Group - Pharmaceutical Regulatory Consultant and FDA Regulatory Strategist

Pharmatest Services - Research Models to Evaluate Drug Candidate Efficacy

Successful Strategies International - Customized Project Management and Leadership Development Courses

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

Biovian - Contract Manufacturing Of Biopharmaceuticals

Press Releases

Electronic Submission for Changes to OTC Monographs?
The US Food and Drug Administration (FDA) would like to accelerate the over-the-counter (OTC) review process and finalise pending monographs as quickly as possible. To that end, they are seeking passage by Congress of The OTC Monograph User Fee Programme (OMUFA).

Upcoming Events Malvern
Malvern will be hosting a wide range of webinars throughout September and October

PDG to Showcase Products at AAPS
Pharmaceutical Development Group has announced it will be attending this year's AAPS Annual Meeting and Exposition in San Diego.

Gamlen Appoints ABL&E as Distributor
Gamlen Instruments has appointed ABL&E as the exclusive distributor for Gamlen Instruments in Eastern Europe.

Powerful Benchtop Spectrometer for Small Spot Analysis
Supplier of analytical X-ray instrumentation and software PANalytical has announced the introduction of a new Epsilon 1 X-ray fluorescence (XRF) spectrometer.

White Papers

Reasons to Replace Your Viscometer with a Rheometer
It may be time to assess what a modern rheometer can do, especially in comparison to a...

Application: Operating Reactor Systems for Process Research and Development
In this case study, three reactor systems (FlexyCUBE 70ml, FlexyPAT 2l, and ChemTeacktor 25l) are operated on the same PC using application software...

Characterisation Information of Critical Excipients for Sourcing Critical Raw Materials
The increasing complexity of large molecule and cell-based therapeutics calls for an evolution in our understanding of the impurity and functional contributions of each formulation...

Orthotopic and metastasis models for preclinical efficacy testing of novel cancer drugs
Lack of efficacy is one of the major causes of attrition in the clinical development of new compounds to treat cancer....

Processability Assessment of Crystal Habit-Modified Active Pharmaceutical Ingredients
The efficiency of downstream processing of active pharmaceutical ingredients (API) can depend on their particulate properties, including size and shape....

Features

August’s top stories: Cancer Research UK’s new oncology trial, Novartis’ malaria drug trial
Cancer Research UK initiated a trial of LY3143921 hydrate to treat patients with advanced solid tumours, and Novartis and MMV initiated a Phase IIb trial of KAF156 to treat multidrug-resistant malaria in Africa. Drugdevelopment-technology.com wraps up the key headlines from August.

July’s top stories: NCI and COG’s paediatric precision cancer trial, AstraZeneca’s NSCLC trial results
NIH’s unit NCI and the COG initiated patient enrolment in a paediatric Phase II clinical trial to evaluate targeted cancer medicines, and AstraZeneca reported positive results from the FLAURA trial of Tagrisso to treat patients with locally advanced or metastatic NSCLC. Drugdevelopment-technology.com wraps up the key headlines from July.

June’s top stories: NIH’s Phase I/II trial for chikungunya, Boehringer & Eli Lilly’s empagliflozin trial
A new Phase I/II clinical trial of MV-CHIKV for the prevention of the chikungunya virus began enrolment, while Boehringer Ingelheim, along with Eli Lilly and Company, made plans to evaluate empagliflozin in a new clinical outcomes trial for chronic kidney disease. Drugdevelopment-technology.com wraps up the key headlines from June.

May's top stories: Funders and NGOs agreed on new standards, Actinogen's Xanamem in Phase II
Medical research funders and international NGOs agreed to implement the new WHO standards for clinical trials, and Actinogen Medical began patient enrolment and dosing in the Phase II XanADu clinical trial of Xanamem for the treatment of Alzheimer’s disease. Drugdevelopment-technology.com wraps up the key headlines from May.

April's top stories: NIAID's Phase II/IIb Zika vaccine trial, Boehringer's nintedanib in Phase III trial
The National Institutes of Health's (NIH) National Institute of Allergy and Infectious Diseases (NIAID) began the Phase II/IIb clinical trial of a Zika vaccine, and Boehringer Ingelheim began patient enrolment in the Phase III PF-ILD trial of nintedanib to treat various progressive fibrosing lung diseases. Drug development-technology.com wraps up the key headlines from April.

Projects

Aliqopa (copanlisib) for the Treatment of Relapsed Follicular Lymphoma
Aliqopa (copanlisib) is a novel intravenous phosphatidylinositol-3-kinase (PI3K) inhibitor indicated for the treatment of adult patients with relapsed follicular lymphoma (FL).

Lartruvo (olaratumab) for the Treatment of Soft Tissue Sarcoma
Developed by Eli Lilly and Company, Lartruvo (olaratumab) in combination with doxorubicin is indicated for the treatment of soft tissue sarcoma (STS) in adult patients. The drug is available as a 10mg/ml injection.

Kymriah (tisagenlecleucel) for the Treatment of Acute Lymphoblastic Leukaemia
Kymriah (tisagenlecleucel) is the first chimeric antigen receptor T cell (CAR-T) therapy approved in the US for the treatment of paediatric and young adult patients with B-cell precursor acute lymphoblastic leukaemia (ALL).

KamRAB/KedRAB (rabies immunoglobulin human) for the Treatment of Rabies
KamRAB/KedRAB™ is a human rabies immunoglobulin (HRIG) indicated for the treatment of passive, transient post-exposure prophylaxis (PEP) of rabies infection. The drug was jointly developed by Kamada and Kedrion Biopharma.

Duzallo (allopurinol and lesinurad) for the Treatment of Hyperuricemia Associated with Gout
Duzallo (allopurinol and lesinurad) is indicated for the treatment of hyperuricemia associated with uncontrolled gout. It contains urate transporter-1 (URAT-1) inhibitor blended with xanthine oxidase inhibitor (XOI).

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