News, views and contacts from the global Drugdevelopment industry
22 September 2017
Industry News

Deals this week: Nabriva Therapeutics, LifeMine Therapeutics, Aldeyra Therapeutics
Nabriva Therapeutics plans to raise $80m through an underwritten public offering of shares of its common stock.

Audentes commences dosing in Phase I/II trial for myotubular myopathy
US-based biotechnology firm Audentes Therapeutics has commenced patient dosing in the Phase I/II ASPIRO clinical trial of its product candidate AT132 to treat X-linked myotubular myopathy (XLMTM).

Shire reports positive data from Phase III trial of Intuniv for ADHD
Irish biotechnology firm Shire and its Japanese partner Shionogi have reported positive top-line results from a Phase III clinical trial of Intuniv (guanfacine hydrochloride prolonged release) in adults with attention deficit hyperactivity disorder (ADHD).

AgeneBio to study AGB101 in Phase III trial to treat MCI due to AD
US-based pharmaceutical firm AgeneBio is set to investigate its therapeutic agent AGB101 in a Phase III clinical trial (HOPE4MCI) for the treatment of mild cognitive impairment due to Alzheimer’s disease (MCI due to AD).

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...

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...

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...

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....

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....

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